Cortexin

Official label

rlsnet.ru drug encyclopedia. Kortexin (Cortexin) lyophilisate for intramuscular solution, Russian prescribing information, manufacturer-approved version dated 10 February 2022; the site's own page-update date reads 21 September 2026.

The label lists the active substance as polypeptides of the cerebral cortex of cattle, ATC code N06BX, as a lyophilisate for intramuscular solution with glycine as stabilizer. It describes Cortexin as a complex of water-soluble polypeptide fractions with molecular weight not more than 10,000 Da. All indications are given in complex therapy: cerebrovascular disorders, traumatic brain injury and its consequences, encephalopathies of various origin, cognitive impairment (memory and thinking disorders), acute and chronic encephalitis and encephalomyelitis, epilepsy, asthenic states, reduced learning ability, delayed psychomotor and speech development in children, and various forms of infantile cerebral palsy. It is contraindicated in individual intolerance, pregnancy (the label cites lack of clinical trial data) and lactation. The label says the composition does not allow conventional pharmacokinetic analysis of individual components. Every listed adverse reaction is very rare (under 1 in 10,000): anaphylactic shock and hypersensitivity; angioedema, erythema, urticaria, rash, itching, allergic dermatitis; psychomotor agitation, impaired coordination, headache, dizziness, somnolence, hypoesthesia; tachycardia and arrhythmia; anxiety and insomnia; injection-site redness, fever, asthenia, chills; raised blood pressure. Lidocaine as the injection solvent is not recommended in children because it is linked to more severe adverse reactions.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate for intramuscular injection

Follow-up

Label version dated 10 February 2022

Study design

Russian-language prescribing information reproduced on a drug-information site; a regional label, not an FDA or EMA review

Funding

not stated in the source

The label's pharmacology statements (nootropic, neuroprotective and antioxidant effects, passage through the blood-brain barrier) are manufacturer text, not trial results. The Russian text was translated for this page. The label version read is dated 10 February 2022, and a later version may differ.

Official label

medi.ru drug-information site. Kortexin leaflet copies for the 10 mg product (copy dated 8 February 2019) and the 5 mg product (copy dated 4 February 2019).

Two Russian leaflet copies on medi.ru give registration numbers and manufacturers. The 10 mg leaflet (copy dated 8 February 2019) prints registration number R N003862/02, the R in Cyrillic letters, with the grouping name polypeptides of the cerebral cortex of cattle, glycine in each vial, prescription-only dispensing, a 3-year shelf life, and two manufacturers: Geropharm LLC and Firma Ferment LLC, both in Russia. The 5 mg leaflet (copy dated 4 February 2019) prints registration number LSR-003190/09 and Geropharm LLC as manufacturer.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate, intramuscular

Follow-up

Leaflet copies dated February 2019

Study design

Russian-language leaflet copies hosted on a commercial drug-information site

Funding

not stated in the source

The copies are on a commercial site, not the Russian state register, so current registration status and label version are not confirmed here.

Chemical identity record

National Library of Medicine. PubChem substance records SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox), registry number 83270-84-2; PubChem name query for cortexin run on 10 October 2026.

A PubChem name query for cortexin returned no compound (No CID found). Three substance records carry the name and the same registry number, 83270-84-2: SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox). None has a linked compound, so there is no formula, molecular weight or structure. The word also names unrelated things in PubMed: an 82-residue neuron-specific membrane protein called cortexin (PMID 8336151), a cortexin 3 gene paper (PMID 17786280) and renal cortexin blood-pressure papers (PMID 20409952), so a bare search mixes them in. A different product, the brain cortex tetrapeptide Cortagen (named in the title of PMID 15159690), also turns up in the same search results and is not this preparation.

Participants / model

Chemical identity, not a clinical population

Treatment

Undefined mixture of polypeptide fractions

Follow-up

Not applicable

Study design

NLM chemical substance records

Funding

not stated in the source

Identity record only. A vendor vial sold as Cortexin cannot be matched to the studied product from public records.

PubMed search record

PubMed search run on 10 October 2026 for cortexin, 217 records returned. ClinicalTrials.gov, openFDA Drugs@FDA and DailyMed searches run the same day.

The PubMed search returned 217 records, of which 150 are flagged Russian-language and 102 appeared in a single Russian journal (Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova). The titles of the 80 most relevant results and the abstracts of the studies cited on this page were reviewed. Two human trials were double-blind (the 490-patient route comparison and the 272-patient placebo-controlled trial); the other human studies reviewed were open, comparison-group or uncontrolled designs with no blinding stated in the abstract. No English-language randomized placebo-controlled human trial of Cortexin turned up. ClinicalTrials.gov API searches returned 0 records each for cortexin, the Cyrillic brand name, polypeptides of cerebral cortex of cattle, Geropharm ischemic stroke and Geropharm cerebral, so registration of the trials above cannot be confirmed. openFDA Drugs@FDA searches on generic name, brand name and active ingredient cortexin each returned no matches, and DailyMed searches for cortexin, cerebral cortex polypeptides and polypeptides of cerebral cortex of cattle returned zero labels, so there is no US label.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 10 October 2026

Study design

Literature, registry and regulator database searches

Funding

not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study or registration exists. Eurasian Economic Union and other post-Soviet registrations were not looked up.

Randomized controlled trial

Aliferova VM et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-6. PMID 24874316.

A multicenter prospective double-blind placebo-controlled trial enrolled 272 patients with ischemic stroke. They received Cortexin 10 mg intramuscularly three times a day as two 10-day courses (group 1), one course then a placebo course (group 2), or two placebo courses (group 3), over 70 days. The abstract reports high efficacy and safety, the best effect in the two-course group, and a favorable pharmacoeconomic result, but gives no numbers, primary endpoint or funding.

Participants / model

272 patients with ischemic stroke in Russia

Treatment

Cortexin 10 mg intramuscularly three times a day versus placebo

Follow-up

70 days

Study design

Multicenter prospective double-blind placebo-controlled trial, three groups

Funding

not stated in the source

This is the only blinded, placebo-controlled efficacy trial of Cortexin found in the records reviewed. The abstract gives no endpoints, effect sizes or funding.

Clinical trial

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12):60-67. PMID 41524350.

In 490 patients aged 30 to 80 with acute ischemic stroke, Cortexin 10 mg intravenous plus placebo intramuscular twice a day (n = 246) was compared with Cortexin 10 mg intramuscular plus placebo intravenous twice a day (n = 244) for 10 days, then both groups got 10 days of intramuscular Cortexin, with 90 days of follow-up. On day 90, 93.64% of the intravenous group and 86.50% of the intramuscular group had a modified Rankin score of 0 to 2; NIHSS fell by 3.93 and 3.72; the MMSE gain was 4.11 and 3.88 (p = 0.249). Adverse events were 74 in 60 patients (intravenous) and 51 in 41 patients (intramuscular), not different (p above 0.05).

