Semax
Small Russian post-stroke and optic-nerve studies reported clinical improvements with intranasal Semax. The studies were nonrandomized or incompletely reported and do not establish cognitive enhancement in healthy people or the safety of online products.
ACTH-derived heptapeptide
- Synthetic heptapeptide
- Usually studied by intranasal administration
- Semax free base and Semax acetate are distinct bulk substances
What molecule do Semax claims refer to?
Semax is the seven-amino-acid sequence Met-Glu-His-Phe-Pro-Gly-Pro, built from ACTH residues 4 through 7 plus Pro-Gly-Pro. FDA's 2026 review found that products sold under the common name may contain different salts or active moieties, so their doses and results are not interchangeable.
A study of one characterized intranasal product does not automatically apply to Semax acetate, free base, a different salt, or an online vial.
FDA Semax review · identity, approval, evidence
FDA compounding review
U.S. Food and Drug Administration, July 2026
FDA found no Semax component in an approved drug and identified identity, device, safety, immunogenicity, and effectiveness concerns.
- Participants / model
- Semax free base and Semax acetate proposed for U.S. compounding
- Treatment
- Intranasal nominated uses
- Follow-up
- Agency review through July 2026
- Study design
- Regulatory evidence review
This is a compounding-list evaluation, not a clinical trial or approval decision.
Read the original sourceIs Semax FDA approved or cleared for compounding?
No Semax substance is a component of an FDA-approved drug. In July 2026, FDA staff concluded that the evidence weighed against placing Semax free base and Semax acetate on the 503A bulks list, citing poor characterization, intranasal-device questions, limited safety information, immunogenicity concern, and insufficient effectiveness evidence for the nominated uses.
A committee discussion is not itself a marketing approval or an endorsement of compounding.
FDA Semax review · identity, approval, evidence
FDA compounding review
U.S. Food and Drug Administration, July 2026
FDA found no Semax component in an approved drug and identified identity, device, safety, immunogenicity, and effectiveness concerns.
- Participants / model
- Semax free base and Semax acetate proposed for U.S. compounding
- Treatment
- Intranasal nominated uses
- Follow-up
- Agency review through July 2026
- Study design
- Regulatory evidence review
This is a compounding-list evaluation, not a clinical trial or approval decision.
Read the original sourcePCAC · recommendation against 503A listing
FDA advisory presentation
U.S. Food and Drug Administration, July 24, 2026
FDA staff concluded that the balancing criteria weighed against adding Semax free base or acetate to the 503A bulks list.
- Participants / model
- Semax bulk substances proposed for compounding
- Treatment
- Proposed compounded intranasal products
- Follow-up
- July 2026 review
- Study design
- FDA advisory-committee material
The committee process does not create an FDA-approved drug.
Read the original sourceIs there a currently registered Semax product in Russia?
Semax has been marketed as prescription nasal drops in Russia. A GRLS-derived register reproduction lists an active 1% product under registration ЛП-№(010596)-(РГ-RU), registered June 18, 2025.
The manufacturer-hosted Russian instructions carry the older 2011 registration. They identify 0.1% and 1% prescription nasal-drop products and specific Russian indications, but do not establish a U.S. product or the current 2025 Russian label.
What does the Russian registration say?
A GRLS-derived register reproduction lists Semax 1% nasal drops as active under registration ЛП-№(010596)-(РГ-RU), registered June 18, 2025 with an indefinite term and linked to the earlier Р N000812/01 record.
Semax Russia status · 2025 replacement record
Russian drug-registration record
Pharm-Portal. GRLS-derived record for Semax 1% nasal drops, registration ЛП-№(010596)-(РГ-RU), registered June 18, 2025.
Lists Semax 1% nasal drops as active under ЛП-№(010596)-(РГ-RU), registered June 18, 2025 with an indefinite term.
- Participants / model
- Russian prescription-drug registration
- Treatment
- Semax 1% nasal drops by INPC Peptogen
- Study design
- Russian medicine registration listing
Semax 0.1% instruction · contraindications and route
Manufacturer-hosted Russian product instruction
INPC Peptogen, registration ЛС-002553 dated December 30, 2011
The instruction defines a prescription 0.1% intranasal product, its named Russian uses, contraindications, and possible mild nasal irritation with prolonged use.
- Participants / model
- People covered by the named Russian 0.1% nasal-drop instruction
- Treatment
- Semax 0.1% prescription nasal drops
- Follow-up
- Label dated 2011; current status not established by this file
- Study design
- Russian-language product instruction hosted by the manufacturer
This older product instruction is not the current 2025 registration file and does not validate a different salt, concentration, or online product.
Read the original sourceWhat clinical stroke evidence exists?
Small Russian studies reported improvements in some stroke-recovery scores. The studies have design weaknesses, and the 2018 study did not show a significant improvement in recovery from limb weakness.
Who was studied, and how were the groups assigned?
The 2018 Russian study enrolled 110 adults in early or late post-stroke rehabilitation and reports random allocation within each timing cohort to rehabilitation with or without Semax. It does not describe the randomization method, allocation concealment, or masking, and the late-rehabilitation subgroups differed in time since stroke at baseline.
All participants received rehabilitation. Semax was given intranasally at 6,000 micrograms a day for 10 days, repeated after a 20-day break. The Semax groups accumulated more of their eventual Barthel-index gain in the first month, 78.5% in early rehabilitation and 62.4% in late rehabilitation, versus 43.8% and 21.9% without Semax. Paresis recovery did not significantly differ between Semax and control subgroups.
A 1997 Russian full report compared 30 acute-stroke Semax recipients with 80 nonrandom controls. Day-6 neurologic-scale changes favored Semax on several measures, but by day 21 the reported acceleration was no longer statistically significant. All groups received other intensive care, and the small, nonrandom comparison used several endpoints.
2018 Russian stroke study · full report
Comparative clinical study
Gusev et al., Zhurnal Nevrologii i Psikhiatrii, 2018
Among 110 adults, Semax subgroups accumulated more Barthel-index improvement in the first month, while Semax did not significantly change paresis recovery versus rehabilitation alone.
- Random allocation was reported, but the method and masking were not.
- The late-rehabilitation Semax and control subgroups differed in time since stroke at baseline.
- Participants / model
- 110 adults after ischemic stroke, 60 in early and 50 in late rehabilitation
- Treatment
- Standard rehabilitation with or without intranasal Semax 6,000 micrograms daily in two 10-day courses
- Follow-up
- Five months, with visits at baseline and months 1, 2, and 5
- Study design
- Russian-language full report of a randomized comparative study; allocation details and masking not reported
Barthel-index and blood-BDNF findings do not establish neural repair.
Read the original source1997 Russian acute-stroke study · full report
Nonrandom comparative clinical study
Skvortsova et al., Nevrologicheskii Vestnik, 1997
The 30-patient Semax group showed faster early neurologic-scale improvement than 80 controls, but the reported acceleration was not significant by day 21.
- Participants / model
- 30 adults treated with Semax during acute ischemic stroke, compared nonrandomly with 80 controls
- Treatment
- Intranasal Semax 12, 18, or 24 mg daily for five days plus standard intensive care versus standard care
- Follow-up
- 21 days
- Study design
- Russian-language full report of a small, nonrandom, multi-endpoint comparison
All groups received other care, and the paper also discussed separate neurotrophic comparator cohorts. The result is not a modern confirmatory stroke trial.
Read the original sourceDid Semax improve vision in controlled trials?
A small Russian comparison reported visual-acuity improvements, but it did not randomly assign treatment or mask the groups. It cannot establish a reliable treatment benefit for optic-nerve disease.
How were patients and affected eyes counted?
The 2000 Russian full report included 74 patients and 98 affected eyes with mixed optic-nerve disorders. Treatment route determined the groups rather than random assignment: 25 patients received nasal drops, 29 received endonasal electrophoresis, and 20 received background therapy without Semax.
Positive visual-acuity change was reported in 83.9% of eyes with nasal drops, 92.1% with electrophoresis, and 68.9% in control. The active-versus-control comparison was only reported at P<0.1, both eyes from one person could enter the analysis, diagnoses and background care varied, and there was no masking.
2000 Russian optic study · full report
Nonrandom comparative clinical study
Polunin et al., Vestnik Oftalmologii, 2000
Positive visual-acuity change was reported in 83.9% of nasal-drop eyes, 92.1% of electrophoresis eyes, and 68.9% of control eyes.
- Participants / model
- 74 patients, 98 eyes, with mixed vascular, inflammatory, toxic-allergic, or atrophic optic-nerve disease
- Treatment
- Semax nasal drops or endonasal electrophoresis plus background treatment versus background treatment alone
- Follow-up
- Five days to two weeks for drops; seven to ten days for electrophoresis
- Study design
- Russian-language full report of a nonrandom, route-defined comparison
The publication is hosted by the product manufacturer. Analyses at eye level, mixed diagnoses, concurrent therapy, no masking, and a weak between-group significance threshold limit inference.
Read the original sourceHas Semax been shown to improve cognition in healthy people?
A human imaging study measured resting-state functional connectivity 5 and 20 minutes after Semax, Selank, or placebo in 52 healthy participants. It did not test durable memory, work performance, dementia prevention, or clinical benefit.
The study measured functional connectivity, not memory, attention, daily function, or clinical benefit.
