Cytotec

(Misoprostol)

ApprovedSmall molecule

Misoprostol is used to prevent stomach ulcers in people taking certain pain medications, and it's also used to help end early pregnancies when combined with other medications.[2] Cytotec is currently approved and in use across 38 indications[4].[1]

Cytotec is one of 460 small molecule programs targeting Abortion. It is currently in Approved.

Indications

324

Total Trials

Active Trials

459

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AbortionUnknown status

PreeclampsiaApproved

Gestational DiabetesActive, not recruiting

OsteoarthritisActive, not recruiting

Peptic Ulcer DiseaseActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Cervical CancerActive, not recruiting

Fetal Growth RestrictionActive, not recruiting

Endometrial DisorderApproved

Neonatal Respiratory DistressApproved

AbortionApproved

Unknown status

PreeclampsiaApproved

Approved

Gestational DiabetesPreclinical

Active, not recruiting

OsteoarthritisApproved

Active, not recruiting

Peptic Ulcer DiseaseApproved

Active, not recruiting

Rheumatoid ArthritisApproved

Active, not recruiting

Cervical CancerPreclinical

Active, not recruiting

Fetal Growth RestrictionPreclinical

Active, not recruiting

Endometrial DisorderApproved

Approved

Neonatal Respiratory DistressApproved

Approved

Showing 10 of 37 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Cytotec

Pfizer

Approved

1 2

Synthroid

IInstitut Jerome Lejeune

Phase 3

1 3

NNC0487-0111

Novo Nordisk

Phase 3

11 4

IBI362

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

4 5

Mibavademab

Regeneron

Phase 3

2 6

Belantamab Mafodotin-Blmf

Novo Nordisk

Phase 3

1 7

Aleniglipron

GGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Phase 3

2 8

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

Phase 3

1 9

Avapro

Sanofi

Preclinical

1 10

Amidate

Pfizer

Preclinical

—

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

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Postpartum Hemorrhage

NCT05245227

Post-ApprovalRecruiting

Duodenal Ulcer

NCT03675672

Q1 2028

N/ANot yet recruiting

Postpartum Hemorrhage

NCT07353281

Clinical

Trials by Indication[1]

Misoprostol37 trials

Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

Completed·—·Phase 2/3·NCT02509351·280 enrolled

Intraumbilical Misoprostol in Retained Placenta

Completed·HHawler Medical University·Phase 1·NCT01840813·46 enrolled

Impact of Misoprostol on Blood Loss In Myomectomy Operations

Completed·—·Phase 3·NCT02061657·50 enrolled

Show 34 more trials

Misoprostol Versus Dilapan-S for Cervical Preparation

Completed·PPlanned Parenthood League of Massachusetts·N/A·NCT00835731·125 enrolled

Immune Modulation by Misoprostol

Completed·VVanderbilt University·Phase 1·NCT02259309·15 enrolled

Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

Completed·—·Phase 3·NCT04339049·147 enrolled

Dinoprostone vs Misoprostol Before LNG-IUD Insertion

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

Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT05568745·520 enrolled

PROMMO Trial: Oral Misoprostol vs IV Oxytocin

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04478942·138 enrolled

Misoprostol Prior to IUD Insertion in Nullipara

Completed·IInstituto Materno Infantil Prof. Fernando Figueira·Phase 3·NCT03490617·179 enrolled

Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

Completed·—·Phase 4·NCT02716142·80 enrolled

Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

Terminated·GGynuity Health Projects·Phase 3·NCT02633761·200 enrolled

Intrarectal Misoprostol in Postpartum Haemorrhage

Completed·UUniversity Hospital, Caen·Phase 3·NCT01116050·116 enrolled

Sublingual Misoprostol in Reduction of Caesarean Blood Loss

Unknown status·OOZORI EBIOGBO STANLEY·N/A·NCT05532215·152 enrolled

Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

Unknown status·SSoudabeh Eshghi ali·Phase 2/3·NCT01477840·180 enrolled

Comparison of Misoprostol Ripening Efficacy With Dilapan

Completed·—·Phase 4·NCT03670836·307 enrolled

A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)