Participants / model

490 adults with acute ischemic stroke in Russia

Treatment

Cortexin 10 mg twice a day, intravenous versus intramuscular

Follow-up

10 days of randomized treatment, then 10 days of intramuscular Cortexin, with 90 days of follow-up

Study design

Multicenter randomized double-blind route comparison with a double-dummy placebo; every patient received Cortexin

Funding

not stated in the source

The abstract calls the design placebo-controlled, but the placebo only masks the route and every patient received Cortexin, so there is no placebo-only or no-treatment arm and the trial says nothing about whether Cortexin beats placebo. Funding is not stated in the abstract.

Systematic review and meta-analysis

Ziganshina LE et al. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733.

The review included seven randomized trials (1773 participants), among them the one Cortexin trial (272 participants), which it judged at low risk of bias for incomplete outcome data and unclear risk for all other domains. For all-cause death, Cerebrolysin or Cortexin probably made little to no difference (RR 0.96, 95% CI 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence). No included study reported poor functional outcome (death or dependence) or quality of life. The authors conclude that Cerebrolysin or Cerebrolysin-like peptide mixtures from cattle brain probably do not prevent death. The increase in non-fatal serious adverse events (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants) is stated for Cerebrolysin, not for Cortexin.

Participants / model

Adults with acute ischaemic stroke across pooled randomized trials

Treatment

Cerebrolysin and Cerebrolysin-like peptide mixtures, including Cortexin in one trial

Follow-up

Pooled randomized trials

Study design

Cochrane systematic review and meta-analysis

Funding

not stated in the source

The serious-adverse-event signal is a class caution only, because it is stated for Cerebrolysin and not for Cortexin.

PubMed search record

PubMed search run on 10 October 2026 for cortexin, 217 records returned. ClinicalTrials.gov, openFDA Drugs@FDA and DailyMed searches run the same day.

The PubMed search returned 217 records, of which 150 are flagged Russian-language and 102 appeared in a single Russian journal (Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova). The titles of the 80 most relevant results and the abstracts of the studies cited on this page were reviewed. Two human trials were double-blind (the 490-patient route comparison and the 272-patient placebo-controlled trial); the other human studies reviewed were open, comparison-group or uncontrolled designs with no blinding stated in the abstract. No English-language randomized placebo-controlled human trial of Cortexin turned up. ClinicalTrials.gov API searches returned 0 records each for cortexin, the Cyrillic brand name, polypeptides of cerebral cortex of cattle, Geropharm ischemic stroke and Geropharm cerebral, so registration of the trials above cannot be confirmed. openFDA Drugs@FDA searches on generic name, brand name and active ingredient cortexin each returned no matches, and DailyMed searches for cortexin, cerebral cortex polypeptides and polypeptides of cerebral cortex of cattle returned zero labels, so there is no US label.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 10 October 2026

Study design

Literature, registry and regulator database searches

Funding

not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study or registration exists. Eurasian Economic Union and other post-Soviet registrations were not looked up.

Human study

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(9):35-42. PMID 30335070.

In 189 patients with stage I to II chronic cerebral ischemia (mean age 64.3), randomized to Cortexin 20 mg or 10 mg intramuscularly daily for 10 days (repeated at 6 months) or basic treatment only, the abstract reports a dose-dependent effect on neurological symptoms, asthenia and sleep, an antioxidant effect, and insignificant antidepressant and anxiolytic effects (PMID 30335070). In 98 patients with depressive disorder, Cortexin added to an antidepressant (n = 48) beat the antidepressant alone (n = 50) on MADRS, social adaptation and global improvement at day 28 (p = 0.001), and the abstract also reports fewer adverse events in the Cortexin group, which it does not explain (PMID 41782536). In 110 patients with neurological complications of type 2 diabetes, the DIACORT trial added ten Cortexin injections to glycine and B vitamins (n = 55 versus the same treatment alone) and reports a 1.2-fold MoCA rise (p < 0.001) and HbA1c of 7.3% versus 7.8% (p < 0.001), with 5 adverse events, none judged related; the PubMed record lists no authors (PMID 42133422).

Participants / model

Adults with chronic cerebral ischemia, depressive disorder, or diabetic neurological complications, in Russia

Treatment

Cortexin 10 or 20 mg intramuscularly daily for 10 days, added to usual care

Follow-up

10-day courses; day 28 follow-up in the depression study

Study design

Randomized or comparison-group studies, Russian-language; none states blinding or a placebo

Funding

not stated in the source

None of the three abstracts reports baseline values or effect sizes.

Human study

Zykov VP et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3):27-31. PMID 29652302.

A multicenter study of 635 children aged 3 to 7 (269 with ADHD, 215 with speech delay, 82 with perinatal CNS lesion consequences, 69 with asthenic or neurotic syndrome) gave a standard course of 10 intramuscular injections and reports a reliable effect on attention, visual memory and thinking, best in ADHD at ages 3 to 4, with good tolerability; the abstract describes no control group or blinding (PMID 29652302). A one-year study in infants with hypoxic CNS damage randomized to two Cortexin courses 3 months apart or none reports fewer myotonic and hypertensive-hydrocephalic symptoms (PMID 39731376); its abstract lists 323 children but the two named groups add to 215 (117 and 98), so the numbers do not reconcile. An 86-child epilepsy series aged 3 to 17 with no control group reports no seizure worsening in 95% and cognitive improvement in 65% (PMID 33834730).

Participants / model

Children with ADHD, speech delay, perinatal brain injury, hypoxic CNS damage, or epilepsy, in Russia

Treatment

Cortexin 10 mg or 0.5 mg/kg intramuscularly in 10-day courses

Follow-up

10-day courses; one year in the infant study

Study design

Uncontrolled or unblinded studies, Russian-language

Funding

not stated in the source

The label allows pediatric use, but none of these is a placebo-controlled trial.

Randomized controlled trial

Aliferova VM et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-6. PMID 24874316.

A multicenter prospective double-blind placebo-controlled trial enrolled 272 patients with ischemic stroke. They received Cortexin 10 mg intramuscularly three times a day as two 10-day courses (group 1), one course then a placebo course (group 2), or two placebo courses (group 3), over 70 days. The abstract reports high efficacy and safety, the best effect in the two-course group, and a favorable pharmacoeconomic result, but gives no numbers, primary endpoint or funding.

Participants / model

272 patients with ischemic stroke in Russia

Treatment

Cortexin 10 mg intramuscularly three times a day versus placebo

Follow-up

70 days

Study design

Multicenter prospective double-blind placebo-controlled trial, three groups

Funding

not stated in the source

This is the only blinded, placebo-controlled efficacy trial of Cortexin found in the records reviewed. The abstract gives no endpoints, effect sizes or funding.