Semax and Selank fMRI · scan endpoint
Human imaging study
Panikratova et al., Doklady Biological Sciences, 2020
The 52-person study found short-term between-group differences in resting-state connectivity after Semax, Selank, or placebo.
- Participants / model
- Healthy participants
- Treatment
- Semax, Selank, or placebo before serial resting-state fMRI
- Follow-up
- 20 minutes after administration
- Study design
- Placebo-comparison imaging study
Connectivity changes are not cognitive-performance or clinical outcomes.
Read the original sourceDoes Semax raise human BDNF within 30 minutes for more than a day?
No human study has demonstrated a rapid, lasting rise in brain BDNF after Semax. The stroke study measured blood BDNF during rehabilitation; rapid brain-expression findings come from animal or cell experiments.
Plasma BDNF is also a biomarker, not proof that a peptide repaired neurons or improved cognition by that mechanism.
2018 Russian stroke study · full report
Comparative clinical study
Gusev et al., Zhurnal Nevrologii i Psikhiatrii, 2018
Among 110 adults, Semax subgroups accumulated more Barthel-index improvement in the first month, while Semax did not significantly change paresis recovery versus rehabilitation alone.
- Random allocation was reported, but the method and masking were not.
- The late-rehabilitation Semax and control subgroups differed in time since stroke at baseline.
- Participants / model
- 110 adults after ischemic stroke, 60 in early and 50 in late rehabilitation
- Treatment
- Standard rehabilitation with or without intranasal Semax 6,000 micrograms daily in two 10-day courses
- Follow-up
- Five months, with visits at baseline and months 1, 2, and 5
- Study design
- Russian-language full report of a randomized comparative study; allocation details and masking not reported
Barthel-index and blood-BDNF findings do not establish neural repair.
Read the original sourceWhat is known about Semax safety and product quality?
The Russian 0.1% product instruction lists hypersensitivity, pregnancy, breastfeeding, acute psychiatric states, anxiety disorders, seizure history, and age restrictions as contraindications. It says prolonged use may cause mild nasal-mucosa irritation. Those label statements do not supply a large comparative safety database.
The same older instruction allows some pediatric use from age 7 but excludes patients under 18 in ophthalmology and neurosurgery. That product-specific wording must not be generalized to another concentration, salt, online vial, or country.
FDA staff separately identified insufficient safety characterization, potential immunogenicity, and uncertainty about compounded intranasal products in its 2026 review.
Semax 0.1% instruction · contraindications and route
Manufacturer-hosted Russian product instruction
INPC Peptogen, registration ЛС-002553 dated December 30, 2011
The instruction defines a prescription 0.1% intranasal product, its named Russian uses, contraindications, and possible mild nasal irritation with prolonged use.
- Participants / model
- People covered by the named Russian 0.1% nasal-drop instruction
- Treatment
- Semax 0.1% prescription nasal drops
- Follow-up
- Label dated 2011; current status not established by this file
- Study design
- Russian-language product instruction hosted by the manufacturer
This older product instruction is not the current 2025 registration file and does not validate a different salt, concentration, or online product.
Read the original sourceFDA Semax review · identity, approval, evidence
FDA compounding review
U.S. Food and Drug Administration, July 2026
FDA found no Semax component in an approved drug and identified identity, device, safety, immunogenicity, and effectiveness concerns.
- Participants / model
- Semax free base and Semax acetate proposed for U.S. compounding
- Treatment
- Intranasal nominated uses
- Follow-up
- Agency review through July 2026
- Study design
- Regulatory evidence review
This is a compounding-list evaluation, not a clinical trial or approval decision.
Read the original sourcePCAC · recommendation against 503A listing
FDA advisory presentation
U.S. Food and Drug Administration, July 24, 2026
FDA staff concluded that the balancing criteria weighed against adding Semax free base or acetate to the 503A bulks list.
- Participants / model
- Semax bulk substances proposed for compounding
- Treatment
- Proposed compounded intranasal products
- Follow-up
- July 2026 review
- Study design
- FDA advisory-committee material
The committee process does not create an FDA-approved drug.
Read the original sourceStudies and sources
FDA Semax review · identity, approval, evidence
FDA compounding review
U.S. Food and Drug Administration, July 2026
FDA found no Semax component in an approved drug and identified identity, device, safety, immunogenicity, and effectiveness concerns.
- Participants / model
- Semax free base and Semax acetate proposed for U.S. compounding
- Treatment
- Intranasal nominated uses
- Follow-up
- Agency review through July 2026
- Study design
- Regulatory evidence review
This is a compounding-list evaluation, not a clinical trial or approval decision.
Read the original sourcePCAC · recommendation against 503A listing
FDA advisory presentation
U.S. Food and Drug Administration, July 24, 2026
FDA staff concluded that the balancing criteria weighed against adding Semax free base or acetate to the 503A bulks list.
