Noopept (omberacetam; GVS-111)
Noopept is omberacetam, a small molecule sold as a registered 10 mg tablet in Russia. In a 53-patient study of vascular or post-traumatic disorders, Noopept and piracetam groups improved, and some subgroup clinician ratings favored Noopept. The study had no placebo group, and two 20-person healthy-volunteer reports do not establish reliable cognitive enhancement.
Synthetic proline-glycine small molecule
- Small molecule, not an amino-acid-chain peptide
- Russian tablet evidence does not authenticate an online supplement
- Healthy-person evidence consists of two reports with 20 participants each
Is Noopept actually a peptide?
No. Omberacetam is a defined chemical substance, N-phenylacetyl-L-prolylglycine ethyl ester. It contains a proline-glycine-derived scaffold, but FDA's substance record classifies it as a chemical and gives molecular formula C17H22N2O4 and molecular weight 318.37.
Noopept is a product name; omberacetam is the nonproprietary substance name. GVS-111 is a development synonym. A substance identity entry does not mean FDA approved the substance as a drug.
FDA GSRS · chemical identity
Official substance identity record
U.S. Food and Drug Administration, Global Substance Registration System
The record classifies omberacetam as a chemical, gives formula C17H22N2O4, molecular weight 318.37, CAS 157115-85-0, UNII 4QBJ98683M, and the systematic name N-phenylacetyl-L-prolylglycine ethyl ester.
- Synonyms include Noopept and GVS-111.
- A UNII identifies a substance; it is not an approval record.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Official chemical-substance registry
The GSRS record establishes chemical identity; it does not establish efficacy or safety.
Read the original sourceWhat is Noopept's current status in Russia and the United States?
Current Russian manufacturer materials describe Noopept as a registered 10 mg omberacetam tablet under ЛП-N(004920)-(РГ-RU), dated March 20, 2024. The registration claim comes from manufacturer materials; the cited evidence does not include a regulator record.
The Russian product indication covers adults with specified cognitive or emotional-lability disorders associated with traumatic brain injury, postconcussion syndrome, vascular cerebral insufficiency, encephalopathy, asthenia, or related loss of intellectual productivity. It is not a general authorization for healthy-person memory enhancement.
The cited Drugs@FDA records list no match for Noopept, omberacetam, or GVS-111 in brand or active-ingredient fields. A 2019 FDA warning letter told one U.S. seller that its named Noopept product was not a dietary supplement and was marketed as an unapproved new drug.
Official product PDF · indication, PK, safety
Manufacturer-hosted current product characteristics
OTCPharm, General Characteristics of the Medicinal Product, omberacetam 10 mg tablets
The Russian-language document gives the adult indication, 15-minute mean Tmax, 0.38-hour plasma half-life, named metabolites, contraindications, frequency-unknown adverse reactions, interaction wording, and a statement that withdrawal was not observed.
- Contraindications include pregnancy, breastfeeding, age under 18, severe liver or kidney impairment, hypersensitivity, and lactose-related restrictions.
- Frequency-unknown adverse reactions are allergic reaction and blood-pressure elevation in people with hypertension, especially severe hypertension.
- Participants / model
- Adults covered by the Russian product characteristics
- Treatment
- Noopept 10 mg omberacetam tablets
- Follow-up
- Product characteristics, not a single trial
- Study design
- Regulatory product document hosted by the manufacturer
- Funding
- OTCPharm
The manufacturer-hosted product characteristics provide the label statements; they do not supply the underlying human study results.
Read the original sourceManufacturer site · 2024 registration
Manufacturer product information
OTCPharm. Noopept product site.
The site identifies Noopept as omberacetam 10 mg tablets and displays registration ЛП-N(004920)-(РГ-RU), dated March 20, 2024.
- Participants / model
- Russian Noopept product
- Treatment
- Omberacetam 10 mg tablets
- Study design
- Manufacturer website
- Funding
- OTCPharm
Russian registration status is stated in manufacturer materials rather than a regulator record.
Read the original sourceDrugs@FDA · no exact-name match
FDA drug records
Drugs@FDA records for Noopept, omberacetam, and GVS-111.
Drugs@FDA listed no matching brand-name or active-ingredient record for Noopept, omberacetam, or GVS-111.
