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Dimetrose (GESTRINONE)

Phase 2 active Small molecule

Dimetrose (generic name: GESTRINONE) is a gestrinone drug. It is currently in Phase 2 development.

Gestrinone works by binding to sex hormone-binding globulin, a protein that regulates the levels of sex hormones in the body.

Dimetrose, also known as gestrinone, is a small molecule drug that targets sex hormone-binding globulin. It is a gestrinone, a class of drugs that mimic the effects of sex hormones. Gestrinone is used to treat conditions such as endometriosis and fibrocystic breast disease. The commercial status of gestrinone is unclear, and it may be patented or have generic manufacturers. Key safety considerations include unknown half-life and bioavailability.

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 nameGESTRINONE
Drug classgestrinone
TargetSex hormone-binding globulin
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Think of sex hormone-binding globulin like a key that unlocks the door to sex hormones. Gestrinone is a key that fits into this lock, allowing sex hormones to be released and have their effects on the body. This can help to treat conditions like endometriosis and fibrocystic breast disease.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Dimetrose

What is Dimetrose?

Dimetrose (GESTRINONE) is a gestrinone drug.

How does Dimetrose work?

Gestrinone works by binding to sex hormone-binding globulin, a protein that regulates the levels of sex hormones in the body.

What is the generic name of Dimetrose?

GESTRINONE is the generic (nonproprietary) name of Dimetrose.

What drug class is Dimetrose in?

Dimetrose belongs to the gestrinone class. See all gestrinone drugs at /class/gestrinone.

What development phase is Dimetrose in?

Dimetrose is in Phase 2.

What does Dimetrose target?

Dimetrose targets Sex hormone-binding globulin and is a gestrinone.

Related

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