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Ampamet (ANIRACETAM)

Phase 2 active Small molecule ✓ Verified May 2026

Ampamet (generic name: ANIRACETAM) is a aniracetam drug. It is currently in Phase 2 development.

Aniracetam works by enhancing the activity of glutamate receptors and increasing the release of the neurotransmitter acetylcholine.

Ampamet, also known as Aniracetam, is a small molecule. It is a synthetic compound with the chemical name 1-P-ANISOYL-2-PYRROLIDINONE.

Likelihood of approval
12.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameANIRACETAM
Drug classaniracetam
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of it like a key that unlocks a door in your brain. Aniracetam helps turn up the volume on certain chemical signals that help us learn and remember new information. This can make it easier to focus and pay attention.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Ampamet

What is Ampamet?

Ampamet (ANIRACETAM) is a aniracetam drug.

How does Ampamet work?

Aniracetam works by enhancing the activity of glutamate receptors and increasing the release of the neurotransmitter acetylcholine.

What is the generic name of Ampamet?

ANIRACETAM is the generic (nonproprietary) name of Ampamet.

What drug class is Ampamet in?

Ampamet belongs to the aniracetam class. See all aniracetam drugs at /class/aniracetam.

What development phase is Ampamet in?

Ampamet is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing