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PeptideAgent

Noopept

A dipeptide-like memory drug approved in Russia, with small open-label human studies, no placebo-controlled RCT indexed in English, and no FDA review.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

At a glance

Noopept (Synthetic dipeptide-like nootropic (proline-glycine ethyl ester with a phenylacetyl group), structurally related to piracetam). Noopept (GVS-111, omberacetam) is a synthetic compound resembling a dipeptide (two linked amino acids) developed at the Zakusov Institute of Pharmacology in Moscow and sold as a prescription nootropic (memory and focus drug) in Russia. The human evidence consists of small open-label Russian studies (everyone knew what they were taking) in people with mild cognitive impairment (memory and thinking problems short of dementia) after stroke, brain injury, or vascular disease, which report modest improvements at 20 mg per day, so PeptideAgent grades it human observational. It has never been approved or reviewed by FDA and is sold in the United States as an unapproved supplement ingredient.

Evidence: Human observational evidenceRegulatory: UnscheduledWADA: WADA status unclearVerified: Verified Sep 22, 2026
Compounding
Noopept has never been nominated to or reviewed for the FDA 503A or 503B bulks lists and does not appear on the FDA Category 2 page (current as of April 22, 2026). It is not a component of any FDA approved drug. In the United States it is sold as a dietary supplement ingredient, but it is a synthetic drug substance approved in Russia and does not meet the definition of a dietary ingredient, so its sale as a supplement is not an approved use. It is not compoundable under 503A or 503B.
Typical cost
Sold as an unapproved supplement in the United States at roughly 15 to 40 USD per month; not available through licensed pharmacy or telehealth channels.
Access path
  1. Prescription product in Russia and some other former Soviet countries.
  2. Not an FDA approved drug and not compoundable in the United States.
  3. Sold online as an unapproved supplement ingredient; identity and purity are not verified.

Legal status: Not FDA approved and not on the 503A bulks list, so no pharmacy has a lawful basis to compound it. WADA status unclear. [5] [8] See legal status

Summary

Noopept (GVS-111, omberacetam) is a synthetic compound resembling a dipeptide (two linked amino acids) developed at the Zakusov Institute of Pharmacology in Moscow and sold as a prescription nootropic (memory and focus drug) in Russia. The human evidence consists of small open-label Russian studies (everyone knew what they were taking) in people with mild cognitive impairment (memory and thinking problems short of dementia) after stroke, brain injury, or vascular disease, which report modest improvements at 20 mg per day, so PeptideAgent grades it human observational. It has never been approved or reviewed by FDA and is sold in the United States as an unapproved supplement ingredient.

What is Noopept?

Noopept is a synthetic dipeptide-like nootropic (proline-glycine ethyl ester with a phenylacetyl group), structurally related to piracetam. It is also known as GVS-111, N-phenylacetyl-L-prolylglycine ethyl ester, Omberacetam, Noopept tablets.

How does it work?

Noopept is metabolized to cycloprolylglycine, an endogenous dipeptide. In rodent and cell studies it increases expression of brain-derived neurotrophic factor and nerve growth factor in the hippocampus, enhances inhibitory synaptic transmission through alpha-7 nicotinic receptors on interneurons, and reduces apoptosis and tau hyperphosphorylation in an Alzheimer cell model. It is also described as anxiolytic in animals. Which of these mechanisms matters in people has not been established.

Key facts
ClusterCognitive and neuroprotective
RoutesOral tablet (Russian prescription product, 10 mg); Oral capsule or powder (sold in the United States as an unapproved supplement ingredient); Sublingual and intranasal use reported anecdotally (no studies)
Conditions studiedCognitive decline and nootropic use; Anxiety disorders; Stroke recovery
Recordv3, draft, verified Sep 22, 2026

What does the evidence say about Noopept?

Evidence: Human observational evidenceGrade assigned per the methodology.

Human data are limited to small Russian studies. An open comparative study of Noopept 20 mg per day versus piracetam in patients with mild cognitive disorders of vascular or traumatic origin reported greater improvement with Noopept. An open prospective study of 60 stroke patients reported improved MMSE and associative test scores after 2 months at 20 mg per day compared with untreated controls. None of these were double-blind placebo-controlled trials, and no trial outside Russia has been indexed.

Indexed studies by evidence grade
Evidence typeIndexed studiesParticipants (human)
Human randomized trials0n/a
Human observational studies260
Animal studies2n/a
All indexed studies460

Human evidence

Neznamov and Teleshova (2009) compared Noopept (20 mg per day) with piracetam in an open comparative study of patients with mild cognitive disorders due to organic brain disease of vascular and traumatic origin and reported a broader and faster effect with Noopept, particularly on attention, memory, and anxiety. Amelin et al. (2011) treated 60 stroke patients with Noopept 20 mg per day in an open prospective study and reported significant improvement in MMSE and associative tests after 2 months versus controls, with good tolerability. Neither study was placebo-controlled or double-blind.

