Last reviewed 2026-04-20 · How we verify

Benzilone (BENZILONIUM)

Phase 2 active Small molecule

Benzilone (generic name: BENZILONIUM) is a benzilonium drug. It is currently in Phase 2 development.

Benzilonium works by interacting with a specific target in the body to produce a therapeutic effect.

Benzilonium is a small molecule drug in the benzilonium class, but specific details about its development, approval status, and commercial status are not available. Its target and mechanism of action are also unknown. As a result, there is limited information available about its use, safety, and efficacy. Further research is needed to understand the potential benefits and risks of benzilonium. Its current status and indications are 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	BENZILONIUM
Drug class	benzilonium
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine benzilonium as a key that fits into a lock in the body. When it binds to the lock, it triggers a series of events that ultimately lead to the desired outcome, such as relieving symptoms or treating a condition. This process is complex and involves many different molecules and cellular processes.

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:

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

Frequently asked questions about Benzilone

What is Benzilone?

Benzilone (BENZILONIUM) is a benzilonium drug.

How does Benzilone work?

Benzilonium works by interacting with a specific target in the body to produce a therapeutic effect.

What is the generic name of Benzilone?

BENZILONIUM is the generic (nonproprietary) name of Benzilone.

What drug class is Benzilone in?

Benzilone belongs to the benzilonium class. See all benzilonium drugs at /class/benzilonium.

What development phase is Benzilone in?

Benzilone is in Phase 2.

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

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