Last reviewed 2026-06-02 · How we verify

Androviron (MESTEROLONE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Androviron (generic name: MESTEROLONE) is a mesterolone drug. It is currently in Phase 2 development.

Mesterolone works by binding to sex hormone-binding globulin, increasing the amount of free testosterone available in the body.

Androviron is a small molecule with the synonyms ANDROVIRON, MESTEROLONA, MESTEROLONE, MESTEROLONE, MESTEROLONE, and MESTEROLONE.

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	MESTEROLONE
Drug class	mesterolone
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 protein that wraps around testosterone, making it unavailable for use by the body. Mesterolone binds to this protein, freeing up the testosterone so it can be used by the body. This can help increase energy, libido, and overall sense of well-being.

Approved indications

No approved indications tracked.

Common side effects

Secondary hypogonadism

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about Androviron

What is Androviron?

Androviron (MESTEROLONE) is a mesterolone drug.

How does Androviron work?

Mesterolone works by binding to sex hormone-binding globulin, increasing the amount of free testosterone available in the body.

What is the generic name of Androviron?

MESTEROLONE is the generic (nonproprietary) name of Androviron.

What drug class is Androviron in?

Androviron belongs to the mesterolone class. See all mesterolone drugs at /class/mesterolone.

What development phase is Androviron in?

Androviron is in Phase 2.

What are the side effects of Androviron?

Common side effects of Androviron include Secondary hypogonadism.

What does Androviron target?

Androviron targets Sex hormone-binding globulin, Androgen receptor and is a mesterolone.

Drug class: All mesterolone 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