Animal evidence

In rats and rat hippocampal slices, Noopept enhanced inhibitory synaptic transmission through alpha-7 nicotinic receptors on interneurons. In an Alzheimer related cellular model it reduced apoptosis and tau hyperphosphorylation. Rat studies also report normalization of incretin system parameters in experimental diabetes. Rodent behavioral studies from the developing laboratory report memory enhancement and anxiolytic effects.

Key studies

Indexed studies of Noopept
StudyDesign and populationOutcomeGrade
Comparative studies of Noopept and piracetam in the treatment of patients with mild cognitive disorders in organic brain diseases of vascular and traumatic origin2009 PMID 19234797Open comparative clinical study, Noopept 20 mg per day versus piracetamAdults with mild cognitive disorders due to organic brain disease of vascular or traumatic originNoopept produced broader and faster improvement than piracetam on cognitive and anxiety measures; no placebo armEvidence: Human observational evidence
Noopept in the treatment of mild cognitive impairment in patients with stroke2011 PMID 22500312Open prospective study with untreated control group, 20 mg per day for 2 months within a 12 month follow upn = 60 Adults with mild cognitive impairment after strokeSignificant improvement in MMSE and lateral and categorical association tests after 2 months versus controls; good tolerabilityEvidence: Human observational evidence
Neuroprotective effect of novel cognitive enhancer noopept on AD-related cellular model involves the attenuation of apoptosis and tau hyperphosphorylation2014 PMID 25096780In vitro cellular model of Alzheimer related toxicityCultured neuronal cells exposed to amyloid betaNoopept reduced apoptosis and tau hyperphosphorylationEvidence: Animal-only evidence
Effect of nootropic dipeptide noopept on CA1 pyramidal neurons involves alpha-7 AChRs on interneurons in hippocampal slices from rat2022 PMID 36195298Rat hippocampal slice electrophysiologyRat hippocampal slicesNoopept enhanced inhibitory input to CA1 pyramidal neurons via alpha-7 nicotinic receptors on interneuronsEvidence: Animal-only evidence

Conditions studied

Conditions with evidence for Noopept
ConditionGradeNote
Cognitive decline and nootropic useEvidence: Human observational evidenceNot a peptide in the strict sense (dipeptide derived); Russian clinical reports only.
Anxiety disordersEvidence: Human observational evidenceA Russian comparison with piracetam reported improvement on anxiety measures alongside cognition, without a placebo arm; a dipeptide derived drug, not approved in the US.
Stroke recoveryEvidence: Human observational evidenceImproved cognitive test scores after two months in 60 stroke patients with mild cognitive impairment versus controls; a single Russian study.

Is Noopept legal in the United States?

Regulatory: UnscheduledWADA: WADA status unclear

FDA and compounding status

Noopept has never been nominated to or reviewed for the FDA 503A or 503B bulks lists and does not appear on the FDA Category 2 page (current as of April 22, 2026). It is not a component of any FDA approved drug. In the United States it is sold as a dietary supplement ingredient, but it is a synthetic drug substance approved in Russia and does not meet the definition of a dietary ingredient, so its sale as a supplement is not an approved use. It is not compoundable under 503A or 503B.

WADA status

WADA status unclear. The current prohibited list does not name this compound explicitly and its class status is not settled. Athletes should ask their anti-doping organization before use.

Regulatory timeline

No regulatory events recorded.

Full tracker for Noopept or the category-wide tracker.

What published studies of Noopept used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Human studies used 10 mg orally twice daily (20 mg per day) for 2 months (Amelin 2011) or for the duration of the comparative study (Neznamov 2009). No dose finding study has been published in English.

Routes reported

Routes of administration reported for Noopept
#Route
1Oral tablet (Russian prescription product, 10 mg)
2Oral capsule or powder (sold in the United States as an unapproved supplement ingredient)
3Sublingual and intranasal use reported anecdotally (no studies)

What are the side effects and interactions of Noopept?

Side effects

Side effects reported for Noopept
#Reported side effect
1Open-label Russian studies describe good tolerability; no systematic placebo-controlled safety data
2Irritability, sleep disturbance, and headache reported anecdotally
3Blood pressure increase reported in some patients in the Russian literature
4No long-term safety data outside Russia

Interactions

Interactions reported for Noopept
#Interaction
1No formal interaction studies exist
2Theoretical additive effects with other nootropics, stimulants, or drugs acting on nicotinic receptors

Contraindications

Contraindications for Noopept
#Contraindication
1Pregnancy and breastfeeding (no data)
2Severe hepatic or renal impairment (no data; listed as a precaution in Russian labeling)
3Children (no data)

How do people access Noopept legally?

Typical cost: Sold as an unapproved supplement in the United States at roughly 15 to 40 USD per month; not available through licensed pharmacy or telehealth channels.

Verified access options

  • Step 1

    Prescription product in Russia and some other former Soviet countries.

  • Step 2

    Not an FDA approved drug and not compoundable in the United States.

  • Step 3

    Sold online as an unapproved supplement ingredient; identity and purity are not verified.

Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.