Completed·GGynuity Health Projects·N/A·NCT01510574·749 enrolled

Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

Completed·KKK Women's and Children's Hospital·Phase 3·NCT00299754·171 enrolled

Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding

Completed·—·Phase 2/3·NCT01998776·82 enrolled

Two Different Regimens of Misoprostol in Retained Placenta

Completed·HHawler Medical University·Phase 2·NCT02704780·509 enrolled

the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation

Unknown status·Aahmed nagy shaker ramadan·Phase 3·NCT03483142·50 enrolled

Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies

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

Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Unknown status·—·Phase 3·NCT04780412·210 enrolled

A Trial of Oral Misoprostol for Labor Augmentation

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00906347·350 enrolled

Oral Misoprostol Before Endometrial Biopsy

Completed·MMemorial University of Newfoundland·Phase 3·NCT00200226·72 enrolled

Misoprostol for Non-Viable Pregnancies

Completed·MMadigan Army Medical Center·Phase 3·NCT00426491·30 enrolled

Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome

Unknown status·—·N/A·NCT03239327·292 enrolled

Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

Completed·GGynuity Health Projects·N/A·NCT01485562·84 enrolled

Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Withdrawn·SStanford University·N/A·NCT02679092

Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

Completed·EEmory University·N/A·NCT01147497·78 enrolled

Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy

Completed·PPak Emirates Military Hospital·Phase 3·NCT05108597·200 enrolled

Misoprostol for NASH

Completed·ZZiauddin University·Phase 2·NCT05804305·50 enrolled

Misoprostol for Bloating and Distension

Withdrawn·MMontefiore Medical Center·Phase 1·NCT04768010

Same-day Dilapan-S With Adjunctive Misoprostol

Terminated·UUniversity of Pittsburgh·N/A·NCT01818414·29 enrolled

Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

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

Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

Completed·UUniversity of Arizona·N/A·NCT01001897·61 enrolled

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Completed·MMaternidade Escola Assis Chateaubriand·Phase 4·NCT01231126·161 enrolled

Abortion24 trials

Different Methods of Termination of Second Trimester Abortion

Unknown status·—·N/A·NCT03400683·150 enrolled

Evaluation of Telemedicine Medical Abortion Service in Ecuador

Recruiting·GGynuity Health Projects··NCT06270056·100 enrolled

Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion

Completed·WWiebe, Ellen, M.D.·Phase 4·NCT00129506·300 enrolled

Show 21 more trials

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Terminated·GGynuity Health Projects·Phase 4·NCT02342002·416 enrolled

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Completed·MMedstar Health Research Institute·Phase 4·NCT02412618·100 enrolled

MisOpRostol Effect on Second Trimester Abortion Blood Loss

Terminated·SStanford University·Phase 3·NCT06078501·7 enrolled

A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks

Completed·GGynuity Health Projects·Phase 4·NCT02720991·50 enrolled

Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

Completed·HHawler Medical University·Phase 2·NCT00892229·100 enrolled

A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Unknown status·GGynuity Health Projects·Phase 4·NCT02708446·320 enrolled

Advance Provision of Medication Abortion

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT03829696

Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Completed·—·Phase 2·NCT03148314·140 enrolled

Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

Unknown status·IIbis Reproductive Health·Phase 4·NCT02745093·648 enrolled

Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

Completed·GGynuity Health Projects·Phase 4·NCT01856985·50 enrolled

Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Unknown status·—·N/A·NCT04500002·240 enrolled

Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks

Terminated·—·N/A·NCT01636063·42 enrolled

Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

Completed·GGynuity Health Projects·N/A·NCT00870272·550 enrolled

Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

Unknown status·RRambam Health Care Campus·Phase 4·NCT03044093·200 enrolled

Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

Completed·WWolfson Medical Center·N/A·NCT01678703·84 enrolled

Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Completed·—·Phase 4·NCT03407521·60 enrolled

