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Mifepristone + Misoprostol
Mifepristone blocks progesterone receptors to stop pregnancy maintenance, while misoprostol induces uterine contractions to expel the pregnancy.
Mifepristone blocks progesterone receptors to stop pregnancy maintenance, while misoprostol induces uterine contractions to expel the pregnancy. Used for Medical abortion up to 10 weeks of gestation.
At a glance
| Generic name | Mifepristone + Misoprostol |
|---|---|
| Sponsor | Gynuity Health Projects |
| Drug class | Progesterone receptor antagonist + prostaglandin analog combination |
| Target | Progesterone receptor (PR); prostaglandin E1 receptor (EP receptor) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Health / Gynecology |
| Phase | FDA-approved |
Mechanism of action
Mifepristone is a selective progesterone receptor antagonist that prevents progesterone from maintaining the uterine lining and pregnancy. Misoprostol is a prostaglandin analog that induces uterine contractions and cervical dilation, facilitating expulsion of pregnancy tissue. Together, they provide a medical abortion regimen effective through the first 10 weeks of gestation.
Approved indications
- Medical abortion up to 10 weeks of gestation
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)
- Mifepristone vs Misoprostol (PHASE1)
- 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
- The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy (PHASE4)
- Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage (NA)
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 + Misoprostol CI brief — competitive landscape report
- Mifepristone + Misoprostol updates RSS · CI watch RSS
- Gynuity Health Projects portfolio CI