Cervical Ripening

8
Pipeline Programs
3
Companies
10
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
3
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Ferring Pharmaceuticals
CERVIDILApproved
dinoprostone
Ferring Pharmaceuticals
Prostaglandin Analog [EPC]vaginal1995

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
8 programs
3
3
1
DinoprostonePhase 31 trial
DinoprostonePhase 31 trial
Misoprostol vaginal insert 100 mcgPhase 31 trial
MVI 100Phase 21 trial
MVI 200Phase 21 trial
+3 more programs
Active Trials
NCT03111316Completed100Est. Jul 2020
NCT04773314Completed409Est. Jun 2022
NCT00828711Completed374Est. Dec 2009
+5 more trials
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
1
Cervical Ripening Balloon, Cook Medical Inc.Phase 41 trial
Active Trials
NCT01720394UnknownEst. Dec 2019
ANI Pharmaceuticals
1 program
Misoprostol 25 µg VaginalN/A1 trial
Active Trials
NCT07121634Active Not RecruitingEst. Aug 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AM-PharmaCervical Ripening Balloon, Cook Medical Inc.
Ferring PharmaceuticalsDinoprostone
Ferring PharmaceuticalsDinoprostone
Ferring PharmaceuticalsMisoprostol vaginal insert 100 mcg
Ferring PharmaceuticalsMVI 200
Ferring PharmaceuticalsMVI 100
ANI PharmaceuticalsMisoprostol 25 µg Vaginal
Ferring PharmaceuticalsPROPESS Cohort
Ferring PharmaceuticalsCervidil 10 MG Vaginal Insert

Clinical Trials (10)

Total enrollment: 2,397 patients across 10 trials

NCT01720394AM-PharmaCervical Ripening Balloon, Cook Medical Inc.

Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

Start: Nov 2013Est. completion: Dec 2019
Phase 4Unknown
NCT03067727Ferring PharmaceuticalsDinoprostone

A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

Start: Apr 2017Est. completion: Aug 2018114 patients
Phase 3Completed
NCT03067597Ferring PharmaceuticalsDinoprostone

An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

Start: Feb 2017Est. completion: Feb 201868 patients
Phase 3Completed
NCT00308711Ferring PharmaceuticalsMisoprostol vaginal insert 100 mcg

Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

Start: Apr 2006Est. completion: Aug 20071,308 patients
Phase 3Completed
NCT00528255Ferring PharmaceuticalsMisoprostol Vaginal Insert

Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

0
Phase 2Withdrawn
NCT01283022Ferring PharmaceuticalsMVI 200

Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

Start: May 2011Est. completion: Jul 201124 patients
Phase 2Completed
NCT00828711Ferring PharmaceuticalsMVI 100

Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor

Start: Apr 2009Est. completion: Dec 2009374 patients
Phase 2Completed
NCT07121634ANI PharmaceuticalsMisoprostol 25 µg Vaginal

Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial

Start: Jan 2024Est. completion: Aug 2026
N/AActive Not Recruiting
NCT04773314Ferring PharmaceuticalsPROPESS Cohort

General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)

Start: Feb 2021Est. completion: Jun 2022409 patients
N/ACompleted
NCT03111316Ferring PharmaceuticalsCervidil 10 MG Vaginal Insert

Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

Start: Apr 2017Est. completion: Jul 2020100 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
3 companies competing in this space