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Prepidil (DINOPROSTONE)
Prepidil (dinoprostone) is a prostaglandin analog that targets the EP4 subtype of the prostaglandin E2 receptor. Originally developed by Pharmacia and Upjohn, it is now owned by Pfizer. It is a small molecule modality that was FDA approved in 1977 for various indications including cervical ripening, induction of labor, and treatment of incomplete miscarriage. Prepidil is off-patent and has no active Orange Book patents, indicating that generic manufacturers are not restricted. As an off-patent medication, its commercial status is subject to market competition.
At a glance
| Generic name | DINOPROSTONE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Prostaglandin Analog [EPC] |
| Target | Prostaglandin E2 receptor EP4 subtype |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1977 |
Approved indications
- Cervical ripening procedure
- Hydatidiform mole, benign
- Incomplete miscarriage
- Induction of labor
- Pregnancy with abortive outcome
Common side effects
- Uterine contractile abnormality
- Any gastrointestinal effect
- Fetal heart rate abnormality
- Back pain
- Bradycardia
- Deceleration Late
- Variable
- Unspecified
- Fever
- Warm feeling in vagina
- Fetal acidosis
- Premature rupture of membranes
Key clinical trials
- An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis (PHASE2)
- Effect of Nigella Sativa Toothpaste on Salivary Biomarkers in Patients With Gingivitis (NA)
- Dexamethasone as ESPB Adjuvant in Lumbar Laminectomy (PHASE3)
- PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM) (NA)
- Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Leveling (NA)
- Evaluation of the Biomechanical Response of Orthodontic Tooth Movement to Clear Aligner vs Fixed Orthodontic Appliance (NA)
- PGE2/IL-22 Pathway in Various Forms of Eczema
- INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Prepidil CI brief — competitive landscape report
- Prepidil updates RSS · CI watch RSS
- Pfizer portfolio CI