indomethacin

Trade name: indocin

Small moleculeapproved

Approved

Jun 10, 1965

Indometacin (INN and BAN) or indomethacin (AAN, USAN, and former BAN) is a nonsteroidal anti-inflammatory drug (NSAID) commonly used as a prescription medication to reduce fever, pain, stiffness, and swelling from inflammation. Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Indometacin, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Indomethacin is a potent inhibitor of prostaglandin synthesis in vitro. Indomethacin concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because indomethacin is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. Indometacin is indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease, Moderate to severe ankylosing spondylitis, Moderate to severe osteoarthritis, Acute painful shoulder (bursitis and/or tendinitis), Acute gouty arthritis. In general, adverse effects seen with indomethacin are similar to all other NSAIDs. For instance, indometacin inhibits both cyclooxygenase-1 and cyclooxygenase-2, it inhibits the production of prostaglandins in the stomach and intestines, which maintain the mucous lining of the gastrointestinal tract. Indometacin, therefore, like other non-selective COX inhibitors can cause peptic ulcers. These ulcers can result in serious bleeding and/or perforation requiring hospitalization of the patient. To reduce the possibility of peptic ulcers, indomethacin should be prescribed at the lowest dosage needed to achieve a therapeutic effect, usually between 50–200 mg/day. It should always be taken with food. Nearly all patients benefit from an ulcer protective drug (e.g. highly dosed antacids, ranitidine 150 mg at bedtime, or omeprazole 20 mg at bedtime). Other common gastrointestinal complaints, including dyspepsia, heartburn and mild diarrhea are less serious and rarely require discontinuation of indomethacin. — NCATS

Clinical trial activity

137 trials · 170 clinical orgs · 45 marketing orgs

Phase 1
23
Phase 2
55
Phase 3
34
Phase 4
31

Earliest trial started Sep 1, 1978 (NCT00000494)

Timeline

1960s

  1. Jun 10, 1965

    Merck — Earliest FDA Approval

  2. Jun 10, 1965

    Zyla Life Sciences — NDA Secondary Org

  3. Jun 10, 1965

    Merck — NDA Organization

1970s

  1. Jan 1, 1978

    Earliest Phase 3 Sponsor(trial)

