Noopept: Evidence, Safety and Legal Status Reviewed

Key points

• Noopept (N-phenylacetyl-L-prolylglycine ethyl ester, GVS-111) is a Russian-developed drug. Its human evidence is a handful of small, mostly open-label Russian studies in patients; we found no placebo-controlled trial in healthy people [11].
• Proposed mechanisms (growth-factor expression, HIF-1 activation) come mainly from the developers’ own cell and rodent work [12][13][14].
• It is not approved in the US. The FDA has warned sellers that marketing it with disease claims makes it an unapproved drug [18].
• Safety data are thin: no long-term studies, a reported blood pressure signal, and surveillance labs find it in illegal products [11][21].
• Verdicts on the two tier lists: “somewhat cope” is closer to the evidence than a placement in C.

What noopept is

Noopept is a synthetic dipeptide derivative. The research on it comes largely from the V. V. Zakusov Institute of Pharmacology in Moscow, part of the Russian Academy of Medical Sciences at the time [2][13]. Ostrovskaya appears as lead author on much of the animal and cell work [13][14][15]. The brief names Seredenin as co-originator; we did not open a source that confirms his role, so we do not state it.

A Russian medical portal reports that, after phase III trials, the tablet was registered as a nootropic under number ЛС-001577 on 12 May 2006 [10]. This is a secondary page dated 2014.

What the proposed mechanisms rest on

The developers’ group has proposed several mechanisms. None has been shown to explain a clinical effect in people.

• Growth factors. In rats, a single dose raised NGF and BDNF mRNA in the hippocampus and lowered it in the cortex; 28-day dosing slightly raised cortical BDNF. Group sizes were not in the abstract [14].
• HIF-1. In a 2016 study in HEK293 cells, 10 micromolar noopept raised HIF-1 DNA-binding activity and none of eight other transcription factors tested. Docking suggested binding to prolyl hydroxylase 2. The authors call HIF-1 activation the primary mechanism; that is a proposal from cells and computer modelling [12].
• Cell protection. In PC12 rat cells exposed to amyloid-beta fragment 25-35, pretreatment improved viability and reduced tau phosphorylation at one site [13].

All three papers come from the Zakusov Institute with Ufa collaborators; none lists independent replication. One animal paper on inflammation and pain (Heliyon, 2021) was retracted [17]; the reason was not stated in the record we opened.

Human studies

We could open bibliographic records and, for some, abstracts. We could not open full texts: Springer and PubMed pages blocked our fetches. Most abstracts lack sample size, blinding and funding. Where a record is silent we say so.

Study	Population and design	What the record reports
Amelin et al., Korsakov J, 2011 [1]	60 stroke patients; open prospective study with a control group; treatment described as 12 months, assessed at 2 months	Better MMSE scores than controls at 2 months; authors report “a high level of safety.” Funding not listed
Neznamov and Teleshova, Neurosci Behav Physiol, 2009; Russian version 2008 [2][3]	Mild cognitive disorders after vascular or traumatic brain disease; noopept versus piracetam	Abstract not available to us. ConsumerLab describes a two-month study of 53 older adults without placebo [11]. Author is at the Zakusov Institute [2]
Bochkarev et al., 2008 [4]	Patients with mild cognitive impairment of traumatic or vascular origin; EEG	More alpha and beta power, less delta; authors read this as nonspecific activation. No sample size in abstract
Barantsevich et al., 2009 [5]	Discirculatory encephalopathy; comparative study	No abstract in the record
Chutko et al., 2008 [6]	Neurasthenia	No abstract in the record
Mordyk et al., 2009 [7]	60 newly diagnosed tuberculosis patients; first group n=30 on noopept for one month	Reported fewer neuro- and cardiotoxic reactions to TB drugs; second group not described in abstract
Shabanov et al., 2007 [8]	Healthy volunteers aged 20-24 in a climate chamber; four drugs	Authors report improved psychological function and heat/cold adaptation; no sample size in abstract
Lysenko et al., 2018 [9]	Older teachers; noopept combined with self-massage	Better performance; no sample size or controls in abstract

The medi.ru page describes three-centre work run under a Russian Ministry of Health committee decision, with piracetam as the comparator, but gives no sample sizes, blinding or statistics [10]. Taken together, the studies are small, mostly open-label or comparator-only, from Russian journals, and several are linked to the institute that developed the drug. A medical portal’s list of cognitive and anxiety benefits [10] is not a substitute for trial data. ConsumerLab (updated 2020) found only two human studies it counted, neither placebo-controlled, and none showing cognitive or mood benefit in healthy people [11]. We did not do a full literature search beyond Europe PMC (127 hits for “noopept”, most animal or unrelated), so a trial we missed is possible.