Compare Noopept

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make noopept lawful. Noopept is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [5] [8]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [5] [6] [9] [10] [11]

What changes for you

  • No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [6]
  • Identity, purity, sterility, and dose accuracy can vary from batch to batch. [5]
  • Insurance rarely covers it, so you usually pay cash.
  • For tested athletes, WADA status is unclear; ask your anti-doping organization before any use. [7]

What to check

These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:

  • A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [6]
  • A real evaluation by a licensed prescriber, not just an online form.
  • A certificate of analysis for the specific batch.

Frequently asked questions

Is Noopept legal in the United States?

Noopept is not an FDA approved drug and has never been reviewed for compounding. It is widely sold online as a supplement ingredient, but because it is a synthetic drug substance approved as a prescription medicine in Russia, it does not meet the legal definition of a dietary ingredient (the substances allowed in supplements) and its sale as a supplement is not an approved use. Possession is not a criminal matter. No US pharmacy can lawfully compound (custom-make) it. [5] [6]

Does Noopept actually work for memory?

The human evidence is weak. Small open-label Russian studies in people with mild cognitive impairment after stroke or brain injury reported modest improvements on tests like the MMSE after 2 months at 20 mg per day, and one comparative study found it outperformed piracetam. None of these were placebo-controlled or double-blind, and no trial in healthy people has been published. PeptideAgent grades the evidence human observational. [1] [2]

What are the side effects of Noopept?

The Russian studies describe good tolerability at 20 mg per day, but they were small and open-label. Anecdotal reports mention irritability, sleep disturbance, headache, and blood pressure increases. There are no long-term or placebo-controlled safety data, and no safety data at the higher doses sometimes used off-label. [1] [2]

How is Noopept taken?

By mouth, as tablets. The published human studies used oral dosing for about 2 months. Sublingual and intranasal use are described online but have not been studied. Noopept is not an approved drug in the United States, so there is no US labeled dose. PeptideAgent does not give doses for unapproved peptides. [1] [2]

How much does Noopept cost?

As an unapproved supplement it is inexpensive, roughly 15 to 40 USD per month, but those products are not verified for identity or purity and are not sold through licensed channels. There is no pharmacy or telehealth price in the United States. [5]

Is Noopept banned by WADA?

It is not named on the WADA Prohibited List. Section S0 covers substances with no approval from any government health authority, and Noopept is approved as a prescription drug in Russia, so S0 does not clearly apply. PeptideAgent lists its status as unclear; athletes should ask their anti-doping organization before use. [7]

Noopept vs Semax: which is better?

Both are Russian nootropics with small, mostly open-label human studies and no placebo-controlled trial indexed in English. Noopept is an oral dipeptide-like compound studied at 20 mg per day for mild cognitive impairment. Semax is a nasal heptapeptide. Neither is FDA approved; Semax was placed on and then withdrawn from the FDA Category 2 compounding list, while Noopept has never been nominated. There is no head to head trial. [1] [5]

How does Noopept work?

It is converted in the body to cycloprolylglycine, a naturally occurring dipeptide. In rat brain tissue it increases BDNF and NGF expression, enhances inhibitory transmission through alpha-7 nicotinic receptors, and in an Alzheimer cell model it reduced tau hyperphosphorylation and apoptosis. Whether these mechanisms operate at human doses has not been shown. [3] [4]

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.

  1. [1]Neznamov GG, Teleshova ES. Comparative studies of Noopept and piracetam in the treatment of patients with mild cognitive disorders in organic brain diseases of vascular and traumatic origin. Neurosci Behav Physiol 2009PubMed 19234797, 2009
  2. [2]Amelin AV et al. Noopept in the treatment of mild cognitive impairment in patients with stroke. Zh Nevrol Psikhiatr Im S S Korsakova 2011 (Russian)PubMed 22500312, 2011
  3. [3]Ostrovskaya RU et al. Neuroprotective effect of novel cognitive enhancer noopept on AD-related cellular model involves the attenuation of apoptosis and tau hyperphosphorylation. J Biomed Sci 2014PubMed 25096780, 2014
  4. [4]Kondratenko RV et al. Effect of nootropic dipeptide noopept on CA1 pyramidal neurons involves alpha-7 AChRs on interneurons in hippocampal slices from rat. Neurosci Lett 2022PubMed 36195298, 2022
  5. [5]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
  6. [6]FDA: Compounding and the FDA, questions and answersFDA, 2026
  7. [7]WADA Prohibited ListWADA, 2026
  8. [8]FDA: Bulk drug substances used in compounding under section 503A of the FD&C ActFDA
  9. [9]FDA: Compounding inspections, recalls, and other actions (warning letters to compounders)FDA
  10. [10]FDA warning letters database: July 30, 2019 letter to a 503A pharmacy that compounded BPC-157 acetate outside section 503AFDA, 2019
  11. [11]FDA Import Alert 66-41: Detention without physical examination of unapproved new drugs promoted in the U.S. (includes peptide entries)FDA

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Free to cite and quote with a link. Data is licensed CC BY 4.0 with attribution to PeptideAgent.

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PeptideAgent. (2026, September 22). Noopept: evidence, legality, and access. https://peptideagent.ai/peptides/noopept
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