Last reviewed 2026-05-27 · How we verify

Lutionex (DEMEGESTONE)

Phase 2 active Small molecule ✓ Verified May 2026

Lutionex (generic name: DEMEGESTONE) is a demegestone drug. It is currently in Phase 2 development.

Demegestone works by binding to and activating the progesterone receptor, mimicking the effects of the hormone progesterone.

Lutionex is a small molecule modality. It is also known by the synonyms DEMEGESTONA, DEMEGESTONE, DEMEGESTONE, NSC-118189, R 2453, and R-2453.

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	DEMEGESTONE
Drug class	demegestone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Demegestone is a key that fits into the progesterone receptor, allowing it to send signals to the body that progesterone is present. This helps to regulate the growth and maintenance of female reproductive tissues.

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:

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

Frequently asked questions about Lutionex

What is Lutionex?

Lutionex (DEMEGESTONE) is a demegestone drug.

How does Lutionex work?

Demegestone works by binding to and activating the progesterone receptor, mimicking the effects of the hormone progesterone.

What is the generic name of Lutionex?

DEMEGESTONE is the generic (nonproprietary) name of Lutionex.

What drug class is Lutionex in?

Lutionex belongs to the demegestone class. See all demegestone drugs at /class/demegestone.

What development phase is Lutionex in?

Lutionex is in Phase 2.

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

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