Last reviewed 2026-06-01 · How we verify

Clorexolon (CLOREXOLONE)

Phase 2 active Small molecule

Clorexolon (generic name: CLOREXOLONE) is a clorexolone drug. It is currently in Phase 2 development.

Clorexolone is thought to work by inhibiting the activity of certain enzymes involved in inflammation and pain.

Clorexolone is a small molecule drug in the clorexolone class, but specific details about its development, approval status, and commercial status are not available. As a result, there is limited information about its target, approved indications, half-life, bioavailability, and generic manufacturers. Further research is needed to understand the pharmacology and clinical applications of clorexolone. The current owner of clorexolone is not specified, and its original developer is also unknown. Overall, clorexolone remains a relatively obscure compound with unclear clinical utility.

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	CLOREXOLONE
Drug class	clorexolone
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body's natural response to injury or infection is like a fire alarm that goes off to alert the immune system. Clorexolone is like a fire extinguisher that helps to reduce the noise and activity of the alarm, which can help to reduce pain and inflammation. This can be beneficial for people with conditions like arthritis or other inflammatory diseases.

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:

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

Frequently asked questions about Clorexolon

What is Clorexolon?

Clorexolon (CLOREXOLONE) is a clorexolone drug.

How does Clorexolon work?

Clorexolone is thought to work by inhibiting the activity of certain enzymes involved in inflammation and pain.

What is the generic name of Clorexolon?

CLOREXOLONE is the generic (nonproprietary) name of Clorexolon.

What drug class is Clorexolon in?

Clorexolon belongs to the clorexolone class. See all clorexolone drugs at /class/clorexolone.

What development phase is Clorexolon in?

Clorexolon is in Phase 2.

Drug class: All clorexolone drugs
Therapeutic area: All drugs in Pain

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