Drugs / Indomethacin
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Indomethacin

Small molecule

Developed for
patent ductus arteriosus · acute pancreatitis · pancreatitis · COVID-19 · intracerebral hemorrhage · obstetric disorder · Alzheimer disease · autoinflammatory syndrome
+31 more · autonomic nervous system disorder · carcinoma of soft palate · cardiac rhythm disease · cervical incompetence · chronic pancreatitis · colorectal cancer · colorectal neoplasm · cutaneous melanoma · enuresis · epicondylitis · Gitelman syndrome · gout · hand-foot syndrome · hemorrhagic disease · hyalitis · Langerhans cell histiocytosis · macular retinal edema · metastatic prostate carcinoma · neoplasm of esophagus · oral cavity squamous cell carcinoma · orthostatic hypotension · ovarian neoplasm · pancreas disorder · periventricular leukomalacia · preterm premature rupture of the membranes · prostate adenocarcinoma · respiratory system disorder · ankylosing spondylitis · asthma · osteoarthritis · spondyloarthropathy
Investigated by
Iroko Pharmaceuticals, LLC · National Heart, Lung, and Blood Institute (NHLBI) · Shaare Zedek Medical Center · University of Wisconsin, Madison · University of California, San Francisco · Air Force Military Medical University, China
+98 more · Brock University · Changhai Hospital · National Cancer Institute (NCI) · National Institutes of Health (NIH) · University of Brescia · American College of Gastroenterology · American Health Assistance Foundation · Assistance Publique - Hôpitaux de Paris · Assiut University · Athena Medical Group · Azad University of Medical Sciences · Bausch & Lomb Incorporated · Bayer · Beth Israel Deaconess Medical Center · CEL-SCI Corporation · Cairo University · China Medical University Hospital · Chinese University of Hong Kong · Dartmouth-Hitchcock Medical Center · David Vitale MD · Eastern Hepatobiliary Surgery Hospital · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · First People's Hospital of Hangzhou · Genfit · GlaxoSmithKline · Göteborg University · Hadassah Medical Organization · Health Sciences Centre, Winnipeg, Manitoba · Histiocyte Society · Hong Huang · Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo · Indiana University · Institute of Liver and Biliary Sciences, India · Janssen Research & Development, LLC · Janssen Scientific Affairs, LLC · Kowa Research Institute, Inc. · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Maastricht University Medical Center · Mamta Parikh · Mayo Clinic · Medical Research Council of Canada · Medical University of South Carolina · Mexican Social Security Institute · NICHD Neonatal Research Network · National Center for Advancing Translational Sciences (NCATS) · National Center for Research Resources (NCRR) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Taiwan University Hospital · National University of Singapore · Netherlands Alzheimer Foundation · Netherlands Brain Foundation · North American Consortium for Histiocytosis · Northwestern University · Organon and Co · Orient Europharma Co., Ltd. · Peking Union Medical College Hospital · Perseverance Research Center, LLC · Pontificia Universidad Catolica de Chile · Queen's University · Radboud University Medical Center · Rundo International Pharmaceutical Research & Development Co.,Ltd. · Saint Thomas Hospital, Panama · Sandoz · Sara Varea · Satish R. Raj · Second Affiliated Hospital, School of Medicine, Zhejiang University · Sen-Jam Pharmaceutical · Shanghai Jiao Tong University School of Medicine · Sheba Medical Center · Sint Maartenskliniek · Soroka University Medical Center · St. Boniface Hospital · St. Luke's Medical Center · Teva Branded Pharmaceutical Products R&D, Inc. · all 104 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) INDOCIN 1986-01-06 fda.gov
Approved US (FDA) INDOCIN 1965-06-10 fda.gov