Animal and cell work, kept separate

Rodent and cell studies are the bulk of the literature. Examples we opened: mice with olfactory bulbectomy, a model of Alzheimer’s-type changes, given a low dose for 21 days showed better water-maze performance (Wellcome Trust grant listed; group sizes not in the abstract) [15]; the rat NGF/BDNF work [14]; PC12 cells [13]; and a rat pharmacokinetics paper in which the active metabolite cyclo-prolylglycine behaved differently from the parent drug [16]. Animal results do not establish that the same effect occurs in people, particularly at oral doses.

Regulatory status

• Russia: sold as a registered medicine; a secondary source gives registration number ЛС-001577 (12 May 2006) [10]. The RLS search page lists “Ноопепт” as a medicinal product, but we could not open the register entry (holder, indications, prescription status) [22]. We did not verify the current status in the state register.
• United States: not an FDA-approved drug. In a letter dated 4 February 2019, the FDA told Peak Nootropics that its noopept claims made the product an unapproved new drug, and said noopept is not a dietary supplement [18]. In February 2022 the FDA sent a similar letter to Crystal Clear Supplements, reported by ConsumerLab; we did not read the letter [19].
• United Kingdom: in October 2014 the MHRA reported seizing noopept tablets among a record haul of “smart drugs,” saying the “sale and supply of a prescription only or unlicensed medicine is an offence” [20]. We did not check the current UK position.
• EU, Germany, Canada, Australia, and controlled-substance schedules elsewhere: not checked against primary sources. A 2025 study by 12 official medicines control laboratories in Europe and Australia names noopept among non-authorised drugs, prescription-only in Russia, seized as bulk raw material [21].

“Research use only” does not make a substance legal to sell for human consumption; the FDA letter turned on the seller’s marketing claims [18].

Risks and unknowns

• No long-term safety studies; noopept is not GRAS in the US (ConsumerLab) [11].
• ConsumerLab reports that in the piracetam comparison, two noopept patients had blood pressure rises needing treatment and left the study, with sleep disturbance and irritability also noted. The label reportedly warns about severe hypertension and advises against use in minors, pregnancy, breastfeeding, kidney or liver disease, and with alcohol, stimulants or antihypertensives [11]. We did not see the label.
• Surveillance labs find unauthorised nootropics in the illegal market, so content of non-pharmacy products is unverified [21].
• Not studied: healthy adults in controlled trials, long-term use, drug interactions, children, pregnancy.

What the tier lists claim

We could not read the images of either post; the placements below are as reported to us, not independently verified.

@Hoostethics (2026-10-15), “ranking the most cope supplements,” noopept rated “somewhat cope” [23]. Verdict: supported, with a caveat. “Cope” implies weak benefit for the effort and cost. That matches the evidence: small, mostly uncontrolled patient studies, no healthy-adult trials. “Somewhat” is fair because it is a real medicine in Russia with some positive patient data.

@dex7official (2026-10-20), “THE ONLY TRUE COGNITIVE ENHANCEMENT TIER LIST (NO COPES EDITION),” noopept in C [24]. Verdict: not supported as a cognitive-enhancement ranking, partly supported as a middling tier. No opened source shows an enhancement effect in healthy people [11]. A C placement is a modest claim, but the premise, that noopept enhances cognition in healthy users, has no controlled evidence behind it. Both posters are opinions, not evidence.

Frequently asked questions

Is noopept FDA approved? No. The FDA has stated that noopept products marketed with disease claims are unapproved new drugs and that noopept is not a dietary supplement [18].

Is noopept a medicine in Russia? A secondary source reports registration as a nootropic in 2006 [10]. We could not open the state register to confirm current status.

Has noopept been tested in healthy people? We found none. The human studies we located were in patients, or, in one case, healthy volunteers in a climate chamber with no sample size in the abstract [8][11].

Is the evidence independent? Mostly not. The authors of the key mechanism, animal and several clinical papers are at the institute that developed the drug [2][12][13].

