Peptides›Cognitive›Piracetam

Piracetam

/ Original racetam-class nootropic (small molecule, pyrrolidone derivative)

TIER 2 · TranslationalN = 0 · TESTING PENDINGMW 142.16 g·mol⁻¹

ALIAS · Nootropil (trade) · UCB-6215 · 2-oxo-1-pyrrolidineacetamide · Lucetam · Memotopril

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Research use onlyAny dose figures below describe what specific cited studies used, reported factually. Nothing on this page is guidance for human use.READ FIRST →

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§ A · Identity

Primary sequence— sequence not captured —

MW · 142.16CLASS · Original racetam-class nootropic (small molecule, pyrrolidone derivative)CATEGORY · Cognitive

Tier 2. The original racetam-class nootropic, synthesised by UCB in 1964. Approved in many EU and CIS countries for cognitive disorders, post-stroke aphasia, and myoclonus; not approved by the FDA for any indication. Multiple RCTs in dementia and stroke recovery with mixed results; Cochrane review found insufficient evidence for dementia indication.

§ B · Mechanism of action

Piracetam is a cyclic derivative of GABA but does not bind GABA receptors at therapeutic concentrations. Proposed mechanisms include modulation of AMPA receptor density, increased fluidity of neuronal membranes, enhanced cerebral microcirculation, and effects on platelet aggregation. None of these mechanisms has been established as the primary clinically relevant action, and the molecule is best characterised pharmacologically as the founding member of the racetam class with a mechanism that remains incompletely defined after six decades of investigation.

§ C · Human clinical evidence

Tier 2. The 2001 Cochrane review (Flicker and Grimley Evison) of piracetam for dementia or cognitive impairment concluded the published evidence did not support routine use. Trials in post-stroke aphasia, cortical myoclonus, and dyslexia have produced mixed results, with effect sizes generally small and methodological heterogeneity high.

§ D · Primary literature

PubMed11405971Flicker L et al. — Piracetam for dementia or cognitive impairment · Cochrane Database of Systematic Reviews · systematic-reviewCochrane review of piracetam trials in dementia and cognitive impairment concluded the published evidence did not support routine clinical use.Limitations: Heterogeneity in trial design and outcome measures; many older, small studies.2001

PubMed16007238Winblad B et al. — Piracetam: a review of pharmacological properties and clinical uses · CNS Drug Reviews · reviewNarrative review summarising piracetam pharmacology, mechanism hypotheses, and clinical trial data across cognitive, cerebrovascular, and myoclonic indications.Limitations: Narrative synthesis; not a systematic review; author affiliated with manufacturer.2005

§ F · Safety signal

Generally well-tolerated in published trials at gram-scale daily doses. Reported adverse events include nervousness, agitation, irritability, sleep disturbance, and weight gain. Renal excretion necessitates dose adjustment in renal impairment.

§ H · Regulatory status

Regulatory status

FDA status:: Not FDA-approved
Compounding:: Compounding eligibility ambiguous

§ I · Notable gaps and controversies

The 2010 FDA warning letter to a US dietary supplement vendor explicitly stated piracetam does not meet the statutory definition of a dietary ingredient, leaving its regulatory status in the US ambiguous. The compound is widely sold internationally but has never received FDA approval, and the supportive trial literature is older, small, and largely European. Vendor marketing as a 'cognitive enhancer' for healthy adults far exceeds the controlled-trial evidence base.