TheraRadar
Data updated: Jun 17, 2026

PREPIDIL (dinoprostone)

Women's Health Approved 1992-12-09

PREPIDIL is indicated for the treatment of Unfavorable Cervix.

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
33
Years on Market

Details

Status
Prescription
First Approved
1992-12-09
Routes
ENDOCERVICAL
Dosage Forms
GEL

Companies

Pfizer
Active Ingredient: DINOPROSTONE

PREPIDIL Approval History

1993
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Original
New Indication
New Form
Label Update
9 FDA actions from 1992 to 2017
Jul 2017 SUPPL
Label · Labeling
FDA Letter Label
Feb 2015 SUPPL
Mfg · Manufacturing (CMC)
Sep 2013 SUPPL
Mfg · Manufacturing (CMC)

What PREPIDIL Treats

1 indications

PREPIDIL is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Unfavorable Cervix
Source: FDA Label
📋

Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT02888041 RE-DINO I15014 (RE-DINO) Ph 3 terminated Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
NCT05761418 REC-H-PhBSU-22021 Ph 3 completed Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy
NCT03001661 SOLVE Solve Ph 3 completed An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt
NCT03067597 000261 Ph 3 completed An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
NCT03067727 000262 Ph 3 completed A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
NCT04044079 dinoprostone misoprostol Ph 4 completed Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients
NCT04079140 vaginal dinoprostone IUD Ph 4 completed Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion
NCT04080336 dinoprostone misoprostol IUD Ph 4 completed Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women
NCT04046302 dinoprostone IUD pain Ph 4 completed Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
NCT04045548 dinoprostone IUD Ph 4 completed Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery
NCT03320187 OG MS27042017 Ph 2, Ph 3 completed Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
NCT01765881 CYTOPRO 1014301 2011-000933-35 Ph 2 completed Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2
NCT01190163 SOFTNES FE999901 CS01 Ph 4 terminated Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PREPIDIL FDA Label Details

Indications & Usage

FDA Label (PDF)

PREPIDIL is indicated for the treatment of Unfavorable Cervix.

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Data Sources

FDA Approval: NDA019617 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.