Last reviewed 2026-06-02 · How we verify

Cholostebol (CLOSTEBOL)

Phase 2 active Small molecule ✓ Verified May 2026

Cholostebol (generic name: CLOSTEBOL) is a clostebol drug. It is currently in Phase 2 development.

Clostebol works by binding to androgen receptors in the body, mimicking the effects of testosterone.

Cholesteryl ester transfer protein (CETP) inhibitors, also known as cholesteryl ester transfer protein inhibitors or CETP inhibitors, are small molecule drugs that target the cholesteryl ester transfer protein.

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	CLOSTEBOL
Drug class	clostebol
Modality	Small molecule
Therapeutic area	Bone
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Clostebol is the key, and the androgen receptors are the lock. When clostebol binds to the lock, it triggers a series of chemical reactions that ultimately lead to the development of male characteristics, such as increased muscle mass and bone density.

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:

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

Frequently asked questions about Cholostebol

What is Cholostebol?

Cholostebol (CLOSTEBOL) is a clostebol drug.

How does Cholostebol work?

Clostebol works by binding to androgen receptors in the body, mimicking the effects of testosterone.

What is the generic name of Cholostebol?

CLOSTEBOL is the generic (nonproprietary) name of Cholostebol.

What drug class is Cholostebol in?

Cholostebol belongs to the clostebol class. See all clostebol drugs at /class/clostebol.

What development phase is Cholostebol in?

Cholostebol is in Phase 2.

Drug class: All clostebol drugs
Therapeutic area: All drugs in Bone

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