Last reviewed 2026-05-20 · How we verify

Etafenon (ETAFENONE)

Phase 2 active Small molecule ✓ Verified May 2026

Etafenon (generic name: ETAFENONE) is a etafenone drug. It is currently in Phase 2 development.

Etafenone is thought to work by inhibiting the sodium channel, which can help to reduce abnormal electrical activity in the heart.

Etafenon is a small molecule. It is also known by the synonyms Etafenona and Etafenone.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	ETAFENONE
Drug class	etafenone
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your heart is like a city with electrical signals that help it beat properly. Sometimes, these signals can get mixed up and cause problems. Etafenone helps to calm down the electrical activity in the heart by blocking the sodium channels, which can help to restore a normal heartbeat.

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:

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

Frequently asked questions about Etafenon

What is Etafenon?

Etafenon (ETAFENONE) is a etafenone drug.

How does Etafenon work?

Etafenone is thought to work by inhibiting the sodium channel, which can help to reduce abnormal electrical activity in the heart.

What is the generic name of Etafenon?

ETAFENONE is the generic (nonproprietary) name of Etafenon.

What drug class is Etafenon in?

Etafenon belongs to the etafenone class. See all etafenone drugs at /class/etafenone.

What development phase is Etafenon in?

Etafenon is in Phase 2.

Drug class: All etafenone drugs
Therapeutic area: All drugs in Cardiovascular

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