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Dimetrose (GESTRINONE)
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.
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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).
| 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 | GESTRINONE |
|---|---|
| Drug class | gestrinone |
| Target | Sex hormone-binding globulin |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 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
Common side effects
Key clinical trials
- Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment (PHASE2)
- Gestrinone and Endothelial Function in Young Women
- Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Dimetrose CI brief — competitive landscape report
- Dimetrose updates RSS · CI watch RSS
Frequently asked questions about Dimetrose
What is Dimetrose?
How does Dimetrose work?
What is the generic name of Dimetrose?
What drug class is Dimetrose in?
What development phase is Dimetrose in?
What does Dimetrose target?
Related
- Drug class: All gestrinone drugs
- Target: All drugs targeting Sex hormone-binding globulin
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing