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Drug

Indomethacin

Established medicine
ClassCyclooxygenase inhibitorResearchOngoing clinical research
Also known as 1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid, Indocin, Indometacinum, Tivorbex+4 more

1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid, Indocin, Indometacinum, Tivorbex, Indometacin, Indometacina, Indometacine, Indomethacin Sodium Trihydrate.

RxNorm5781ChEMBLCHEMBL6ATCC01EB03ATCM02AA23ATCM01AB51ATCS01BC01ATCM01AB01UNIIXXE1CET956
8
Active clinical trials
2
Protein targets
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy

Clinical trial2026-06-22Results expected Q3 2031 · ClinicalTrials.gov

Rectal Indomethacin Versus Diclofenac for Prevention of Post-ERCP Panceratitis (IDPPP2): A Multicenter, Double-blind, Randomized, Control Trial

Clinical trial2026-06-15Results expected Q4 2026 · ClinicalTrials.gov

Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

Clinical trial2026-05-26Results expected Q3 2031 · ClinicalTrials.gov

Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

Clinical trial2026-03-31Completed · ClinicalTrials.gov

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

Clinical trial2026-03-09Results posted · ClinicalTrials.gov

A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer

Clinical trial2025-12-03Results posted · ClinicalTrials.gov

Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial

Clinical trial2025-11-18Results expected Q4 2026 · ClinicalTrials.gov

Label change: INDOMETHACIN (ANDA090403)

Regulatory2024-11-21FDA

Label change: INDOMETHACIN (ANDA090403)

Regulatory2024-03-09FDA

Label change: INDOMETHACIN (ANDA090403)

Regulatory2021-04-28FDA

Label change: INDOMETHACIN (ANDA090403)

Regulatory2019-09-18FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Indomethacin
Aliases & brands
1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acidIndocinIndometacinumTivorbexIndometacinIndometacinaIndometacineIndomethacin Sodium Trihydrate
RxNorm CUI
5781
ChEMBL ID
CHEMBL6
ATC codes
C01EB03M02AA23M01AB51S01BC01M01AB01
UNII
XXE1CET956
Primary mechanism
Cyclooxygenase inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prostaglandin G/H synthase 2
PTGS2 · P35354
INHIBITORCyclooxygenase inhibitor
Prostaglandin G/H synthase 1
PTGS1 · P23219
INHIBITORCyclooxygenase inhibitor

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-11-15
Latest approval
2010-11-15
Authorities
FDA
Total events
7
fdaU.S. Food and Drug Administration· 7 events
2024-11-21Label change
Label change: INDOMETHACIN (ANDA090403)
Evidence ↗
2024-03-09Label change
Label change: INDOMETHACIN (ANDA090403)
Evidence ↗
2021-04-28Label change
Label change: INDOMETHACIN (ANDA090403)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

95 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
95
registered trials across all phases
LATEST COMPLETION 2026
8
Active studies
6
Recruiting
57
Late-stage (III+)
52
Completed
35
Discontinued
PHASE DISTRIBUTIONn = 95
Early Phase 16Phase 110Phase 1 / 29Phase 213Phase 2 / 35Phase 318Phase 420Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy

Not yet recruitingPH IVUniversity of California, San Franciscon=8602031

Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial

RecruitingPH IVKey trialChanghai Hospitaln=1,3662026

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

CompletedPH IVUniversity of Wisconsin, Madisonn=222025

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

Unknown statusPH IVUniversity of Saskatchewann=302025

Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial

TerminatedPH IVThe University of Texas Health Science Center, Houstonn=492019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

CompletedPH IMayo Clinicn=562026

A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer

CompletedPH IProvidence Health & Servicesn=162025

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

CompletedPH I/IINational Cancer Institute (NCI)n=2242025

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

CompletedPH IVUniversity of Wisconsin, Madisonn=222025

Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)

CompletedPH I/IIMayo Clinicn=272023

Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants (BeNeDuctus Trial - Belgium Netherlands Ductus Trial)

CompletedN/ARadboud University Medical Centern=2732022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.