# Noopept: Evidence, Mechanism, Dosing & Legal Status

> A clinical monograph on Noopept (omberacetam) — the proline-glycine dipeptide nootropic and cycloprolylglycine prodrug. Small Russian human trials in cognitive impairment, a deep preclinical mechanism, and an unsettled 2026 legal status.

*Published 2026-06-30 · Updated 2026-07-01 · By Marcus Feld, PharmD, BCPS*

The short answer
Noopept (omberacetam) is a proline-glycine dipeptide nootropic and **prodrug of the endogenous neuropeptide cycloprolylglycine**. Its best human evidence is a small body of mostly Russian trials in vascular or post-traumatic mild cognitive impairment, graded **B**; neuroprotection and BDNF/NGF claims are preclinical (**C**), and healthy-adult enhancement is unproven. It is **not FDA-approved** and not a lawful U.S. supplement ingredient.[1](https://peptidevox.com/#r1)[6](https://peptidevox.com/#r6)

Noopept (omberacetam, GVS-111; ethyl 1-(phenylacetyl)-L-prolylglycinate) is a synthetic, orally active proline-containing dipeptide ethyl ester designed in Russia as a peptide-derived nootropic.[6](https://peptidevox.com/#r6) Its popularity as a "smart drug" is large; its proof in people is narrow. This monograph separates the two.

*This article is informational and editorial content for research and educational purposes only. It is not medical advice, not a protocol to follow, and not a sourcing or buying guide. Noopept is not an FDA-approved drug and is not a lawful U.S. dietary-supplement ingredient. Dosing figures are reported strictly as seen in the published literature for completeness — not as recommendations. Consult a licensed clinician before any health decision.*

## What is Noopept and how does it work?

Noopept is N-phenylacetyl-L-prolylglycine ethyl ester (molecular formula C17H22N2O4, molar mass roughly 318.4 g/mol), first synthesized in 1996 at the V.V. Zakusov Institute of Pharmacology.[6](https://peptidevox.com/#r6) It is a dipeptide (proline-glycine) ethyl ester acylated with phenylacetic acid — a true peptide-derived small molecule rather than a long peptide, which is why it is orally bioavailable and crosses the blood-brain barrier.[3](https://peptidevox.com/#r3) Structurally it is grouped with the racetam family and is reported to be active at doses roughly a thousand-fold lower than piracetam.[6](https://peptidevox.com/#r6)

The compound behaves as a prodrug of the endogenous neuropeptide cycloprolylglycine (cPG). Ester hydrolysis yields the free acid, with subsequent cyclization to cPG; because cPG is present in mammalian brain and has a longer residence than the rapidly cleared parent, it is considered a key contributor to the drug's prolonged effect.[6](https://peptidevox.com/#r6) The mechanistic story — almost entirely preclinical — centers on three threads. First, neurotrophin upregulation: in rat hippocampus Noopept increased NGF and BDNF mRNA, with chronic 28-day dosing potentiating rather than diminishing the effect.[4](https://peptidevox.com/#r4) Second, HIF-1 activation: in HEK293 cells Noopept selectively raised HIF-1 DNA-binding activity, with docking implicating inhibition of prolyl hydroxylase 2 and stabilization of HIF-1-alpha, upregulating cytoprotective and angiogenic genes.[3](https://peptidevox.com/#r3) Third, glutamatergic and cholinergic modulation, with cPG described as a positive modulator of AMPA-receptor currents.[3](https://peptidevox.com/#r3) The parent half-life is very short (about 16 minutes in rats), but human pharmacokinetics show slower, highly variable elimination and remained poorly characterized as of 2017.[5](https://peptidevox.com/#r5)

## What is the evidence by indication?

The human evidence is confined to a narrow clinical population; everything else is preclinical or unproven. The table below summarizes the picture.

  Noopept evidence by indication

    IndicationBest evidenceGrade

    Mild cognitive impairment (vascular / post-traumatic)56-day Russian active-comparator trial vs piracetam; open-label clinical experienceB (small human)
    Anxiety / asthenia (anxiolysis)Rodent anxiolytic data; secondary affective improvement within MCI trialsC (preclinical / signal)
    Neuroprotection / amyloid-tau pathologyIn vitro PC12 and neuroblastoma models (apoptosis, ROS, tau)C (preclinical)
    Healthy-adult cognitive enhancementNo controlled human trials; extrapolation onlyC-to-D (unproven)

The cornerstone is Neznamov and Teleshova (2009), a 56-day comparative study in patients with mild cognitive disorders of vascular or post-traumatic organic brain disease, comparing Noopept 10 mg twice daily against piracetam 400 mg three times daily.[1](https://peptidevox.com/#r1) Both groups improved on cognitive and mood measures, with the Noopept arm reportedly improving on standardized scales and showing a favorable effect on anxiety and affective symptoms.[2](https://peptidevox.com/#r2) Supporting open-label experience in MCI and post-stroke patients is uncontrolled.[5](https://peptidevox.com/#r5) The caveats are decisive: small, single-country literature; an active-comparator rather than rigorous placebo design; no independent Western replication; no meta-analysis; and a longest human trial of only about 56 days. That is why the cognitive indication is graded B, not A.

