Peptides›Cognitive›Fasoracetam

Fasoracetam

/ Racetam-class nootropic (small molecule); proposed mGluR3 / Group II metabotropic glutamate receptor agonist

TIER 2 · TranslationalN = 0 · TESTING PENDINGMW 196.25 g·mol⁻¹

ALIAS · NS-105 · MDGN-001

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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 · 196.25CLASS · Racetam-class nootropic (small molecule); proposed mGluR3 / Group II metabotropic glutamate receptor agonistCATEGORY · Cognitive

Tier 2. Originally developed by Nippon Shinyaku for vascular dementia in the 1990s (program discontinued for failure to meet endpoints), then resurrected by Aevi Medical (later Cerecor) for adolescent ADHD with mGluR-network gene variants. Phase 2 (Elia 2018) reported behavioural improvement in the genotype-selected subgroup, but subsequent Phase 2/3 development was discontinued and the asset was deprioritised.

§ B · Mechanism of action

Fasoracetam is a pyrrolidone-containing small molecule of the racetam structural class. The proposed pharmacology centres on agonism at metabotropic glutamate receptors of Group II (mGluR2 / mGluR3) and modulation of GABA-B receptor density with sustained dosing. The Aevi development thesis was that adolescents carrying disruptive variants in genes of the mGluR network would respond preferentially to fasoracetam compared with unselected ADHD populations.

§ C · Human clinical evidence

Tier 2. The principal modern human-data anchor is Elia 2018 — an open-label dose-escalation Phase 1b/2a study in adolescents with ADHD and mGluR-network gene variants, reporting reductions in ADHD-rating-scale scores. The original Nippon Shinyaku vascular-dementia program produced internal trial results that did not support approval and is not well-represented in the indexed primary literature. Subsequent randomised placebo-controlled work in the ADHD indication was not published in a form supporting approval, and development was discontinued.

§ D · Primary literature

PubMed29339723Elia J et al. — Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling · Nature Communications · human-phase-2Open-label dose-escalation in adolescents with ADHD and mGluR-network gene variants reported clinically meaningful reductions in ADHD-rating-scale scores over 5 weeks.Limitations: Open-label, no placebo control, small n, single-site, genotype-selected population; not generalisable to unselected ADHD.2018

PubMed31167583Nageye F et al. — Beyond stimulants: a systematic review of randomised controlled trials assessing novel compounds for ADHD · Expert Review of Neurotherapeutics · systematic-reviewSystematic review of non-stimulant novel compounds for ADHD; positions fasoracetam among emerging agents with modest randomised evidence.Limitations: Review-level; constrained by small primary trials of fasoracetam available at the time.2019

§ F · Safety signal

Open-label adolescent ADHD data reported acceptable short-term tolerability with mild gastrointestinal and headache adverse events; the safety database is small and short-duration. No identified major safety signal in the published record, but the absence of large-scale randomised exposure limits inference.

§ H · Regulatory status

Regulatory status

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

§ I · Notable gaps and controversies

Multiple development cycles ending in discontinuation — first the Nippon Shinyaku vascular-dementia program, then the Aevi/Cerecor pediatric ADHD program. The genotype-selected efficacy hypothesis (mGluR-network variants predicting response) was novel and not subsequently confirmed in larger placebo-controlled work to a level supporting regulatory approval.