Trials 85 · started per year

today
US approved 1965
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196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT07218653 Jul 2026 → Jul 2031 expected metabolic syndrome X University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 0 NCT04265053 Apr 2021 → Mar 2025 cerebral arterial disease University of Wisconsin, Madison Completed No outcome recorded
Phase 0 NCT04821323 Mar → May 2021 Janssen Research & Development, LLC Completed No outcome recorded
Phase 0 NCT02653638 Jun 2016 → Apr 2019 cerebrovascular disorder University of Wisconsin, Madison Completed No outcome recorded
Phase 0 NCT00943345 Sep 2009 → Feb 2012 digestive system disorder Maastricht University Medical Center Unknown No outcome recorded
Phase 14 trials
Phase 1 NCT03985969 Sep 2019 → Mar 2020 Genfit Completed No outcome recorded
Phase 1 NCT01719926 Sep 2012 → Aug 2017 colorectal neoplasm, neoplasm of esophagus, ovarian neoplasm UMC Utrecht Completed No outcome recorded
Phase 1 NCT00858195 Jun → Jul 2006 Sandoz Completed No outcome recorded
Phase 1 NCT00223691 Mar 2002 → Jan 2017 autonomic nervous system disorder, orthostatic hypotension Vanderbilt University Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT04207060 Jul 2020 → Apr 2023 chronic pancreatitis Mayo Clinic Completed No outcome recorded
Phase 1/2 NCT04344457 Apr → Jun 2020 COVID-19 Perseverance Research Center, LLC Unknown No outcome recorded
Phase 1/2 NCT02935205 Jan 2017 → Mar 2024 metastatic prostate carcinoma Mamta Parikh Unknown No outcome recorded
Phase 1/2 NCT02221219 Aug 2014 → Oct 2019 brain injury, intracerebral hemorrhage, periventricular leukomalacia Hong Huang Completed No outcome recorded
Phase 1/2 NCT01280006 Jan → Dec 2011 hypertensive disorder, obstructive sleep apnea syndrome, stroke disorder University of Calgary Completed No outcome recorded
Phase 1/2 NCT01146197 Feb 2010 → Dec 2012 Gitelman syndrome Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 1/2 NCT00262470 Apr 1997 → Dec 2029 expected cardiac rhythm disease Satish R. Raj Active not recruiting No outcome recorded
Phase 217 trials
Phase 2 NCT07560566 Dec 2025 → Apr 2029 expected hand-foot syndrome, hepatocellular carcinoma National Taiwan University Hospital Recruiting No outcome recorded
Phase 2 NCT06572917 Nov 2025 → Dec 2028 expected intracerebral hemorrhage University of British Columbia Not yet recruiting No outcome recorded
Phase 2 NCT05722548 Feb → Dec 2023 pancreas disorder Shanghai Jiao Tong University School of Medicine Unknown No outcome recorded
Phase 2 NCT04025177 Jan 2020 → Aug 2021 patent ductus arteriosus University of Manitoba Withdrawn No outcome recorded
Phase 2 NCT03562624 Jun 2018 → May 2019 Bayer Completed No outcome recorded
Phase 2 NCT02849990 Mar 2017 → Dec 2018 prostate adenocarcinoma University of Washington Completed No outcome recorded
Phase 2 NCT02633969 Dec 2015 → Jan 2017 Iroko Pharmaceuticals, LLC Completed No outcome recorded
Phase 2 NCT01958320 Dec 2013 → Jun 2017 intestinal perforation, necrotizing enterocolitis, patent ductus arteriosus University of California, San Francisco Completed No outcome recorded
Phase 2 NCT01291654 Apr 2012 → Dec 2014 patent ductus arteriosus Shaare Zedek Medical Center Unknown No outcome recorded
Phase 2 NCT01577121 Apr 2012 → Sep 2014 Sara Varea Completed No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT04404686 Oct 2020 → Apr 2024 obstetric disorder Hadassah Medical Organization Unknown No outcome recorded
Phase 2/3 NCT02205762 Nov 2016 → Jul 2026 overdue Langerhans cell histiocytosis North American Consortium for Histiocytosis Active not recruiting No outcome recorded
Phase 2/3 NCT02642601 Mar 2014 → Dec 2015 Cairo University Unknown No outcome recorded
Phase 2/3 NCT01912716 Jul 2013 → Apr 2018 pancreatitis Indiana University Completed No outcome recorded
Phase 318 trials
Phase 3 NCT07599605 Mar → Dec 2024 pancreatitis Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo Completed No outcome recorded
