NDAVAGINALSUPPOSITORYPriority Review
Approved
Aug 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
PROSTIN E2 (dinoprostone) by Pfizer is hormone. First approved in 1977.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROSTIN E2 (dinoprostone) is a prostaglandin E2 analog administered as a vaginal suppository for cervical ripening and labor induction in pregnant women. It works by stimulating prostaglandin F2α production, which sensitizes the myometrium to oxytocin and promotes cervical changes including dilation and effacement. The drug has been the standard-of-care cervical ripening agent since FDA approval in 1977.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and shift toward defensive positioning.
Mechanism of Action
hormone. In pregnancy, dinoprostone is secreted continuously by the fetal membranes and placenta and plays an important role in the final events leading to the initiation of labor including cervical ripening. Dinoprostone stimulates the production of prostaglandin F 2α ( PGF 2α), which sensitizes…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt
Started Dec 2017
674 enrolled
Induction of Labor Affected Fetus / Newborn
Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert
Started Nov 2013
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
Started Sep 2010
1,358 enrolled
Reducing Time to Vaginal DeliveryCervical RipeningInduction of Labor
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
Started Jun 2010
170 enrolled
Vaginal DeliveryCesarean Section
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.