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
National Heart, Lung, and Blood Institute (NHLBI) · Iroko Pharmaceuticals, LLC · Shaare Zedek Medical Center · University of Wisconsin, Madison · University of California, San Francisco · Air Force Military Medical University, China
+97 more · Brock University · Changhai Hospital · National Cancer Institute (NCI) · 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 · 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 Institutes of Health (NIH) · 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. · The Cooper Health System · all 103 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 84 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT07218653 Oct 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 13 trials
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 Mixed
Phase 1/27 trials · 2 missed
Phase 1/2 NCT04207060 Jul 2020 → Apr 2023 chronic pancreatitis Mayo Clinic Completed Missed primary
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 Missed primary
Phase 217 trials · 1 met primary · 1 missed
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 Missed primary
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 · 1 missed
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 Missed primary
Phase 318 trials · 4 met primary · 3 missed
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 Met primary
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 Met primary
Phase 420 trials · 2 met primary
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 Met primary
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 Met primary
Phase not applicable10 trials · 2 met primary
— 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 Met primary
— 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 Met primary
— 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
Comparator or background therapy70 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 1 NCT05999708 Background Oct 2023 → Dec 2024 ulcerative colitis GlaxoSmithKline Withdrawn No outcome recorded Stop: Business
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

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 156 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 ↗
146

“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% indomethacin” NCT02089425 ↗

Show 136 more sources

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 Indometacin” NCT03629600 ↗

NCT02770950 ↗

NCT07599605 ↗

NCT00462111 ↗

NCT00943345 ↗

NCT05637281 ↗

Known as Indomethacin 5 MG/ML Ophthalmic Suspension “Indomethacin 5 MG/ML Ophthalmic Suspension” NCT03597867 ↗
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 ↗