Phase 3 NCT05007522 May 2022 → Jun 2024 COVID-19 Sen-Jam Pharmaceutical Completed No outcome recorded
Phase 3 NCT03713879 Mar 2019 → Dec 2026 expected pancreatitis Chinese University of Hong Kong Recruiting No outcome recorded
Phase 3 NCT03662269 Oct 2018 → Aug 2020 respiratory system disorder The First Affiliated Hospital of Guangzhou Medical University Unknown No outcome recorded
Phase 3 NCT03597867 Apr → Jul 2018 University of Trieste Completed No outcome recorded
Phase 3 NCT01360034 Dec 2015 → May 2016 obstetric disorder Saint Thomas Hospital, Panama Unknown No outcome recorded
Phase 3 NCT02641561 Oct 2014 → Jun 2016 acute pancreatitis The Cooper Health System Completed No outcome recorded
Phase 3 NCT02089425 Apr → Dec 2014 Kowa Research Institute, Inc. Terminated No outcome recorded
Phase 3 NCT02361645 Mar → Nov 2014 hyalitis University of Brescia Completed No outcome recorded
Phase 3 NCT02110810 Jan 2014 → Jan 2015 acute pancreatitis Mexican Social Security Institute Completed No outcome recorded
Phase 420 trials
Phase 4 NCT07661498 Jul 2026 → Jul 2031 expected acute pancreatitis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT07536425 Apr 2026 → Oct 2027 expected Western Galilee Hospital-Nahariya Not yet recruiting No outcome recorded
Phase 4 NCT07247682 Dec 2025 → Dec 2028 expected pancreatitis The First Affiliated Hospital of Anhui Medical University Not yet recruiting No outcome recorded
Phase 4 NCT03547232 Dec 2024 → Jun 2028 expected acute pancreatitis, multiple organ dysfunction syndrome Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 4 NCT06253702 Jul 2024 → May 2025 cerebrovascular disorder University of Wisconsin, Madison Completed No outcome recorded
Phase 4 NCT05664074 Nov 2022 → Feb 2025 acute pancreatitis David Vitale MD Completed No outcome recorded
Phase 4 NCT02797067 May 2016 → Jul 2019 pancreatitis Changhai Hospital Completed No outcome recorded
Phase 4 NCT02711358 Mar → Jul 2016 Assiut University Completed No outcome recorded
Phase 4 NCT03261635 Jan → Dec 2016 macular retinal edema University of Brescia Completed No outcome recorded
Phase 4 NCT01957215 Oct 2013 → Sep 2014 GlaxoSmithKline Completed No outcome recorded
Phase not applicable10 trials
NCT07071441 Jun 2025 → Dec 2026 expected pancreatitis Air Force Military Medical University, China Recruiting No outcome recorded
NCT05637281 Dec 2022 → Dec 2023 acute pancreatitis, autoinflammatory syndrome Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
NCT06031363 Nov 2022 → Dec 2023 pancreatitis The First Affiliated Hospital of Soochow University Completed No outcome recorded
NCT05109143 Oct 2020 → Apr 2022 Institute of Liver and Biliary Sciences, India Completed No outcome recorded
NCT03643900 Aug 2018 → Aug 2021 acute necrotizing pancreatitis First People's Hospital of Hangzhou Completed No outcome recorded
NCT02002650 Dec 2013 → Nov 2015 acute pancreatitis Air Force Military Medical University, China Completed No outcome recorded
NCT01744314 Nov 2012 → Nov 2019 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Unknown No outcome recorded
NCT01114516 Mar 2010 → Mar 2013 cervical incompetence Northwestern University Completed No outcome recorded
NCT00727740 Aug 2005 → Aug 2011 pancreatitis Yale University Completed No outcome recorded
NCT00239512 Mar 2005 → Jun 2006 patent ductus arteriosus China Medical University Hospital Terminated No outcome recorded
Also used as a comparator or background therapy in 68 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05538247 Background Apr 2023 → Dec 2025 Mayo Clinic Completed No outcome recorded
Phase 0 NCT01869361 Comparator Aug 2020 → Nov 2021 MetroHealth Medical Center Withdrawn No outcome recorded
Phase 18 trials
Phase 1 NCT05999708 Background Oct 2023 → Dec 2024 ulcerative colitis GlaxoSmithKline Withdrawn No outcome recorded