Systematic review and meta-analysis

Ziganshina LE et al. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733.

The review included seven randomized trials (1773 participants), among them the one Cortexin trial (272 participants), which it judged at low risk of bias for incomplete outcome data and unclear risk for all other domains. For all-cause death, Cerebrolysin or Cortexin probably made little to no difference (RR 0.96, 95% CI 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence). No included study reported poor functional outcome (death or dependence) or quality of life. The authors conclude that Cerebrolysin or Cerebrolysin-like peptide mixtures from cattle brain probably do not prevent death. The increase in non-fatal serious adverse events (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants) is stated for Cerebrolysin, not for Cortexin.

Participants / model

Adults with acute ischaemic stroke across pooled randomized trials

Treatment

Cerebrolysin and Cerebrolysin-like peptide mixtures, including Cortexin in one trial

Follow-up

Pooled randomized trials

Study design

Cochrane systematic review and meta-analysis

Funding

not stated in the source

The serious-adverse-event signal is a class caution only, because it is stated for Cerebrolysin and not for Cortexin.

Animal study

Zhang L et al. J Neurol Sci. 2019;398:22-26. PMID 30665068.

Working blinded and randomized in male Wistar rats with embolic middle cerebral artery occlusion, the group gave Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days from 4 hours after occlusion. Functional outcome was similar to saline, and infarct size was not different (33.5 +/- 1.9% versus 30.8 +/- 2.1% for saline), while Cerebrolysin alone improved neurological outcome (p < 0.002).

Participants / model

Male Wistar rats with embolic middle cerebral artery occlusion

Treatment

Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days, compared with saline and Cerebrolysin

Follow-up

10 days of treatment

Study design

Blinded, randomized animal study

Funding

not stated in the abstract; the group's earlier work was on Cerebrolysin, so interest on the Cerebrolysin side cannot be ruled out

A US group. This is not human evidence, and it disagrees with the Volgograd rat study.

PubMed search record

PubMed search run on 10 October 2026: cortexin AND (healthy volunteers OR healthy subjects OR healthy adults OR students OR athletes). 5 records returned.

The search returned 5 records. None was a placebo-controlled test of cognition in healthy people. One title concerns cisplatin ototoxicity (PMID 29092803, abstract not reviewed), one is a neuroimaging reproducibility paper and one a resistance-training trial that matched on unrelated words, one is a 2007 Russian study of healthy volunteers aged 20 to 24 in a climate chamber that classes Cortexin as an adaptogen only under hypobaric hypoxia, with no cognition endpoint (PMID 18318195), and one is a 2020 report in elderly university teachers where breathing exercises plus Cortexin beat the drug alone, with no placebo stated (PMID 32593245). A 2004 review of Cortexin for memory and attention (PMID 15537099), found in the general search, holds no new data.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Search run on 10 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. The better-cognition claim has no healthy-person trial behind it in the records reviewed.

PubMed search record

PubMed search run on 10 October 2026: cortexin AND (traumatic brain injury OR head injury OR craniocerebral OR TBI OR concussion OR brain trauma). 11 records returned.

The search returned 11 records and every title was reviewed. Two were review articles (PMID 36946393, a 2023 Russian review of long-term brain injury treatment that calls Cortexin highly effective without data in the abstract, and PMID 36537632, a 2022 review of combat and emergency neurology). Two were human studies (PMID 32323940, 74 children aged 6 to 13 with moderate brain contusion, Cortexin plus standard therapy versus standard therapy, re-examined at 30 days, with no blinding or placebo stated, reporting fewer symptoms and EEG normalization; and PMID 21246892, a 2010 paper on severe brain injury with no abstract). The rest were rodent, rabbit, in-vitro, neonatal or perinatal papers. No placebo-controlled trial of Cortexin in adults with brain injury turned up.

Participants / model

Records returned; the one clinical study is 74 children with moderate brain contusion

Treatment

Not applicable

Follow-up

Search run on 10 October 2026

Study design

Literature search

Funding

not stated in the source

The recovery-after-brain-injury claim rests on one comparison-group pediatric study and reviews in the records reviewed.

Animal study

Zhang L et al. J Neurol Sci. 2019;398:22-26. PMID 30665068.

Working blinded and randomized in male Wistar rats with embolic middle cerebral artery occlusion, the group gave Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days from 4 hours after occlusion. Functional outcome was similar to saline, and infarct size was not different (33.5 +/- 1.9% versus 30.8 +/- 2.1% for saline), while Cerebrolysin alone improved neurological outcome (p < 0.002).

Participants / model

Male Wistar rats with embolic middle cerebral artery occlusion

Treatment

Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days, compared with saline and Cerebrolysin

Follow-up

10 days of treatment

Study design

Blinded, randomized animal study

Funding

not stated in the abstract; the group's earlier work was on Cerebrolysin, so interest on the Cerebrolysin side cannot be ruled out

A US group. This is not human evidence, and it disagrees with the Volgograd rat study.

Animal study

Kurkin DV et al. PLoS One. 2021;16(7):e0254493. PMID 34260655.

In rats with acute or chronic brain ischemia, Cortexin 1 or 3 mg/kg a day for 10 days improved neurological recovery and, in the acute model, reduced the size of brain tissue necrosis. Radiolabeled Cortexin reached 6 to 8% of whole-blood concentrations in mouse brain, and in vitro it bound AMPA receptors (80.1%) and kainate receptors (73.5%) at 10 ug/ml.

Participants / model

Rats (acute and chronic brain ischemia models), mice, and receptor preparations in vitro

Treatment

Cortexin 1 or 3 mg/kg a day for 10 days in rats; in vitro exposure at 10 ug/ml

Follow-up

10 days of treatment in rats

Study design

Animal and in-vitro study

Funding

not stated in the abstract; three authors are employed by Pharm-Holding CJSC, a company the abstract does not otherwise describe

Not human evidence. The route of administration in the rat experiments is not stated here, so the study is described in the text and not listed as a dosing row.

Official label

rlsnet.ru drug encyclopedia. Kortexin (Cortexin) lyophilisate for intramuscular solution, Russian prescribing information, manufacturer-approved version dated 10 February 2022; the site's own page-update date reads 21 September 2026.

