Last reviewed 2026-04-20 · How we verify

Gestanin (ALLYLESTRENOL)

Phase 2 active Small molecule

Gestanin (generic name: ALLYLESTRENOL) is a allylestrenol drug. It is currently in Phase 2 development.

Gestanin works by mimicking the effects of progesterone in the body.

Gestanin (allylestrenol) is a small molecule drug in the allylestrenol class, originally developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are unknown, but it is used to treat certain conditions. Gestanin's commercial status, including its patent status and generic availability, is also unknown. As a result, its safety profile, including its half-life and bioavailability, is not well-documented. Further research is needed to fully understand Gestanin's properties and uses.

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	ALLYLESTRENOL
Drug class	allylestrenol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

In simple terms, Gestanin helps to maintain a healthy balance of hormones in the body, particularly progesterone, which is essential for pregnancy and menstrual cycles. By doing so, it can help to regulate the menstrual cycle and support pregnancy. This is achieved by binding to progesterone receptors in the body, triggering a series of downstream effects that help to maintain a healthy hormonal balance.

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:

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

Frequently asked questions about Gestanin

What is Gestanin?

Gestanin (ALLYLESTRENOL) is a allylestrenol drug.

How does Gestanin work?

Gestanin works by mimicking the effects of progesterone in the body.

What is the generic name of Gestanin?

ALLYLESTRENOL is the generic (nonproprietary) name of Gestanin.

What drug class is Gestanin in?

Gestanin belongs to the allylestrenol class. See all allylestrenol drugs at /class/allylestrenol.

What development phase is Gestanin in?

Gestanin is in Phase 2.

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

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