Phase 1 NCT05035407 Background Mar 2022 → Jul 2025 National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1 NCT03712241 Comparator Oct 2018 → Jan 2019 Kowa Research Institute, Inc. Completed No outcome recorded
Phase 1 NCT03648437 Background Sep 2018 → Oct 2024 patent ductus arteriosus University of Oulu Terminated No outcome recorded
Phase 1 NCT02950259 Background Feb 2017 → May 2019 triple-negative breast carcinoma Providence Health & Services Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT02858310 Background Jan 2017 → Jul 2025 cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT00486824 Comparator Apr 2007 → Dec 2012 obstetric disorder Stanford University Completed No outcome recorded
Phase 1/2 NCT00002796 Background May 1997 → Dec 2004 colon mucinous adenocarcinoma, colon signet ring cell adenocarcinoma, rectal signet ring cell adenocarcinoma, rectum mucinous adenocarcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 26 trials
Phase 2 NCT06623513 Comparator Oct 2024 → Sep 2026 expected acute pancreatitis Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT03267680 Background Nov 2017 → Aug 2023 uterine cervix carcinoma in situ, vulvar intraepithelial neoplasia University of Southern California Terminated No outcome recorded
Phase 2 NCT02609386 Background Jan 2016 → Feb 2022 oral cavity squamous cell carcinoma Brooklyn ImmunoTherapeutics, LLC Completed No outcome recorded
Phase 2 NCT02602054 Comparator Oct 2015 → Apr 2016 patent ductus arteriosus Hospital General Naval de Alta Especialidad - Escuela Medico Naval Unknown No outcome recorded
Phase 2 NCT00997581 Comparator Apr → Dec 2010 gout Dartmouth-Hitchcock Medical Center Withdrawn No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03629600 Comparator Oct 2017 → Feb 2018 acute pancreatitis Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 2/3 NCT00750581 Comparator Aug 2008 → Jan 2013 patent ductus arteriosus University of Calgary Terminated No outcome recorded
Phase 310 trials
Phase 3 NCT05252754 Background Jan 2023 → Dec 2026 expected acute pancreatitis Johns Hopkins University Recruiting No outcome recorded
Phase 3 NCT05381428 Comparator May 2022 → Oct 2024 acute pancreatitis Azienda USL Reggio Emilia - IRCCS Completed No outcome recorded
Phase 3 NCT03533803 Comparator Jun → Dec 2018 Cairo University Completed No outcome recorded
Phase 3 NCT03537144 Comparator Jun 2016 → Sep 2018 patent ductus arteriosus University of Tennessee Terminated No outcome recorded
Phase 3 NCT02692391 Comparator Jul 2013 → Jul 2019 acute pancreatitis University of Pittsburgh Completed No outcome recorded
Phase 418 trials
Phase 4 NCT07088757 Comparator Sep 2025 → Nov 2026 expected pancreatitis Changhai Hospital Recruiting No outcome recorded
Phase 4 NCT06433453 Background Apr → Dec 2024 anovulation University of Saskatchewan Unknown No outcome recorded
Phase 4 NCT07037888 Background Dec 2023 → Sep 2026 expected Henry Ford Health System Recruiting No outcome recorded
Phase 4 NCT07173179 Comparator Jan 2023 → Mar 2025 acute pancreatitis Duzce University Completed No outcome recorded
Phase 4 NCT05132829 Background Dec 2021 → Dec 2024 cervical incompetence, pregnancy disorder Thomas Jefferson University Unknown No outcome recorded
Phase not applicable19 trials
NCT06837831 Background Feb 2026 → Jul 2027 expected anus disorder, radiodermatitis, rectal cancer Qianfoshan Hospital Recruiting No outcome recorded
NCT07495111 Background Dec 2025 → Jun 2028 expected choledocholithiasis Qilu Hospital of Shandong University Recruiting No outcome recorded
NCT07117318 Background Jul 2025 → Dec 2026 expected acute pancreatitis Air Force Military Medical University, China Recruiting No outcome recorded
NCT05947461 Comparator Jun 2023 → Jun 2024 acute pancreatitis Air Force Military Medical University, China Terminated No outcome recorded
NCT05857514 Comparator May 2023 → May 2024 acute pancreatitis Moti Lal Nehru Medical College Unknown No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 155 sources stand behind the page.

