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Misoprostol, per-oral tablets
Misoprostol is a prostaglandin E1 analogue that binds to prostaglandin receptors to increase gastric mucus production and reduce gastric acid secretion.
Misoprostol is a prostaglandin E1 analogue that binds to prostaglandin receptors to increase gastric mucus production and reduce gastric acid secretion. Used for Prevention of NSAID-induced gastric ulcers, Treatment of gastric ulcers, Medical abortion (in combination with mifepristone).
At a glance
| Generic name | Misoprostol, per-oral tablets |
|---|---|
| Also known as | Cytotec |
| Sponsor | Tampere University Hospital |
| Drug class | Prostaglandin analogue |
| Target | Prostaglandin E1 receptor (EP receptor) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology; Obstetrics |
| Phase | FDA-approved |
Mechanism of action
Misoprostol acts as a synthetic prostaglandin analogue that activates EP3 and other prostaglandin receptors on gastric mucosa. This stimulates mucus and bicarbonate secretion while simultaneously reducing gastric acid production, thereby protecting the gastric lining. It is commonly used to prevent nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers and is also employed for cervical ripening and labor induction due to its uterotonic effects.
Approved indications
- Prevention of NSAID-induced gastric ulcers
- Treatment of gastric ulcers
- Cervical ripening and labor induction
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Dyspepsia
- Uterine contractions (when used for labor induction)
Key clinical trials
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion (NA)
- Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening (PHASE3)
- Interest of Cervical Dilators in Second Trimester Termination of Pregnancy (NA)
- MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor (PHASE3)
- Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
- Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2) (PHASE4)
- Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation (PHASE4)
- Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery (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:
- Misoprostol, per-oral tablets CI brief — competitive landscape report
- Misoprostol, per-oral tablets updates RSS · CI watch RSS
- Tampere University Hospital portfolio CI