Last reviewed 2026-04-20 · How we verify

Piribenzil (BEVONIUM)

Phase 2 active Small molecule

Piribenzil (generic name: BEVONIUM) is a bevonium drug. It is currently in Phase 2 development.

Piribenzil is thought to work by interacting with a specific molecular target, although the exact nature of this interaction is not well understood.

Piribenzil, also known as Bevonium, is a small molecule drug of the bevonium class. Its exact target and mechanism of action are unknown, and it has not been approved by the FDA for any indications. The commercial status of Piribenzil is unclear, with no information available on its patent status, generic manufacturers, or off-patent status. Further research is needed to understand the potential uses and safety considerations of this compound. As a result, Piribenzil is not a commercially available treatment option at this time.

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	BEVONIUM
Drug class	bevonium
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Piribenzil is a key that fits into one of those locks. When it binds to the lock, it can either turn it on or off, depending on the type of lock and the key's shape. This can help regulate various bodily functions, but more research is needed to understand how Piribenzil works and what effects it might have on the body.

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:

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

Frequently asked questions about Piribenzil

What is Piribenzil?

Piribenzil (BEVONIUM) is a bevonium drug.

How does Piribenzil work?

Piribenzil is thought to work by interacting with a specific molecular target, although the exact nature of this interaction is not well understood.

What is the generic name of Piribenzil?

BEVONIUM is the generic (nonproprietary) name of Piribenzil.

What drug class is Piribenzil in?

Piribenzil belongs to the bevonium class. See all bevonium drugs at /class/bevonium.

What development phase is Piribenzil in?

Piribenzil is in Phase 2.

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

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