Medical Abortion With Single Daily Dose of Misoprostol

Completed·—·Phase 2/3·NCT03487354·200 enrolled

Mid Trimester Abortion Effectiveness by Dilapan s

Unknown status·—·N/A·NCT05147857·60 enrolled

Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

Completed·GGynuity Health Projects·N/A·NCT00680394·440 enrolled

Acceptability and Feasibility of Medical Abortion in Singapore

Completed·GGynuity Health Projects·Phase 3·NCT02985229·130 enrolled

Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Completed·—·Phase 2/3·NCT02405156·400 enrolled

Postpartum Hemorrhage19 trials

CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

Completed·—·Phase 4·NCT03556852·150 enrolled

Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage

Recruiting·SStony Brook University·Phase 3·NCT05245227·1,358 enrolled

Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Completed·GGynuity Health Projects·Phase 3·NCT02163616·635 enrolled

Show 16 more trials

Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia Using Carbetocin Versus Misoprostol

Completed·Kkhalid abd aziz mohamed·Phase 3·NCT02086994·60 enrolled

Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.

Unknown status·—·Phase 4·NCT02277067·200 enrolled

Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India

Completed·GGynuity Health Projects·N/A·NCT01462422·3,032 enrolled

Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section

Not yet recruiting·—·Phase 3·NCT06765473·400 enrolled

Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Completed·GGynuity Health Projects·N/A·NCT01080846·50 enrolled

Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Completed·—·N/A·NCT03870256·135 enrolled

Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention

Not yet recruiting·WWestern Galilee Hospital-Nahariya·N/A·NCT07353281·146 enrolled

Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities

Withdrawn·GGynuity Health Projects·Phase 3·NCT01710566

Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

Completed·GGynuity Health Projects·Phase 4·NCT02805426·260 enrolled

Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage

Completed·—·Phase 4·NCT03676621·154 enrolled

Misoprostol for the Treatment of Postpartum Hemorrhage

Completed·GGynuity Health Projects·N/A·NCT00116350·1,786 enrolled

Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Unknown status·—·N/A·NCT05077540·150 enrolled

Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

Completed·GGynuity Health Projects·Phase 4·NCT02226588·2,827 enrolled

RCT of Misoprostol for Postpartum Hemorrhage in India

Completed·NNICHD Global Network for Women's and Children's Health·N/A·NCT00097123·1,600 enrolled

Misoprostol in the Treatment of Postpartum Hemorrhage

Completed·GGynuity Health Projects·N/A·NCT00116480·61 enrolled

Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

Completed·GGynuity Health Projects·N/A·NCT01713153·1,365 enrolled

Induction of Labor19 trials

Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study

Unknown status·UUniversity of Palermo··NCT06184139·104 enrolled

Vaginal Misoprostol and Foley Catheter for Induction of Labor

Completed·ZZagazig University·Phase 2·NCT02952807·160 enrolled

Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women

Unknown status·—·N/A·NCT05696574·80 enrolled

Show 16 more trials

Sublingual Misoprostol for Induction of Labor

Completed·PProfessor Fernando Figueira Integral Medicine Institute·Phase 4·NCT01406392·150 enrolled

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

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

Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor

Active, not recruiting·HHagar Muhammad Abdulfattah Muhammad·Phase 1·NCT06874049·80 enrolled

Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration

Unknown status·UUnidade Local de Saúde de Coimbra, EPE·N/A·NCT05857059·228 enrolled

Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor

Completed·UUniversidad de la Republica·Phase 4·NCT02732522·102 enrolled

Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

Terminated·UUniversity of California, Los Angeles·Phase 4·NCT01519765·73 enrolled

Combined Method for Induction of Labor

Unknown status·WWoman's Health University Hospital, Egypt·Phase 2·NCT02685085·300 enrolled

A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor

Completed·VVanderbilt University Medical Center·N/A·NCT01634854·130 enrolled

Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Completed·AAultman Health Foundation·N/A·NCT01139801·50 enrolled

Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Unknown status·CConsorci Sanitari de Terrassa·Phase 4·NCT02762942·80 enrolled

MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor

Completed·KKarolinska Institutet·Phase 3·NCT05424445·884 enrolled

Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women

Unknown status·AAbdelrahman Ali Fadel Youssef Mohamed·Phase 2·NCT03854383·100 enrolled

Oral Versus Vaginal Misoprostol for Induction of Labor

Completed·—·Phase 2/3·NCT00148473·180 enrolled

Misoprostol Versus Dinoprostone in Induction of Labor

Completed·—·N/A·NCT06909721·200 enrolled

Comparison of Outcome of Foley Catheter Versus Misoprostol for Induction of Labor

Completed·MMuhammad Aamir Latif·N/A·NCT07416487·76 enrolled

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

Unknown status·UUniversity of Arizona·Phase 2·NCT01866488·200 enrolled

Pregnancy14 trials

A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination

Completed·KKaiser Permanente·Phase 2·NCT00310921·200 enrolled

Misoprostol for Second Trimester Termination of Pregnancy

Completed·—·N/A·NCT00945997·176 enrolled

Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

Completed·TThe University of Western Australia·N/A·NCT00120042·251 enrolled

Show 11 more trials

Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up

Completed·GGynuity Health Projects·Phase 2/3·NCT02299401·401 enrolled

Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss

Completed·UUniversity of California, San Diego·Phase 2/3·NCT02141555·4 enrolled

Misoprostol for Second Trimester Termination of Pregnancy

Completed·—·Phase 3·NCT02048098·130 enrolled

Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Completed·GGynuity Health Projects·Phase 3·NCT00671060·153 enrolled

Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial

Completed·WWashington University School of Medicine·Phase 4·NCT05322252·30 enrolled

Comparing Two Medical Treatments for Early Pregnancy Failure.

Terminated·RRadboud University Medical Center·Phase 4·NCT03212352·342 enrolled

Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Completed·KKasr El Aini Hospital··NCT02788305·288 enrolled

Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy

Unknown status·TThe University of Hong Kong·N/A·NCT01475318·50 enrolled

Comparative Effectiveness of Pregnancy Failure Management Regimens

Completed·UUniversity of Pennsylvania·Phase 3·NCT02012491·300 enrolled

Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

Unknown status·GGynuity Health Projects·Phase 3·NCT03269279·100 enrolled

Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy

Unknown status·—·Phase 4·NCT03106389·108 enrolled

35 more indications

Miscarriage11 trials

Optimal Treatment of Miscarriage

Completed·RRegion Skane·N/A·NCT01033903·190 enrolled

Misoprostol for Management of Women With an Incomplete Miscarriage

Unknown status·—·N/A·NCT05088720·200 enrolled

Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage

Unknown status·—·N/A·NCT05088707·200 enrolled

Show 8 more trials

Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage

Recruiting·NNishtar Medical University·Phase 4·NCT07160855·92 enrolled

Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Unknown status·Hhany farouk·N/A·NCT05094375·200 enrolled

Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Unknown status·Hhany farouk·N/A·NCT05103098·200 enrolled

Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

Completed·—·Phase 3·NCT02686840·200 enrolled

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Completed·—·Phase 2/3·NCT03479879·200 enrolled

Management of Women With an Incomplete Miscarriage

Completed·—·N/A·NCT03148561·84 enrolled

Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

Unknown status·—·Phase 2·NCT03628625·80 enrolled

Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage

Unknown status·—·Phase 4·NCT04499976·240 enrolled

Labour Induction9 trials

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

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

Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol

Completed·MMenoufia University·N/A·NCT04514770·140 enrolled

A Novel Protocol for Labour Induction

Completed·—·Phase 3·NCT01506388·400 enrolled

Show 6 more trials

qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction

Completed·UUniversity of Liverpool··NCT04037683·136 enrolled

Misoprostol Labour Induction Study

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

A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction

Completed·UUniversity of Liverpool·Phase 4·NCT03749902·520 enrolled

Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

Unknown status·SServices Institute of Medical Sciences, Pakistan·Phase 2/3·NCT05957666·176 enrolled

