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Noopept

Also known as Omberacetam, GVS-111, N-phenylacetyl-L-prolylglycine ethyl ester, Noopept (Russian trade name)

Not a peptide therapeutic but a small dipeptide-derived synthetic drug, registered in Russia as a nootropic.

early-clinical Neuro & cognition approved drug

At a glance

Category
Neuro & cognition
Status
approved drug
Route
oral (the registered form is a 10 mg tablet)
Half-life
Short. Russian pharmacokinetic work reports very rapid absorption with a serum Tmax of the order of minutes; the parent ester is largely converted to the metabolite cycloprolylglycine. No peer-reviewed human pharmacokinetic study in an internationally indexed journal was found, so all circulating half-life figures should be treated as unsourced.
Onset
The registered course is 1.5 to 3 months, repeatable after a one-month interval 12; claims of acute effects within hours come from user reports, not from trials
Molecular weight
318.4 g/mol (C17H22N2O4) 10
Sequence
Derived from Pro-Gly: N-phenylacetyl-L-prolylglycine ethyl ester. It is a modified dipeptide, not a peptide chain in the pharmacological sense

Registered as a medicine in Russia and several CIS states (tablets, 10 mg), developed at the V.V. Zakusov Research Institute of Pharmacology in Moscow. It is dispensed without prescription in Russia 12, not as a prescription-only medicine - a point worth stating precisely, because 'approved in Russia' and 'prescription-controlled' are often assumed to go together here and do not. Never assessed by the EMA or FDA. In the EU and US it is sold as an unapproved 'nootropic' or research chemical; in the UK, sale and supply for human consumption are prohibited 11. It is a substituted dipeptide ester with a molecular weight of 318.4 g/mol 10, closer to a small-molecule drug than to a peptide therapeutic, and it is administered orally - which no true peptide drug of this class is.

Doping status: Not listed by name; as a substance without EMA or FDA approval it falls under the S0 residual category

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

Mechanism of action

Noopept is the ethyl ester of N-phenylacetyl-L-prolylglycine. It was designed as a conformationally restricted analogue of the piracetam pharmacophore, with a proline-glycine dipeptide backbone intended to mimic the presumed active conformation of the racetams. Calling it a 'peptide' is misleading: two residues, an N-terminal phenylacetyl cap and a C-terminal ethyl ester make it a small molecule that survives oral dosing.

The best-supported mechanistic claim is that Noopept functions as a prodrug for cycloprolylglycine (cPG), an endogenous cyclic dipeptide. Russian work reports that oral Noopept raises brain cPG levels and that cPG itself reproduces several of the electrophysiological and behavioural effects. cPG has been described as a positive modulator of AMPA receptors. This chain of reasoning rests almost entirely on one research group.

In rodents, Noopept increases hippocampal expression of NGF and BDNF 4 - the same neurotrophin story told for Semax and Cerebrolysin, and the mechanism most often cited in marketing. It has also been reported to activate HIF-1 9, to reduce alpha-synuclein amyloid cytotoxicity in vitro 6, and to have antioxidant, anti-inflammatory and mild anti-platelet effects. None of these has been shown to occur in a human brain at a clinically used dose.

The claimed potency advantage over piracetam (active at 10-30 mg per day versus 1200-4800 mg) is real in the sense that the effective dose in rodent assays is orders of magnitude lower. It is not evidence of a better clinical effect; piracetam itself has never demonstrated a convincing cognitive benefit in rigorous trials, so a thousandfold more potent version of an unproven effect is not a strong argument.

What the research shows

Noopept has a large preclinical literature and a very thin clinical one, and both come overwhelmingly from a single Russian institute and its collaborators. There is no multicentre, independently replicated, placebo-controlled trial in an internationally indexed journal, no Cochrane review, and no regulatory assessment outside Russia. Registration in Russia reflects a national regulatory tradition that also registers Cerebrolysin and Cortexin, and says little about efficacy by Western standards.

Research in humans

The clinical literature is small and almost entirely Russian-language. The most-cited example is a 2011 study of Noopept in mild cognitive impairment after stroke, published in Zh Nevrol Psikhiatr Im S S Korsakova 5. Comparative studies against piracetam in post-traumatic and cerebrovascular cognitive impairment have been reported by the developing institute. Common features are small samples, recruitment at a single centre or a small group of centres, subjective or clinician-rated outcomes, and blinding that is either absent or not described in enough detail to assess. No trial of Noopept in healthy people for cognitive enhancement - which is what almost all Western buyers use it for - was found.

