Last reviewed 2026-05-22 · How we verify

Amfenidone (AMPHENIDONE)

Phase 2 active Small molecule ✓ Verified May 2026

Amfenidone (generic name: AMPHENIDONE) is a drug. It is currently in Phase 2 development.

Amfenidone is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

Amfenidone is a small molecule with synonyms including Amfenidona and Amphenidone.

Likelihood of approval

15.3% 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).

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	AMPHENIDONE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking the right response is a specific molecule. Amfenidone is designed to fit that key, allowing it to turn the lock and trigger a response that can help treat a particular condition. However, the exact details of how it works are still unclear.

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:

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

Frequently asked questions about Amfenidone

What is Amfenidone?

Amfenidone (AMPHENIDONE) is a Small molecule drug.

How does Amfenidone work?

Amfenidone is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Amfenidone?

AMPHENIDONE is the generic (nonproprietary) name of Amfenidone.

What development phase is Amfenidone in?

Amfenidone is in Phase 2.

Therapeutic area: All drugs in Other

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