The label lists the active substance as polypeptides of the cerebral cortex of cattle, ATC code N06BX, as a lyophilisate for intramuscular solution with glycine as stabilizer. It describes Cortexin as a complex of water-soluble polypeptide fractions with molecular weight not more than 10,000 Da. All indications are given in complex therapy: cerebrovascular disorders, traumatic brain injury and its consequences, encephalopathies of various origin, cognitive impairment (memory and thinking disorders), acute and chronic encephalitis and encephalomyelitis, epilepsy, asthenic states, reduced learning ability, delayed psychomotor and speech development in children, and various forms of infantile cerebral palsy. It is contraindicated in individual intolerance, pregnancy (the label cites lack of clinical trial data) and lactation. The label says the composition does not allow conventional pharmacokinetic analysis of individual components. Every listed adverse reaction is very rare (under 1 in 10,000): anaphylactic shock and hypersensitivity; angioedema, erythema, urticaria, rash, itching, allergic dermatitis; psychomotor agitation, impaired coordination, headache, dizziness, somnolence, hypoesthesia; tachycardia and arrhythmia; anxiety and insomnia; injection-site redness, fever, asthenia, chills; raised blood pressure. Lidocaine as the injection solvent is not recommended in children because it is linked to more severe adverse reactions.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate for intramuscular injection

Follow-up

Label version dated 10 February 2022

Study design

Russian-language prescribing information reproduced on a drug-information site; a regional label, not an FDA or EMA review

Funding

not stated in the source

The label's pharmacology statements (nootropic, neuroprotective and antioxidant effects, passage through the blood-brain barrier) are manufacturer text, not trial results. The Russian text was translated for this page. The label version read is dated 10 February 2022, and a later version may differ.

Animal study

Kurkin DV et al. PLoS One. 2021;16(7):e0254493. PMID 34260655.

In rats with acute or chronic brain ischemia, Cortexin 1 or 3 mg/kg a day for 10 days improved neurological recovery and, in the acute model, reduced the size of brain tissue necrosis. Radiolabeled Cortexin reached 6 to 8% of whole-blood concentrations in mouse brain, and in vitro it bound AMPA receptors (80.1%) and kainate receptors (73.5%) at 10 ug/ml.

Participants / model

Rats (acute and chronic brain ischemia models), mice, and receptor preparations in vitro

Treatment

Cortexin 1 or 3 mg/kg a day for 10 days in rats; in vitro exposure at 10 ug/ml

Follow-up

10 days of treatment in rats

Study design

Animal and in-vitro study

Funding

not stated in the abstract; three authors are employed by Pharm-Holding CJSC, a company the abstract does not otherwise describe

Not human evidence. The route of administration in the rat experiments is not stated here, so the study is described in the text and not listed as a dosing row.

Animal study

Zhang L et al. J Neurol Sci. 2019;398:22-26. PMID 30665068.

Working blinded and randomized in male Wistar rats with embolic middle cerebral artery occlusion, the group gave Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days from 4 hours after occlusion. Functional outcome was similar to saline, and infarct size was not different (33.5 +/- 1.9% versus 30.8 +/- 2.1% for saline), while Cerebrolysin alone improved neurological outcome (p < 0.002).

Participants / model

Male Wistar rats with embolic middle cerebral artery occlusion

Treatment

Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days, compared with saline and Cerebrolysin

Follow-up

10 days of treatment

Study design

Blinded, randomized animal study

Funding

not stated in the abstract; the group's earlier work was on Cerebrolysin, so interest on the Cerebrolysin side cannot be ruled out

A US group. This is not human evidence, and it disagrees with the Volgograd rat study.

Official label

rlsnet.ru drug encyclopedia. Kortexin (Cortexin) lyophilisate for intramuscular solution, Russian prescribing information, manufacturer-approved version dated 10 February 2022; the site's own page-update date reads 21 September 2026.

The label lists the active substance as polypeptides of the cerebral cortex of cattle, ATC code N06BX, as a lyophilisate for intramuscular solution with glycine as stabilizer. It describes Cortexin as a complex of water-soluble polypeptide fractions with molecular weight not more than 10,000 Da. All indications are given in complex therapy: cerebrovascular disorders, traumatic brain injury and its consequences, encephalopathies of various origin, cognitive impairment (memory and thinking disorders), acute and chronic encephalitis and encephalomyelitis, epilepsy, asthenic states, reduced learning ability, delayed psychomotor and speech development in children, and various forms of infantile cerebral palsy. It is contraindicated in individual intolerance, pregnancy (the label cites lack of clinical trial data) and lactation. The label says the composition does not allow conventional pharmacokinetic analysis of individual components. Every listed adverse reaction is very rare (under 1 in 10,000): anaphylactic shock and hypersensitivity; angioedema, erythema, urticaria, rash, itching, allergic dermatitis; psychomotor agitation, impaired coordination, headache, dizziness, somnolence, hypoesthesia; tachycardia and arrhythmia; anxiety and insomnia; injection-site redness, fever, asthenia, chills; raised blood pressure. Lidocaine as the injection solvent is not recommended in children because it is linked to more severe adverse reactions.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate for intramuscular injection

Follow-up

Label version dated 10 February 2022

Study design

Russian-language prescribing information reproduced on a drug-information site; a regional label, not an FDA or EMA review

Funding

not stated in the source

The label's pharmacology statements (nootropic, neuroprotective and antioxidant effects, passage through the blood-brain barrier) are manufacturer text, not trial results. The Russian text was translated for this page. The label version read is dated 10 February 2022, and a later version may differ.

Clinical trial

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12):60-67. PMID 41524350.

In 490 patients aged 30 to 80 with acute ischemic stroke, Cortexin 10 mg intravenous plus placebo intramuscular twice a day (n = 246) was compared with Cortexin 10 mg intramuscular plus placebo intravenous twice a day (n = 244) for 10 days, then both groups got 10 days of intramuscular Cortexin, with 90 days of follow-up. On day 90, 93.64% of the intravenous group and 86.50% of the intramuscular group had a modified Rankin score of 0 to 2; NIHSS fell by 3.93 and 3.72; the MMSE gain was 4.11 and 3.88 (p = 0.249). Adverse events were 74 in 60 patients (intravenous) and 51 in 41 patients (intramuscular), not different (p above 0.05).

Participants / model

490 adults with acute ischemic stroke in Russia

Treatment

Cortexin 10 mg twice a day, intravenous versus intramuscular

Follow-up

10 days of randomized treatment, then 10 days of intramuscular Cortexin, with 90 days of follow-up

Study design

Multicenter randomized double-blind route comparison with a double-dummy placebo; every patient received Cortexin

Funding

not stated in the source

The abstract calls the design placebo-controlled, but the placebo only masks the route and every patient received Cortexin, so there is no placebo-only or no-treatment arm and the trial says nothing about whether Cortexin beats placebo. Funding is not stated in the abstract.

Randomized controlled trial

Aliferova VM et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-6. PMID 24874316.

A multicenter prospective double-blind placebo-controlled trial enrolled 272 patients with ischemic stroke. They received Cortexin 10 mg intramuscularly three times a day as two 10-day courses (group 1), one course then a placebo course (group 2), or two placebo courses (group 3), over 70 days. The abstract reports high efficacy and safety, the best effect in the two-course group, and a favorable pharmacoeconomic result, but gives no numbers, primary endpoint or funding.

