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 40 indications[4].[1]

Cytotec is one of 628 small molecule programs targeting Benign Muscle Neoplasm. It is currently in Approved.

Indications

324

Total Trials

Active Trials

627

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Benign Muscle NeoplasmApproved

Premature BirthApproved

ContraceptionApproved

Endometrial PolypActive, not recruiting

Premature Rupture of MembranesActive, not recruiting

Duodenal UlcerActive, not recruiting

Fetal Growth RestrictionActive, not recruiting

Incomplete AbortionActive, not recruiting

ToxicityActive, not recruiting

Gestational DiabetesActive, not recruiting

Benign Muscle NeoplasmApproved

Approved

Premature BirthApproved

Approved

ContraceptionApproved

Approved

Endometrial PolypPhase 2/Phase 3

Active, not recruiting

Premature Rupture of MembranesApproved

Active, not recruiting

Duodenal UlcerApproved

Active, not recruiting

Fetal Growth RestrictionPreclinical

Active, not recruiting

Incomplete AbortionPhase 1

Active, not recruiting

ToxicityPhase 3

Active, not recruiting

Gestational DiabetesPreclinical

Active, not recruiting

Showing 10 of 39 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Cytotec

Orencia

47 3

Cimzia

UCB

Preclinical

30 4

Simponi

Johnson & Johnson

Preclinical

19 5

Enbrel

IImmunex

Preclinical

64 6

Remicade

OOrganon and Co

Preclinical

43 7

Ilaris

Novartis

Preclinical

3 8

Celexa

AbbVie

Preclinical

1 9

Rituxan

Pfizer

Preclinical

7 10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Pregnancy

NCT06452719

N/AActive, not recruiting

Randomized Controlled Trial

NCT07121634

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]

Misoprostol41 trials

Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

Completed·LLuis Bahamondes·Phase 4·NCT01754649·102 enrolled

Misoprostol Prior to Intrauterine Contraceptive Device Insertion

Completed·—·Phase 1·NCT02412033·140 enrolled

Induction With Foley OR Misoprostol (INFORM) Study

Completed·UUniversity of Liverpool·Phase 3·NCT01801410·602 enrolled

Show 38 more trials

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

Misoprostol With Intrauterine Device Insertion

Completed·OOregon Health and Science University·N/A·NCT00613366·40 enrolled

400mcg Sublingual Misoprostol as First Line Treatment

Completed·GGynuity Health Projects·N/A·NCT01939457·641 enrolled

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

Completed·GGynuity Health Projects·N/A·NCT01508429·70 enrolled

Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

Completed·CChristiana Care Health Services·Phase 1·NCT03976037·216 enrolled

Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

Unknown status·—·N/A·NCT04505943·200 enrolled

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

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

Pharmacokinetics of Misoprostol With Titrated Oral Administration

Completed·—·Phase 1·NCT01271257·10 enrolled

Pitocin or Oral Misoprostol for PROM IOL

Completed·UUniversity of Pennsylvania·Phase 4·NCT04028765·108 enrolled

Two Different Regimens of Misoprostol in Retained Placenta

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

Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome

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

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

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

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

Completed·—·Phase 4·NCT04080336·129 enrolled

Impact of Misoprostol on Blood Loss In Myomectomy Operations

Completed·—·Phase 3·NCT02061657·50 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

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

PROMMO Trial: Oral Misoprostol vs IV Oxytocin

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

24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

Completed·VVirginia Commonwealth University·Phase 4·NCT03134183·70 enrolled

Misoprostol Prior to IUD Insertion in Nullipara

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

Immune Modulation by Misoprostol

Completed·VVanderbilt University·Phase 1·NCT02259309·15 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

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

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

Completed·UUniversity of New Mexico·N/A·NCT01307111·85 enrolled

Comparison of Misoprostol Ripening Efficacy With Dilapan

Completed·—·Phase 4·NCT03670836·307 enrolled

Abortion19 trials

Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion

Terminated·—·Phase 3·NCT01436266·3 enrolled

Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

Completed·GGynuity Health Projects·Phase 4·NCT02981030·102 enrolled

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

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

Show 16 more trials

Management of RPOC After Induced Abortion

Completed·TTel-Aviv Sourasky Medical Center·Phase 4·NCT04685694·141 enrolled

Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Completed·—·Phase 4·NCT03407521·60 enrolled

Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Completed·—·Phase 2/3·NCT02401425·423 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

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

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

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

MisOpRostol Effect on Second Trimester Abortion Blood Loss

Terminated·SStanford University·Phase 3·NCT06078501·7 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

Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Completed·—·Phase 2·NCT03148314·140 enrolled

Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Unknown status·WWolfson Medical Center·Phase 4·NCT02480543·120 enrolled

Advance Provision of Medication Abortion

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

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

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Completed·—·Phase 4·NCT04989400·24 enrolled