Sources

1. Amelin AV et al., “Noopept in the treatment of mild cognitive impairment in patients with stroke,” Zh Nevrol Psikhiatr Im S S Korsakova (2011), PMID 22500312, read via Europe PMC. https://pubmed.ncbi.nlm.nih.gov/22500312/
2. Neznamov GG, Teleshova ES, “Comparative studies of Noopept and piracetam…,” Neurosci Behav Physiol (2009), PMID 19234797 (record only, no abstract). https://pubmed.ncbi.nlm.nih.gov/19234797/
3. Neznamov GG, Teleshova ES, Zh Nevrol Psikhiatr Im S S Korsakova (2008), PMID 18697252 (record only). https://pubmed.ncbi.nlm.nih.gov/18697252/
4. Bochkarev VK et al., EEG characteristic of noopept, Korsakov J (2008), PMID 19008801. https://pubmed.ncbi.nlm.nih.gov/19008801/
5. Barantsevich ER et al., “Efficacy of noopept in discirculatory encephalopathy” (2009), PMID 19938275 (record only). https://pubmed.ncbi.nlm.nih.gov/19938275/
6. Chutko LS et al., “The using of noopept in treatment of neurasthenia” (2008), PMID 19253467 (record only). https://pubmed.ncbi.nlm.nih.gov/19253467/
7. Mordyk AV et al., noopept and tuberculosis chemotherapy side effects, Klin Med (2009), PMID 19565831. https://pubmed.ncbi.nlm.nih.gov/19565831/
8. Shabanov PD et al., “Meteoadaptogenic properties of peptide drugs in healthy volunteers” (2007), PMID 18318195. https://pubmed.ncbi.nlm.nih.gov/18318195/
9. Lysenko AV et al., self-massage with noopept in older teachers, Adv Gerontol (2018), PMID 30877834. https://pubmed.ncbi.nlm.nih.gov/30877834/
10. medi.ru, “Ноотроп Ноопепт: Результаты клинического изучения ноопепта” (6 Nov 2014). https://medi.ru/info/10614/
11. ConsumerLab, “Can Noopept really improve memory and cognition, and is it safe?” (updated 26 Sep 2020). https://www.consumerlab.com/answers/can-noopept-really-improve-memory-and-cognition-and-is-it-safe/Noopept/
12. Vakhitova YV et al., “Molecular Mechanism Underlying the Action of Substituted Pro-Gly Dipeptide Noopept,” Acta Naturae (2016), PMID 27099787. https://pmc.ncbi.nlm.nih.gov/articles/PMC4837574
13. Ostrovskaya RU et al., noopept in an Alzheimer’s-related cell model, J Biomed Sci (2014), PMID 25096780. https://pubmed.ncbi.nlm.nih.gov/25096780/
14. Ostrovskaya RU et al., “Noopept stimulates the expression of NGF and BDNF in rat hippocampus,” Bull Exp Biol Med (2008), PMID 19240853. https://pubmed.ncbi.nlm.nih.gov/19240853/
15. Ostrovskaya RU et al., J Psychopharmacol (2007), PMID 17092975. https://pubmed.ncbi.nlm.nih.gov/17092975/
16. Boyko SS et al., pharmacokinetics of noopept and cyclo-prolylglycine in rats, Biomed Khim (2018), PMID 30378564. https://pubmed.ncbi.nlm.nih.gov/30378564/
17. Taghizadeh M et al., Heliyon (2021), retracted; PMID 33644478 (retraction notice PMID 34041381). https://pubmed.ncbi.nlm.nih.gov/33644478/
18. FDA, Warning Letter to Peak Nootropics LLC aka Advanced Nootropics, 557887 (4 Feb 2019; listed 5 Feb 2019). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-nootropics-llc-aka-advanced-nootropics-557887-02052019
19. ConsumerLab, “Seller of L-theanine, lutein, noopept and more warned for drug claims” (17 Feb 2022; FDA letter dated 4 Feb 2022). https://www.consumerlab.com/recalls/14635/seller-of-l-theanine-lutein-noopept-and-more-warned-for-drug-claims/
20. MHRA, “Medicines watchdog makes record seizure of experimental smart drugs” (24 Oct 2014). https://www.gov.uk/government/news/medicines-watchdog-makes-record-seizure-of-experimental-smart-drugs
21. Vanhee C et al., “The Occurrence of Illicit Smart Drugs or Nootropics in Europe and Australia…,” J Xenobiot (2025), PMID 40558871. https://pubmed.ncbi.nlm.nih.gov/40558871/
22. RLS (rlsnet.ru), search results for “ноопепт” (accessed 2026-11-08; register entry not opened). https://www.rlsnet.ru/search_result.htm?word=ноопепт
23. @Hoostethics on X, “ranking the most cope supplements” (2026-10-15); tier-list image not read. https://x.com/Hoostethics/status/2110728908735979632
24. @dex7official on X, “THE ONLY TRUE COGNITIVE ENHANCEMENT TIER LIST (NO COPES EDITION)” (2026-10-20); tier-list image not read. https://x.com/dex7official/status/2112691493261484516

This article is information, not medical advice.