- Participants / model
- Drugs@FDA application records
- Treatment
- Exact-name aliases Noopept, omberacetam, and GVS-111
FDA 2019 letter · named Noopept product
Official enforcement letter
U.S. Food and Drug Administration, February 5, 2019
FDA said the seller's Noopept product did not meet the statutory definition of a dietary supplement and that disease and structure/function claims made it an unapproved and misbranded new drug.
- Participants / model
- Products and marketing claims named in the letter
- Treatment
- Noopept sold by Peak Nootropics
- Follow-up
- Inspection and enforcement record issued in 2019
- Study design
- FDA enforcement document
The letter is seller- and claim-specific; it is not a clinical study or a blanket assay of all products.
Read the original sourceWhat exactly did the 53-patient comparison show?
Both groups improved; the authors called the nootropic effects comparable, reported some subgroup clinician-rating advantages for Noopept, and reported undesirable effects 1.8-fold less often. The study compared Noopept with piracetam in patients with vascular or post-traumatic disorders, without placebo or healthy volunteers.
The full English translation describes 53 randomized patients: 31 assigned to Noopept 20 mg a day and 22 to piracetam 1,200 mg a day for 56 days. Thirty-seven patients had vascular-origin disorders and 16 had postconcussion syndrome. The paper does not describe how the random sequence was generated, allocation was concealed, or assessors were masked.
Forty-one patients completed. In the Noopept group, four vascular-disease patients stopped: one moved away, two had blood-pressure increases requiring antihypertensive treatment, and one reported no benefit. In the piracetam group, eight stopped across the two diagnostic groups, including adverse effects and lack of efficacy.
Small subgroups, missing placebo, unclear masking, and unequal attrition prevent the study from showing how much improvement came from either drug or whether Noopept helps healthy people.
53-patient comparison · no placebo or healthy group
Randomized active-comparator trial
Neznamov GG, Teleshova ES. Neuroscience and Behavioral Physiology. 2009;39(3):311-321
Among 53 patients assigned to Noopept or piracetam for 56 days, the authors reported cognitive and clinical improvement in both groups, comparable nootropic effects, stronger Noopept CGI results in some subgroups, and 1.8-fold fewer undesirable effects. Only 41 completed, there was no placebo, and the paper does not describe randomization or masking methods.
- Noopept: 31 assigned, 20 mg/day. Piracetam: 22 assigned, 1,200 mg/day.
- Two Noopept recipients stopped because blood pressure increased and required antihypertensive treatment.
- Participants / model
- 37 patients with vascular-origin organic emotional-lability or asthenic disorder and 16 with postconcussion syndrome
- Treatment
- Noopept 20 mg/day versus piracetam 1,200 mg/day
- Follow-up
- 56 days
- Study design
- Randomized comparative study with active comparator and no placebo; randomization and masking methods not reported
Small diagnostic subgroups and unequal attrition limit comparison.
Read the original sourceWhat evidence exists in healthy volunteers?
Two small reports involved healthy volunteers, each with 20 people. One was a placebo-controlled conference abstract and the other was an uncontrolled Russian before-and-after report. Neither gives a dependable estimate of cognitive benefit.
What did the placebo-controlled abstract report?
Conference abstract P.4.E.052 describes 20 healthy men, 10 given oral DVD-111 at 20 mg a day for 13 days and 10 given placebo in a double-blind comparison. The authors reported favorable changes across spatial and logical thinking, attention, task speed, fine motor accuracy, reaction latency, and memory, with no side effects reported. The abstract gives no effect sizes, numerical outcome table, randomization method, multiplicity plan, or follow-up.
20-man placebo abstract · many unquantified outcomes
Double-blind placebo-controlled conference abstract
International Journal of Neuropsychopharmacology. Volume 5, Supplement 1, abstract P.4.E.052
The abstract describes 10 healthy men receiving oral DVD-111 at 20 mg/day for 13 days and 10 receiving placebo. It reports favorable changes across several cognitive and motor tasks and no side effects, but provides no numerical effect sizes, outcome table, randomization details, or multiplicity analysis.
- Participants / model
- 20 healthy men
- Treatment
- DVD-111 20 mg/day, 10 participants, versus placebo, 10 participants
- Follow-up
- 13 days
- Study design
- Double-blind placebo-controlled phase I conference abstract
The conference abstract provides no author metadata or numerical outcomes.
