Last reviewed 2026-04-19 · How we verify

CLOXOTESTOSTERONE

Phase 2 active Small molecule

CLOXOTESTOSTERONE is a Androgen drug. It is currently in Phase 2 development.

Cloxotestosterone works by binding to androgen receptors in the body, mimicking the effects of natural male hormones.

Cloxotestosterone is a synthetic androgen, a small molecule drug belonging to the androgen class. Its original development and current ownership are unknown. The target and approved indications of Cloxotestosterone are also not specified. It is not known whether Cloxotestosterone is FDA-approved or off-patent. Further information on its commercial status and key safety considerations is required.

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	CLOXOTESTOSTERONE
Drug class	Androgen
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has locks on cells that only male hormones can open. Cloxotestosterone is a key that fits into these locks, allowing it to influence the activity of cells and tissues that respond to male hormones.

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:

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

Frequently asked questions about CLOXOTESTOSTERONE

What is CLOXOTESTOSTERONE?

CLOXOTESTOSTERONE is a Androgen drug.

How does CLOXOTESTOSTERONE work?

Cloxotestosterone works by binding to androgen receptors in the body, mimicking the effects of natural male hormones.

What drug class is CLOXOTESTOSTERONE in?

CLOXOTESTOSTERONE belongs to the Androgen class. See all Androgen drugs at /class/androgen.

What development phase is CLOXOTESTOSTERONE in?

CLOXOTESTOSTERONE is in Phase 2.

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

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