Synthetic peptidomimetic / dipeptide-derived small molecule
Also known as:Noopept· common name
Post-stroke cognitive i…mild cognitive impairme…
Omberacetam (Noopept)
Evidence levelHuman clinical
Human evidenceLimited
Regulatory statusNo FDA approval implied
What you need to know in 20 seconds
What is it?
Synthetic peptidomimetic / dipeptide-derived small molecule
Research focus
Post-stroke cognitive impairment, mild cognitive impairment, neuroprotection; commonly discussed as a nootropic
Human evidence
Human evidence consists mainly of older regional open/comparative studies in patients with vascular or traumatic cognitive impairment; no modern placebo-controlled healthy-adult cognitive-enhancement programme was identified.
Regulatory status
FDA substance records identify omberacetam/Noopept but explicitly note that UNII listing does not imply regulatory review or approval. Regulatory status varies internationally.
Main limitations
Robust efficacy in healthy adults, long-term safety or a modern validated nootropic treatment regimen.
Safety
No large contemporary healthy-volunteer safety programme was identified; evidence gaps should be prominent.
i
Human evidence consists mainly of older regional open/comparative studies in patients with vascular or traumatic cognitive impairment; no modern placebo-controlled healthy-adult cognitive-enhancement programme was identified.
What the evidence actually supports
✓Do not market as established cognitive enhancer in healthy adults.
✓Keep disease-patient observations separate from healthy-user cognitive enhancement.
What is not established / key limitations
×No modern large blinded placebo-controlled trial located in this pass; not tested as healthy enhancement.
×No good evidence establishes cognitive enhancement in healthy adults.
Selected study & evidence records
Noopept in mild cognitive impairment after stroke
2011 · Open prospective clinical study · n=60
MMSE and association tests improved relative to controls after two months.
No large contemporary healthy-volunteer safety programme was identified; evidence gaps should be prominent.
Modern large randomized safety datasets are lacking. 'Widely used' or long market presence in some regions should not be mistaken for robust contemporary safety evidence.
Technical details
Mechanism / biologyMechanistic hypotheses include modulation of neurotrophin signalling, excitatory neurotransmission and oxidative/inflammatory pathways, but translation to human cognitive enhancement is uncertain.
Route / formulation boundaryMost clinical literature concerns oral use in neurologic patients; it should not be extrapolated to other formulations or healthy-user 'nootropic' protocols.
Identity / data-quality noteCorrectly classify as omberacetam/peptidomimetic rather than a conventional peptide.
Dosing evidence statusLimited human regimen identified. A 60-patient open prospective post-stroke study reported 20 mg/day for two months; this is not a healthy-person dosing recommendation.
Identifiers & alternate namesNoopept · GVS-111
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