Read the original sourceWhat did the Russian student report find?
A 2017 Russian conference-proceedings report measured the same 20 volunteers before and after one month of 20 mg a day. It reported short-term memory index rising from 40.0% to 62.2%, working memory from 29.3% to 36.2%, and long-term memory from 25.4% to 34.9%, with P<0.05 markers. Information-coding index and elementary-thinking speed did not change significantly. There was no placebo group, no masking, and no adverse-event reporting.
Russian n=20 report · uncontrolled before and after
Uncontrolled conference-proceedings report
Slobodenyuk TF. OPEN INNOVATION international conference proceedings. 2017:166-168
Twenty healthy volunteers took 10 mg twice daily for one month. The report found higher short-term, working, and long-term memory indices after treatment, but no significant change in information coding or elementary-thinking speed.
- Short-term memory index was 40.0% before and 62.2% after treatment; working memory was 29.3% and 36.2%; long-term memory was 25.4% and 34.9%, with P<0.05 markers.
- There was no concurrent control group, masking, or adverse-event account.
- Participants / model
- 20 healthy volunteers described as students
- Treatment
- Noopept 10 mg twice daily
- Follow-up
- One month
- Study design
- Uncontrolled before-and-after cognitive testing
In this Russian report, "control" means each participant's pretreatment result, not a separate placebo group.
Read the original sourceThe controlled report is only an abstract with many tested outcomes, while the full Russian report is vulnerable to practice effects and expectation because it reused cognitive tests without a concurrent comparator. Neither is a replicated healthy-person efficacy program.
Does Russian tablet evidence apply to U.S. Noopept supplements?
No product equivalence has been shown. The clinical studies tested specified oral drug products, while a U.S. assay found undeclared drugs and inaccurate label quantities across a targeted sample of cognitive-enhancement supplements.
Researchers bought 10 products in 2019 after searching two supplement databases for five unapproved cognitive-enhancement drugs. Testing found up to four unapproved drugs in one product, nine of 12 declared quantities were inaccurate, and the maximum omberacetam amount was 40.6 mg per recommended serving. This targeted sample does not describe every product, but it shows that the name on a supplement label cannot establish identity, dose, or equivalence to the Russian 10 mg tablet.
U.S. supplement assay · undeclared drugs and wrong quantities
Targeted laboratory survey
Cohen PA, et al. Neurology: Clinical Practice. 2021;11(3):e303-e307
In 10 products bought in 2019, laboratory testing identified unapproved drugs including omberacetam, up to four unapproved drugs per product, and inaccurate quantities for nine of 12 drugs whose amounts were declared. The maximum omberacetam quantity was 40.6 ± 0.4 mg per recommended serving.
- Participants / model
- 10 cognitive-enhancement supplements found through two U.S. supplement databases
- Treatment
- Product analysis, not human exposure
- Follow-up
- Products selected and purchased in 2019
- Study design
- Targeted LC-QTOF mass-spectrometry assay
This targeted sample demonstrates possible identity and quantity failures; it is not a prevalence estimate for every Noopept product.
Read the original sourceFDA 2019 letter · named Noopept product
Official enforcement letter
U.S. Food and Drug Administration, February 5, 2019
FDA said the seller's Noopept product did not meet the statutory definition of a dietary supplement and that disease and structure/function claims made it an unapproved and misbranded new drug.
- Participants / model
- Products and marketing claims named in the letter
- Treatment
- Noopept sold by Peak Nootropics
- Follow-up
- Inspection and enforcement record issued in 2019
- Study design
- FDA enforcement document
The letter is seller- and claim-specific; it is not a clinical study or a blanket assay of all products.
Read the original sourceHow well are Noopept pharmacokinetics, adverse effects, and interactions defined?
The Russian label reports a mean 15-minute time to peak and a 0.38-hour parent-drug plasma half-life. Human data do not establish a dosing interval, cognitive-effect duration, or metabolite half-life.
A 2005 conference abstract describes a 10 mg oral test dose in patients with vascular or traumatic cognitive disorders. It reports that most reached maximum plasma concentration at 15 minutes, parent drug was detected through 45 minutes, and mean elimination half-time was 22.05 ± 14.37 minutes. It omits the human sample size and detailed concentration-time results. A separate 2004 abstract emphasizes considerable individual variability.
The current Russian label lists allergic reaction and blood-pressure elevation in people with hypertension, especially severe hypertension, with frequency unknown. It contraindicates use during pregnancy or breastfeeding, under age 18, with severe liver or kidney impairment, or with hypersensitivity. The tablets contain lactose.
The label says no interaction was established with alcohol, hypnotics, antihypertensives, or psychostimulants. That wording does not document a comprehensive interaction program. The 53-patient comparison reported worsened sleep, irritability, and increased blood pressure among Noopept recipients, including two discontinuations for blood-pressure increases.
The label also says withdrawal was not observed. The controlled trial lasted eight weeks, so this does not settle dependence, withdrawal after longer use, reproductive safety in humans, or chronic toxicity.
Official product PDF · indication, PK, safety
Manufacturer-hosted current product characteristics
OTCPharm, General Characteristics of the Medicinal Product, omberacetam 10 mg tablets
The Russian-language document gives the adult indication, 15-minute mean Tmax, 0.38-hour plasma half-life, named metabolites, contraindications, frequency-unknown adverse reactions, interaction wording, and a statement that withdrawal was not observed.
- Contraindications include pregnancy, breastfeeding, age under 18, severe liver or kidney impairment, hypersensitivity, and lactose-related restrictions.
- Frequency-unknown adverse reactions are allergic reaction and blood-pressure elevation in people with hypertension, especially severe hypertension.
- Participants / model
- Adults covered by the Russian product characteristics
- Treatment
- Noopept 10 mg omberacetam tablets
- Follow-up
- Product characteristics, not a single trial
- Study design
- Regulatory product document hosted by the manufacturer
- Funding
- OTCPharm
The manufacturer-hosted product characteristics provide the label statements; they do not supply the underlying human study results.
Read the original sourceHuman PK abstract · 10 mg oral test dose
Conference pharmacokinetic abstract
Bojko SS. European Neuropsychopharmacology. 2005;15:S222-S223
After a 10 mg oral test dose in patients with vascular or traumatic cognitive disorders, most reached peak parent-drug concentration at 15 minutes, plasma detection continued through 45 minutes, and mean elimination half-time was 22.05 ± 14.37 minutes.
- Participants / model
- Patients with cognitive disorders of vascular or traumatic origin; the abstract does not state the sample size
- Treatment
- Single oral 10 mg test dose, tablet or capsule formulations
- Follow-up
- Sampling reported through 45 minutes
- Study design
- HPLC pharmacokinetic conference abstract
The abstract omits the human sample size, detailed concentration-time data, and metabolite half-lives.
Read the original sourceComparative PK abstract · human variability
Indexed comparative pharmacokinetic abstract
Boiko SS, et al. Eksperimental'naia i Klinicheskaia Farmakologiia. 2004;67(1):40-43
The abstract reports slower elimination from rat to rabbit to human and considerable individual variability in humans. It does not give a numerical human half-life.
- Participants / model
- Rats, rabbits, and humans
- Treatment
- GVS-111 exposure; the abstract does not state the human dose
- Follow-up
- Single-dose pharmacokinetic work
- Study design
- Interspecies pharmacokinetic study reported in abstract form
The abstract reports no numerical human half-life.
Read the original source53-patient comparison · no placebo or healthy group
Randomized active-comparator trial
Neznamov GG, Teleshova ES. Neuroscience and Behavioral Physiology. 2009;39(3):311-321
Among 53 patients assigned to Noopept or piracetam for 56 days, the authors reported cognitive and clinical improvement in both groups, comparable nootropic effects, stronger Noopept CGI results in some subgroups, and 1.8-fold fewer undesirable effects. Only 41 completed, there was no placebo, and the paper does not describe randomization or masking methods.
- Noopept: 31 assigned, 20 mg/day. Piracetam: 22 assigned, 1,200 mg/day.
- Two Noopept recipients stopped because blood pressure increased and required antihypertensive treatment.
- Participants / model
- 37 patients with vascular-origin organic emotional-lability or asthenic disorder and 16 with postconcussion syndrome
- Treatment
- Noopept 20 mg/day versus piracetam 1,200 mg/day
- Follow-up
- 56 days
- Study design
- Randomized comparative study with active comparator and no placebo; randomization and masking methods not reported
Small diagnostic subgroups and unequal attrition limit comparison.
Read the original sourceDo NGF, BDNF, or cycloprolylglycine explain a human effect?
No human target mechanism has been established. The familiar NGF and BDNF explanation comes from animal experiments, and a later rat study under different conditions did not reproduce a hippocampal NGF or BDNF increase.
A Russian rat study reported higher hippocampal NGF and BDNF messenger RNA after acute and 28-day Noopept exposure. Another study divided 60 prepubertal male rats into six groups and found no spatial-learning or hippocampal NGF or BDNF difference after 14 days of 0.5 mg/kg intraperitoneal Noopept. The models, ages, disease conditions, routes, and doses differ, so the second experiment is context for uncertainty rather than a direct replication.
The label describes phenylacetic acid, phenylacetylproline, and cycloprolylglycine as metabolites and attributes activity to several pathways. Metabolite formation and animal gene-expression findings do not show which target, if any, mediates a clinical effect in people.
Rat study · hippocampal transcript changes
Preclinical animal study
Ostrovskaya RU, et al. Bulletin of Experimental Biology and Medicine. 2008
The rat experiment reported increased hippocampal NGF and BDNF messenger RNA after acute exposure and after a 28-day course.
- Participants / model
- Rats
- Treatment
- Noopept under experimental conditions
- Follow-up
- Acute and 28-day experiments
- Study design
- Preclinical gene-expression study
Gene-expression changes in rat hippocampus do not establish a human clinical mechanism.
Read the original sourceRat study · no learning or neurotrophin difference
Preclinical animal study
Karabulut S, et al. Behavioural Brain Research. 2019
Across six groups of 10 prepubertal male rats, the investigators found no difference in spatial learning or hippocampal NGF and BDNF after 14 days of intraperitoneal Noopept under the tested conditions.
- Participants / model
- 60 prepubertal male rats, including healthy and diabetic groups
- Treatment
- Noopept 0.5 mg/kg intraperitoneally
- Follow-up
- 14 days
- Study design
- Controlled preclinical animal experiment
Different age, disease models, route, and dose mean this is not a direct replication of the earlier rat study.
Read the original sourceOfficial product PDF · indication, PK, safety
Manufacturer-hosted current product characteristics
OTCPharm, General Characteristics of the Medicinal Product, omberacetam 10 mg tablets
The Russian-language document gives the adult indication, 15-minute mean Tmax, 0.38-hour plasma half-life, named metabolites, contraindications, frequency-unknown adverse reactions, interaction wording, and a statement that withdrawal was not observed.
- Contraindications include pregnancy, breastfeeding, age under 18, severe liver or kidney impairment, hypersensitivity, and lactose-related restrictions.
- Frequency-unknown adverse reactions are allergic reaction and blood-pressure elevation in people with hypertension, especially severe hypertension.
- Participants / model
- Adults covered by the Russian product characteristics
- Treatment
- Noopept 10 mg omberacetam tablets
- Follow-up
- Product characteristics, not a single trial
- Study design
- Regulatory product document hosted by the manufacturer
- Funding
- OTCPharm
The manufacturer-hosted product characteristics provide the label statements; they do not supply the underlying human study results.
Read the original sourceStudies and sources
FDA GSRS · chemical identity
Official substance identity record
U.S. Food and Drug Administration, Global Substance Registration System
The record classifies omberacetam as a chemical, gives formula C17H22N2O4, molecular weight 318.37, CAS 157115-85-0, UNII 4QBJ98683M, and the systematic name N-phenylacetyl-L-prolylglycine ethyl ester.
- Synonyms include Noopept and GVS-111.
- A UNII identifies a substance; it is not an approval record.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Official chemical-substance registry
The GSRS record establishes chemical identity; it does not establish efficacy or safety.
Read the original sourceManufacturer site · 2024 registration
Manufacturer product information
OTCPharm. Noopept product site.
The site identifies Noopept as omberacetam 10 mg tablets and displays registration ЛП-N(004920)-(РГ-RU), dated March 20, 2024.
- Participants / model
- Russian Noopept product
- Treatment
- Omberacetam 10 mg tablets
- Study design
- Manufacturer website
- Funding
- OTCPharm
Russian registration status is stated in manufacturer materials rather than a regulator record.
