Noopept
Omberacetam, GVS-111, N-phenylacetyl-L-prolylglycine ethyl ester
A Russian prescription nootropic sold in the West as a supplement it legally is not, with real trials in cognitive impairment and none in the healthy people taking it.
Human trials
A registered prescription medication in Russia and several neighbouring countries for cognitive impairment and asthenic conditions. Not FDA-approved, and the FDA has stated it does not meet the statutory definition of a dietary ingredient, so supplements containing it are not lawfully marketed.
What it is
Noopept is a dipeptide, a proline-glycine derivative, developed in Russia and structurally related to the racetam family without actually being a racetam. It is a registered prescription drug there for cognitive impairment and asthenic states.
It is a peptide, which is why it appears on this site, and it is sold in the West alongside supplements, which is where the legal problem begins.
The regulatory position is worth being precise about
In Russia noopept is a licensed medicine. In the United States it is not an approved drug, and the FDA has stated that it does not meet the statutory definition of a dietary ingredient. That means products marketed as dietary supplements containing noopept are not lawfully marketed as supplements.
It sits in a gap: too pharmaceutical to be a supplement, not approved as a drug. Vendors resolve this by selling it as research material, which is a labelling convention rather than a legal safe harbour.
What the evidence covers, and who it does not include
The human trials exist and they are real, and they studied patients, not healthy adults.
Russian studies dosed 20 mg daily for around two months in people with mild cognitive impairment following stroke or traumatic brain injury, reporting improvement in cognitive measures with good tolerability. A comparison against piracetam in patients with cognitive disorders of vascular and traumatic origin is among the more frequently cited.
There is no substantial body of independent randomised evidence for cognitive enhancement in healthy people, which is what almost everyone buying it wants it for. Detailed publication of the phase 3 work supporting Russian registration is limited in English-language indexed journals, so even the evidence underpinning the approval is hard to inspect from outside.
Practical notes
- Improvement in an impaired population does not predict improvement in an unimpaired one. This is the single most common inferential error in the nootropics space. A drug that restores deficient function often does nothing when function is already normal.
- The courses were finite. Trials ran one to two months and stopped. Indefinite daily use has not been studied.
- Dose is small and easy to get wrong. Active doses are in the tens of milligrams, an order of magnitude below the racetams it gets compared to, and bulk powder plus an inaccurate scale is how people take far too much.
Side effects and warning signs
Commonly reported
- Irritability and restlessness
- Headache
- Sleep disturbance if taken late
- Raised blood pressure, reported in the Russian literature
Stop and get medical help
- Any use as a substitute for investigating genuine cognitive decline, which needs a diagnosis
- Combination with prescribed psychiatric or cardiovascular medication, since interaction data outside Russia does not exist
Sources
From the community
Discussion for this compound concentrates in r/Nootropics.
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