1980s

  1. Apr 20, 1984

    Rising Pharmaceuticals — Marketing Organization

  2. Apr 20, 1984

    Mylan — NDA Secondary Org

  3. Apr 20, 1984

    Rising Pharmaceuticals — NDA Secondary Org

  4. May 4, 1984

    Teva — NDA Secondary Org

  5. May 18, 1984

    Heritage Pharma — NDA Secondary Org

  6. Jun 21, 1984

    Chartwell Pharmaceuticals — NDA Secondary Org

  7. Jan 30, 1985

    Recordati — NDA Secondary Org

  8. Oct 10, 1985

    Zyla Life Sciences — Marketing Organization

  9. Oct 18, 1985

    Duramed Research — Marketing Organization

  10. Nov 7, 1985

    Teva — Marketing Organization

  11. Feb 12, 1986

    Heritage Pharma — Marketing Organization

  12. Oct 3, 1986

    Mutual Pharmaceutical — Marketing Organization

  13. Oct 10, 1986

    Superpharm — Marketing Organization

  14. Mar 18, 1987

    Pliva — Marketing Organization

  15. Mar 18, 1987

    Ani Pharmaceuticals — Marketing Organization

  16. Mar 18, 1987

    Hikma — Marketing Organization

  17. Apr 29, 1987

    Sandoz — Marketing Organization

  18. May 18, 1987

    Watson Pharmaceuticals — Marketing Organization

  19. Mar 15, 1989

    Inwood Laboratories — Marketing Organization

1990s

  1. Aug 31, 1992

    G & W Laboratories Inc. — Marketing Organization

  2. Aug 31, 1992

    ACP Nimble — Marketing Organization

  3. Aug 31, 1992

    Cosette — Marketing Organization

  4. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  6. May 28, 1998

    Novartis — Marketing Organization

2000s

  1. Feb 6, 2002

    Able Laboratories — Marketing Organization

  2. Jul 16, 2008

    West-Ward Pharmaceutical — Marketing Organization

  3. Mar 6, 2009

    Avanthi Pharma — Marketing Organization

2010s

  1. Mar 17, 2010

    Fresenius — NDA Secondary Org

  2. Nov 15, 2010

    Cadila Healthcare — Marketing Organization

  3. Nov 30, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  4. Dec 1, 2010

    Amneal Pharmaceuticals — Marketing Organization

  5. Dec 22, 2010

    Glenmark Pharmaceuticals — Marketing Organization

  6. Apr 12, 2011

    Hetero Labs Ltd — Marketing Organization

  7. Mar 28, 2013

    Sun Pharmaceuticals — Marketing Organization

  8. Dec 9, 2013

    Actavis — Marketing Organization

  9. Feb 24, 2014

    Genus Oncology, LLC — Marketing Organization

  10. Feb 24, 2014

    Genus Oncology, LLC — NDA Secondary Org

  11. Oct 5, 2015

    Jubilant Innovation Ltd. — Marketing Organization

  12. Apr 19, 2016

    Hospira — Marketing Organization

  13. Apr 19, 2016

    Pfizer — Marketing Organization

  14. Dec 27, 2016

    Aurobindo Pharma — Marketing Organization

  15. May 8, 2017

    Novast Labs — Marketing Organization

  16. Jul 19, 2017

    Navinta — Marketing Organization

  17. Sep 25, 2017

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Jan 12, 2024

    Novitium Pharma — Marketing Organization

  2. Jul 3, 2025

    Annora Pharma — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 10, 1965

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2c(c1)c(CC(=O)[O-])c(C)n2C(=O)c1ccc(Cl)cc1.O.O.O.[Na+]
Mol. weight
433.82 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • {1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1h-indol-3-yl}acetic acid
  • {1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1h-indol-3-yl}acetic acid
  • 1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid
  • 1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid
  • aconip
  • aconip
  • artracin
  • artracin
  • artracin sr
  • berlind 75 ret
  • flexin-25 continus
  • flexin-50 continus
  • flexin-75 continus
  • glucametacin
  • glucametacin
  • glucametacin
  • glucametacin
  • glucametacin
  • glucametacine
  • glucamethacin
  • imbrilon
  • imbrilon
  • indocid-r
  • indocid ret
  • indocin
  • indocin
  • indocin
  • indocin
  • indocin
  • indocin sr
  • indocin sr
  • indoderm
  • indoflex
  • indolar
  • indolar
  • indolar sr
  • indolar sr
  • indo-lemmon
  • indo-lemmon
  • indomax-25
  • indomax-75 sr
  • indometacin
  • indometacin
  • indometacin
  • indometacin
  • indometacina
  • indometacina
  • indometacine
  • indometacine
  • indometacine
  • indometacin farnesil
  • indometacin farnesil
  • indometacin farnesil
  • indometacinum
  • indometacinum
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacin
  • indomethacine
  • indomethacin farnesil
  • indomethacin glucosamide
  • indomethacin hcl
  • indomethacin hydrochloride
  • indomethacin hydrochloride
  • indomethacin hydrochloride
  • indomethacin hydrochloride
  • indomethacin hydrochloride
  • indomethacin hydrochloride
  • indomethacin sodium
  • indomethacin sodium
  • indomethacin sodium
  • indomethacin sodium
  • indomod
  • indomod
  • indo-paed
  • indoptol
  • indoptol
  • indotard mr 75
  • ledmecin
  • maximet sr
  • mobilan
  • mobilan
  • mobilan
  • pardelprin mr
  • rheumacin la
  • rheumacin la
  • rimacid
  • slo-indo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07218653Early Phase 1 (Phase 1)Jul 31, 2026National Institutes of Health (NIH), University of Wisconsin
NCT07202559N/ADec 1, 2025Baotou Medical University, Central South University, Changhai Hospital, Chinese Academy of Medical Sciences, First People's Hospital of Hangzhou, Jiao Tong University, Ningxia Medical University, Shandong University, Yunnan University of Traditional Chinese Medicine
NCT07088757Phase 4Sep 15, 2025Changhai Hospital, Dongyang People's Hospital, Jiao Tong University, Jinhua Central Hospital, Nanchang University, Ningbo University, People's Hospital of Quzhou, Shaoxing People's Hospital, Taizhou Enze Medical Center Group, Zhejiang University, Zhuji People's Hospital of Zhejiang Province
NCT07071441N/AJun 1, 2025Air Force Military Medical University, China
NCT06572917Phase 3Jun 1, 2025University of British Columbia
NCT06433453Phase 4Apr 22, 2024University of Saskatchewan
NCT05999708Phase 1Oct 31, 2023GlaxoSmithKline
NCT05947461N/AJun 1, 2023Air Force Military Medical University, China
NCT05857514N/AMay 10, 2023Moti Lal Nehru Medical College, Sheffield Hallam University
NCT05722548Phase 2Feb 1, 2023Jiao Tong University
NCT05252754Phase 3Jan 1, 2023Johns Hopkins University
NCT05538247Early Phase 1 (Phase 1)Dec 15, 2022Mayo Clinic
NCT05637281N/ADec 11, 2022Zhejiang University
NCT05664074Phase 4Nov 7, 2022University of Cincinnati
NCT06031363N/ANov 1, 2022Soochow University
NCT07173179Phase 4Jul 1, 2022Duke University
NCT05381428Phase 3May 13, 2022University of Modena and Reggio Emilia, University of Parma
NCT05007522Phase 3Dec 1, 2021Duke University, National University of Singapore, Sen-Jam Pharmaceutical
NCT05132829Phase 4Nov 30, 2021Thomas Jefferson University
NCT04821323Early Phase 1 (Phase 1)Mar 10, 2021Janssen Pharmaceutica NV
Showing 20 of 137 trials
Page 1 / 7