Participants / model

272 patients with ischemic stroke in Russia

Treatment

Cortexin 10 mg intramuscularly three times a day versus placebo

Follow-up

70 days

Study design

Multicenter prospective double-blind placebo-controlled trial, three groups

Funding

not stated in the source

This is the only blinded, placebo-controlled efficacy trial of Cortexin found in the records reviewed. The abstract gives no endpoints, effect sizes or funding.

Human study

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(9):35-42. PMID 30335070.

In 189 patients with stage I to II chronic cerebral ischemia (mean age 64.3), randomized to Cortexin 20 mg or 10 mg intramuscularly daily for 10 days (repeated at 6 months) or basic treatment only, the abstract reports a dose-dependent effect on neurological symptoms, asthenia and sleep, an antioxidant effect, and insignificant antidepressant and anxiolytic effects (PMID 30335070). In 98 patients with depressive disorder, Cortexin added to an antidepressant (n = 48) beat the antidepressant alone (n = 50) on MADRS, social adaptation and global improvement at day 28 (p = 0.001), and the abstract also reports fewer adverse events in the Cortexin group, which it does not explain (PMID 41782536). In 110 patients with neurological complications of type 2 diabetes, the DIACORT trial added ten Cortexin injections to glycine and B vitamins (n = 55 versus the same treatment alone) and reports a 1.2-fold MoCA rise (p < 0.001) and HbA1c of 7.3% versus 7.8% (p < 0.001), with 5 adverse events, none judged related; the PubMed record lists no authors (PMID 42133422).

Participants / model

Adults with chronic cerebral ischemia, depressive disorder, or diabetic neurological complications, in Russia

Treatment

Cortexin 10 or 20 mg intramuscularly daily for 10 days, added to usual care

Follow-up

10-day courses; day 28 follow-up in the depression study

Study design

Randomized or comparison-group studies, Russian-language; none states blinding or a placebo

Funding

not stated in the source

None of the three abstracts reports baseline values or effect sizes.

Systematic review and meta-analysis

Ziganshina LE et al. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733.

The review included seven randomized trials (1773 participants), among them the one Cortexin trial (272 participants), which it judged at low risk of bias for incomplete outcome data and unclear risk for all other domains. For all-cause death, Cerebrolysin or Cortexin probably made little to no difference (RR 0.96, 95% CI 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence). No included study reported poor functional outcome (death or dependence) or quality of life. The authors conclude that Cerebrolysin or Cerebrolysin-like peptide mixtures from cattle brain probably do not prevent death. The increase in non-fatal serious adverse events (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants) is stated for Cerebrolysin, not for Cortexin.

Participants / model

Adults with acute ischaemic stroke across pooled randomized trials

Treatment

Cerebrolysin and Cerebrolysin-like peptide mixtures, including Cortexin in one trial

Follow-up

Pooled randomized trials

Study design

Cochrane systematic review and meta-analysis

Funding

not stated in the source

The serious-adverse-event signal is a class caution only, because it is stated for Cerebrolysin and not for Cortexin.

Chemical identity record

National Library of Medicine. PubChem substance records SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox), registry number 83270-84-2; PubChem name query for cortexin run on 10 October 2026.

A PubChem name query for cortexin returned no compound (No CID found). Three substance records carry the name and the same registry number, 83270-84-2: SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox). None has a linked compound, so there is no formula, molecular weight or structure. The word also names unrelated things in PubMed: an 82-residue neuron-specific membrane protein called cortexin (PMID 8336151), a cortexin 3 gene paper (PMID 17786280) and renal cortexin blood-pressure papers (PMID 20409952), so a bare search mixes them in. A different product, the brain cortex tetrapeptide Cortagen (named in the title of PMID 15159690), also turns up in the same search results and is not this preparation.

Participants / model

Chemical identity, not a clinical population

Treatment

Undefined mixture of polypeptide fractions

Follow-up

Not applicable

Study design

NLM chemical substance records

Funding

not stated in the source

Identity record only. A vendor vial sold as Cortexin cannot be matched to the studied product from public records.

Randomized controlled trial

Aliferova VM et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-6. PMID 24874316.

A multicenter prospective double-blind placebo-controlled trial enrolled 272 patients with ischemic stroke. They received Cortexin 10 mg intramuscularly three times a day as two 10-day courses (group 1), one course then a placebo course (group 2), or two placebo courses (group 3), over 70 days. The abstract reports high efficacy and safety, the best effect in the two-course group, and a favorable pharmacoeconomic result, but gives no numbers, primary endpoint or funding.

Participants / model

272 patients with ischemic stroke in Russia

Treatment

Cortexin 10 mg intramuscularly three times a day versus placebo

Follow-up

70 days

Study design

Multicenter prospective double-blind placebo-controlled trial, three groups

Funding

not stated in the source

This is the only blinded, placebo-controlled efficacy trial of Cortexin found in the records reviewed. The abstract gives no endpoints, effect sizes or funding.

Clinical trial

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12):60-67. PMID 41524350.

In 490 patients aged 30 to 80 with acute ischemic stroke, Cortexin 10 mg intravenous plus placebo intramuscular twice a day (n = 246) was compared with Cortexin 10 mg intramuscular plus placebo intravenous twice a day (n = 244) for 10 days, then both groups got 10 days of intramuscular Cortexin, with 90 days of follow-up. On day 90, 93.64% of the intravenous group and 86.50% of the intramuscular group had a modified Rankin score of 0 to 2; NIHSS fell by 3.93 and 3.72; the MMSE gain was 4.11 and 3.88 (p = 0.249). Adverse events were 74 in 60 patients (intravenous) and 51 in 41 patients (intramuscular), not different (p above 0.05).

Participants / model

490 adults with acute ischemic stroke in Russia

Treatment

Cortexin 10 mg twice a day, intravenous versus intramuscular

Follow-up

10 days of randomized treatment, then 10 days of intramuscular Cortexin, with 90 days of follow-up

Study design

Multicenter randomized double-blind route comparison with a double-dummy placebo; every patient received Cortexin

Funding

not stated in the source

The abstract calls the design placebo-controlled, but the placebo only masks the route and every patient received Cortexin, so there is no placebo-only or no-treatment arm and the trial says nothing about whether Cortexin beats placebo. Funding is not stated in the abstract.

Systematic review and meta-analysis

Ziganshina LE et al. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733.

The review included seven randomized trials (1773 participants), among them the one Cortexin trial (272 participants), which it judged at low risk of bias for incomplete outcome data and unclear risk for all other domains. For all-cause death, Cerebrolysin or Cortexin probably made little to no difference (RR 0.96, 95% CI 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence). No included study reported poor functional outcome (death or dependence) or quality of life. The authors conclude that Cerebrolysin or Cerebrolysin-like peptide mixtures from cattle brain probably do not prevent death. The increase in non-fatal serious adverse events (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants) is stated for Cerebrolysin, not for Cortexin.

Participants / model

Adults with acute ischaemic stroke across pooled randomized trials

Treatment

Cerebrolysin and Cerebrolysin-like peptide mixtures, including Cortexin in one trial

Follow-up

Pooled randomized trials

Study design

Cochrane systematic review and meta-analysis

Funding

not stated in the source

The serious-adverse-event signal is a class caution only, because it is stated for Cerebrolysin and not for Cortexin.

Animal study

Zhang L et al. J Neurol Sci. 2019;398:22-26. PMID 30665068.

Working blinded and randomized in male Wistar rats with embolic middle cerebral artery occlusion, the group gave Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days from 4 hours after occlusion. Functional outcome was similar to saline, and infarct size was not different (33.5 +/- 1.9% versus 30.8 +/- 2.1% for saline), while Cerebrolysin alone improved neurological outcome (p < 0.002).

Participants / model

Male Wistar rats with embolic middle cerebral artery occlusion

Treatment

Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days, compared with saline and Cerebrolysin

Follow-up

10 days of treatment

Study design

Blinded, randomized animal study

Funding

not stated in the abstract; the group's earlier work was on Cerebrolysin, so interest on the Cerebrolysin side cannot be ruled out

A US group. This is not human evidence, and it disagrees with the Volgograd rat study.

PubMed search record

PubMed search run on 10 October 2026 for cortexin, 217 records returned. ClinicalTrials.gov, openFDA Drugs@FDA and DailyMed searches run the same day.

The PubMed search returned 217 records, of which 150 are flagged Russian-language and 102 appeared in a single Russian journal (Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova). The titles of the 80 most relevant results and the abstracts of the studies cited on this page were reviewed. Two human trials were double-blind (the 490-patient route comparison and the 272-patient placebo-controlled trial); the other human studies reviewed were open, comparison-group or uncontrolled designs with no blinding stated in the abstract. No English-language randomized placebo-controlled human trial of Cortexin turned up. ClinicalTrials.gov API searches returned 0 records each for cortexin, the Cyrillic brand name, polypeptides of cerebral cortex of cattle, Geropharm ischemic stroke and Geropharm cerebral, so registration of the trials above cannot be confirmed. openFDA Drugs@FDA searches on generic name, brand name and active ingredient cortexin each returned no matches, and DailyMed searches for cortexin, cerebral cortex polypeptides and polypeptides of cerebral cortex of cattle returned zero labels, so there is no US label.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 10 October 2026

Study design

Literature, registry and regulator database searches

Funding

not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study or registration exists. Eurasian Economic Union and other post-Soviet registrations were not looked up.

Official label

rlsnet.ru drug encyclopedia. Kortexin (Cortexin) lyophilisate for intramuscular solution, Russian prescribing information, manufacturer-approved version dated 10 February 2022; the site's own page-update date reads 21 September 2026.

The label lists the active substance as polypeptides of the cerebral cortex of cattle, ATC code N06BX, as a lyophilisate for intramuscular solution with glycine as stabilizer. It describes Cortexin as a complex of water-soluble polypeptide fractions with molecular weight not more than 10,000 Da. All indications are given in complex therapy: cerebrovascular disorders, traumatic brain injury and its consequences, encephalopathies of various origin, cognitive impairment (memory and thinking disorders), acute and chronic encephalitis and encephalomyelitis, epilepsy, asthenic states, reduced learning ability, delayed psychomotor and speech development in children, and various forms of infantile cerebral palsy. It is contraindicated in individual intolerance, pregnancy (the label cites lack of clinical trial data) and lactation. The label says the composition does not allow conventional pharmacokinetic analysis of individual components. Every listed adverse reaction is very rare (under 1 in 10,000): anaphylactic shock and hypersensitivity; angioedema, erythema, urticaria, rash, itching, allergic dermatitis; psychomotor agitation, impaired coordination, headache, dizziness, somnolence, hypoesthesia; tachycardia and arrhythmia; anxiety and insomnia; injection-site redness, fever, asthenia, chills; raised blood pressure. Lidocaine as the injection solvent is not recommended in children because it is linked to more severe adverse reactions.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate for intramuscular injection

Follow-up

Label version dated 10 February 2022

Study design

Russian-language prescribing information reproduced on a drug-information site; a regional label, not an FDA or EMA review

Funding

not stated in the source

The label's pharmacology statements (nootropic, neuroprotective and antioxidant effects, passage through the blood-brain barrier) are manufacturer text, not trial results. The Russian text was translated for this page. The label version read is dated 10 February 2022, and a later version may differ.

Official label

rlsnet.ru drug encyclopedia. Kortexin (Cortexin) lyophilisate for intramuscular solution, Russian prescribing information, manufacturer-approved version dated 10 February 2022; the site's own page-update date reads 21 September 2026.

The label lists the active substance as polypeptides of the cerebral cortex of cattle, ATC code N06BX, as a lyophilisate for intramuscular solution with glycine as stabilizer. It describes Cortexin as a complex of water-soluble polypeptide fractions with molecular weight not more than 10,000 Da. All indications are given in complex therapy: cerebrovascular disorders, traumatic brain injury and its consequences, encephalopathies of various origin, cognitive impairment (memory and thinking disorders), acute and chronic encephalitis and encephalomyelitis, epilepsy, asthenic states, reduced learning ability, delayed psychomotor and speech development in children, and various forms of infantile cerebral palsy. It is contraindicated in individual intolerance, pregnancy (the label cites lack of clinical trial data) and lactation. The label says the composition does not allow conventional pharmacokinetic analysis of individual components. Every listed adverse reaction is very rare (under 1 in 10,000): anaphylactic shock and hypersensitivity; angioedema, erythema, urticaria, rash, itching, allergic dermatitis; psychomotor agitation, impaired coordination, headache, dizziness, somnolence, hypoesthesia; tachycardia and arrhythmia; anxiety and insomnia; injection-site redness, fever, asthenia, chills; raised blood pressure. Lidocaine as the injection solvent is not recommended in children because it is linked to more severe adverse reactions.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate for intramuscular injection

Follow-up

Label version dated 10 February 2022

Study design

Russian-language prescribing information reproduced on a drug-information site; a regional label, not an FDA or EMA review

Funding

not stated in the source

The label's pharmacology statements (nootropic, neuroprotective and antioxidant effects, passage through the blood-brain barrier) are manufacturer text, not trial results. The Russian text was translated for this page. The label version read is dated 10 February 2022, and a later version may differ.

Official label

medi.ru drug-information site. Kortexin leaflet copies for the 10 mg product (copy dated 8 February 2019) and the 5 mg product (copy dated 4 February 2019).

Two Russian leaflet copies on medi.ru give registration numbers and manufacturers. The 10 mg leaflet (copy dated 8 February 2019) prints registration number R N003862/02, the R in Cyrillic letters, with the grouping name polypeptides of the cerebral cortex of cattle, glycine in each vial, prescription-only dispensing, a 3-year shelf life, and two manufacturers: Geropharm LLC and Firma Ferment LLC, both in Russia. The 5 mg leaflet (copy dated 4 February 2019) prints registration number LSR-003190/09 and Geropharm LLC as manufacturer.

Participants / model

Adults and children in Russia, label population

Treatment

Kortexin lyophilisate, intramuscular

Follow-up

Leaflet copies dated February 2019

Study design

Russian-language leaflet copies hosted on a commercial drug-information site

Funding

not stated in the source

The copies are on a commercial site, not the Russian state register, so current registration status and label version are not confirmed here.

Clinical trial

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12):60-67. PMID 41524350.

In 490 patients aged 30 to 80 with acute ischemic stroke, Cortexin 10 mg intravenous plus placebo intramuscular twice a day (n = 246) was compared with Cortexin 10 mg intramuscular plus placebo intravenous twice a day (n = 244) for 10 days, then both groups got 10 days of intramuscular Cortexin, with 90 days of follow-up. On day 90, 93.64% of the intravenous group and 86.50% of the intramuscular group had a modified Rankin score of 0 to 2; NIHSS fell by 3.93 and 3.72; the MMSE gain was 4.11 and 3.88 (p = 0.249). Adverse events were 74 in 60 patients (intravenous) and 51 in 41 patients (intramuscular), not different (p above 0.05).

Participants / model

490 adults with acute ischemic stroke in Russia

Treatment

Cortexin 10 mg twice a day, intravenous versus intramuscular

Follow-up

10 days of randomized treatment, then 10 days of intramuscular Cortexin, with 90 days of follow-up

Study design

Multicenter randomized double-blind route comparison with a double-dummy placebo; every patient received Cortexin

Funding

not stated in the source

The abstract calls the design placebo-controlled, but the placebo only masks the route and every patient received Cortexin, so there is no placebo-only or no-treatment arm and the trial says nothing about whether Cortexin beats placebo. Funding is not stated in the abstract.

Chemical identity record

National Library of Medicine. PubChem substance records SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox), registry number 83270-84-2; PubChem name query for cortexin run on 10 October 2026.

A PubChem name query for cortexin returned no compound (No CID found). Three substance records carry the name and the same registry number, 83270-84-2: SID 134223142 (Comparative Toxicogenomics Database), SID 135311035 (ChemIDplus) and SID 472219636 (EPA DSSTox). None has a linked compound, so there is no formula, molecular weight or structure. The word also names unrelated things in PubMed: an 82-residue neuron-specific membrane protein called cortexin (PMID 8336151), a cortexin 3 gene paper (PMID 17786280) and renal cortexin blood-pressure papers (PMID 20409952), so a bare search mixes them in. A different product, the brain cortex tetrapeptide Cortagen (named in the title of PMID 15159690), also turns up in the same search results and is not this preparation.

Participants / model

Chemical identity, not a clinical population

Treatment

Undefined mixture of polypeptide fractions

Follow-up

Not applicable

Study design

NLM chemical substance records

Funding

not stated in the source

Identity record only. A vendor vial sold as Cortexin cannot be matched to the studied product from public records.

Randomized controlled trial

Aliferova VM et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-6. PMID 24874316.

A multicenter prospective double-blind placebo-controlled trial enrolled 272 patients with ischemic stroke. They received Cortexin 10 mg intramuscularly three times a day as two 10-day courses (group 1), one course then a placebo course (group 2), or two placebo courses (group 3), over 70 days. The abstract reports high efficacy and safety, the best effect in the two-course group, and a favorable pharmacoeconomic result, but gives no numbers, primary endpoint or funding.

Participants / model

272 patients with ischemic stroke in Russia

Treatment

Cortexin 10 mg intramuscularly three times a day versus placebo

Follow-up

70 days

Study design

Multicenter prospective double-blind placebo-controlled trial, three groups

Funding

not stated in the source

This is the only blinded, placebo-controlled efficacy trial of Cortexin found in the records reviewed. The abstract gives no endpoints, effect sizes or funding.

Systematic review and meta-analysis

Ziganshina LE et al. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733.

The review included seven randomized trials (1773 participants), among them the one Cortexin trial (272 participants), which it judged at low risk of bias for incomplete outcome data and unclear risk for all other domains. For all-cause death, Cerebrolysin or Cortexin probably made little to no difference (RR 0.96, 95% CI 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence). No included study reported poor functional outcome (death or dependence) or quality of life. The authors conclude that Cerebrolysin or Cerebrolysin-like peptide mixtures from cattle brain probably do not prevent death. The increase in non-fatal serious adverse events (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants) is stated for Cerebrolysin, not for Cortexin.

Participants / model

Adults with acute ischaemic stroke across pooled randomized trials

Treatment

Cerebrolysin and Cerebrolysin-like peptide mixtures, including Cortexin in one trial

Follow-up

Pooled randomized trials

Study design

Cochrane systematic review and meta-analysis

Funding

not stated in the source

The serious-adverse-event signal is a class caution only, because it is stated for Cerebrolysin and not for Cortexin.

Human study

Fedin AI et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(9):35-42. PMID 30335070.

In 189 patients with stage I to II chronic cerebral ischemia (mean age 64.3), randomized to Cortexin 20 mg or 10 mg intramuscularly daily for 10 days (repeated at 6 months) or basic treatment only, the abstract reports a dose-dependent effect on neurological symptoms, asthenia and sleep, an antioxidant effect, and insignificant antidepressant and anxiolytic effects (PMID 30335070). In 98 patients with depressive disorder, Cortexin added to an antidepressant (n = 48) beat the antidepressant alone (n = 50) on MADRS, social adaptation and global improvement at day 28 (p = 0.001), and the abstract also reports fewer adverse events in the Cortexin group, which it does not explain (PMID 41782536). In 110 patients with neurological complications of type 2 diabetes, the DIACORT trial added ten Cortexin injections to glycine and B vitamins (n = 55 versus the same treatment alone) and reports a 1.2-fold MoCA rise (p < 0.001) and HbA1c of 7.3% versus 7.8% (p < 0.001), with 5 adverse events, none judged related; the PubMed record lists no authors (PMID 42133422).

Participants / model

Adults with chronic cerebral ischemia, depressive disorder, or diabetic neurological complications, in Russia

Treatment

Cortexin 10 or 20 mg intramuscularly daily for 10 days, added to usual care

Follow-up

10-day courses; day 28 follow-up in the depression study

Study design

Randomized or comparison-group studies, Russian-language; none states blinding or a placebo

Funding

not stated in the source

None of the three abstracts reports baseline values or effect sizes.

Human study

Zykov VP et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3):27-31. PMID 29652302.

A multicenter study of 635 children aged 3 to 7 (269 with ADHD, 215 with speech delay, 82 with perinatal CNS lesion consequences, 69 with asthenic or neurotic syndrome) gave a standard course of 10 intramuscular injections and reports a reliable effect on attention, visual memory and thinking, best in ADHD at ages 3 to 4, with good tolerability; the abstract describes no control group or blinding (PMID 29652302). A one-year study in infants with hypoxic CNS damage randomized to two Cortexin courses 3 months apart or none reports fewer myotonic and hypertensive-hydrocephalic symptoms (PMID 39731376); its abstract lists 323 children but the two named groups add to 215 (117 and 98), so the numbers do not reconcile. An 86-child epilepsy series aged 3 to 17 with no control group reports no seizure worsening in 95% and cognitive improvement in 65% (PMID 33834730).

Participants / model

Children with ADHD, speech delay, perinatal brain injury, hypoxic CNS damage, or epilepsy, in Russia

Treatment

Cortexin 10 mg or 0.5 mg/kg intramuscularly in 10-day courses

Follow-up

10-day courses; one year in the infant study

Study design

Uncontrolled or unblinded studies, Russian-language

Funding

not stated in the source

The label allows pediatric use, but none of these is a placebo-controlled trial.

PubMed search record

PubMed search run on 10 October 2026 for cortexin, 217 records returned. ClinicalTrials.gov, openFDA Drugs@FDA and DailyMed searches run the same day.

The PubMed search returned 217 records, of which 150 are flagged Russian-language and 102 appeared in a single Russian journal (Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova). The titles of the 80 most relevant results and the abstracts of the studies cited on this page were reviewed. Two human trials were double-blind (the 490-patient route comparison and the 272-patient placebo-controlled trial); the other human studies reviewed were open, comparison-group or uncontrolled designs with no blinding stated in the abstract. No English-language randomized placebo-controlled human trial of Cortexin turned up. ClinicalTrials.gov API searches returned 0 records each for cortexin, the Cyrillic brand name, polypeptides of cerebral cortex of cattle, Geropharm ischemic stroke and Geropharm cerebral, so registration of the trials above cannot be confirmed. openFDA Drugs@FDA searches on generic name, brand name and active ingredient cortexin each returned no matches, and DailyMed searches for cortexin, cerebral cortex polypeptides and polypeptides of cerebral cortex of cattle returned zero labels, so there is no US label.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 10 October 2026

Study design

Literature, registry and regulator database searches

Funding

not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study or registration exists. Eurasian Economic Union and other post-Soviet registrations were not looked up.

PubMed search record

PubMed search run on 10 October 2026: cortexin AND (healthy volunteers OR healthy subjects OR healthy adults OR students OR athletes). 5 records returned.

The search returned 5 records. None was a placebo-controlled test of cognition in healthy people. One title concerns cisplatin ototoxicity (PMID 29092803, abstract not reviewed), one is a neuroimaging reproducibility paper and one a resistance-training trial that matched on unrelated words, one is a 2007 Russian study of healthy volunteers aged 20 to 24 in a climate chamber that classes Cortexin as an adaptogen only under hypobaric hypoxia, with no cognition endpoint (PMID 18318195), and one is a 2020 report in elderly university teachers where breathing exercises plus Cortexin beat the drug alone, with no placebo stated (PMID 32593245). A 2004 review of Cortexin for memory and attention (PMID 15537099), found in the general search, holds no new data.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Search run on 10 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. The better-cognition claim has no healthy-person trial behind it in the records reviewed.

PubMed search record

PubMed search run on 10 October 2026: cortexin AND (traumatic brain injury OR head injury OR craniocerebral OR TBI OR concussion OR brain trauma). 11 records returned.

The search returned 11 records and every title was reviewed. Two were review articles (PMID 36946393, a 2023 Russian review of long-term brain injury treatment that calls Cortexin highly effective without data in the abstract, and PMID 36537632, a 2022 review of combat and emergency neurology). Two were human studies (PMID 32323940, 74 children aged 6 to 13 with moderate brain contusion, Cortexin plus standard therapy versus standard therapy, re-examined at 30 days, with no blinding or placebo stated, reporting fewer symptoms and EEG normalization; and PMID 21246892, a 2010 paper on severe brain injury with no abstract). The rest were rodent, rabbit, in-vitro, neonatal or perinatal papers. No placebo-controlled trial of Cortexin in adults with brain injury turned up.

Participants / model

Records returned; the one clinical study is 74 children with moderate brain contusion

Treatment

Not applicable

Follow-up

Search run on 10 October 2026

Study design

Literature search

Funding

not stated in the source

The recovery-after-brain-injury claim rests on one comparison-group pediatric study and reviews in the records reviewed.

Animal study

Zhang L et al. J Neurol Sci. 2019;398:22-26. PMID 30665068.

Working blinded and randomized in male Wistar rats with embolic middle cerebral artery occlusion, the group gave Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days from 4 hours after occlusion. Functional outcome was similar to saline, and infarct size was not different (33.5 +/- 1.9% versus 30.8 +/- 2.1% for saline), while Cerebrolysin alone improved neurological outcome (p < 0.002).

Participants / model

Male Wistar rats with embolic middle cerebral artery occlusion

Treatment

Cortexin 1.7 mg/kg intraperitoneally once daily for 10 days, compared with saline and Cerebrolysin

Follow-up

10 days of treatment

Study design

Blinded, randomized animal study

Funding

not stated in the abstract; the group's earlier work was on Cerebrolysin, so interest on the Cerebrolysin side cannot be ruled out

A US group. This is not human evidence, and it disagrees with the Volgograd rat study.

Animal study

Kurkin DV et al. PLoS One. 2021;16(7):e0254493. PMID 34260655.

In rats with acute or chronic brain ischemia, Cortexin 1 or 3 mg/kg a day for 10 days improved neurological recovery and, in the acute model, reduced the size of brain tissue necrosis. Radiolabeled Cortexin reached 6 to 8% of whole-blood concentrations in mouse brain, and in vitro it bound AMPA receptors (80.1%) and kainate receptors (73.5%) at 10 ug/ml.

Participants / model

Rats (acute and chronic brain ischemia models), mice, and receptor preparations in vitro

Treatment

Cortexin 1 or 3 mg/kg a day for 10 days in rats; in vitro exposure at 10 ug/ml

Follow-up

10 days of treatment in rats

Study design

Animal and in-vitro study

Funding

not stated in the abstract; three authors are employed by Pharm-Holding CJSC, a company the abstract does not otherwise describe

Not human evidence. The route of administration in the rat experiments is not stated here, so the study is described in the text and not listed as a dosing row.