Last reviewed 2026-06-02 · How we verify

Surgestone (PROMEGESTONE)

Phase 2 active Small molecule

Surgestone (generic name: PROMEGESTONE) is a promegestone drug. It is currently in Phase 2 development.

Surgestone works by binding to the progesterone receptor, mimicking the effects of the natural hormone progesterone.

Surgestone, also known as promegestone, is a synthetic progestogen that targets the progesterone receptor. It is a small molecule drug of the promegestone class, but its current commercial status and approved indications are unknown. As a progestogen, it works by binding to the progesterone receptor, which plays a crucial role in the menstrual cycle and pregnancy. However, without more information on its approved indications and commercial status, it is difficult to provide a comprehensive summary. Further research is needed to determine its potential uses and safety considerations.

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	PROMEGESTONE
Drug class	promegestone
Target	Progesterone receptor, Androgen receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a lock that only progesterone can open. Surgestone is a key that fits into that lock, allowing it to turn on or off certain processes in the body. This can help regulate the menstrual cycle and support pregnancy.

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:

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

Frequently asked questions about Surgestone

What is Surgestone?

Surgestone (PROMEGESTONE) is a promegestone drug.

How does Surgestone work?

Surgestone works by binding to the progesterone receptor, mimicking the effects of the natural hormone progesterone.

What is the generic name of Surgestone?

PROMEGESTONE is the generic (nonproprietary) name of Surgestone.

What drug class is Surgestone in?

Surgestone belongs to the promegestone class. See all promegestone drugs at /class/promegestone.

What development phase is Surgestone in?

Surgestone is in Phase 2.

What does Surgestone target?

Surgestone targets Progesterone receptor, Androgen receptor and is a promegestone.

Drug class: All promegestone drugs
Target: All drugs targeting Progesterone receptor, Androgen receptor
Therapeutic area: All drugs in Other

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