Last reviewed 2026-04-20 · How we verify

Amacetam (PRAMIRACETAM)

Phase 2 active Small molecule

Amacetam (generic name: PRAMIRACETAM) is a pramiracetam drug. It is currently in Phase 2 development for Memory impairment, Senile dementia.

Pramiracetam works by increasing the activity of certain neurotransmitters in the brain, such as acetylcholine, to enhance memory and cognitive function.

Amacetam, also known as Pramiracetam, is a small molecule drug in the pramiracetam class. It is used to treat memory impairment and senile dementia, although its exact target is unknown. The commercial status of Amacetam is unclear, and it is not FDA-approved. Pramiracetam is a nootropic agent that has been shown to improve memory and cognitive function in various studies. Further research is needed to fully understand its safety and efficacy.

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 name	PRAMIRACETAM
Drug class	pramiracetam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of your brain like a computer. Pramiracetam helps your brain's 'computer chips' (neurons) communicate more efficiently with each other, allowing you to process and store information better. This can lead to improved memory and concentration.

Approved indications

Memory impairment
Senile dementia

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:

Amacetam CI brief — competitive landscape report
Amacetam updates RSS · CI watch RSS

Frequently asked questions about Amacetam

What is Amacetam?

Amacetam (PRAMIRACETAM) is a pramiracetam drug, indicated for Memory impairment, Senile dementia.

How does Amacetam work?

Pramiracetam works by increasing the activity of certain neurotransmitters in the brain, such as acetylcholine, to enhance memory and cognitive function.

What is Amacetam used for?

Amacetam is indicated for Memory impairment, Senile dementia.

What is the generic name of Amacetam?

PRAMIRACETAM is the generic (nonproprietary) name of Amacetam.

What drug class is Amacetam in?

Amacetam belongs to the pramiracetam class. See all pramiracetam drugs at /class/pramiracetam.

What development phase is Amacetam in?

Amacetam is in Phase 2.

Drug class: All pramiracetam drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Memory impairment
Indication: Drugs for Senile dementia

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