- Participants / model
- Semax bulk substances proposed for compounding
- Treatment
- Proposed compounded intranasal products
- Follow-up
- July 2026 review
- Study design
- FDA advisory-committee material
The committee process does not create an FDA-approved drug.
Read the original source2018 Russian stroke study · full report
Comparative clinical study
Gusev et al., Zhurnal Nevrologii i Psikhiatrii, 2018
Among 110 adults, Semax subgroups accumulated more Barthel-index improvement in the first month, while Semax did not significantly change paresis recovery versus rehabilitation alone.
- Random allocation was reported, but the method and masking were not.
- The late-rehabilitation Semax and control subgroups differed in time since stroke at baseline.
- Participants / model
- 110 adults after ischemic stroke, 60 in early and 50 in late rehabilitation
- Treatment
- Standard rehabilitation with or without intranasal Semax 6,000 micrograms daily in two 10-day courses
- Follow-up
- Five months, with visits at baseline and months 1, 2, and 5
- Study design
- Russian-language full report of a randomized comparative study; allocation details and masking not reported
Barthel-index and blood-BDNF findings do not establish neural repair.
Read the original source2000 Russian optic study · full report
Nonrandom comparative clinical study
Polunin et al., Vestnik Oftalmologii, 2000
Positive visual-acuity change was reported in 83.9% of nasal-drop eyes, 92.1% of electrophoresis eyes, and 68.9% of control eyes.
- Participants / model
- 74 patients, 98 eyes, with mixed vascular, inflammatory, toxic-allergic, or atrophic optic-nerve disease
- Treatment
- Semax nasal drops or endonasal electrophoresis plus background treatment versus background treatment alone
- Follow-up
- Five days to two weeks for drops; seven to ten days for electrophoresis
- Study design
- Russian-language full report of a nonrandom, route-defined comparison
The publication is hosted by the product manufacturer. Analyses at eye level, mixed diagnoses, concurrent therapy, no masking, and a weak between-group significance threshold limit inference.
Read the original sourceSemax and Selank fMRI · scan endpoint
Human imaging study
Panikratova et al., Doklady Biological Sciences, 2020
The 52-person study found short-term between-group differences in resting-state connectivity after Semax, Selank, or placebo.
- Participants / model
- Healthy participants
- Treatment
- Semax, Selank, or placebo before serial resting-state fMRI
- Follow-up
- 20 minutes after administration
- Study design
- Placebo-comparison imaging study
Connectivity changes are not cognitive-performance or clinical outcomes.
Read the original source1997 Russian acute-stroke study · full report
Nonrandom comparative clinical study
Skvortsova et al., Nevrologicheskii Vestnik, 1997
The 30-patient Semax group showed faster early neurologic-scale improvement than 80 controls, but the reported acceleration was not significant by day 21.
- Participants / model
- 30 adults treated with Semax during acute ischemic stroke, compared nonrandomly with 80 controls
- Treatment
- Intranasal Semax 12, 18, or 24 mg daily for five days plus standard intensive care versus standard care
- Follow-up
- 21 days
- Study design
- Russian-language full report of a small, nonrandom, multi-endpoint comparison
All groups received other care, and the paper also discussed separate neurotrophic comparator cohorts. The result is not a modern confirmatory stroke trial.
Read the original sourceSemax Russia status · 2025 replacement record
Russian drug-registration record
Pharm-Portal. GRLS-derived record for Semax 1% nasal drops, registration ЛП-№(010596)-(РГ-RU), registered June 18, 2025.
Lists Semax 1% nasal drops as active under ЛП-№(010596)-(РГ-RU), registered June 18, 2025 with an indefinite term.
- Participants / model
- Russian prescription-drug registration
- Treatment
- Semax 1% nasal drops by INPC Peptogen
- Study design
- Russian medicine registration listing
Semax 0.1% instruction · contraindications and route
Manufacturer-hosted Russian product instruction
INPC Peptogen, registration ЛС-002553 dated December 30, 2011
The instruction defines a prescription 0.1% intranasal product, its named Russian uses, contraindications, and possible mild nasal irritation with prolonged use.
- Participants / model
- People covered by the named Russian 0.1% nasal-drop instruction
- Treatment
- Semax 0.1% prescription nasal drops
- Follow-up
- Label dated 2011; current status not established by this file
- Study design
- Russian-language product instruction hosted by the manufacturer
This older product instruction is not the current 2025 registration file and does not validate a different salt, concentration, or online product.
Read the original sourceWhy is Semax in B tier?
The B tier reflects small human stroke and optic-nerve studies plus a Russian prescription-drug history. The trials do not meet modern pivotal standards, establish healthy-person enhancement, or validate U.S. compounded products.