FieldValueCited text
Known as Indomethacin “IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals...” NCT01291654
144

“The role of prostaglandin E2 is the permeability of the conduit, by which is indicated the use of cyclooxygenase inhibitors for closure (indomethacin and ibuprofen).” NCT02602054

“All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure” NCT07117318

Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery” NCT03597867

“Those randomized to rectal Indomethacin received only per-rectal 100 mg suppository immediately post-ERCP.” PMID 35470300 Apr 2022

“A 30 mg indomethacin suppository was administered rectally 30 minutes before dressing placement.” NCT06837831

Indomethacin, ibuprofen or acetaminophen will be used as standard of care treatment” NCT01958320

indomethacin 75mg 1 tablet QD to start on POD0 10 tablets” NCT07037888

“additional reservoir containing indomethacin (IND)” PMID 36648744 Jan 2023

indomethacin suppository 50-100 mg” NCT04410536

“K-103-IP: 0.5% indomethacinNCT02089425

IndomethacinNCT01638962

NCT02653638

NCT01577121

NCT01774604

NCT02577809

NCT00858195

NCT04207060

NCT06031363

NCT02111707

NCT02609386

NCT00009646

NCT04145336

NCT00904904

NCT01848665

NCT02205762

NCT00262470

NCT02641561

NCT02950259

NCT03662269

NCT00466128

NCT00033917

NCT01733485

NCT00820612

NCT00142558

NCT00000494

NCT02002650

NCT04265053

NCT05857514

NCT02849990

NCT02183168

NCT01912716

NCT04404686

NCT05664074

NCT03057769

NCT01360034

NCT05132829

NCT05999708

NCT01265849

NCT00226122

NCT06623513

NCT05722548

NCT00964431

NCT04726085

NCT05947461

NCT03712241

NCT02964403

NCT04025177

NCT01830335

NCT00432081

NCT02361645

NCT00997581

NCT01957215

NCT00485160

NCT00811057

NCT02947932

NCT00002796

NCT01543685

NCT04344457

NCT02221219

NCT02858310

NCT05381428

NCT02959112

NCT00473980

NCT00616382

NCT01070745

NCT03547232

NCT00478335

NCT00210470

NCT07661498

NCT01114516

NCT00554476

NCT03582332

NCT00239512

NCT01742689

NCT07088757

NCT01626118

NCT03643900

NCT07173179

NCT06433453

NCT02797067

NCT02642601

NCT01884272

NCT00116623

NCT02884219

NCT01869361

NCT00187447

NCT03537144

NCT02438371

NCT00470743

NCT03620825

NCT00549549

NCT06253702

NCT04425993

NCT00002535

NCT05007522

NCT03708458

NCT02110810

NCT01280006

NCT07536425

NCT02711358

NCT04964180

NCT01073670

NCT02935205

NCT07218653

NCT03261635

NCT02692391

NCT07071441

NCT02603822

NCT07495111

NCT02183155

NCT06572917

NCT00486824

NCT05252754

NCT00722033

NCT05035407

NCT00223691

NCT03473665

NCT05109143

NCT01719926

NCT03533803

NCT03648437

NCT03129945

NCT00855920

NCT04821323

NCT03713879

NCT05538247

NCT00750581

NCT01744314

NCT03267680

NCT07560566

NCT02116309

NCT02368795

NCT02633969

NCT00727740

Known as CHRONO-INDOCID ClinicalTrials.gov intervention name — accepted as the source's own label NCT03985969
Known as Extended-release indomethacin Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects.” NCT02183155
Known as IND “additional reservoir containing indomethacin (IND)” PMID 36648744 Jan 2023
Known as INDO “However, Indomethacin (INDO) can be prescribed for medical ductal closure if this is preferred by a participating center.” NCT02884219
Known as Indom Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery” NCT03597867
Known as indometacin “Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients” PMID 31780277 Nov 2019
8

“administration of 100 mg rectal indometacin immediately after ERCP” NCT07247682

“75mg/day indometacin (Chronoindocid®)” NCT01146197

“Drug: Rectal Form IndometacinNCT03629600

NCT07599605

NCT05637281

NCT02770950

NCT00943345

NCT00462111

Known as Indomethacin 5 MG/ML Ophthalmic Suspension Indomethacin 5 MG/ML Ophthalmic SuspensionNCT03597867
Action Inhibit “the use of indomethacin, a prostaglandin inhibitor, may decrease prostaglandin synthesis” NCT00466128
Modality Small molecule “non-steroidal antiinflammatory drug” NCT00820612
Route Oral “Given orally” NCT00002796