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Trimegeston (TRIMEGESTONE)
Trimegeston (generic name: TRIMEGESTONE) is a trimegestone drug. It is currently in Phase 3 development.
Trimegestone is a synthetic steroid that acts as a selective progesterone receptor modulator.
Trimegestone is a small molecule that acts as a progesterone receptor agonist. It is classified as a drug that belongs to the agonist class, specifically targeting the progesterone receptor.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | TRIMEGESTONE |
|---|---|
| Drug class | trimegestone |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Think of progesterone as a hormone that helps prepare the uterus for pregnancy. Trimegestone works by binding to progesterone receptors in the body, which can help regulate the menstrual cycle and prevent pregnancy. This can be beneficial for women who want to avoid pregnancy, but more research is needed to understand its full effects on the body.
Approved indications
Common side effects
Key clinical trials
- Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings (PHASE1)
- Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women (PHASE4)
- Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women. (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:
- Trimegeston CI brief — competitive landscape report
- Trimegeston updates RSS · CI watch RSS
Frequently asked questions about Trimegeston
What is Trimegeston?
How does Trimegeston work?
What is the generic name of Trimegeston?
What drug class is Trimegeston in?
What development phase is Trimegeston in?
Related
- Drug class: All trimegestone drugs
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing