Last reviewed 2026-05-27 · How we verify

Translon (NEFIRACETAM)

Phase 2 active Small molecule ✓ Verified May 2026

Translon (generic name: NEFIRACETAM) is a nefiracetam drug. It is currently in Phase 2 development.

Nefiracetam is a nootropic agent that works by enhancing the activity of neurotransmitters in the brain.

Nefiracetam is a small molecule. It is also known by the synonyms NEFIRACETAM, NEFIRACETAM, NEFIRACETAM, NEFIRACETAM, and NSC-759830.

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	NEFIRACETAM
Drug class	nefiracetam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a busy city with many different streets and intersections. Nefiracetam helps to improve communication between the different areas of the city by making the streets (neurotransmitters) work more efficiently. This can help to improve memory, learning, and other cognitive functions.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Nefiracetam in the Treatment of Alzheimer's Disease (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

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

Frequently asked questions about Translon

What is Translon?

Translon (NEFIRACETAM) is a nefiracetam drug.

How does Translon work?

Nefiracetam is a nootropic agent that works by enhancing the activity of neurotransmitters in the brain.

What is the generic name of Translon?

NEFIRACETAM is the generic (nonproprietary) name of Translon.

What drug class is Translon in?

Translon belongs to the nefiracetam class. See all nefiracetam drugs at /class/nefiracetam.

What development phase is Translon in?

Translon is in Phase 2.

Drug class: All nefiracetam drugs
Therapeutic area: All drugs in Neuroscience

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