Last reviewed 2026-06-02 · How we verify

BISBENTIAMINE

Phase 2 active Small molecule ✓ Verified Jun 2026

BISBENTIAMINE is a bisbentiamine drug. It is currently in Phase 2 development.

Bisbentiamine is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

Bisbentiamine is a small molecule drug in the bisbentiamine class, but its target and mechanism of action are unknown. Its commercial status and approved indications are also unclear. As a result, there is limited information available on its safety profile, pharmacokinetics, or generic availability. Further research is needed to fully understand this compound. Its development history is also unclear.

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	BISBENTIAMINE
Drug class	bisbentiamine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and bisbentiamine is a key that fits into one of those locks. When it binds, it can either unlock or block the lock, depending on how it interacts with the target. However, since its target is unknown, we can't say exactly how it works.

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:

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

Frequently asked questions about BISBENTIAMINE

What is BISBENTIAMINE?

BISBENTIAMINE is a bisbentiamine drug.

How does BISBENTIAMINE work?

Bisbentiamine is a small molecule that works by interacting with a specific target in the body, but its exact mechanism is unknown.

What drug class is BISBENTIAMINE in?

BISBENTIAMINE belongs to the bisbentiamine class. See all bisbentiamine drugs at /class/bisbentiamine.

What development phase is BISBENTIAMINE in?

BISBENTIAMINE is in Phase 2.

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

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