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Mifegyne ®
Mifegyne ® is a Progesterone receptor antagonist Small molecule drug developed by Assistance Publique Hopitaux De Marseille. It is currently in Phase 3 development for Medical abortion (termination of early pregnancy up to 49 days gestation), Cushing's syndrome (progesterone-dependent conditions).
Mifepristone is a progesterone receptor antagonist that blocks progesterone signaling to induce abortion or manage progesterone-dependent conditions.
Mifegyne (Mifepristone) is a small molecule that acts as a glucocorticoid receptor antagonist. It has been studied in various clinical trials for conditions such as breast cancer, surgical abortion, and Cushing's syndrome.
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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 | Mifegyne ® |
|---|---|
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Drug class | Progesterone receptor antagonist |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Health / Obstetrics |
| Phase | Phase 3 |
Mechanism of action
Mifepristone competitively binds to progesterone receptors in the uterus and other tissues, blocking the effects of endogenous progesterone. This leads to detachment of the blastocyst or embryo from the uterine wall and, when combined with a prostaglandin analog, results in expulsion of pregnancy tissue. It is also used to manage conditions where progesterone excess is pathological.
Approved indications
- Medical abortion (termination of early pregnancy up to 49 days gestation)
- Cushing's syndrome (progesterone-dependent conditions)
Common side effects
- Vaginal bleeding
- Abdominal pain/cramping
- Nausea
- Diarrhea
- Headache
- Dizziness
Key clinical trials
- Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer (PHASE2)
- Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST) (PHASE4)
- Pain Assessment in MToP Up to 7 WA (during 5h After Misoprostol Intake) (NA)
- Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency (PHASE2)
- Medication Abortion Via Pharmacy Dispensing (PHASE4)
- Study of Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (PHASE2)
- Advance Provision of Medication Abortion (PHASE4)
- Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors (PHASE1)
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:
- Mifegyne ® CI brief — competitive landscape report
- Mifegyne ® updates RSS · CI watch RSS
- Assistance Publique Hopitaux De Marseille portfolio CI
Frequently asked questions about Mifegyne ®
What is Mifegyne ®?
How does Mifegyne ® work?
What is Mifegyne ® used for?
Who makes Mifegyne ®?
What drug class is Mifegyne ® in?
What development phase is Mifegyne ® in?
What are the side effects of Mifegyne ®?
What does Mifegyne ® target?
Related
- Drug class: All Progesterone receptor antagonist drugs
- Target: All drugs targeting Progesterone receptor (PR)
- Manufacturer: Assistance Publique Hopitaux De Marseille — full pipeline
- Therapeutic area: All drugs in Reproductive Health / Obstetrics
- Indication: Drugs for Medical abortion (termination of early pregnancy up to 49 days gestation)
- Indication: Drugs for Cushing's syndrome (progesterone-dependent conditions)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing