Last reviewed 2026-05-15 · How we verify

NORGESTRIENONE

Phase 2 active Small molecule

NORGESTRIENONE is a norgestrienone drug. It is currently in Phase 2 development.

Norgestrienone works by binding to progesterone receptors in the body, mimicking the effects of the natural hormone progesterone.

Norgestrienone is a synthetic progestin, a type of small molecule drug belonging to the norgestrienone class. Its exact target and mechanism of action are unknown, but it is believed to work by mimicking the effects of progesterone in the body. Norgestrienone is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. As a result, there is limited information available on its safety profile and potential side effects. Further research is needed to fully understand the properties and potential uses of norgestrienone.

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	NORGESTRIENONE
Drug class	norgestrienone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has locks that only progesterone can open. Norgestrienone is a key that fits into those locks, allowing it to turn on or off certain processes in the body. This can help regulate things like hormone levels and menstrual cycles.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

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

Frequently asked questions about NORGESTRIENONE

What is NORGESTRIENONE?

NORGESTRIENONE is a norgestrienone drug.

How does NORGESTRIENONE work?

Norgestrienone works by binding to progesterone receptors in the body, mimicking the effects of the natural hormone progesterone.

What drug class is NORGESTRIENONE in?

NORGESTRIENONE belongs to the norgestrienone class. See all norgestrienone drugs at /class/norgestrienone.

What development phase is NORGESTRIENONE in?

NORGESTRIENONE is in Phase 2.

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

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