Induction of Labor18 trials

Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

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

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

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

Show 15 more trials

Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas

Completed·AAhmed mohamed fathy ismail·Phase 2·NCT04533841·128 enrolled

Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

Completed·—·Phase 4·NCT03682718·120 enrolled

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

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

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

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

Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

Unknown status·—·N/A·NCT03863392·100 enrolled

Induction of Labor by Oral Misoprostol Solution

Completed·—·N/A·NCT04891679·264 enrolled

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

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

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

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

Sublingual Misoprostol for Induction of Labor

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

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

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

Combined Method for Induction of Labor

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

Postpartum Hemorrhage13 trials

Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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

The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Completed·—·Phase 4·NCT03680339·200 enrolled

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

Show 10 more trials

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

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

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

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

Withdrawn·GGynuity Health Projects·Phase 3·NCT01710566

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

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

Pregnancy11 trials

Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

Completed·WWolfson Medical Center·Phase 4·NCT02515604·180 enrolled

Termination Of Anembryonic Pregnancy

Withdrawn·—·Phase 2·NCT02573051

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

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

Show 8 more trials

Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone

Unknown status·—··NCT00206193

Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy

Completed·UUnknown Sponsor·Phase 4·NCT00401440·185 enrolled

Letrozole and Misoprostol for Early Pregnancy Loss Management

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT06452719·30 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

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

Completed·KKaiser Permanente·Phase 2·NCT00310921·200 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

Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

Completed·UUniversity of Utah·Phase 1·NCT05342974·9 enrolled

42 more indications

Miscarriage10 trials

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

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

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

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

Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Terminated·KKristina Gemzell Danielsson·Phase 2/3·NCT01615224·23 enrolled

Show 7 more 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

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

Cesarean Section8 trials

Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Completed·—·Phase 2/3·NCT03144401·240 enrolled

Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

Unknown status·—·N/A·NCT03774706·150 enrolled

Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section

Completed·QQazvin University Of Medical Sciences·Phase 1/2·NCT01571323·150 enrolled

Show 5 more trials

Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

Completed·—·Phase 2/3·NCT02141321·124 enrolled

Uterotonics Using to Reduce Bleeding at Cesarean Section

Completed·—·Phase 2·NCT02562300·120 enrolled

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

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

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

Misoprostol Before and After Cesarean Section

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

Hysteroscopy6 trials

Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

Completed·SSamsung Medical Center·Phase 3·NCT01024270·141 enrolled

Misoprostol For Nulliparous Women Before Hysteroscopy

Unknown status·WWenzhou Medical University·Phase 3·NCT01156948·120 enrolled

Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

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

Show 3 more trials

Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

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

Misoprostol Administration Before Operative Hysteroscopy

Completed·—·Phase 3·NCT01805115·120 enrolled

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

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

Labour Induction6 trials

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

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

Show 3 more trials

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

Completed·UUniversity of Liverpool··NCT04037683·136 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

Induction of Labour5 trials

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

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

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

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

Oral Titrated Misoprostol for Induction of Labour

Completed·IInstituto Materno Infantil Prof. Fernando Figueira·N/A·NCT00992524·400 enrolled

Show 2 more trials

Isosorbide Mononitrate in Induction of Labour

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

To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour

Unknown status·MMinistry of Health, Bhutan·N/A·NCT04887493·500 enrolled

Cervical Ripening5 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

Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

Completed·—·N/A·NCT03600064·80 enrolled

Show 2 more trials

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy

Withdrawn·UUniversity of Saskatchewan·Phase 3·NCT00953641

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

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

Efficacy and Safety4 trials

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

Completed· Ferring logo

Ferring·Phase 2·NCT00925938·51 enrolled

Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion

Completed·—·Phase 4·NCT04273984·180 enrolled

Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

Unknown status·—·Phase 4·NCT00695331·143 enrolled

Show 1 more trial

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

Labor Induction4 trials

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

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

Mifepristone for Labor Induction

Completed·SStanford University·Phase 3·NCT05097326·30 enrolled

Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Completed·UUniversity of Florida·Phase 2·NCT00325026·130 enrolled

Show 1 more trial

Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both

Terminated·—·N/A·NCT03866772·250 enrolled

Vaginal Delivery4 trials

Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

Completed·MMontefiore Medical Center·Phase 2·NCT02680314·243 enrolled

Failure of Vaginal Delivery After Induction

Completed·—·Phase 3·NCT02758340·335 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

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

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

Caesarean Section4 trials

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

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

Sublingual Misoprostol & Isoflurane During Caesarean Section

Completed·MMansoura University·Phase 2·NCT01466530·366 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

