Last reviewed · How we verify
Misoprostol 400 Microgram Oral Tablet
Misoprostol is a prostaglandin E1 analogue that increases gastric mucus production and bicarbonate secretion while reducing gastric acid secretion.
Misoprostol is a prostaglandin E1 analogue that increases gastric mucus production and bicarbonate secretion while reducing gastric acid secretion. Used for Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastric ulcers, Treatment of gastric ulcers, Medical abortion (in combination with mifepristone).
At a glance
| Generic name | Misoprostol 400 Microgram Oral Tablet |
|---|---|
| Sponsor | Assuta Ashdod Hospital |
| Drug class | Prostaglandin E1 analogue |
| Target | Prostaglandin E receptor (EP receptor) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology; Obstetrics |
| Phase | FDA-approved |
Mechanism of action
Misoprostol binds to prostaglandin receptors in the gastric mucosa, enhancing protective mechanisms against acid-induced injury. It also promotes gastric blood flow and accelerates mucosal healing. Additionally, it has uterotonic properties that increase uterine contractions, which is why it is used both for gastrointestinal protection and for obstetric indications.
Approved indications
- Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastric ulcers
- Treatment of gastric ulcers
- Medical abortion (in combination with mifepristone)
- Induction of labor
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Flatulence
- Uterine cramping
- Headache
Key clinical trials
- Use of Misoprostol in Hysteroscopic Myomectomy (PHASE4)
- Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation (PHASE4)
- Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal (PHASE4)
- Outpatient Service for Mid-trimester Termination of Pregnancy (PHASE4)
- Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery (PHASE2)
- Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence? (NA)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec (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:
- Misoprostol 400 Microgram Oral Tablet CI brief — competitive landscape report
- Misoprostol 400 Microgram Oral Tablet updates RSS · CI watch RSS
- Assuta Ashdod Hospital portfolio CI