CYTOTEC (misoprostol)
CYTOTEC is indicated for the treatment of Gastric Ulcer.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1988-12-27
- Routes
- ORAL
- Dosage Forms
- TABLET
CYTOTEC Approval History
What CYTOTEC Treats
1 indicationsCYTOTEC is approved for 1 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastric Ulcer
CYTOTEC Boxed Warning
WARNINGS CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE TH...
WARNINGS CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, Cytotec may be prescribed if the patient • has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. • is capable of complying with effective contraceptive measures. • has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake. • will begin Cytotec only on the second or third day of the next normal menstrual period.
CYTOTEC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CYTOTEC
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
107 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05322252 MIST results posted | 202202144 | Ph 4 | completed | Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial |
| NCT06259097 BLOOM | STUDY-24-00118 | Ph 3 | recruiting | Different Medications to Induce Labor |
| NCT01113229 CYTOCINON | P081104 2009-013177-18 | Ph 4 | terminated | Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage |
| NCT04940013 MPP | 20-30048 | Ph 4 | terminated | Missed Period Pill Study |
| NCT06502158 | 2024-15999 | Ph 1 | recruiting | Mifepristone vs Misoprostol |
| NCT06452719 LeMi | 855835 | Ph 2 | recruiting | Letrozole and Misoprostol for Early Pregnancy Loss Management |
| NCT04117243 | 280391 | Ph 2 | completed | Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases |
| NCT06946914 Miso/CS | KFSIRB200-244 | Ph 4 | recruiting | Misoprostol Before Caesarean Section |
| NCT06765473 | Pre-vaginal+ Postperative PPH | Ph 3 | not yet recruiting | Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section |
| NCT02573051 | ANP | Ph 2 | withdrawn | Termination Of Anembryonic Pregnancy |
| NCT05097326 MiLI results posted | 62448 | Ph 3 | completed | Mifepristone for Labor Induction |
| NCT03670836 COMRED results posted | AAAR8566 | Ph 4 | completed | Comparison of Misoprostol Ripening Efficacy With Dilapan |
| NCT04028765 POM PROM results posted | 833536 | Ph 4 | completed | Pitocin or Oral Misoprostol for PROM IOL |
| NCT06364098 | prevention of PPH | Ph 1 | completed | Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections |
| NCT02209545 results posted | STU00091259 | Ph 4 | terminated | Misoprostol for Reduction of Blood Loss During Fibroid Surgery |
| NCT05424445 | EudraCT 2020-000663-23 | Ph 3 | completed | MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor |
| NCT03680339 | 42 | Ph 4 | completed | The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS |
| NCT05804305 | 3280221MSGE | Ph 2 | completed | Misoprostol for NASH |
| NCT05761418 | REC-H-PhBSU-22021 | Ph 3 | completed | Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy |
| NCT05340205 | Placenta previa disorders | Ph 4 | completed | Blood Loss During Cesarean Delivery in Placenta Previa Patients |
| NCT02777190 results posted | 00005107 | Ph 4 | terminated | A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor |
| NCT02680314 results posted | 2015-5341 | Ph 2 | completed | Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix? |
| NCT04533841 | Ahmed mohamed fathy ismail | Ph 2 | completed | Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas |
| NCT05215873 | FMASU MS 733/2020/2021 | Ph 4 | completed | Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol |
| NCT04604366 | IslamabadMDC | Ph 2 | completed | Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage |
| NCT04685694 RPOC | 0444-19-TLV | Ph 4 | completed | Management of RPOC After Induced Abortion |
| NCT02412618 MMSAP results posted | 2012-245 | Ph 4 | completed | Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation |
| NCT05108597 | 25102021 | Ph 3 | completed | Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy |
| NCT03676621 | BMISO | Ph 4 | completed | Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage |
| NCT04989400 | 5181 | Ph 4 | completed | Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion |
| NCT02704481 | 1035 | Ph 4 | terminated | Non-surgical Alternatives to Treatment of Failed Medical Abortion |
| NCT04063904 | 1044 | Ph 4 | terminated | Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia |
| NCT03148574 | IUM | Ph 3 | completed | Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery |
| NCT03682718 | ase36278 | Ph 4 | completed | Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor |
| NCT04044079 | dinoprostone misoprostol | Ph 4 | completed | Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients |
| NCT02562300 | Utrotonics during CS | Ph 2 | completed | Uterotonics Using to Reduce Bleeding at Cesarean Section |
| NCT04273984 | Misoprostol Prior to IUCD | Ph 4 | completed | Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion |
| NCT02786992 CS | AS1301 | Ph 2, Ph 3 | completed | Misoprostol+Oxytocin vs. Carbetocin in CS |
| NCT04080336 | dinoprostone misoprostol IUD | Ph 4 | completed | Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women |
| NCT03212352 Triple M | 62449 | Ph 4 | terminated | Comparing Two Medical Treatments for Early Pregnancy Failure. |
| NCT04270994 | MSP_2016 | Ph 2, Ph 3 | completed | Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients |
| NCT01615224 | WMA11 | Ph 2, Ph 3 | terminated | Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage |
| NCT03556852 | 38 | Ph 4 | completed | CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE |
| NCT02012491 PreFaiR results posted | 818434 1R01HD071920-01A1 | Ph 3 | completed | Comparative Effectiveness of Pregnancy Failure Management Regimens |
| NCT03930069 | Hysterscopioc myomectomy | Ph 2, Ph 3 | completed | Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time. |
| NCT02704780 | HawlerMU | Ph 2 | completed | Two Different Regimens of Misoprostol in Retained Placenta |
| NCT01998776 | MISO-SB | Ph 2, Ph 3 | completed | Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding |
| NCT03479879 | AS1731 | Ph 2, Ph 3 | completed | Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage |
| NCT03487354 | AS1753 | Ph 2, Ph 3 | completed | Medical Abortion With Single Daily Dose of Misoprostol |
| NCT02342002 | 1015 | Ph 4 | terminated | Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial |
Showing 50 of 107 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CYTOTEC FDA Label Details
Indications & Usage
FDA Label (PDF)CYTOTEC is indicated for the treatment of Gastric Ulcer.
WARNINGS CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASE...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment