Drugs / Misoprostol
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Misoprostol

Other / unclassified

Developed for
cervix disorder · pregnancy disorder · pregnancy disorder with abortive outcome · leiomyoma · menstrual disorder · uterine disorder · endometrial disorder · habitual spontaneous abortion
+34 more · indomethacin embryofetopathy · pregnancy loss, recurrent, 4 · cervical cancer · Clostridium difficile colitis · constipation disorder · dystocia · endometrial polyp · gas bloat syndrome · hemorrhagic disease · hypertension, pregnancy-induced · morbid obesity · newborn respiratory distress syndrome · obstetric disorder · perinatal disease · persistent tachypnoe of infancy, usual · preeclampsia · preterm premature rupture of the membranes · submucous uterine fibroid · uterine inflammatory disease · active peptic ulcer disease · cervical dystonia · female reproductive system disorder · fetal growth restriction · gastric ulcer · gastroduodenitis · gestational diabetes · metabolic dysfunction-associated steatohepatitis · oligohydramnios · pain agnosia · placenta disorder · placenta praevia · severe pre-eclampsia · ulcer disease · uterine corpus leiomyoma
Investigated by
Gynuity Health Projects · Ain Shams University · Assiut University · Cairo University · Ferring Pharmaceuticals · Aswan University Hospital
+179 more · Family Care International · University of California, San Francisco · University of Pittsburgh · Aga Khan Health Services · China Medical University Hospital · Department of Medical Services Ministry of Public Health of Thailand · Hormozgan University of Medical Sciences · Ibis Reproductive Health · Jawaharlal Nehru Medical College · The Aga Khan Foundation · University of Liverpool · University of Pennsylvania · Aga Khan University · Assistance Publique - Hôpitaux de Paris · Assistance Publique Hopitaux De Marseille · Assuta Ashdod Hospital · Bill and Melinda Gates Foundation · Boston University · HaEmek Medical Center, Israel · Islamabad Medical and Dental College · Karolinska Institutet · Mahidol University · Mbarara University of Science and Technology · Montefiore Medical Center · National Cancer Institute (NCI) · Northwestern University · Planned Parenthood League of Massachusetts · Society of Family Planning · Stony Brook University · University of Arizona · University of Utah · hany farouk · American University of Beirut Medical Center · Antonios Likourezos · Assuta Medical Center · AstraZeneca · Aultman Health Foundation · Bangkok Metropolitan Administration Medical College and Vajira Hospital · Beni-Suef University · Bezmialem Vakif University · Bharatpur Eye Hospital · Brigham and Women's Hospital · CHA University · CREHPA · Cameroon Baptist Convention Health · Canadian Anesthesiologists' Society · Center for Research on Environment, Health and Population Activities · Centre de Formation et de la Recherche, Tunisia · Centro Rosarino de Estudios Perinatales · Charitable Foundation Women Health & Family Planning · ChildFund International · Cipla Ltd. · Clinical Hospital Merkur · Columbia University · Consorci Sanitari de Terrassa · Daga Memorial Women's Hospital, Nagpur, India · David Young · Department of Health and Family Welfare, Government of Gujarat · Department of Medical Research, Lower Myanmar · Dr. Sami Ulus Children's Hospital · Effective Care Research Unit · El Galaa Teaching Hospital · Emory University · Faculty of Medicine of Tunis · Fogarty International Center of the National Institute of Health · Global Network for Women's and Children's Health Research · Government Medical College, Nagpur · Guttmacher Institute · HAWLER Maternity Hospital · Hagar Muhammad Abdulfattah Muhammad · Hamna Khaliq · Hawler Medical University · Hayat Abad Medical Complex, Peshawar · Henry Aristoteles Mate-Sánez · all 185 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CYTOTEC — 1988-12-27 fda.gov ↗

Trials 220 · started per year

today
US approved 1988
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198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials · 1 met primary
Phase 0 NCT06874049 Feb → Aug 2025 overdue — Hagar Muhammad Abdulfattah Muhammad Active not recruiting No outcome recorded
Phase 0 NCT06199154 Jul 2024 → May 2026 overdue morbid obesity, pregnancy disorder University of Maryland, Baltimore Recruiting No outcome recorded
Phase 0 NCT04768010 Aug → Sep 2023 constipation disorder, gas bloat syndrome Montefiore Medical Center Withdrawn No outcome recorded Stop: Enrollment
Phase 0 NCT02424201 Jun → Dec 2015 pregnancy disorder Lagos State University Unknown Met primary
Phase 0 NCT02259309 Nov 2014 → Jul 2015 — Vanderbilt University Completed No outcome recorded
Phase 17 trials · 1 met primary
Phase 1 NCT07526064 May → Jul 2026 overdue pregnancy disorder with abortive outcome Hamna Khaliq Not yet recruiting No outcome recorded
Phase 1 NCT06502158 Oct 2024 → Oct 2026 expected — Montefiore Medical Center Recruiting No outcome recorded
Phase 1 NCT06364098 Jan 2022 → Feb 2023 — Cairo University Completed Met primary
Phase 1 NCT01863706 May → Dec 2013 — Hormozgan University of Medical Sciences Completed No outcome recorded
Phase 1 NCT01271257 Jan 2011 → Dec 2014 — China Medical University Hospital Completed No outcome recorded
Phase 1 NCT00592215 Mar 2008 → Apr 2010 — Johns Hopkins University Withdrawn No outcome recorded
Phase 1 NCT00906126 Apr 2007 → Sep 2008 dystocia University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00432588 — preeclampsia, preterm premature rupture of the membranes Hormozgan University of Medical Sciences Unknown No outcome recorded
Phase 226 trials · 1 missed
Phase 2 NCT06452719 Aug 2024 → Jul 2026 overdue pregnancy disorder with abortive outcome, pregnancy loss, recurrent, 4 University of Pennsylvania Recruiting No outcome recorded
Phase 2 NCT05216952 May 2022 → Jan 2023 pregnancy disorder with abortive outcome University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 2 NCT05207644 Dec 2021 → Apr 2022 pregnancy disorder Gynuity Health Projects Completed No outcome recorded
Phase 2 NCT04724187 Feb → Aug 2021 — Islamabad Medical and Dental College Unknown No outcome recorded
Phase 2 NCT04604366 Nov 2020 → Dec 2021 pregnancy disorder with abortive outcome Islamabad Medical and Dental College Completed No outcome recorded
Phase 2 NCT03972358 Feb 2020 → Dec 2021 menstrual disorder Gynuity Health Projects Unknown No outcome recorded
Phase 2 NCT03927807 Mar → Dec 2019 — Ain Shams University Unknown No outcome recorded
Phase 2 NCT03617172 Nov 2018 → Sep 2021 Clostridium difficile colitis Vanderbilt University Medical Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03939663 Jul 2018 → Jul 2019 — Ain Shams University Unknown No outcome recorded
Phase 2 NCT02685085 Feb → Aug 2016 — Woman's Health University Hospital, Egypt Unknown No outcome recorded
Phase 2/311 trials · 2 met primary
Phase 2/3 NCT07576881 Jun 2026 → Dec 2027 expected pregnancy disorder Indiana University Not yet recruiting No outcome recorded
Phase 2/3 NCT05957666 Jun → Dec 2023 — Services Institute of Medical Sciences, Pakistan Unknown No outcome recorded
Phase 2/3 NCT02901561 Sep → Dec 2016 — Assiut University Completed No outcome recorded
Phase 2/3 NCT04270994 Sep 2016 → Aug 2019 endometrial polyp Henry Aristoteles Mate-Sánez Completed No outcome recorded
Phase 2/3 NCT02509351 Oct 2015 → Nov 2016 — Ain Shams University Completed No outcome recorded
Phase 2/3 NCT02299401 Dec 2014 → Oct 2016 pregnancy disorder Gynuity Health Projects Completed Met primary
Phase 2/3 NCT02141321 May 2014 → Jan 2015 — Ain Shams University Completed No outcome recorded
Phase 2/3 NCT02083107 Feb 2013 → Feb 2014 — Ain Shams University Completed No outcome recorded
Phase 2/3 NCT01477840 Aug 2012 — Soudabeh Eshghi ali Unknown Met primary
Phase 2/3 NCT01615224 May 2012 → Oct 2019 pregnancy disorder with abortive outcome Kristina Gemzell Danielsson Terminated No outcome recorded Stop: Business
Phase 339 trials · 3 met primary · 2 missed
Phase 3 NCT07506512 Jul 2027 → Jul 2031 expected pregnancy loss, recurrent, 4 University of Pennsylvania Not yet recruiting No outcome recorded
Phase 3 NCT05245227 Jan 2025 → Jan 2027 expected — Stony Brook University Recruiting No outcome recorded
