Last reviewed 2026-04-20 · How we verify

Neoprogestin (NORVINISTERONE)

Phase 2 active Small molecule

Neoprogestin (generic name: NORVINISTERONE) is a norvinisterone drug. It is currently in Phase 2 development.

Neoprogestin works by interacting with progesterone receptors in the body.

Neoprogestin, also known as norvinisterone, is a small molecule drug in the norvinisterone class. Its exact target and mechanism of action are unknown, but it is believed to work by interacting with progesterone receptors in the body. Neoprogestin's commercial status and approved indications are currently unclear. Further research is needed to determine its efficacy and safety profile. As a result, it is not yet available on the market.

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	NORVINISTERONE
Drug class	norvinisterone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of progesterone like a key that unlocks certain processes in the body. Neoprogestin is like a similar key that can fit into those locks, but instead of turning them, it blocks or changes the way they work. This can affect how the body regulates hormones and other processes.

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:

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

Frequently asked questions about Neoprogestin

What is Neoprogestin?

Neoprogestin (NORVINISTERONE) is a norvinisterone drug.

How does Neoprogestin work?

Neoprogestin works by interacting with progesterone receptors in the body.

What is the generic name of Neoprogestin?

NORVINISTERONE is the generic (nonproprietary) name of Neoprogestin.

What drug class is Neoprogestin in?

Neoprogestin belongs to the norvinisterone class. See all norvinisterone drugs at /class/norvinisterone.

What development phase is Neoprogestin in?

Neoprogestin is in Phase 2.

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

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