Last reviewed 2026-06-03 · How we verify

Bamiphylline (BAMIFYLLINE)

Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 24/100

Bamiphylline (generic name: BAMIFYLLINE) is a bamifylline drug. It is currently in Phase 2 development.

Bamiphylline is thought to work by modulating phosphodiesterase activity, although the exact details of its mechanism are unclear.

Bamiphylline is a small molecule with synonyms including AC-3810 FREE BASE, BAMIFILINA, BAMIFYLLINE, and BAX-2739Z FREE BASE.

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	BAMIFYLLINE
Drug class	bamifylline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a messaging system that helps them communicate with each other. Bamiphylline is believed to affect this system by influencing the way cells break down and reuse these messages, which can help regulate various bodily functions.

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:

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

Frequently asked questions about Bamiphylline

What is Bamiphylline?

Bamiphylline (BAMIFYLLINE) is a bamifylline drug.

How does Bamiphylline work?

Bamiphylline is thought to work by modulating phosphodiesterase activity, although the exact details of its mechanism are unclear.

What is the generic name of Bamiphylline?

BAMIFYLLINE is the generic (nonproprietary) name of Bamiphylline.

What drug class is Bamiphylline in?

Bamiphylline belongs to the bamifylline class. See all bamifylline drugs at /class/bamifylline.

What development phase is Bamiphylline in?

Bamiphylline is in Phase 2.

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

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