Last reviewed 2026-05-19 · How we verify

Norvinodrel (NORGESTERONE)

Phase 2 active Small molecule ✓ Verified May 2026

Norvinodrel (generic name: NORGESTERONE) is a norgesterone drug. It is currently in Phase 2 development.

Norgesterone works by mimicking the effects of the hormone progesterone in the body.

Norvinodrel is a small molecule with synonyms including NORGESTERONA, NORGESTERONE, and NSC-72160.

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	NORGESTERONE
Drug class	norgesterone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a delicate balance of hormones that control your menstrual cycle and pregnancy. Progesterone is one of these hormones that helps prepare the uterus for a fertilized egg. Norgesterone is a synthetic version of progesterone that helps maintain this balance by binding to the same receptors in the body, but its effects and safety are not well-understood.

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:

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

Frequently asked questions about Norvinodrel

What is Norvinodrel?

Norvinodrel (NORGESTERONE) is a norgesterone drug.

How does Norvinodrel work?

Norgesterone works by mimicking the effects of the hormone progesterone in the body.

What is the generic name of Norvinodrel?

NORGESTERONE is the generic (nonproprietary) name of Norvinodrel.

What drug class is Norvinodrel in?

Norvinodrel belongs to the norgesterone class. See all norgesterone drugs at /class/norgesterone.

What development phase is Norvinodrel in?

Norvinodrel is in Phase 2.

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

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