Last reviewed 2026-06-01 · How we verify

Metrogestone (MEDROGESTONE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Metrogestone (generic name: MEDROGESTONE) is a medrogestone drug. It is currently in Phase 2 development.

Metrogestone works by binding to and activating the glucocorticoid receptor, mimicking the effects of cortisol in the body.

Metrogestone is a small molecule medication with the synonyms AY-13615, AY-13615S, AY 62022, AY-62022, COLPRO, and COLPRONE.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	MEDROGESTONE
Drug class	medrogestone
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Metrogestone is a key that fits into a receptor in our cells, which then triggers a response that helps to reduce inflammation and suppress the immune system. This can be helpful in treating conditions where the immune system is overactive, but it can also have side effects if not used carefully.

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:

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

Frequently asked questions about Metrogestone

What is Metrogestone?

Metrogestone (MEDROGESTONE) is a medrogestone drug.

How does Metrogestone work?

Metrogestone works by binding to and activating the glucocorticoid receptor, mimicking the effects of cortisol in the body.

What is the generic name of Metrogestone?

MEDROGESTONE is the generic (nonproprietary) name of Metrogestone.

What drug class is Metrogestone in?

Metrogestone belongs to the medrogestone class. See all medrogestone drugs at /class/medrogestone.

What development phase is Metrogestone in?

Metrogestone is in Phase 2.

Drug class: All medrogestone drugs
Therapeutic area: All drugs in Immunology

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