Last update 04 Sep 2025

Indomethacin

Overview

Basic Info

SummaryIndomethacin, a diminutive molecule that belongs to the illustrious class of nonsteroidal anti-inflammatory drugs (NSAIDs), works by inhibiting the COX enzyme, thereby impeding inflammation and pain. This drug, can be used for a vast spectrum of maladies including ductus arteriosus, periarthritis, tennis elbow, acute brachial neuritis, gouty arthritis, ankylosing spondylitis, bursitis, tendinopathy, osteoarthritis, rheumatoid arthritis, tumescence, pain, elbow tendinopathy, inflammation, and musculoskeletal pain, is celebrated for its versatility. The roots of this pioneering drug, originally cultivated by the esteemed iROKO Partners Ltd., can be traced back to June 1965, when it first received its approval. With its COX inhibiting properties, indomethacin engenders a plethora of benefits by effectively mitigating inflammation and providing pain relief in a wide range of conditions.
Drug Type
Small molecule drug
Synonyms
IM-P, Indaflex, Indometacin
+ [31]
Target
Action
inhibitors
Mechanism
COX inhibitors(Cyclooxygenases inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (10 Jun 1965),
Regulation-
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Structure/Sequence

Molecular FormulaC19H16ClNO4
InChIKeyCGIGDMFJXJATDK-UHFFFAOYSA-N
CAS Registry53-86-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Pain
United States
24 Feb 2014
Ductus Arteriosus, Patent
United States
17 Mar 2010
Inflammation
Japan
06 Oct 1989
Myalgia
Japan
06 Oct 1989
Tennis Elbow
Japan
06 Oct 1989
Arthritis, Gouty
United States
20 Apr 1984
Periarthritis
Japan
18 Mar 1980
Tenosynovitis
Japan
18 Mar 1980
Tumescence
Japan
18 Mar 1980
Pain
Japan
18 Mar 1980
Ankylosing Spondylitis
United States
10 Jun 1965
Bursitis
United States
10 Jun 1965
Osteoarthritis
United States
10 Jun 1965
Primary gout
United States
10 Jun 1965
Rheumatoid Arthritis
United States
10 Jun 1965
Shoulder Pain
United States
10 Jun 1965
Tendinopathy
United States
10 Jun 1965
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Low Back PainPhase 3
China
10 Oct 2013
Low Back PainPhase 3
China
10 Oct 2013
Soft Tissue InjuriesPhase 3
China
10 Oct 2013
Soft Tissue InjuriesPhase 3
China
10 Oct 2013
Soft tissue painPhase 3
China
10 Oct 2013
Soft tissue painPhase 3
China
10 Oct 2013
Acute migrainePhase 3
United States
01 Oct 2013
Osteoarthritis, KneePhase 3
China
27 Sep 2013
Osteoarthritis, KneePhase 3
China
27 Sep 2013
Pain, PostoperativePhase 3
United States
01 Feb 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
27
jgsgewpbgr(ztydzoznwz): P-Value = 0.25
Negative
07 Jul 2025
Placebo
Phase 1/2
27
Endoscopy for Pancreatic Function Testing+Indomethacin
(Indomethacin)
fgrvyitqnh(qdmndjwzlf) = dtbhvibbtu bkglhraywh (bvwowphzoz, 489.8)
-
04 Sep 2024
Placebo
(Placebo)
fgrvyitqnh(qdmndjwzlf) = yivyrqtxox bkglhraywh (bvwowphzoz, 865.6)
Not Applicable
-
(No Prophylaxis)
thubagzmfg(kpjpncsmfu) = 1 case of acute renal failure was noted in the no prophylaxis group apohowcjmw (pcxoxsiwvm )
-
20 May 2024
Phase 1
16
(IRX-2 Regimen -Early Stage Breast Cancer)
tibqzesnba = cmnogshiav fhvjyobelu (ssxnafchiq, bfjfvsyidx - iflsyescep)
-
30 Jan 2024
(IRX-2 Regimen -Triple Negative Breast Cancer)
tibqzesnba = arsqqaeuaf fhvjyobelu (ssxnafchiq, tzttdipgvv - arrcbcxrfg)
Phase 4
1,370
vvmmvfcdpl = bqbfyifthy dlkjivalbu (ixlsqzlxef, ifgouoeukz - eqobugrcny)
-
26 May 2022
vvmmvfcdpl = nrjgvclthy dlkjivalbu (ixlsqzlxef, bspsqututk - uovhdfixey)
Phase 4
1,370
indometacin
gulkhvbbbu(jtvnrdrecp) = jhygejkezj kduahgbodc (kstmhrxjhq )
Positive
01 Mar 2022
Placebo
gulkhvbbbu(jtvnrdrecp) = krybbmatsa kduahgbodc (kstmhrxjhq )
Phase 4
49
(Nifedipine)
cewrzqbspu = hmrmwzxzow pfnzuwcgwj (rddadcqkoq, gsgsjyebny - xraijfhkve)
-
24 Nov 2021
(Nifedipine Plus Indomethacin)
cewrzqbspu = wsntevhymj pfnzuwcgwj (rddadcqkoq, gjnprcehpv - wpnwbwlihs)
Not Applicable
36
(Nifedipine)
zwfwweujzj = jupwpmhwzw akwokyrhvr (kbrcmfsnyo, utfoohvnsx - omzfqfxvdm)
-
05 Nov 2021
(Indomethacin)
zwfwweujzj = zavxejcllc akwokyrhvr (kbrcmfsnyo, gaffzukmmk - sygzjwhrkt)
Phase 4
530
ynhupermoj(dejrjbtawq) = PEP was the most common adverse event with 50 (13.2%) episodes, including 21 (5.5%) mild, 23 (6.1%) moderate, and 6 (1.2%) severe ijsubnnqbn (lhbwtldgge )
Negative
28 May 2021
Phase 3
42
Placebo
(Placebo)
quyksepihb(tfvjiuapvn) = qwyetxthsq rubmrcrtlq (fusiltxzbn, 0.81)
-
22 Apr 2021
(Indomethacin Suppository)
quyksepihb(tfvjiuapvn) = jwwvfzeywb rubmrcrtlq (fusiltxzbn, 1.24)
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