Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-26. ← Back to Evidence Library
Noopept (omberacetam): what the evidence says
At a glance
What it is: a lab-made dipeptide-like molecule (N-phenylacetyl-L-prolylglycine ethyl ester, GVS-111), developed in Russia as a nootropic related to piracetam. Usually sold as powder or capsules rather than injections. R1, R2
What the evidence says: small Russian clinical studies report cognitive improvement in people with mild cognitive impairment after stroke or brain injury, but we found no blinded, placebo-controlled trial in PubMed. R3, R4 Rat work shows rises in brain growth factors (NGF, BDNF). R1
Biggest risks: largely unknown. US "brain supplements" have contained about 4× a typical drug amount per serving (see Study details), without clear labeling. R5
Rating
| Human Human evidence | Very limited: open and comparative studies in mild cognitive impairment R3, R4 |
| Animal Animal / lab evidence | Rat and cell studies on growth factors and neuroprotection R1, R2 |
| Regulatory | Not approved in the US · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page · WADA: not named R6, R7, R8 |
| Established human dose | None in the US. Study details lists what studies used |
Evidence verdict: Mild cognitive impairment: Very limited (small Russian studies, no blinded RCT found) · Memory in healthy people: No human data
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: nearly all research comes from the Russian institute that developed it. The stroke study was open-label. R4, R2
What is it?
Noopept is broken down to cycloprolylglycine, a natural brain peptide. It is often grouped with peptides but is a small synthetic molecule. R2 Related pages: Semax, Selank, Dihexa, Cerebrolysin.
Does it work?
- Human Stroke patients: 60 patients, open prospective study; MMSE and word-association scores improved after 2 months vs controls. R4
- Human Noopept vs piracetam: comparative study in mild cognitive disorders after vascular or traumatic brain disease. R3 UNVERIFIED results not in the PubMed abstract.
- Animal Rats: NGF and BDNF rose in the hippocampus. R1
- Unknown No trial in healthy people.
Is it safe?
- Human The stroke study reported "a high level of safety," without detail. R4
- Human Supplement testing: 10 US products labeled for cognition contained omberacetam and other unapproved drugs (phenibut, vinpocetine, picamilon), sometimes at pharmaceutical levels. R5
- Unknown No long-term safety data.
Gray-market noopept: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe. Products may contain more drug than expected or undeclared drugs. R5
What we don't know
- Unknown Whether it works in blinded trials
- Unknown Long-term safety
Is it legal?
- US (FDA): not approved; not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R6, R7, R8 FDA-flagged supplement findings are summarized in the 2021 testing study. R5
- Russia: marketed as a prescription nootropic. UNVERIFIED registration not checked against the Russian drug register.
- Athletes: not named on the WADA 2026 list. UNVERIFIED
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Stroke study 2011 | 60 stroke patients | Oral | 20 mg daily | 2 months (12-month study) | Cognitive scores improved vs controls | PMID 22500312 |
| Supplement testing 2021 | 10 US products | Oral | Up to 40.6 mg per serving found | n/a | Unlabeled drug levels | PMID 34484905 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Ostrovskaya RU, et al. Bull Exp Biol Med. 2008. PMID 19240853
- R2 Ostrovskaia RU, et al. Eksp Klin Farmakol. 2002. PMID 12596521
- R3 Neznamov GG, et al. Neurosci Behav Physiol. 2009. PMID 19234797
- R4 Amelin AV, et al. Zh Nevrol Psikhiatr Im S S Korsakova. 2011. PMID 22500312
- R5 Cohen PA, et al. Neurol Clin Pract. 2021. PMID 34484905
- R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Noopept (omberacetam). Talk to a clinician you trust, especially if you take other brain-active drugs, are pregnant, or are a tested athlete. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).