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Noopept (Omberacetam)

Omberacetam · GVS-111

Animal replicated

OTCNootropic Dipeptide-Derived Small Molecule Cycloprolylglycine Prodrug

RouteOralGray-market only

Evidence grade: Animal replicated

Effect demonstrated in multiple animal studies; human data sparse or extrapolated. Grades summarize evidence quality, not whether a compound is appropriate, legal, or risk-free.

At a glance

What it is: N-Phenylacetyl-L-Prolylglycine Ethyl Ester — Dipeptide Nootropic — Prodrug of Cycloprolylglycine — Russian Approved 2006 — Nootropic, Dipeptide-Derived Small Molecule, Cycloprolylglycine Prodrug.
Why people use it: Used primarily for cognitive support and sleep and recovery.

If you only read one thing

Noopept has Phase III human clinical trial data supporting regulatory approval in Russia. Those trials are real. They supported a real pharmaceutical approval. And yet: they were conducted at the same institution that developed and commercializes Noopept; they are published primarily in Russian-language journals; they have not been independently replicated by Western research groups; and they are not accessible to Western systematic reviewers who require peer-reviewed English-language publications for meta-analysis. The compound sits in an uncomfortable evidential position — better supported than most nootropics (which have no human trial data at all), but with evidence that is almost impossible to evaluate for bias and quality from outside the Russian institutional system. This chapter documents what is known from accessible evidence, notes what is not accessible, and grades claims accordingly.

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Route / form

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Evidence fit

Route-specific

Use the route notes below to match form, goal, and evidence quality.

Route caveat

Protocol not standardized

No route-matched protocol rows were parsed for this form; use the route notes and full dosing chapter before comparing options.

Protocol anchor

Full dosing section

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Typical dose snapshot

See route notes

Evidence varies by use case

Published literature

3human RCTs0human studies4animal2in vitro

Human counts reflect Russian Phase I/II/III clinical development and approval-supporting trials; accessibility and independent replication limits are part of the evidence caveat.

Evidence reality check

Human evidence

3 human studies

3 randomized; 0 observational.

Preclinical base

6 lab signals

4 animal; 2 in-vitro/mechanistic.

Risk posture

No major flags listed

Review route-specific cautions before use.

Categories

Cognition & Mood Sleep & Recovery

Properties

✓ Human RCTNot injectable

Evidence

CAnimal replicated

The Prodrug Architecture

Noopept is a prodrug. After oral or sublingual absorption, plasma and tissue esterases rapidly hydrolyze the ethyl ester to produce N-phenylacetyl-L-prolylglycine (the free acid), which then undergoes enzymatic cyclization to form cycloprolylglycine (cPG) — a cyclic dipeptide that is naturally present in the mammalian brain as an endogenous neuropeptide. Phenylacetic acid is released as the other metabolic byproduct. cPG, not the parent Noopept molecule, appears to be the primary active compound. cPG has a substantially longer plasma residence time than Noopept, explaining why cognitive effects persist for hours despite Noopept's short parent plasma half-life.

Not a Racetam

Noopept is structurally related to racetams and is commonly grouped with them, but it is not a racetam. Racetams share a pyrrolidone core; Noopept is a dipeptide-derived compound (N-phenylacetyl-L-prolylglycine ethyl ester). Its mechanism overlaps with racetams in some respects (AMPA/NMDA modulation, cholinergic enhancement) but it additionally upregulates NGF and BDNF in the hippocampus — a neurotrophic mechanism absent in piracetam and most racetams. It is approximately 1,000x more potent than piracetam per mg (10-30 mg vs 1,200-4,800 mg), which changes the safety margin and dosing implications significantly.

The Russian Evidence Problem

Phase III clinical trials of Noopept were conducted in Russia and are the basis for its 2006 Russian approval. These trials demonstrated cognitive improvements in MCI of cerebrovascular and post-traumatic origin, and specifically in APOE ε4+ allele carriers. However: the trials were conducted at the same institution that developed and holds commercial interests in Noopept; most are published in Russian-language journals without full English translations; they are not indexed in standard Western meta-analysis pipelines; and they have not been replicated by independent groups in Western peer-reviewed journals. This creates a legitimately difficult evidence evaluation problem — the trials exist, they support approval, and Western reviewers largely cannot read them.

Routes and Dosing

Oral: 10-30 mg/day (Russian protocol: 10 mg twice daily; max 30 mg/day); low oral bioavailability (~10%) due to rapid first-pass metabolism. Sublingual: faster onset, better bioavailability than oral; powder under tongue or liquid drops. Intranasal (Limitless spray, 0.1% solution): ~50-100 mcg per drop; 2-3 drops per nostril for most users; bypasses GI first-pass. Standard cycle: 1.5-3 months per Russian clinical guidelines; rest period between cycles. Avoid evening dosing (stimulatory effects may interfere with sleep).

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