Effect of Dexamethasone on Labour Induction in Term Pregnancies

Recruiting·—·Phase 1·NCT07109258·150 enrolled

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Completed·—·Phase 2/3·NCT02485821·200 enrolled

Cervical Ripening7 trials

Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol

Unknown status·UUniversity of Cincinnati·N/A·NCT03748147·300 enrolled

Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT02639429·236 enrolled

A Randomized, Control Trial for Preinduction Cervical Ripening

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00393731·540 enrolled

Show 4 more trials

The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Completed·MMahidol University·Phase 4·NCT00886860·64 enrolled

Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

Unknown status·—·Phase 2·NCT02738177·90 enrolled

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Withdrawn·UUniversity of Saskatchewan·Phase 3·NCT00953641

Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

Terminated·MMemorialCare Health System·N/A·NCT00514618·5 enrolled

Cesarean Section7 trials

Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections

Completed·—·Phase 1·NCT06364098·192 enrolled

Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

Completed·—·Phase 2/3·NCT03148717·300 enrolled

Misoprostol Before and After Cesarean Section

Unknown status·Ssarah mohamed hassan·Phase 3·NCT03463070·140 enrolled

Show 4 more trials

Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

Unknown status·—·N/A·NCT03774524·150 enrolled

Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section

Unknown status·—·Phase 2·NCT03723031·98 enrolled

Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section

Completed·UUniversity Hospital, Basel, Switzerland·Phase 2·NCT00107874·56 enrolled

Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

Unknown status·—·N/A·NCT03587077·113 enrolled

Hysteroscopy6 trials

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Completed·—·N/A·NCT01718314·138 enrolled

Misoprostol Administration Before Operative Hysteroscopy

Completed·—·Phase 3·NCT01805115·120 enrolled

Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

Unknown status·WWolfson Medical Center·Phase 4·NCT02474433·120 enrolled

Show 3 more trials

Misoprostol Prior to Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain

Unknown status·—·Phase 2·NCT02318225·100 enrolled

Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

Completed·—·Phase 2·NCT02328495·76 enrolled

Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Completed·UUllevaal University Hospital·Phase 3·NCT00572819·100 enrolled

Vaginal Delivery4 trials

REgistry of MisOprostol 200 µg Vaginal dElivery System

Completed· Ferring logo

Ferring··NCT02242214·106 enrolled

Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery

Completed·—·N/A·NCT03708497·360 enrolled

A Trial of Sublingual Misoprostol to Reduce Primary Postpartum Haemorrhage After Vaginal Delivery

Unknown status·TThe University of Hong Kong·Phase 4·NCT05079061·1,300 enrolled

Show 1 more trial

Failure of Vaginal Delivery After Induction

Completed·—·Phase 3·NCT02758340·335 enrolled

Hysterectomy3 trials

Preoperative Misoprostol in Reducing Blood Loss in Total Abdominal Hysterectomy (TAH)

Completed·TThe University of Hong Kong·N/A·NCT01199159·77 enrolled

Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction

Completed·QQueen Savang Vadhana Memorial Hospital, Thailand·N/A·NCT05862428·56 enrolled

Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Unknown status·—·Phase 3·NCT02265562·220 enrolled

Caesarean Section3 trials

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Unknown status·—·N/A·NCT03031353·170 enrolled

Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

Unknown status·—·Phase 2·NCT03939663·210 enrolled

Control of Blood Loss During Caesarean Section

Completed·—·Phase 3·NCT01412073·600 enrolled

Induction of Labour2 trials

Isosorbide Mononitrate in Induction of Labour

Unknown status·—·Phase 1·NCT04482881·130 enrolled

Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour

Unknown status·KKarolinska Institutet·Phase 4·NCT02918110·320 enrolled

Labor Induction at Term2 trials

Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

Completed·—·Phase 3·NCT00529295·220 enrolled

Sublingual Versus Vaginal Misoprostol for Labor Induction at Term

Completed·—·Phase 3·NCT00140114·170 enrolled

Labor Induction2 trials

Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

Terminated·MMayo Clinic·N/A·NCT02546193·39 enrolled

Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Completed·NNorthwestern University·N/A·NCT03039036·69 enrolled