Organizations

Research & Development (170)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jiao Tong UniversityAcademic/Hospital5332016
Changhai HospitalAcademic/Hospital4332016
Hebrew UniversityAcademic/Hospital4422002
IrokoFor profit4422009
National Cancer Institute (NCI)Government4111997
People's Liberation Army of ChinaGovernment4322013
University of MichiganAcademic/Hospital4132005
University of WisconsinAcademic/Hospital4331993
Case Western Reserve UniversityAcademic/Hospital3131993
IRX TherapeuticsFor profit3222005
Mayo ClinicAcademic/Hospital3322015
National Institutes of Health (NIH)Government3021997
Radboud UniversityAcademic/Hospital3232000
University of CalgaryAcademic/Hospital3321997
Zhejiang UniversityAcademic/Hospital3132019
Aarhus UniversityAcademic/Hospital2122003
Air Force Military Medical University, ChinaAcademic/Hospital2212023
Boehringer IngelheimFor profit2222000
Brock UniversityAcademic/Hospital2212013
Cairo UniversityAcademic/Hospital2212014
170 organizations
Page 1 / 9

Marketing (69)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGAug 31, 1992
Able LaboratoriesFor profitMKTGFeb 6, 2002
ActavisFor profitMKTGDec 9, 2013
Amneal PharmaceuticalsFor profitMKTGDec 1, 2010
Amneal PharmaceuticalsFor profitSYNFeb 24, 2025
Ani PharmaceuticalsFor profitSYNMar 18, 1987
Ani PharmaceuticalsFor profitMKTGMar 18, 1987
Annora PharmaFor profitMKTGJul 3, 2025
Aurobindo PharmaFor profitMKTGDec 27, 2016
Aurobindo PharmaFor profitSYNDec 27, 2016
Avanthi PharmaFor profitMKTGMar 6, 2009
Cadila HealthcareFor profitMKTGNov 15, 2010
Chartwell PharmaceuticalsFor profitNDA2Jun 21, 1984
Chartwell PharmaceuticalsFor profitMKTGNov 30, 2010
CosetteFor profitMKTGAug 31, 1992
Cycle Pharmaceuticals Ltd.For profitMKTG
Dow ChemicalFor profitMKTG
Duramed ResearchFor profitMKTGOct 18, 1985
FreseniusFor profitNDA2Mar 17, 2010
G & W Laboratories Inc.For profitMKTGAug 31, 1992
Genus Oncology, LLCFor profitMKTGFeb 24, 2014
Genus Oncology, LLCFor profitNDA2Feb 24, 2014
Glenmark PharmaceuticalsFor profitMKTGDec 22, 2010
Glenmark PharmaceuticalsFor profitSYNJun 22, 2017
HalseyFor profitMKTG
Heritage PharmaFor profitNDA2May 18, 1984
Heritage PharmaFor profitMKTGFeb 12, 1986
Heritage PharmaFor profitSYNMay 18, 1984
Heritage PharmaFor profitSYNMay 18, 1984
Hetero Labs LtdFor profitMKTGApr 12, 2011
HikmaFor profitSYNMar 18, 1987
HikmaFor profitMKTGMar 18, 1987
HospiraFor profitMKTGApr 19, 2016
HospiraFor profitSYNApr 19, 2016
Inwood LaboratoriesFor profitMKTGMar 15, 1989
Jubilant Innovation Ltd.For profitMKTGOct 5, 2015
MerckFor profitNDAJun 10, 1965
Mutual PharmaceuticalFor profitMKTGOct 3, 1986
MylanFor profitNDA2Apr 20, 1984
MylanFor profitSYNMar 20, 2014
NavintaFor profitMKTGJul 19, 2017
NovartisFor profitMKTGMay 28, 1998
Novast LabsFor profitMKTGMay 8, 2017
Novitium PharmaFor profitMKTGJan 12, 2024
Parke-DavisFor profitNDA2
PfizerFor profitMKTGApr 19, 2016
PlivaFor profitMKTGMar 18, 1987
RecordatiFor profitNDA2Jan 30, 1985
Rising PharmaceuticalsFor profitMKTGApr 20, 1984
Rising PharmaceuticalsFor profitSYNMar 20, 2014
Rising PharmaceuticalsFor profitNDA2Apr 20, 1984
SandozFor profitMKTGApr 29, 1987
Sun PharmaceuticalsFor profitMKTGMar 28, 2013
Sun PharmaceuticalsFor profitSYNFeb 9, 1987
SuperpharmFor profitMKTGOct 10, 1986
TevaFor profitNDA2May 4, 1984
TevaFor profitSYNNov 7, 1985
TevaFor profitMKTGNov 7, 1985
Watson PharmaceuticalsFor profitMKTGMay 18, 1987
Watson PharmaceuticalsFor profitSYNDec 9, 2013
Watson PharmaceuticalsFor profitNDA2
West-Ward PharmaceuticalFor profitMKTGJul 16, 2008
Zydus Discovery DMCCFor profitMKTGSep 25, 2017
Zydus Discovery DMCCFor profitSYNNov 15, 2010
Zydus Discovery DMCCFor profitSYNAug 2, 2023
Zydus Discovery DMCCFor profitSYNNov 15, 2010
Zyla Life SciencesFor profitNDA2Jun 10, 1965
Zyla Life SciencesFor profitMKTGOct 10, 1985
Zyla Life SciencesFor profitSYNAug 13, 1984