Cervidil

(Dinoprostone)

ApprovedSmall molecule

Dinoprostone is used to help induce labor in pregnant women by causing the uterus to contract, and it can also help expel tissue after a miscarriage or abortion.[2] Cervidil is currently approved and in use across 5 indications[4].[1]

Cervidil is one of 42 small molecule programs targeting Induced vaginal delivery. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Induced Vaginal DeliveryActive, not recruiting

Incomplete AbortionApproved

Premature Rupture of MembranesActive, not recruiting

MigraineActive, not recruiting

Induction of LabourCompleted

Induced Vaginal DeliveryPreclinical

Active, not recruiting

Incomplete AbortionApproved

Approved

Premature Rupture of MembranesPreclinical

Active, not recruiting

MigrainePreclinical

Active, not recruiting

Induction of LabourPreclinical

Completed

Competition

Competitive Landscape

105 competitors in Migraine

#DrugCompanyPhaseTrials

Cervidil

Pfizer

Approved

1 2

Zonegran

AAzurity Pharmaceuticals

Phase 3

3 3

Triptans

Pfizer

Phase 3

2 4

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 5

Elismetrep

KKallyope Inc.

Phase 3

3 6

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 7

Tizanidine Hydrochloride

EElan Pharmaceuticals

Phase 3

1 8

Bayer Aspirin

Bayer

Preclinical

2 9

Cymbalta

Jazz Pharmaceuticals

Preclinical

1 10

Adempas

Bayer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Induction of Labor9 trials

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

Unknown status·MMedical University of Graz·Phase 4·NCT01720394·253 enrolled

Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?

Terminated·UUniversity Hospital, Limoges·Phase 3·NCT02888041·160 enrolled

Combined Agent Randomized Trial of Induction of Labor

Completed·WWeill Medical College of Cornell University·N/A·NCT00504465·210 enrolled

Show 6 more trials

Modality of Induction of Labor in Obese Women at Term (MODOBAT)

Completed·—··NCT04299854·77 enrolled

Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

Unknown status·—·Phase 3·NCT02036437·200 enrolled

Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor

Completed·UUniversity Hospital Center of Martinique·Phase 2·NCT04413890·268 enrolled

Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

Completed·SSeoul National University Hospital·N/A·NCT01596296·154 enrolled

Induction of Labor in Term Pregnancies With Unfavourable Cervix

Completed·—·Phase 4·NCT04280874·212 enrolled

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

Completed·UUnknown Sponsor·Phase 4·NCT03744364·198 enrolled

Cervical Ripening5 trials

Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

Terminated·—·N/A·NCT02649920·2 enrolled

Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening

Unknown status·KKanuni Sultan Suleyman Training and Research Hospital·Phase 2·NCT03016442·200 enrolled

Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

Terminated· Ferring logo

Ferring·Phase 4·NCT01190163·170 enrolled

Show 2 more trials

Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.

Completed·RRambam Health Care Campus·N/A·NCT03033264·164 enrolled

DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies

Unknown status·HHanoi Obstetrics and Gynecology Hospital·N/A·NCT04747301·540 enrolled

Hysteroscopy5 trials

Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Completed·—·Phase 4·NCT04044079·150 enrolled

Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Unknown status·—·N/A·NCT04500496·200 enrolled

Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

Unknown status·ZZekai Tahir Burak Women's Health Research and Education Hospital·Phase 4·NCT01620814·30 enrolled

Show 2 more trials

Cervical Preparation in Hysteroscopy

Unknown status·—·N/A·NCT03675802·100 enrolled

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Completed·—·Phase 4·NCT03683914·102 enrolled

Labor Induction4 trials

Comparing Cervical Foley Catheter, Dinoprostone and a Combination of the Two for Labor Induction

Unknown status·KKaplan Medical Center·N/A·NCT02815865·360 enrolled

Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

Completed·SSeoul National University Hospital·N/A·NCT02416583·140 enrolled

Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term

Completed·SSeoul National University Hospital·N/A·NCT02618096·154 enrolled

Show 1 more trial

Labor Induction After Failed Induction With Dinoprostone.