Randomized Controlled Trial2 trials

The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

Completed·IIstanbul Bakirkoy Maternity and Children Diseases Hospital·Phase 4·NCT01931410·618 enrolled

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

Active, not recruiting·RRaid M. Al-Ani·N/A·NCT07121634·80 enrolled

Cesarean Delivery2 trials

Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

Completed·—·N/A·NCT03710304·400 enrolled

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Unknown status·—·Phase 2·NCT03140033·158 enrolled

Incomplete Abortion2 trials

Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

Completed·GGynuity Health Projects·N/A·NCT00674232·311 enrolled

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Completed·GGynuity Health Projects·N/A·NCT00466999·1,000 enrolled

Efficacy and Safety2 trials

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

Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy

Completed· Ferring logo

Ferring·Phase 2·NCT00925938·51 enrolled

Cervical Ripening and Induction of Labor2 trials

Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Completed·RRegenex Pharmaceutical, China·Phase 3·NCT01428037·225 enrolled

Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Completed·—·N/A·NCT01140971·180 enrolled

Hemorrhage2 trials

Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 3·NCT04560218·135 enrolled

Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

Completed·—·Phase 3·NCT01866241·1,140 enrolled

Dilation and Evacuation2 trials

Cervical Preparation Before Dilation and Evacuation

Completed·PPlanned Parenthood League of Massachusetts·N/A·NCT01751087·300 enrolled

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Completed·SStanford University·N/A·NCT01862991·80 enrolled

Death1 trial

Medical Management of Late Intrauterine Death.

Completed·NNational Institute of Perinatology·Phase 4·NCT02488642·60 enrolled

Toxicity1 trial

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 3·NCT00576706·396 enrolled

Women1 trial

In Vitro Myometrial Contractions in Laboring and Non-laboring Women

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT01689311·53 enrolled

Catheter1 trial

Ripening Interventions: Prostaglandins vs EASI Catheter

Terminated·LLoyola University·Phase 4·NCT00383942·80 enrolled

Intraoperative1 trial

Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 4·NCT02908295·20 enrolled

Safety and Efficacy1 trial

Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

Completed·—·Phase 3·NCT04339348·210 enrolled

Duodenal Ulcer1 trial

Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

Recruiting·—·Phase 4·NCT03675672·154 enrolled

Tranexamic Acid1 trial

Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

Unknown status·—·Phase 4·NCT04358965·162 enrolled

Analgesic1 trial

Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?

Unknown status·—·N/A·NCT02522130·200 enrolled

Hysteroscopic Myomectomy1 trial

Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Completed·ZZagazig University·Phase 2/3·NCT03930069·40 enrolled

Trial1 trial

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Completed·CChristiana Care Health Services·Phase 1·NCT04496908·160 enrolled

Premature rupture of membranes1 trial

Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

Completed·UUnknown Sponsor·Phase 4·NCT00355966·212 enrolled

High-Risk Pregnancy1 trial

Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions

Completed·TThomas Jefferson University·N/A·NCT04492072·150 enrolled

Efficacy1 trial

Techniques to Improve Efficacy of Second Trimester Medical Termination

Completed·KKing Edward Memorial Hospital·N/A·NCT00864799·302 enrolled

ESS1 trial

Assessing Medical Menstrual Regulation in the United States

Unknown status·GGynuity Health Projects·Phase 2·NCT03972358·284 enrolled

Pilot Study1 trial

Oral Misoprostol for Labor Augmentation: A Pilot Study

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT00906126·46 enrolled

Obesity1 trial

Obesity Study to Assess Induction of Labor

Withdrawn·UUniversity of Maryland, Baltimore·N/A·NCT03796416

Regulatory

FDA Approval Timeline[5]

Feb 8, 1989

CYTOTEC

NDA NDA019268

Apr 18, 1989

CYTOTEC

NDA NDA019268

Jun 27, 1989

CYTOTEC

NDA NDA019268

Apr 5, 1990

CYTOTEC

NDA NDA019268

Apr 5, 1990

CYTOTEC

NDA NDA019268

May 9, 1990

CYTOTEC

NDA NDA019268

Jul 16, 1990

CYTOTEC

NDA NDA019268

Sep 6, 1990

CYTOTEC

NDA NDA019268

Sep 21, 1990

CYTOTEC

NDA NDA019268

Sep 21, 1990

CYTOTEC

NDA NDA019268

Apr 23, 1991

CYTOTEC

NDA NDA019268

Jun 21, 1991

CYTOTEC

NDA NDA019268

Jul 29, 1991

CYTOTEC

NDA NDA019268

Oct 28, 1992

CYTOTEC

NDA NDA019268

May 10, 1993

CYTOTEC

NDA NDA019268

May 31, 1994

CYTOTEC

NDA NDA019268

Jun 10, 1996

CYTOTEC

NDA NDA019268

Jun 11, 1996

CYTOTEC

NDA NDA019268

Apr 10, 1997

CYTOTEC

NDA NDA019268

Jul 30, 1997

CYTOTEC

NDA NDA019268

Aug 13, 1997

CYTOTEC

NDA NDA019268

Jul 14, 1998

CYTOTEC

NDA NDA019268

Oct 15, 1998

CYTOTEC

NDA NDA019268

Oct 15, 1998

CYTOTEC

NDA NDA019268

Dec 3, 1998

CYTOTEC

NDA NDA019268

Aug 11, 1999

CYTOTEC

NDA NDA019268

Jan 7, 2000

CYTOTEC

NDA NDA019268

Jun 22, 2000

CYTOTEC

NDA NDA019268

Oct 19, 2000

CYTOTEC

NDA NDA019268

Oct 19, 2000

CYTOTEC

NDA NDA019268

Apr 17, 2002

CYTOTEC

NDA NDA019268

Jul 1, 2002

CYTOTEC

NDA NDA019268

Aug 13, 2003

CYTOTEC

NDA NDA019268

Aug 13, 2003

CYTOTEC

NDA NDA019268

Sep 11, 2009

CYTOTEC

NDA NDA019268

Nov 19, 2012

CYTOTEC

NDA NDA019268

Feb 8, 2013

CYTOTEC

NDA NDA019268

Dec 19, 2016

CYTOTEC

NDA NDA019268

Feb 28, 2018

CYTOTEC

NDA NDA019268

Sources

References

[1]
ClinicalTrials.gov — 324 trial records for Misoprostol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cytotec drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Misoprostol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Misoprostol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019268). 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: Prostanoid EP3 Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Cytotec

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Trials by Indication[1]

Misoprostol37 trials

Abortion24 trials

Postpartum Hemorrhage19 trials

Induction of Labor19 trials

Pregnancy14 trials

Miscarriage11 trials

Labour Induction9 trials

Cervical Ripening7 trials

Cesarean Section7 trials

Hysteroscopy6 trials

Vaginal Delivery4 trials

Hysterectomy3 trials

Caesarean Section3 trials

Induction of Labour2 trials

Labor Induction at Term2 trials

Labor Induction2 trials

Randomized Controlled Trial2 trials

Cesarean Delivery2 trials

Incomplete Abortion2 trials

Efficacy and Safety2 trials

Cervical Ripening and Induction of Labor2 trials

Hemorrhage2 trials

Dilation and Evacuation2 trials

Death1 trial

Toxicity1 trial

Women1 trial

Catheter1 trial

Intraoperative1 trial

Safety and Efficacy1 trial

Duodenal Ulcer1 trial

Tranexamic Acid1 trial

Analgesic1 trial

Hysteroscopic Myomectomy1 trial

Trial1 trial

Premature rupture of membranes1 trial

High-Risk Pregnancy1 trial

Efficacy1 trial

ESS1 trial

Pilot Study1 trial

Obesity1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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