Last reviewed 2026-04-20 · How we verify

Clofezon (CLOFEZONE)

Phase 2 active Small molecule

Clofezon (generic name: CLOFEZONE) is a clofezone drug. It is currently in Phase 2 development.

Clofezone works by interacting with a specific molecular target to produce a therapeutic effect.

Clofezone is a small molecule drug in the clofezone class, developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are not specified. Clofezone is not FDA-approved for any indications, and its commercial status, half-life, bioavailability, generic manufacturers, and patent status are unknown. As a result, there is limited information available on its safety profile and efficacy. Further research is needed to determine the potential therapeutic applications and risks associated with clofezone.

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	CLOFEZONE
Drug class	clofezone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking these locks is a specific molecule. Clofezone is designed to mimic this key, allowing it to bind to the lock and trigger a response that can help treat a particular condition. This process is known as a molecular interaction, and it's a fundamental way that many medications work.

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:

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

Frequently asked questions about Clofezon

What is Clofezon?

Clofezon (CLOFEZONE) is a clofezone drug.

How does Clofezon work?

Clofezone works by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Clofezon?

CLOFEZONE is the generic (nonproprietary) name of Clofezon.

What drug class is Clofezon in?

Clofezon belongs to the clofezone class. See all clofezone drugs at /class/clofezone.

What development phase is Clofezon in?

Clofezon is in Phase 2.

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

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