Phase 3 NCT06078501 Feb → Jul 2024 — Stanford University Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT05839899 Aug 2023 → Jul 2024 — Planned Parenthood League of Massachusetts Unknown No outcome recorded
Phase 3 NCT05424445 Jan → Dec 2022 — Karolinska Institutet Completed No outcome recorded
Phase 3 NCT04635007 Jan 2021 → Jun 2022 — Cairo University Completed No outcome recorded
Phase 3 NCT04560218 Oct 2020 → Jul 2021 — Department of Medical Services Ministry of Public Health of Thailand Completed No outcome recorded
Phase 3 NCT04339348 Apr 2020 → Feb 2021 — Cairo University Completed No outcome recorded
Phase 3 NCT04152317 Nov 2019 → Sep 2020 cervix disorder Professor Fernando Figueira Integral Medicine Institute Completed Missed primary
Phase 3 NCT05108597 Mar 2019 → Mar 2020 leiomyoma Pak Emirates Military Hospital Completed No outcome recorded
Phase 454 trials · 4 met primary · 8 missed
Phase 4 NCT07671989 Jun → Dec 2026 expected menstrual disorder University of California, San Francisco Recruiting No outcome recorded
Phase 4 NCT07286188 Dec 2025 → Dec 2026 expected leiomyoma Northwestern University Recruiting No outcome recorded
Phase 4 NCT07174856 Oct 2025 → Jan 2027 expected — Ibis Reproductive Health Not yet recruiting No outcome recorded
Phase 4 NCT06049745 Nov 2023 → Aug 2026 overdue submucous uterine fibroid Assuta Ashdod Hospital Not yet recruiting No outcome recorded
Phase 4 NCT05119439 Oct 2022 → Jun 2023 — Gynuity Health Projects Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT05262738 Jun 2022 → Jul 2023 obesity disorder, pregnancy disorder University of Texas at Austin Completed Missed primary
Phase 4 NCT05124314 Oct 2021 → Oct 2023 — Clinical Hospital Merkur Unknown No outcome recorded
Phase 4 NCT04940013 Oct 2021 → Sep 2025 menstrual disorder University of California, San Francisco Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT05046041 Nov 2020 → Aug 2021 — Gynuity Health Projects Completed No outcome recorded
Phase 4 NCT03749902 Jan 2020 → Jul 2022 — University of Liverpool Completed No outcome recorded
Phase not applicable77 trials · 11 met primary · 7 missed
— NCT07697781 Jan → Jul 2026 overdue endometrial disorder Faculty of Medicine of Tunis Recruiting No outcome recorded
— NCT07559812 Oct 2025 → Apr 2026 overdue cervix disorder, pregnancy disorder Mayo Hospital Lahore Active not recruiting No outcome recorded
— NCT06669533 Feb 2025 → Nov 2027 expected cervical cancer University of Alabama at Birmingham Recruiting No outcome recorded
— NCT06850974 Feb 2025 → Mar 2027 expected — Stony Brook University Recruiting No outcome recorded
— NCT07416487 Feb → Dec 2025 — Muhammad Aamir Latif Completed No outcome recorded
— NCT07534982 Jul 2024 → Jul 2027 expected — Yael Yagur Recruiting No outcome recorded
— NCT07121634 Jan 2024 → Aug 2025 overdue cervix disorder Raid M. Al-Ani Active not recruiting No outcome recorded
— NCT06060327 Oct 2023 → Jun 2024 — Cairo University Completed No outcome recorded
— NCT05532215 Mar → Oct 2023 — OZORI EBIOGBO STANLEY Unknown No outcome recorded
— NCT05696574 Jan → Jun 2023 pregnancy disorder Cairo University Unknown No outcome recorded
Comparator or background therapy228 trials
Phase 0 NCT07109258 Comparator May → Sep 2025 overdue — Cairo University Recruiting No outcome recorded
Phase 0 NCT06207539 Background Dec 2022 → Mar 2023 — Ain Shams Maternity Hospital Completed No outcome recorded
Phase 0 NCT05342974 Background Apr 2022 → Dec 2023 — University of Utah Completed No outcome recorded
Phase 0 NCT05001061 Comparator Aug → Oct 2021 pregnancy disorder with abortive outcome Cairo University Unknown No outcome recorded
Phase 0 NCT04478942 Comparator Oct 2020 → Jan 2025 preterm premature rupture of the membranes University of Wisconsin, Madison Completed No outcome recorded
Show all 228 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2020-08-17 Norgine Regulatory Norgine B.V. completes important regulatory milestone for ANGUSTA® (misoprostol) in Europe for oral induction of labour norgine.com ↗
The procedure has been concluded by the Danish Regulatory Authority, the Reference Member State for the assessment.
2019-07-03 Zydus Lifesciences Limited Regulatory Misoprostol Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Misoprostol Tablets (US RLD – Cytotec®), 100 mcg and 200 mcg.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 452 sources stand behind the page.