Animal and lab research

The rodent work is extensive and consistent within itself: improved acquisition, consolidation and retrieval in passive avoidance and maze tasks; protection in photothrombotic and ischaemic lesion models; reduced cognitive deficit after intracerebral beta-amyloid injection 3; upregulation of NGF and BDNF in hippocampus 4; anxiolytic-like effects. The limitations are the usual ones - lesion and toxin models that translate poorly to human cognition, and near-total dependence on one laboratory. A 2019 study specifically found that Noopept does not stimulate cell proliferation 8, which constrains some of the neurogenesis claims made for it.

Caveats. Nearly every primary study lists authors from or affiliated with the V.V. Zakusov Institute, which developed and holds the interests in the compound. Publication is concentrated in a handful of Russian journals (Eksperimental'naia i Klinicheskaia Farmakologiia, Bulletin of Experimental Biology and Medicine, Zh Nevrol Psikhiatr) whose peer review cannot be independently assessed and whose full texts are often unavailable in English. There is no registered protocol culture, no pre-specified primary endpoint reporting, no dose-response study in healthy humans, and no long-term safety dataset. Independent Western replication of any clinical finding is absent.

What it is used for

  • In Russia, registered for disorders of memory, attention and other cognitive functions and for emotionally labile disorders, including after brain injury, in cerebrovascular insufficiency and in asthenic states 12
  • Widely self-administered outside Russia as an oral nootropic for memory and focus - a use that has not been tested in any trial in healthy people
  • Studied preclinically in models of ischaemia, Alzheimer-type amyloid toxicity and experimental diabetes

Dosing

Dose
Registered Russian dosing: treatment starts at 20 mg per day as 10 mg twice daily, and is raised to 30 mg per day as 10 mg three times daily only if the response is insufficient and tolerance is good. Taken orally after meals. User protocols outside Russia typically report 10-30 mg per day, sometimes sublingually or intranasally - routes for which no data exist.
Frequency
twice daily (10 mg morning and midday) at the starting dose of 20 mg, and three times daily if raised to 30 mg; the label instructs that no dose be taken after 18:00 because of reported sleep disturbance
Route
oral (registered); sublingual and intranasal use is off-label and undocumented
Duration
Registered courses of 1.5 to 3 months, with a repeat course after a one-month interval if required
  • This is one of the few compounds in this reference with an actual approved label dose 12, so the numbers are not invented - but the label comes from a regulator that approved the drug on the Russian evidence described above.
  • The maximum labelled dose is 30 mg per day, reached only if 20 mg per day proves insufficient and is well tolerated 12; higher amounts circulate in user forums with no basis in any study.
  • The label instruction not to take a dose after 18:00 12 is a titration constraint with a reason behind it, not folklore: it exists because the drug disturbs sleep when taken late.
  • There is no dose-finding study in healthy people and no dose-response curve for cognitive effect.
  • Because it is orally active, none of the reconstitution and injection practice that applies to actual peptides is relevant here.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Reconstitution

Storage
Tablets and bulk powder: room temperature, dry, protected from light. The ethyl ester is susceptible to hydrolysis in aqueous solution, so dissolving the powder in advance and storing it is a poor idea.

Noopept is an orally active small molecule, not an injectable peptide; there is nothing to reconstitute. Bulk powder sold online is dosed at the single-milligram level, where household scales are not accurate - a common practical source of large accidental overdoses.

Safety

Side effects

  • The Russian label's entire adverse-effect list is two items: allergic reactions are possible, and in patients with severe arterial hypertension blood pressure may rise during treatment 12
  • Sleep disturbance is not in that list, but the label's instruction not to dose after 18:00 12 is an implicit acknowledgement of it; irritability and restlessness with late-day dosing are the most consistently reported user effects
  • Headache - reported by users, not on the label
  • Reported by users but not systematically documented: fatigue or 'flatness' on withdrawal after prolonged use, and reduced effect over weeks
  • There is no long-term safety study; the labelled side effect list is short because surveillance has been limited, not because safety has been demonstrated

Do not use if

  • The Russian label contraindicates: hypersensitivity to the components; lactase deficiency, lactose intolerance and glucose-galactose malabsorption, because of the tablet excipient; severe hepatic or renal impairment; pregnancy; breastfeeding; and age under 18 12
  • Caution in poorly controlled hypertension, given the label's own note that blood pressure may rise in severe arterial hypertension 12

Interactions

No formal interaction trials have been published. The Russian label states that no interaction was established with alcohol, hypnotics, antihypertensives or psychostimulants 12 - which is a statement that none was found, not that any was looked for systematically. Theoretical concerns remain with antihypertensive therapy given the reported pressor effect, and with stimulants or other agents that disturb sleep. Combination with other unapproved nootropics is entirely undocumented.

Sources