Last reviewed 2026-04-20 · How we verify

Bunaftide (BUNAFTINE)

Phase 2 active Small molecule

Bunaftide (generic name: BUNAFTINE) is a bunaftine drug. It is currently in Phase 2 development.

Bunaftine works by interacting with a specific target to produce its therapeutic effect.

Bunaftine is a small molecule drug in the bunaftine class, developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are not specified. The commercial status of bunaftine is unclear, with unknown patent status and generic manufacturers. Further information on its approved indications, half-life, and bioavailability is also unavailable. As a result, key safety considerations and clinical use cannot be accurately assessed.

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	BUNAFTINE
Drug class	bunaftine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and the key to unlocking a specific problem is a molecule that fits perfectly into that lock. Bunaftine is designed to be that key, but the exact lock it fits into is not well understood. By binding to this target, bunaftine aims to modulate the body's response to a particular condition.

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:

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

Frequently asked questions about Bunaftide

What is Bunaftide?

Bunaftide (BUNAFTINE) is a bunaftine drug.

How does Bunaftide work?

Bunaftine works by interacting with a specific target to produce its therapeutic effect.

What is the generic name of Bunaftide?

BUNAFTINE is the generic (nonproprietary) name of Bunaftide.

What drug class is Bunaftide in?

Bunaftide belongs to the bunaftine class. See all bunaftine drugs at /class/bunaftine.

What development phase is Bunaftide in?

Bunaftide is in Phase 2.

Drug class: All bunaftine drugs
Therapeutic area: All drugs in Other

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