Noopept
/ Synthetic peptide-derived nootropic (small molecule); cleaves to bioactive cyclic prolyl-glycine in vivoALIAS · GVS-111 · Omberacetam · N-phenylacetyl-L-prolylglycine ethyl ester
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Tier 3. Synthetic peptide-derived nootropic developed at the Russian Institute of Pharmacology (Ostrovskaya and colleagues). Approved in Russia and several CIS states for cognitive disorders. Russian primary literature is substantial, including small RCT-design studies (Neznamov 2009) and an extensive rodent pharmacology corpus; no FDA-grade Phase 3 trial in Western literature.
Noopept (N-phenylacetyl-L-prolylglycine ethyl ester) is a small-molecule dipeptide-mimic prodrug. After oral administration it is hydrolysed in vivo to a bioactive cyclic prolyl-glycine fragment (cyclo-Pro-Gly). Reported mechanisms in rodent models include enhancement of hippocampal long-term potentiation, modulation of α7 nicotinic acetylcholine receptors on hippocampal interneurons, elevation of BDNF and NGF expression, and antioxidant activity. The Russian-origin literature treats the molecule as a piracetam-class nootropic with broader mechanistic footprint at lower doses.
Tier 3. Primary evidence is rodent and in-vitro. Small Russian RCT-design studies in mild cognitive disorders of organic brain origin (Neznamov 2009) report comparable cognitive endpoints to piracetam, but trial sizes are modest and the work has not been independently replicated in Western RCTs.
In Russian clinical use, well tolerated at the approved doses; comprehensive Western post-marketing safety data are unavailable. No major signal reported for hepatic, cardiovascular, or psychiatric adverse events in published Russian sources, but the size and rigour of the safety database are below the standard expected for FDA approval.
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- Compounding eligibility ambiguous
Russian-origin literature without independent Western replication is the central evidentiary issue. The Russian regulatory approval informs availability but does not import the methodological rigour of Phase 3 trial evidence. Vendor-sold material in the US research-chemical channel cannot be assumed equivalent in identity or purity to the Russian therapeutic preparation.