Neuroprotection sits a tier lower. In NGF-differentiated PC12 cells and alpha-synuclein neuroblastoma, Noopept pretreatment reduced amyloid-beta-induced apoptosis, lowered reactive oxygen species and tau Ser396 phosphorylation, and restored mitochondrial potential and neurite outgrowth.[4](https://peptidevox.com/#r4) These are cell-culture findings with no qualifying human efficacy data in dementia. The dominant real-world use — boosting memory and focus in healthy people — has no supporting controlled human trials at all and relies on extrapolation from rodent data and the MCI literature.[11](https://peptidevox.com/#r11) Readers can confirm the headline human trial directly on [PubMed (PMID 19234797)](https://pubmed.ncbi.nlm.nih.gov/19234797/); no large, independent, placebo-controlled RCT and no meta-analysis exists for any indication.

Proven vs hyped
Proven in humans: modest cognitive and mood improvement in a specific vascular/post-traumatic MCI population, on weak (Grade B) evidence. Hyped: the general "smart drug for healthy people" claim, which has no controlled human support. Mechanism far outruns the human data.[1](https://peptidevox.com/#r1)

## What doses appear in the literature?

Reported strictly as information, not a protocol. The studied pharmaceutical regimen in the Russian cognitive-impairment literature was 10 mg orally twice daily — 20 mg per day — for courses of up to 56 days.[1](https://peptidevox.com/#r1) Secondary and over-the-counter use cites a wider band of roughly 10 to 30 mg per day, but no dose has been validated as optimal and the longest human trial ran only about two months.[6](https://peptidevox.com/#r6) Because the molecule is an orally bioavailable small molecule designed to cross the blood-brain barrier, the human clinical literature describes no injectable or reconstituted use — Noopept is not a reconstituted lyophilized peptide.[3](https://peptidevox.com/#r3) A serious real-world caution applies to consumer products: independent testing found supplement units containing omberacetam at up to about 40.6 mg — roughly four times the 10 mg pharmaceutical dose — and frequently mislabeled, meaning the dose printed on a label cannot be trusted.[7](https://peptidevox.com/#r7)

## How safe is Noopept?

Reported adverse events from clinical use and reviews include irritability, sleep disturbance or insomnia, increased blood pressure, headache (anecdotally choline-responsive), and gastrointestinal discomfort; in the comparator trial some treated patients reported sleep problems, irritability and raised blood pressure by study end.[5](https://peptidevox.com/#r5) Preclinical toxicology reported low acute toxicity with no mutagenic, immunotoxic or allergenic signal at high chronic animal doses — but this does not establish human long-term safety.[5](https://peptidevox.com/#r5) Theoretical, mechanism-based concerns include HIF-1/VEGF-mediated angiogenic signaling (undesirable in active malignancy or proliferative retinopathy) and a glutamatergic seizure-threshold consideration in susceptible individuals — neither demonstrated clinically.[3](https://peptidevox.com/#r3) No formal human drug-interaction studies exist; precautionary concern attaches to other CNS stimulants and to antihypertensives. In practice the combination risk is amplified because contaminated supplements may co-contain phenibut, vinpocetine, picamilon and aniracetam — combinations never tested in humans.[7](https://peptidevox.com/#r7) Precautionary contraindications include pregnancy and lactation, children and adolescents, uncontrolled hypertension, and significant hepatic or renal impairment.

## What is the FDA and WADA status in 2026?

In the United States, Noopept (omberacetam) is not approved for any use and is not a lawful dietary-supplement ingredient.[6](https://peptidevox.com/#r6) The FDA treats it as an unapproved new drug and piracetam analog requiring proper drug review and labeling, and it has been subject to import alerts; no 503A or 503B compounding pathway applies because it is not an approved drug and not on a recognized compounding bulk-substances list.[6](https://peptidevox.com/#r6) Despite this, it persists in over-the-counter cognitive supplements, often mislabeled or combined with other unapproved drugs, as documented by Harvard's Cohen group.[7](https://peptidevox.com/#r7) It is not a controlled or scheduled substance with the DEA. In Russia it is sold over-the-counter as a medicine; in the United Kingdom, production and import are not prohibited under the Psychoactive Substances Act, but sale or supply for human consumption is prohibited.[6](https://peptidevox.com/#r6)

For athletes the picture is interpretive rather than explicit. Noopept is not named on the in-force 2026 WADA Prohibited List.[9](https://peptidevox.com/#r9) However, because it lacks current regulatory approval for human therapeutic use, it may fall within category S0 (non-approved substances), which is prohibited at all times. Status is therefore interpretive, and any tested athlete should verify the specific compound through GlobalDRO or their national anti-doping organization before use.[10](https://peptidevox.com/#r10) Online vendors frequently label it "not for human consumption" to skirt drug law — a marker of an unregulated product, not a safety assurance.

**Bottom line.** Noopept is a mechanistically credible proline-glycine dipeptide nootropic and cycloprolylglycine prodrug whose mechanism far outruns its human evidence. What has actually been studied in people is narrow: small, mostly Russian trials in vascular or post-traumatic mild cognitive impairment, headlined by one 56-day active-comparator study (Grade B). Neuroprotection and neurotrophin claims are preclinical (Grade C), and the popular healthy-adult use is unproven. Layered on top is a serious product-integrity problem — unapproved, not a lawful supplement, import-alerted, yet sold OTC in frequently mislabeled or multi-drug-adulterated products. Regulatory facts here are current as of June 2026 and should be re-verified before relying on them.

---
Source: https://peptidevox.com/peptide-encyclopedia/semax-na-long
Index: https://peptidevox.com/llms.txt · Full text: https://peptidevox.com/llms-full.txt