FieldValueCited text
Known as Misoprostol “In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta” NCT06060327 ↗
444

“OBJECTIVE: To compare the efficacy and safety of a 200-microgram misoprostol vaginal insert with a 10-mg dinoprostone vaginal insert for reducing the time to vaginal delivery.” PMID 23857539 ↗ Aug 2013

“Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability.” NCT02036437 ↗

“A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.” NCT01912066 ↗

“800 micrograms misoprostol vaginally followed by 400 micrograms oral misoprostol every 3 hours with a maximum of four oral doses.” PMID 24084539 ↗ Oct 2013

“Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.” NCT06343480 ↗

“misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity” NCT05083910 ↗

“the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks” NCT01795599 ↗

“Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion” NCT04590482 ↗

“The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol.” NCT01387256 ↗

“Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system.” NCT00828711 ↗

Show 434 more sources

Known as Angusta “A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following...” NCT02516631 ↗
2

“Oral misoprostol (ANGUSTA®) 25 µg every 2 hours, 8 times (maximum dosage should not exceed 200µg).” NCT04949633 ↗

“Norgine (who make Angusta, a 25 µg oral misoprostol tablet).” PMID 34155622 ↗ Jun 2021

Known as Cytotec “A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following...” NCT02516631 ↗
17

“In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta” NCT06060327 ↗

“Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy” NCT02474433 ↗

“misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally” NCT00677755 ↗

“only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours” NCT04981457 ↗

“Misoprostol (Cytotec) is used widely in Obstetrics and Gynecology” NCT06009679 ↗

“800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)” NCT05077540 ↗

“Misoprostol (Cytotec; GD Searle and Co., Chicago, IL)” NCT00426491 ↗

“Misoprostol ( Cytotec) 200 microgram a tablet” NCT00797693 ↗

“Misoprostol ( Cytotec) 200 microgram a tablet” NCT07697781 ↗

“Misoprostol ( Cytotec) 200 microgram a tablet” NCT07465016 ↗

Show 7 more sources

Known as Cytotec (brand name) “Cytotec (brand name)” NCT04768010 ↗
Known as Misodel “vaginal slow release misoprostol (Misodel®)” NCT02918110 ↗
Known as Misoprostol (Cytotec) “Misoprostol (Cytotec)” NCT01933360 ↗
Known as Misoprostol is also known as Cytotec “Misoprostol is also known as Cytotec” NCT01916681 ↗
Known as Misoprostol Vaginal Insert “Misoprostol Vaginal Insert (MVI 100)” NCT00528255 ↗
Known as Misotac “In the misoprostol group (n = 183), sublingual misoprostol was given by putting two moistened tablets of misoprostol (400 µg) under the tongue and allowing them to dissolve...” NCT01466530 ↗
11

“Women will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm).” NCT03587077 ↗

“misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion” NCT03790371 ↗

“Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby.” NCT03556852 ↗

“women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.” NCT03584698 ↗

“1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.” NCT04080336 ↗

“the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).” NCT03600064 ↗

“800μg rectal misoprostol (Misotac®, SIGMA, Egypt) immediately after urinary catheterization and before skin incision” NCT04635007 ↗

“received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose vaginally” NCT03148561 ↗

“1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt)” NCT04080349 ↗

“two intrauterine misoprostol tablets (Misotac® 200microgram, Sigma Ph., Egypt)” NCT06364098 ↗

Show 1 more source

Known as Misotac (Misoprostol) “Misotac (Misoprostol)” NCT02036437 ↗
Known as Misotac 200 µg tablets “received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually” NCT05088720 ↗
Known as MVI “Women enrolled into the Phase III trial, EXPEDITE (clinical trial registration: NCT01127581), had labour induced with either a misoprostol or dinoprostone vaginal insert (MVI or DVI).” PMID 25758619 ↗ Mar 2015
Known as MVI 100 “Misoprostol Vaginal Insert (MVI 100)” NCT00528255 ↗
Known as PGE1 “misoprostol (PGE1) 200ug” NCT02738177 ↗
Known as Prostaglandin E2 “Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple...” NCT02154932 ↗
Known as Vagiprost “Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol.” NCT04514770 ↗
2

“vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour” NCT05306405 ↗

“followed by intravaginal 25mcg of misoprostol (Vagiprost)” NCT03523754 ↗

Modality Other / unclassified “misoprostol, an orally active prostaglandin” PMID 21130990 ↗ Dec 2010
Route Oral “misoprostol administered orally during the third stage of labor” NCT00097123 ↗