Show 1 more trial

Control of Blood Loss During Caesarean Section

Completed·—·Phase 3·NCT01412073·600 enrolled

Incomplete Abortion3 trials

Misoprostol for the Treatment of Incomplete Abortion

Completed·GGynuity Health Projects·N/A·NCT00670761·720 enrolled

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

Completed·GGynuity Health Projects·Phase 1·NCT01539408·90 enrolled

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

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

Cesarean Delivery3 trials

Blood Loss During Cesarean Delivery in Placenta Previa Patients

Completed·—·Phase 4·NCT05340205·81 enrolled

Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

Unknown status·Hhany farouk·N/A·NCT03777696·300 enrolled

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

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

Premature rupture of membranes3 trials

Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

Unknown status·Ssammour.rami·N/A·NCT04143685·200 enrolled

Cervical Ripening in Premature Rupture of Membranes

Completed·MMontefiore Medical Center·N/A·NCT02314728·230 enrolled

Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

Completed·UUnknown Sponsor·Phase 4·NCT00355303·932 enrolled

Preoperative2 trials

Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

Completed·EEgymedicalpedia·N/A·NCT06049160·128 enrolled

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Completed·—·Phase 3·NCT05761418·90 enrolled

Randomized Controlled Trial2 trials

Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial

Completed·—·N/A·NCT03928600·140 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

Dilation and Evacuation2 trials

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

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

Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

Completed·SStanford University·N/A·NCT01615731·50 enrolled

Tranexamic Acid2 trials

Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases

Completed·—·Phase 2·NCT04117243·345 enrolled

Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

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

Preeclampsia1 trial

Uterotonics for Severe Preeclampsia

Completed·—·N/A·NCT04756661·124 enrolled

Spinal Stenosis1 trial

Misoprostol for Spinal Stenosis

Completed·—··NCT04611464·23 enrolled

Dilation1 trial

Cervical Priming Before Dilation & Evacuation

Completed·IIbis Reproductive Health·N/A·NCT01597726·159 enrolled

Post Operative Pain1 trial

A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Completed·—·N/A·NCT03359655·120 enrolled

ISS1 trial

Missed Period Pill Study

Terminated·UUniversity of California, San Francisco·Phase 4·NCT04940013·17 enrolled

Placenta Previa1 trial

Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S.

Unknown status·—·Phase 4·NCT02277041·200 enrolled

Post Partum Haemorrhage1 trial

Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT01113229·1,721 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

Bleeding1 trial

Methods Decreasing Bleeding in Open Myomectomy

Unknown status·—·Phase 4·NCT05806307·105 enrolled

Trial1 trial

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

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

Medication1 trial

Different Medications to Induce Labor

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 3·NCT06259097·300 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

ESS1 trial

Assessing Medical Menstrual Regulation in the United States

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

Efficacy1 trial

Techniques to Improve Efficacy of Second Trimester Medical Termination

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

Abnormal Uterine Bleeding1 trial

Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol

Unknown status·MMahidol University·N/A·NCT01762319·52 enrolled

Postmenopausal Women1 trial

Cervical Ripening in Postmenopausal Women

Terminated·SSt. Louis University·N/A·NCT02534883·11 enrolled

Completed·—·Phase 3·NCT00140114·170 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

Analgesic1 trial

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

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

Duodenal Ulcer1 trial

Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

Recruiting·—·Phase 4·NCT03675672·154 enrolled

Cervical Ripening and Induction of Labor1 trial

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

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

Regulatory

FDA Approval Timeline[5]

Sep 21, 1990

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

Q3 2026

Q1 2027

Q1 2028

Trials by Indication[1]

Misoprostol41 trials

Abortion19 trials

Induction of Labor18 trials

Postpartum Hemorrhage13 trials

Pregnancy11 trials

Miscarriage10 trials

Cesarean Section8 trials

Hysteroscopy6 trials

Labour Induction6 trials

Induction of Labour5 trials

Cervical Ripening5 trials

Efficacy and Safety4 trials

Labor Induction4 trials

Vaginal Delivery4 trials

Caesarean Section4 trials

Incomplete Abortion3 trials

Cesarean Delivery3 trials

Premature rupture of membranes3 trials

Preoperative2 trials

Randomized Controlled Trial2 trials

Dilation and Evacuation2 trials

Tranexamic Acid2 trials

Preeclampsia1 trial

Spinal Stenosis1 trial

Dilation1 trial

Post Operative Pain1 trial

ISS1 trial

Placenta Previa1 trial

Post Partum Haemorrhage1 trial

Hysteroscopic Myomectomy1 trial

Bleeding1 trial

Trial1 trial

Medication1 trial

High-Risk Pregnancy1 trial

ESS1 trial

Efficacy1 trial

Abnormal Uterine Bleeding1 trial

Postmenopausal Women1 trial

Women1 trial

Hemorrhage1 trial

Hysterectomy1 trial

Labor Induction at Term1 trial

Intraoperative1 trial

Safety and Efficacy1 trial

Analgesic1 trial

Duodenal Ulcer1 trial

Cervical Ripening and Induction of Labor1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News