Last reviewed 2026-05-27 · How we verify

Dimethiderome (DIMETHISTERONE)

Phase 2 active Small molecule ✓ Verified May 2026

Dimethiderome (generic name: DIMETHISTERONE) is a dimethisterone drug. It is currently in Phase 2 development.

Dimethisterone works by mimicking the effects of progesterone in the body, influencing hormone balance and reproductive processes.

Dimethisterone is a small molecule with the synonyms 5048, Dimethisteron, Dimethisterone, and Dimethisterone.

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	DIMETHISTERONE
Drug class	dimethisterone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's hormones as a delicate balance of chemicals. Dimethisterone helps to regulate this balance by acting like a natural hormone called progesterone, which is involved in menstrual cycles and pregnancy. By doing so, it can help to treat conditions related to hormone imbalances.

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:

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

Frequently asked questions about Dimethiderome

What is Dimethiderome?

Dimethiderome (DIMETHISTERONE) is a dimethisterone drug.

How does Dimethiderome work?

Dimethisterone works by mimicking the effects of progesterone in the body, influencing hormone balance and reproductive processes.

What is the generic name of Dimethiderome?

DIMETHISTERONE is the generic (nonproprietary) name of Dimethiderome.

What drug class is Dimethiderome in?

Dimethiderome belongs to the dimethisterone class. See all dimethisterone drugs at /class/dimethisterone.

What development phase is Dimethiderome in?

Dimethiderome is in Phase 2.

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

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