Completed·RRambam Health Care Campus·N/A·NCT04597333·144 enrolled

Labour Induction4 trials

Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)

Completed·LLiverpool Women's NHS Foundation Trust··NCT01026948·70 enrolled

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

Completed·KKarolinska University Hospital·Phase 3·NCT00602095·592 enrolled

Misoprostol Labour Induction Study

Completed·DDavid Young·Phase 3·NCT03489928·511 enrolled

Show 1 more trial

24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Completed·UUniversità degli Studi di Brescia·Phase 4·NCT00843362·133 enrolled

19 more indications

Misoprostol4 trials

Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

Completed·UUniversity Hospital, Toulouse·Phase 2·NCT01765881·1,700 enrolled

Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies

Unknown status·HHormozgan University of Medical Sciences·Phase 1/2·NCT00432588

Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women

Completed·—·Phase 4·NCT04080336·129 enrolled

Show 1 more trial

Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Unknown status·—·Phase 3·NCT04301349·200 enrolled

Induction of Labour3 trials

Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial

Unknown status·—·N/A·NCT02168881·342 enrolled

An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt

Completed·BBirmingham Women's NHS Foundation Trust·Phase 3·NCT03001661·674 enrolled

Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

Completed·UUniversity of Alexandria·N/A·NCT06560515·370 enrolled

Efficacy and Safety3 trials

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

Completed· Ferring logo

Ferring·Phase 3·NCT03067597·68 enrolled

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

Completed· Ferring logo

Ferring·Phase 3·NCT03067727·114 enrolled

Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction

Unknown status·OOihane Lapuente Ocamica·Phase 4·NCT02902653·372 enrolled

Preoperative2 trials

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Completed·—·Phase 3·NCT05761418·90 enrolled

Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

Unknown status·—·Phase 3·NCT04080375·100 enrolled

Randomized Controlled Trial2 trials

Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial

Completed·—·Phase 2/3·NCT03320187·100 enrolled

Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

Completed·SSaskatchewan Health Authority - Regina Area·N/A·NCT01962831·41 enrolled

Women2 trials

Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Completed·—·Phase 4·NCT04046302·160 enrolled

Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

Completed·—·Phase 3·NCT03686085·200 enrolled

Migraine1 trial

Prostaglandin E2 in Migraine Suffers Without Aura.

Completed·TTroels Wienecke·N/A·NCT01384812·12 enrolled

Vaginal Delivery1 trial

Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

Completed·—·Phase 4·NCT04045548·200 enrolled

Age1 trial

Dinoprostone Induction vs. Expectant Management After PROM at Term

Unknown status·UUniversity Medical Centre Ljubljana·Phase 4·NCT05430711·70 enrolled

Safety and Efficacy1 trial

Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

Unknown status·—·Phase 3·NCT04340778·210 enrolled

Infertile Patients1 trial

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Unknown status·—·Phase 4·NCT04042974·100 enrolled

Tranexamic Acid1 trial

Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Unknown status·—·Phase 4·NCT04357002·180 enrolled

Lidocaine1 trial

Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

Unknown status·—·Phase 4·NCT04339361·111 enrolled

Hysterectomy1 trial

Single-dose Vaginal Dinoprostone and Hysterectomy

Completed·—·Phase 3·NCT04080323·118 enrolled

Cesarean Delivery1 trial

Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

Unknown status·—·Phase 4·NCT04080349·300 enrolled

Miscarriage1 trial

Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Completed·NNational University of Malaysia·Phase 2·NCT05342467·101 enrolled

Premature rupture of membranes1 trial

Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

Completed·RRambam Health Care Campus·N/A·NCT02825641·458 enrolled

Fetal Growth Retardation1 trial

Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)

Completed·HHospital Universitario 12 de Octubre·Phase 3·NCT05774236·172 enrolled

Unspecified1 trial

Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

Completed·—·Phase 4·NCT04079140·130 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PROSTIN E2

NDA NDA017810

Dec 9, 1992

PREPIDIL

NDA NDA019617

Mar 30, 1995

CERVIDIL

NDA NDA020411

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Dinoprostone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cervidil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dinoprostone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dinoprostone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020411). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Prostaglandin E2 Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Cervidil

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Induction of Labor9 trials

Cervical Ripening5 trials

Hysteroscopy5 trials

Labor Induction4 trials

Labour Induction4 trials

Misoprostol4 trials

Induction of Labour3 trials

Efficacy and Safety3 trials

Preoperative2 trials

Randomized Controlled Trial2 trials

Women2 trials

Migraine1 trial

Vaginal Delivery1 trial

Age1 trial

Safety and Efficacy1 trial

Infertile Patients1 trial

Tranexamic Acid1 trial

Lidocaine1 trial

Hysterectomy1 trial

Cesarean Delivery1 trial

Miscarriage1 trial

Premature rupture of membranes1 trial

Fetal Growth Retardation1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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