Last reviewed 2026-04-20 · How we verify

Mesanolon (MESTANOLONE)

Phase 2 active Small molecule

Mesanolon (generic name: MESTANOLONE) is a mestanolone drug. It is currently in Phase 2 development.

Mesanolone works by binding to sex hormone-binding globulin, which is a protein that regulates the levels of sex hormones in the body.

Mesanolone (MESTANOLONE) is a small molecule drug that targets sex hormone-binding globulin. It is classified as a mestanolone, but its commercial status and approved indications are unknown. The mechanism of action involves binding to sex hormone-binding globulin, but further details are not available. As a result, key safety considerations and pharmacokinetic properties such as half-life and bioavailability are also unknown. Further research is needed to determine its potential therapeutic applications.

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	MESTANOLONE
Drug class	mestanolone
Target	Sex hormone-binding globulin, Androgen receptor
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Think of sex hormone-binding globulin like a key that unlocks the cells where sex hormones live. By binding to this key, mesanolone can affect how sex hormones are delivered to the cells, which can impact various bodily functions. This can potentially lead to changes in hormone levels and related symptoms.

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:

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

Frequently asked questions about Mesanolon

What is Mesanolon?

Mesanolon (MESTANOLONE) is a mestanolone drug.

How does Mesanolon work?

Mesanolone works by binding to sex hormone-binding globulin, which is a protein that regulates the levels of sex hormones in the body.

What is the generic name of Mesanolon?

MESTANOLONE is the generic (nonproprietary) name of Mesanolon.

What drug class is Mesanolon in?

Mesanolon belongs to the mestanolone class. See all mestanolone drugs at /class/mestanolone.

What development phase is Mesanolon in?

Mesanolon is in Phase 2.

What does Mesanolon target?

Mesanolon targets Sex hormone-binding globulin, Androgen receptor and is a mestanolone.

Drug class: All mestanolone drugs
Target: All drugs targeting Sex hormone-binding globulin, Androgen receptor
Therapeutic area: All drugs in Hematology

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