Noopept
Noopept is a dipeptide-derived small molecule, N-phenylacetyl-L-prolylglycine ethyl ester, developed in Russia as a nootropic research compound. It has been studied mostly in rodent models, with limited clinical data, and is not approved by the FDA.
Overview
Noopept, also known as omberacetam or by its development code GVS-111, was developed at the Zakusov Institute of Pharmacology in Moscow as part of a program designing small dipeptide-based molecules intended to mimic aspects of the racetam class of nootropics. It is built from a prolylglycine core with an N-terminal phenylacetyl group and a C-terminal ethyl ester. Although it is derived from a dipeptide, it is a small molecule rather than a peptide in the usual sense, and it is orally absorbed in animal studies.
Most published work on noopept comes from Russian research groups and consists of rodent studies of memory, anxiety-related behavior and models of brain injury, alongside in-vitro neuroprotection experiments. A smaller number of clinical studies, mainly published in Russian-language journals, have examined patients with cognitive complaints. These trials were generally small and are not widely accessible for independent assessment. Outside Russia and nearby countries the compound has no established clinical role, and the preclinical findings should be interpreted with caution.
Structure
Noopept is N-phenylacetyl-L-prolylglycine ethyl ester. Its core is the dipeptide Pro-Gly, with the proline nitrogen acylated by a phenylacetyl group and the glycine carboxyl converted to an ethyl ester. It has no free N-terminal amine or C-terminal acid, which distinguishes it from ordinary short peptides and increases its lipophilicity. In animals it has been reported to be metabolized in part to cycloprolylglycine, a cyclic dipeptide that occurs endogenously in the brain. Because of the capping groups, its mass should be checked against the specific small-molecule structure.
Mechanism
The mechanism of noopept is not firmly established. Proposed actions from rodent and cell studies include increased expression of neurotrophins such as nerve growth factor and brain-derived neurotrophic factor in the hippocampus, modulation of glutamatergic AMPA receptor signaling, antioxidant and anti-inflammatory effects, and activation of the transcription factor HIF-1. Some authors attribute part of its activity to its metabolite cycloprolylglycine. These hypotheses come largely from the originating research community and have not been integrated into a validated mechanism.
Research
Rodent memory and learning
Much of the noopept literature consists of rodent experiments using passive avoidance, maze learning and conditioned reflex tasks, often in animals with deficits induced by drugs, hypoxia or surgical lesions. Investigators reported improved performance in treated animals. These studies vary in design, and many were published in Russian journals with limited peer scrutiny outside that community. They suggest pharmacological activity in animal models but do not establish clinical effects in people.
Neuroprotection models
In-vitro and animal studies have examined noopept in models of oxidative stress, glutamate toxicity, amyloid-beta exposure and experimental brain ischemia or trauma. Authors reported reduced markers of cell damage and improved survival of cultured neurons. These are mechanistic and preclinical observations; neuroprotection in such models has historically translated poorly to human neurological disease, so the findings are best viewed as hypothesis-generating.
Clinical studies
Small clinical studies, mainly from Russia, have compared noopept with piracetam in patients with mild cognitive disorders of vascular or post-traumatic origin, reporting changes in cognitive and anxiety scales. These trials were modest in size, often not placebo-controlled in a modern sense, and are not easily accessible to international reviewers. There are no large randomized controlled trials published in major international journals, so the human evidence base remains limited. Researchers seeking to evaluate these studies may need to rely on secondary summaries, which adds a further layer of uncertainty.
Evidence quality
Noopept has a sizeable but geographically concentrated literature. Strengths include a defined chemical structure and many animal studies; weaknesses include few independent replications, limited international clinical data, and incomplete characterization of long-term safety. Researchers should treat it as an investigational nootropic compound with early clinical evidence of uncertain quality. Its classification as a peptide-derived small molecule, rather than a peptide, also matters for how it is characterized, stored and regulated.
Regulatory status
Noopept is not approved by the FDA for any use, and it is not on the Section 503A bulk drug substances list. It has been marketed as a medicine in Russia; its status in other countries varies and should be checked locally. FDA has taken the position that some nootropic compounds sold in products labeled as dietary supplements do not meet the definition of a dietary ingredient; check current FDA statements for noopept specifically. For sport, check the current WADA Prohibited List.
Status changes often. See the regulatory tracker for dated updates.
Quality and identity testing
Because noopept is a small molecule rather than a peptide, a certificate of analysis should confirm identity by mass spectrometry against the expected mass of N-phenylacetyl-L-prolylglycine ethyl ester, ideally supported by NMR or infrared spectroscopy. Purity should be reported by HPLC with the chromatogram. Specific pitfalls include hydrolysis of the ethyl ester to the free acid, which appears as a distinct related-substance peak, and the stereochemical purity of the L-proline residue. Residual solvents from synthesis should also be reported.
For a walkthrough of each section of a certificate, see how to read a COA.
Storage and stability
Store solid noopept in a tightly sealed container at room temperature or below, protected from light and moisture; refrigeration or -20 °C storage is reasonable for long-term reference material. The ethyl ester is susceptible to hydrolysis, particularly in aqueous solution and at elevated pH, so prepare solutions shortly before use, keep them cold, and avoid prolonged storage in water. Allow cold containers to warm before opening to prevent condensation.
Download the Noopept data sheet (PDF): sequence, masses, expected MS ions and handling on one printable page.
Latest research
The newest PubMed-indexed papers that mention Noopept in their title or abstract, retrieved through Europe PMC and refreshed automatically. Inclusion is not an endorsement of a paper's findings.
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Frequently asked questions
Is noopept a peptide?
Not in the usual sense. Noopept is derived from the dipeptide prolylglycine, but its N-terminus is capped with a phenylacetyl group and its C-terminus is an ethyl ester. It behaves as a small, orally absorbed molecule, which is why it is described as dipeptide-derived rather than as a peptide.
Is noopept FDA approved?
No. Noopept is not approved by the FDA for any use. It has been marketed as a medicine in Russia, but its clinical evidence consists mainly of small studies published in Russian journals, and it has no approved indication in the United States.
What is the difference between noopept and piracetam?
Piracetam is a cyclic derivative of GABA and the prototype racetam, while noopept is a dipeptide-derived molecule designed later in Russia. Noopept was developed partly with racetam-like effects in mind and is active at much lower concentrations in animal studies, but the two are structurally distinct and have different proposed mechanisms.
Related compounds
- Semax
Semax is a synthetic heptapeptide developed in Russia as an analogue of the adrenocorticotropic hormone fragment ACTH(4-7), extended with a Pro-Gly-Pro tail. It is studied for neurotrophic signaling and in models of brain injury.
- Selank
Selank is a synthetic heptapeptide developed in Russia, built from the immunomodulatory tetrapeptide tuftsin extended with a Pro-Gly-Pro tail. It is studied mainly for effects on anxiety-related behavior and immune signaling.
- Dihexa
Dihexa is a small, chemically modified peptide-like analogue of angiotensin IV developed as a metabolically stabilized research compound. It has been studied in rodent models of cognitive impairment and is not approved for any use.
- Cerebrolysin
Cerebrolysin is a preparation of low-molecular-weight peptides and amino acids derived from porcine brain proteins. It is approved in some countries for neurological conditions such as stroke and dementia, but it is not approved in the US.
References
- PubMed: all indexed literature on Noopept
- ClinicalTrials.gov: registered studies mentioning Noopept
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