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VITAMINS & SUPPLEMENTS · GUIDE

Noopept: Regulatory Status, Evidence and Safety Questions

What noopept is, what FDA and UK regulators have said, how little human research exists in the sources we read, and the safety questions that remain unanswered.

Content last updated . This page has not been medically reviewed.

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This page is information only. It does not recommend noopept, suggest amounts or explain where to get it. If memory or concentration is a concern, a clinician should be the first stop; see Mild Cognitive Impairment and Dementia.

What noopept is

Noopept (also written as GVS-111 or omberacetam) is a lab-made, orally available active ingredient [1]. A chemistry paper places it in the racetam group "although its chemical structure is quite different" [1]. Its developers describe a short-peptide (dipeptide) design based on the structure of piracetam [2]. One seller's web page, quoted by FDA, described it as a nootropic with a structure similar to racetams [3]. That is a marketing description, not an official classification. For the racetam family, see Racetams.

What regulators have said

5 items reportedMost serious first. The colour shows how severe each report was.

  1. Is there an approved drug?

    Unclear

    A search of Drugs@FDA data returned no matching product [4]. A search of the Health Canada Drug Product Database also came back empty [5]. Both are database searches, not legal opinions.

    Body, country, year: FDA data via openFDA, United States, 2026; Health Canada, 2026

  2. Has FDA taken action on noopept sold online?

    Unclear

    FDA wrote to a seller that products including a noopept powder were "new drugs" that are not generally recognized as safe and effective for the uses claimed [3]. The letter was dated February 4, 2022 [3].

    Body, country, year: FDA warning letter, United States, 2022

  3. Is FDA approval a given for supplements?

    Unclear

    FDA states it does not approve dietary supplements for safety and effectiveness [6].

    Body, country, year: FDA, United States, 2026

  4. UK

    Unclear

    The MHRA listed noopept among the cognitive enhancers seized in 2014 [7]. It said that possessing such medicines is not illegal, while sale and supply of a prescription-only or unlicensed medicine is an offence [7].

    Body, country, year: MHRA, United Kingdom, 2014 (older; current rules not verified)

  5. EU, Australia

    Unclear

    Could not be verified from pages we read.

    Body, country, year: Not available

A warning letter is FDA's statement of concern at a point in time. This one noted that it was not an all-inclusive statement of violations [3]. We did not look up how the seller responded.

What does research show?

Evidence labels used here: "preclinical" (lab or animal work), "insufficient evidence" and "Proper evidence not found".

  • Preclinical. Early pharmacology papers describe results in laboratory models, including brain-ischemia models in animals and neuron cultures [2]. Findings in animals and cells do not show the same effect in people.
  • Human studies: insufficient evidence. We searched PubMed for "noopept randomized placebo", "omberacetam" and noopept clinical trials. The first search returned no results, and most results from the others were rat or cell studies. One Russian-language report was an open prospective study of 60 patients with stroke treated for 12 months [8]. "Open" means participants and doctors knew who got the treatment, which makes results less reliable than a blinded placebo trial.
  • Healthy adults, students and older adults: Proper evidence not found. We found no randomized placebo-controlled trial in these groups in our searches. We also found no Cochrane review or official guideline on noopept.

Safety questions that remain open

  • Long-term safety. A commentator quoted by the MHRA said there are no long-term safety studies of cognitive enhancing drugs in healthy people [7]. The MHRA also said side-effect reports for some cognitive enhancers include dependence, cardiovascular problems and psychosis [7]. That was about the group, not a verified list for noopept.
  • What is in the product. In a 2021 analysis of supplements labeled with unapproved cognitive-enhancer drugs, omberacetam (a name for noopept [1]) was among the drugs detected, several detected drugs were not declared on the label and several declared drugs were not detected [9]. For products that gave amounts, 75% (9/12) of declared quantities were inaccurate [9].
  • Counterfeits. The MHRA warned that a huge number of medicines bought online are counterfeit, substandard or adulterated [7].
  • Pregnancy, breastfeeding, children, older adults, kidney or liver disease, interactions, surgery: not described in the sources we read, so no safety statement can be made. Tell your clinician or pharmacist about anything you use; see Medication Interactions and Supplements Before Surgery.

Lack of evidence of harm is not proof of safety. For quality and labeling, see Quality Testing and Certifications. For other claims on "brain" products, see Nootropic Safety and Claim Checks.

Frequently asked questions

Is noopept legal?

It depends on the country and on how it is sold. In the United States we found no approved drug [4], and FDA has written that a noopept powder sold with drug-type claims was an unapproved "new drug" [3]. For the UK we read a 2014 MHRA statement only [7]. We could not verify EU or Australian status.

Is noopept an FDA-approved ingredient?

We found no FDA-approved product containing it [4]. "FDA-approved ingredient" is also a marketing phrase to question, because FDA states it does not approve dietary supplements for safety and effectiveness [6].

Does noopept improve memory?

Proper evidence not found for healthy adults. The human report we found was a small, open Russian-language study in people who had a stroke [8], and animal and cell work cannot be assumed to apply to people [2].

What are noopept's side effects?

We did not find a reliable list in the sources we read. The MHRA mentioned dependence, cardiovascular problems and psychosis as reported with some cognitive enhancers [7]. If you feel unwell after any product, contact a clinician; for suspected poisoning call 911 or Poison Help at 1-800-222-1222.

Is it safe to combine noopept with other supplements or medicines?

We found no reliable interaction information. A pharmacist can review a full list; see Medication Interactions.

References
  1. Physicochemical and structural analysis of N-phenylacetyl-L-prolylglycine ethyl ester (Noopept). J Pharm Biomed Anal. 2025 (abstract). Read 2026-10-23.
  2. The original novel nootropic and neuroprotective agent noopept. Eksp Klin Farmakol. 2002 (Russian-language pharmacology paper, English abstract). Read 2026-10-23.
  3. FDA warning letter 620285 (Center for Drug Evaluation and Research), February 4, 2022. Read 2026-10-23.
  4. openFDA Drugs@FDA data, search for products with the active ingredient noopept (no matches), run 2026-10-23. Read 2026-10-23.
  5. Health Canada Drug Product Database, active-ingredient search for noopept (empty result), run 2026-10-23. Read 2026-10-23.
  6. FDA, Information on Select Dietary Supplement Ingredients and Other Substances, content current as of May 1, 2026. Read 2026-10-23.
  7. UK Medicines and Healthcare products Regulatory Agency (MHRA), Medicines watchdog makes record seizure of experimental smart drugs, October 24, 2014. Read 2026-10-23.
  8. Noopept in the treatment of mild cognitive impairment in patients with stroke. Zh Nevrol Psikhiatr Im S S Korsakova. 2011 (Russian-language open study, English abstract). Read 2026-10-23.
  9. Cohen PA, et al. Five unapproved drugs found in cognitive enhancement supplements. Neurol Clin Pract. 2021 (abstract). Read 2026-10-23.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.