Read the original sourceOfficial product PDF · indication, PK, safety
Manufacturer-hosted current product characteristics
OTCPharm, General Characteristics of the Medicinal Product, omberacetam 10 mg tablets
The Russian-language document gives the adult indication, 15-minute mean Tmax, 0.38-hour plasma half-life, named metabolites, contraindications, frequency-unknown adverse reactions, interaction wording, and a statement that withdrawal was not observed.
- Contraindications include pregnancy, breastfeeding, age under 18, severe liver or kidney impairment, hypersensitivity, and lactose-related restrictions.
- Frequency-unknown adverse reactions are allergic reaction and blood-pressure elevation in people with hypertension, especially severe hypertension.
- Participants / model
- Adults covered by the Russian product characteristics
- Treatment
- Noopept 10 mg omberacetam tablets
- Follow-up
- Product characteristics, not a single trial
- Study design
- Regulatory product document hosted by the manufacturer
- Funding
- OTCPharm
The manufacturer-hosted product characteristics provide the label statements; they do not supply the underlying human study results.
Read the original sourceDrugs@FDA · no exact-name match
FDA drug records
Drugs@FDA records for Noopept, omberacetam, and GVS-111.
Drugs@FDA listed no matching brand-name or active-ingredient record for Noopept, omberacetam, or GVS-111.
- Participants / model
- Drugs@FDA application records
- Treatment
- Exact-name aliases Noopept, omberacetam, and GVS-111
FDA 2019 letter · named Noopept product
Official enforcement letter
U.S. Food and Drug Administration, February 5, 2019
FDA said the seller's Noopept product did not meet the statutory definition of a dietary supplement and that disease and structure/function claims made it an unapproved and misbranded new drug.
- Participants / model
- Products and marketing claims named in the letter
- Treatment
- Noopept sold by Peak Nootropics
- Follow-up
- Inspection and enforcement record issued in 2019
- Study design
- FDA enforcement document
The letter is seller- and claim-specific; it is not a clinical study or a blanket assay of all products.
Read the original source53-patient comparison · no placebo or healthy group
Randomized active-comparator trial
Neznamov GG, Teleshova ES. Neuroscience and Behavioral Physiology. 2009;39(3):311-321
Among 53 patients assigned to Noopept or piracetam for 56 days, the authors reported cognitive and clinical improvement in both groups, comparable nootropic effects, stronger Noopept CGI results in some subgroups, and 1.8-fold fewer undesirable effects. Only 41 completed, there was no placebo, and the paper does not describe randomization or masking methods.
- Noopept: 31 assigned, 20 mg/day. Piracetam: 22 assigned, 1,200 mg/day.
- Two Noopept recipients stopped because blood pressure increased and required antihypertensive treatment.
- Participants / model
- 37 patients with vascular-origin organic emotional-lability or asthenic disorder and 16 with postconcussion syndrome
- Treatment
- Noopept 20 mg/day versus piracetam 1,200 mg/day
- Follow-up
- 56 days
- Study design
- Randomized comparative study with active comparator and no placebo; randomization and masking methods not reported
Small diagnostic subgroups and unequal attrition limit comparison.
Read the original source20-man placebo abstract · many unquantified outcomes
Double-blind placebo-controlled conference abstract
International Journal of Neuropsychopharmacology. Volume 5, Supplement 1, abstract P.4.E.052
The abstract describes 10 healthy men receiving oral DVD-111 at 20 mg/day for 13 days and 10 receiving placebo. It reports favorable changes across several cognitive and motor tasks and no side effects, but provides no numerical effect sizes, outcome table, randomization details, or multiplicity analysis.
- Participants / model
- 20 healthy men
- Treatment
- DVD-111 20 mg/day, 10 participants, versus placebo, 10 participants
- Follow-up
- 13 days
- Study design
- Double-blind placebo-controlled phase I conference abstract
The conference abstract provides no author metadata or numerical outcomes.
Read the original sourceRussian n=20 report · uncontrolled before and after
Uncontrolled conference-proceedings report
Slobodenyuk TF. OPEN INNOVATION international conference proceedings. 2017:166-168
Twenty healthy volunteers took 10 mg twice daily for one month. The report found higher short-term, working, and long-term memory indices after treatment, but no significant change in information coding or elementary-thinking speed.
- Short-term memory index was 40.0% before and 62.2% after treatment; working memory was 29.3% and 36.2%; long-term memory was 25.4% and 34.9%, with P<0.05 markers.
- There was no concurrent control group, masking, or adverse-event account.
- Participants / model
- 20 healthy volunteers described as students
- Treatment
- Noopept 10 mg twice daily
- Follow-up
- One month
- Study design
- Uncontrolled before-and-after cognitive testing
In this Russian report, "control" means each participant's pretreatment result, not a separate placebo group.
Read the original sourceU.S. supplement assay · undeclared drugs and wrong quantities
Targeted laboratory survey
Cohen PA, et al. Neurology: Clinical Practice. 2021;11(3):e303-e307
In 10 products bought in 2019, laboratory testing identified unapproved drugs including omberacetam, up to four unapproved drugs per product, and inaccurate quantities for nine of 12 drugs whose amounts were declared. The maximum omberacetam quantity was 40.6 ± 0.4 mg per recommended serving.
- Participants / model
- 10 cognitive-enhancement supplements found through two U.S. supplement databases
- Treatment
- Product analysis, not human exposure
- Follow-up
- Products selected and purchased in 2019
- Study design
- Targeted LC-QTOF mass-spectrometry assay
This targeted sample demonstrates possible identity and quantity failures; it is not a prevalence estimate for every Noopept product.
Read the original sourceHuman PK abstract · 10 mg oral test dose
Conference pharmacokinetic abstract
Bojko SS. European Neuropsychopharmacology. 2005;15:S222-S223
After a 10 mg oral test dose in patients with vascular or traumatic cognitive disorders, most reached peak parent-drug concentration at 15 minutes, plasma detection continued through 45 minutes, and mean elimination half-time was 22.05 ± 14.37 minutes.
- Participants / model
- Patients with cognitive disorders of vascular or traumatic origin; the abstract does not state the sample size
- Treatment
- Single oral 10 mg test dose, tablet or capsule formulations
- Follow-up
- Sampling reported through 45 minutes
- Study design
- HPLC pharmacokinetic conference abstract
The abstract omits the human sample size, detailed concentration-time data, and metabolite half-lives.
Read the original sourceComparative PK abstract · human variability
Indexed comparative pharmacokinetic abstract
Boiko SS, et al. Eksperimental'naia i Klinicheskaia Farmakologiia. 2004;67(1):40-43
The abstract reports slower elimination from rat to rabbit to human and considerable individual variability in humans. It does not give a numerical human half-life.
- Participants / model
- Rats, rabbits, and humans
- Treatment
- GVS-111 exposure; the abstract does not state the human dose
- Follow-up
- Single-dose pharmacokinetic work
- Study design
- Interspecies pharmacokinetic study reported in abstract form
The abstract reports no numerical human half-life.
Read the original sourceRat study · hippocampal transcript changes
Preclinical animal study
Ostrovskaya RU, et al. Bulletin of Experimental Biology and Medicine. 2008
The rat experiment reported increased hippocampal NGF and BDNF messenger RNA after acute exposure and after a 28-day course.
- Participants / model
- Rats
- Treatment
- Noopept under experimental conditions
- Follow-up
- Acute and 28-day experiments
- Study design
- Preclinical gene-expression study
Gene-expression changes in rat hippocampus do not establish a human clinical mechanism.
Read the original sourceRat study · no learning or neurotrophin difference
Preclinical animal study
Karabulut S, et al. Behavioural Brain Research. 2019
Across six groups of 10 prepubertal male rats, the investigators found no difference in spatial learning or hippocampal NGF and BDNF after 14 days of intraperitoneal Noopept under the tested conditions.
- Participants / model
- 60 prepubertal male rats, including healthy and diabetic groups
- Treatment
- Noopept 0.5 mg/kg intraperitoneally
- Follow-up
- 14 days
- Study design
- Controlled preclinical animal experiment
Different age, disease models, route, and dose mean this is not a direct replication of the earlier rat study.
Read the original sourceWhy is Noopept (omberacetam; GVS-111) in B tier?
The B tier reflects a registered-drug history and several human reports. Healthy-person evidence consists of two 20-person reports, and long-term safety, a human target mechanism, and equivalence with products sold online remain unestablished.