Last reviewed 2026-05-30 · How we verify

Methosarb (CALUSTERONE)

Phase 2 active Small molecule ✓ Verified May 2026

Methosarb (generic name: CALUSTERONE) is a calusterone drug. It is currently in Phase 2 development.

Methosarb works by inhibiting certain cellular processes, although the exact mechanism is unknown.

Methosarb is a small molecule with the synonyms CALUSTERONA, CALUSTERONE, CALUSTERONE, DIMETHYLTESTOSTERONE, and NSC-88536.

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	CALUSTERONE
Drug class	calusterone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that fits into a lock, but instead of unlocking a door, it blocks a specific pathway in the body that cells use to communicate with each other. This can help slow down or stop the growth of certain cells, but it's a complex process and more research is needed to fully understand how it works. By blocking this pathway, methosarb may be able to treat certain diseases or conditions, but it's still a relatively unknown drug.

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:

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

Frequently asked questions about Methosarb

What is Methosarb?

Methosarb (CALUSTERONE) is a calusterone drug.

How does Methosarb work?

Methosarb works by inhibiting certain cellular processes, although the exact mechanism is unknown.

What is the generic name of Methosarb?

CALUSTERONE is the generic (nonproprietary) name of Methosarb.

What drug class is Methosarb in?

Methosarb belongs to the calusterone class. See all calusterone drugs at /class/calusterone.

What development phase is Methosarb in?

Methosarb is in Phase 2.

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

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