TheraRadar
Data updated: Nov 8, 2026

INDOMETHACIN · WATSON LABS

Generic · see INDO-LEMMON
Pain Approved 1982-02-23
Jump to: Indications Approvals Trials Competitors Safety Patents
43
Indications
--
Phase 3 Trials
44
Years on Market

Details

Status
Discontinued
First Approved
1982-02-23
Routes
ORAL, RECTAL, INJECTION
Dosage Forms
CAPSULE, EXTENDED RELEASE, SUSPENSION, CAPSULE, SUPPOSITORY, INJECTABLE

Companies

WATSON LABS JUBILANT GENERICS NOVITIUM PHARMA DURAMED PHARMS BARR Sun Pharma GLENMARK PHARMS LTD Aurobindo Pharma PIONEER PHARMS HERITAGE PHARMA Novartis AVANTHI INC PARKE DAVIS CYCLE HALSEY HERITAGE HETERO LABS LTD III Hikma RISING ANI PHARMS Teva ZYDUS LIFESCIENCES CHARTWELL RX ANNORA PHARMA MUTUAL PHARM SUPERPHARM INWOOD LABS ABLE Viatris AMNEAL COSETTE CHARTWELL MOLECULES AMNEAL PHARMS ZYDUS PHARMS NOVAST LABS Fresenius Kabi IVAX SUB TEVA PHARMS
Active Ingredient: INDOMETHACIN

INDOMETHACIN Approval History

1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
557 FDA actions from 1984 to 2026
Oct 2026 SUPPL
Label · Labeling
Sep 2026 SUPPL
Label · Labeling
Jul 2025 ORIGINAL
Update

What INDOMETHACIN Treats

43 FDA approvals

Originally approved for its first indication in 1984 . Covers 43 distinct patient populations.

  • Other (43)
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Clinical Trial Registry

42 trials
Trial Sponsor ID Phase Status Title
NCT02205762 13-428 2011-001699-20, 042011 Ph 2, Ph 3 active not recruiting LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis
NCT02858310 results posted 160154 16-C-0154 Ph 1, Ph 2 completed E7 TCR T Cells for Human Papillomavirus-Associated Cancers
NCT02950259 results posted 16-126B IRX-2 2016-B Ph 1 completed Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
NCT05035407 results posted 10000045 000045-C Ph 1 terminated T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
NCT07173179 PEIR-PEP Rectal NSAID vs Epi injection Ph 4 completed Papillary Epinephrine Injection vs Rectal Indomethacin
NCT06572917 SPIN H24-02525 Ph 2 not yet recruiting Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
NCT06253702 results posted 2023-0548 1R01HL150361-01, EDUC/KINESIOLOGY Ph 4 completed Brain Blood Flow Responses to Stress: Sex Differences
NCT03267680 results posted 5GYN-16-2 NCI-2017-01402, 5GYN-16-2 Ph 2 terminated IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
NCT03713879 StentvsNSAID Ph 3 recruiting Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
NCT03648437 PAI 38/2018 Ph 1 terminated Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
NCT04207060 results posted 18-008193 R21DK117212 Ph 1, Ph 2 completed Trial of Indomethacin in Chronic Pancreatitis
NCT02609386 INSPIRE results posted IRX-2 2015-A Ph 2 completed IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
NCT05999708 218680 Ph 1 withdrawn A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
NCT01265849 IT-MATTERS results posted CS001P3 2010-019952-35 Ph 3 completed Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
NCT02849990 results posted 9628 NCI-2016-01027, 9628 Ph 2 completed A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
NCT02438371 results posted HSC-MS-15-0134 Ph 4 terminated Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
NCT02221219 results posted HD070792 R01HD070792 Ph 1, Ph 2 completed Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
NCT02692391 results posted STUDY19050212 Ph 3 completed A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
NCT00549549 results posted A3191219 Ph 3 completed Celebrex In Acute Gouty Arthritis Study
NCT03473665 results posted AAAR3505 Ph 4 terminated Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
NCT03537144 16-04411-FB Ph 3 terminated Acetaminophen vs Indomethacin in Treating hsPDA
NCT02603822 15-003603 Ph 1 completed Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability
NCT03712241 K-285-101 Ph 1 completed Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
NCT02641561 IND+LRPEP results posted 14-091 Ph 3 completed Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
NCT01848665 EEL 073.3 Ph 4 completed The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress
NCT01830335 12-167 Ph 4 completed Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Environmental Stress
NCT03261635 NSAIDs_02 Ph 4 completed Ranibizumab Plus Indomethacin
NCT01719926 PIFA NL40487.041.12 Ph 1 completed Phase I Platinum Based Chemotherapy Plus Indomethacin
NCT01733485 EFADA U10HL098177 Ph 1 completed Electrophilic Fatty Acid Derivatives in Asthma
NCT00855920 SURGE results posted IL1T-GA-0814 Ph 3 completed Study Utilizing Rilonacept in Gout Exacerbations
NCT01774604 results posted CPHS#23749 Ph 3 terminated Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
NCT00750581 RT734510 Ph 2, Ph 3 terminated An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants
NCT02577809 M141181 Ph 4 completed Intrathecal Opioid Study
NCT01957215 results posted 202177 RH01778 Ph 4 completed Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
NCT02110810 Indomethacin Indomethacin-2014-02 Ph 3 completed Indomethacin Decreases Post-ERCP Pancreatitis
NCT01577121 INDOGEST INDOGEST Ph 2 completed Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
NCT01626118 results posted IND3-10-06 Ph 3 completed Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
NCT01543685 results posted IND3-08-04b Ph 3 completed Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
NCT00820612 results posted HUM00022847 Ph 4 terminated Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
NCT01070745 chammerman3 Ph 2 withdrawn Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)
NCT01280006 UC-MMHAP-COX-IH-2010001 Ph 1, Ph 2 completed Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
NCT07661498 25-44446 Ph 4 not yet recruiting Indomethacin for Biliary ERCP Patients
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

INDOMETHACIN FDA Label Details

Looking for the branded version?

INDO-LEMMON

Full clinical data, patents, trials, and competitive landscape for indomethacin.

See INDO-LEMMON

Data Sources

FDA Approval: ANDA202572 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.