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Mifepristone and misoprostol
Mifepristone blocks progesterone receptors to stop pregnancy development, while misoprostol causes uterine contractions to expel pregnancy tissue.
Mifepristone blocks progesterone receptors to stop pregnancy development, while misoprostol causes uterine contractions to expel pregnancy tissue. Used for Medical abortion up to 10 weeks of gestation (or per regulatory approval in specific jurisdictions).
At a glance
| Generic name | Mifepristone and misoprostol |
|---|---|
| Sponsor | Gynuity Health Projects |
| Drug class | Progesterone antagonist + prostaglandin analog combination |
| Target | Progesterone receptor (mifepristone); prostaglandin E1 receptor (misoprostol) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Health / Obstetrics |
| Phase | FDA-approved |
Mechanism of action
Mifepristone is a progesterone antagonist that prevents the hormone from maintaining the uterine lining and pregnancy. Misoprostol, a prostaglandin analog, is administered after mifepristone to induce uterine contractions and facilitate expulsion of pregnancy tissue. Together, they constitute a medical abortion regimen.
Approved indications
- Medical abortion up to 10 weeks of gestation (or per regulatory approval in specific jurisdictions)
Common side effects
- Vaginal bleeding
- Abdominal pain/cramping
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
Key clinical trials
- Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial (PHASE4)
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion (NA)
- The Misoprostol-Only Regimen Evidence Study (PHASE4)
- IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (NA)
- Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
- Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage (NA)
- Mail Order Mifepristone Study (PHASE4)
- Mifepristone for Labor Induction (PHASE3)
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:
- Mifepristone and misoprostol CI brief — competitive landscape report
- Mifepristone and misoprostol updates RSS · CI watch RSS
- Gynuity Health Projects portfolio CI