Indocin

(Indomethacin)

ApprovedSmall molecule

Indomethacin is used to reduce pain, fever, and inflammation caused by conditions like arthritis, gout, and other inflammatory diseases. It can also be used to close a patent ductus arteriosus (a heart condition in newborns).[2] Indocin is currently approved and in use across 34 indications[4].[1]

Indocin is one of 559 small molecule programs targeting Patent ductus arteriosus after premature birth. It is currently in Approved.

Indications

113

Total Trials

Active Trials

558

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Patent Ductus Arteriosus After Premature BirthApproved

Ulcerative ColitisApproved

Squamous Cell Intraepithelial NeoplasiaApproved

Alzheimer DiseaseApproved

Premature BirthApproved

PancreatectomyApproved

Fish-Eye DiseaseApproved

Preterm Premature Rupture of the MembranesApproved

Adverse EffectActive, not recruiting

CataractActive, not recruiting

Patent Ductus Arteriosus After Premature BirthApproved

Approved

Ulcerative ColitisApproved

Approved

Squamous Cell Intraepithelial NeoplasiaApproved

Approved

Alzheimer DiseaseApproved

Approved

Premature BirthApproved

Approved

PancreatectomyApproved

Approved

Fish-Eye DiseaseApproved

Approved

Preterm Premature Rupture of the MembranesApproved

Approved

Adverse EffectApproved

Active, not recruiting

CataractApproved

Active, not recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Indocin

CCosette Pharmaceuticals, Inc.

Actos

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Pancreatitis

NCT06623513

Q4 2026

Phase 3Recruiting

Pancreatitis

NCT05252754

N/ARecruiting

Indomethacin

NCT07071441

Phase 3Recruiting

Pancreatitis

NCT03713879

Q3 2027

Phase 3Not yet recruiting

Pain

NCT07792668

Q4 2029

Phase 1/2Active, not recruiting

Orthostatic Intolerance

NCT00262470

Clinical

Trials by Indication[1]

Pancreatitis23 trials

Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Completed·—·Phase 4·NCT02797067·1,370 enrolled

Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac

Terminated·—·N/A·NCT05947461·1,204 enrolled

Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis

Not yet recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT06623513·100 enrolled

Show 20 more trials

Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

Recruiting·JJohns Hopkins University·Phase 3·NCT05252754·4,874 enrolled

The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis

Completed·TThe First Affiliated Hospital of Soochow University·N/A·NCT06031363·192 enrolled

Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05109143·44 enrolled

The Efficacy of Pancreatic Duct Stenting With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis

Completed·FFirst People's Hospital of Hangzhou·N/A·NCT03643900·618 enrolled

Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Unknown status·—·Phase 4·NCT03708458·250 enrolled

Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis

Unknown status·—·N/A·NCT05857514·384 enrolled

Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Completed·JJohns Hopkins University·N/A·NCT02116309·948 enrolled

Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography

Terminated·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·N/A·NCT02959112·548 enrolled

A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

Completed·YYale University·N/A·NCT00727740·117 enrolled

Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Completed·TThe Cooper Health System·Phase 3·NCT02641561·192 enrolled

Indomethacin Decreases Post-ERCP Pancreatitis

Completed·IInstituto Mexicano del Seguro Social·Phase 3·NCT02110810·160 enrolled

Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

Recruiting·—·Phase 3·NCT03713879·1,734 enrolled

COX-2 Inhibitor to Prevent Post-ERCP Pancreatitis

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT02964403·2,700 enrolled

7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients

Unknown status·—·N/A·NCT04145336·800 enrolled

Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin

Terminated·—·N/A·NCT03057769·3,300 enrolled

Oral Resveratrol to Prevent Post-ERCP Pancreatitis

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT02947932·2,700 enrolled

Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

Unknown status·TTehran University of Medical Sciences·N/A·NCT02368795·400 enrolled

Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Terminated·—·Phase 3·NCT01774604·449 enrolled

Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

Terminated·UUniversity of Michigan·Phase 4·NCT00820612·602 enrolled

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

Not yet recruiting·UUniversity of California, San Francisco·Approved·NCT07661498·860 enrolled

Indomethacin13 trials

Indomethacin vs Diclofenac for Preventing PEP

Recruiting·—·N/A·NCT07071441·4,050 enrolled

Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention

Unknown status·—·N/A·NCT04425993·2,700 enrolled

Rectal Indomethacin vs Intravenous Ketorolac

Completed·—·Phase 4·NCT05664074·192 enrolled

Show 10 more trials

Indomethacin PK-PD in Extremely Preterm Neonates

Withdrawn·UUniversity of Manitoba·Phase 2·NCT04025177

Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Terminated·WWoman's·N/A·NCT04726085·11 enrolled

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Unknown status·SSaint Thomas Hospital, Panama·Phase 3·NCT01360034·216 enrolled

Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

Completed·NNICHD Neonatal Research Network·Phase 3·NCT00009646·1,202 enrolled

Indomethacin and Cardiac Bypass Surgery

Completed·QQueen's University·Phase 4·NCT01073670·82 enrolled

Ranibizumab Plus Indomethacin

Completed·UUniversità degli Studi di Brescia·Phase 4·NCT03261635·58 enrolled

Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

Completed·IIroko Pharmaceuticals, LLC·Phase 3·NCT01543685·462 enrolled

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Not yet recruiting·UUniversity of British Columbia·Phase 2·NCT06572917·500 enrolled

Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

Completed·IIroko Pharmaceuticals, LLC·Phase 3·NCT01626118·373 enrolled

Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults

Completed·KKowa Research Institute, Inc.·Phase 1·NCT03712241·15 enrolled

Preterm Labor7 trials

Vaginal Indomethacin for Preterm Labor

Unknown status·HHadassah Medical Organization·Phase 2/3·NCT04404686·300 enrolled

Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Completed·SStanford University·Phase 1/2·NCT00486824·29 enrolled

Indomethacin for Tocolysis of Preterm Labor

Withdrawn·MMetroHealth Medical Center·Phase 1·NCT01869361

Show 4 more trials

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT02438371·49 enrolled

Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation

Completed·SSara Varea·Phase 2·NCT01577121·16 enrolled

Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

Completed·UUniversity of California, Irvine·N/A·NCT03129945·36 enrolled

Tocolysis for Preterm Labor

Completed·UUniversity of Mississippi Medical Center·N/A·NCT00811057·301 enrolled

Patent ductus arteriosus7 trials

Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

Completed·UUniversity of California, San Francisco·Phase 2·NCT00187447·100 enrolled

Treating the Resistant Patent Ductus Arteriosus (PDA)

Unknown status·SShaare Zedek Medical Center·Phase 2·NCT00616382·68 enrolled

Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Completed·UUniversity of Ulm··NCT01428180·35 enrolled

Show 4 more trials

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

Terminated·UUniversity of Oulu·Phase 1·NCT03648437·22 enrolled

Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies

Withdrawn·KKK Women's and Children's Hospital·Phase 4·NCT00470743

An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants

Terminated·UUniversity of Calgary·Phase 2/3·NCT00750581·9 enrolled

Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)

Withdrawn·SShaare Zedek Medical Center·Phase 2·NCT01070745

Acute Pancreatitis4 trials

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT05722548·200 enrolled

Prophylaxis of Post-ERCP Acute Pancreatitis

Completed·AAzienda USL Reggio Emilia - IRCCS·Phase 3·NCT05381428·184 enrolled

A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

Completed·UUniversity of Pittsburgh·Phase 3·NCT02692391·42 enrolled

Show 1 more trial

Papillary Undiluted Epinephrine Injection vs Rectal Indomethacin in Preventing Post-ERCP Pancreatitis (PEIR-PEP): A Prospective, Double-blind, Randomized Controlled Trial

Completed·DDuzce University·Approved·NCT07173179·504 enrolled

52 more indications

Function3 trials

Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

Recruiting·MMayo Clinic·Phase 1·NCT05538247·56 enrolled

The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress

Completed·—·Phase 4·NCT01848665·8 enrolled

Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Environmental Stress

Completed·—·Phase 4·NCT01830335·8 enrolled

Treatment2 trials

Canadian National PDA Treatment Study

Completed·IIWK Health Centre··NCT04347720·1,663 enrolled

Early Treatment Versus Expectative Management of PDA in Preterm Infants

Completed·RRadboud University Medical Center·N/A·NCT02884219·273 enrolled

Embryo Transfer2 trials

Role of Indomethacin in Difficult Embryo Transfer.

Unknown status·—·Phase 2/3·NCT02642601·100 enrolled

Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Completed·—·Phase 3·NCT03533803·200 enrolled

Prostate Cancer2 trials

Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer

Unknown status·MMamta Parikh·Phase 1/2·NCT02935205·38 enrolled

A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy

Completed·UUniversity of Washington·Phase 2·NCT02849990·22 enrolled

Arthritis2 trials

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Terminated·—·Phase 4·NCT03473665·9 enrolled

Celebrex In Acute Gouty Arthritis Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00549549·402 enrolled

Alzheimer's Disease1 trial

Effect of Indomethacin on the Progression of Alzheimer's Disease

Completed·RRadboud University Medical Center·Phase 3·NCT00432081·160 enrolled

Bleeding1 trial

Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02183155·82 enrolled

Cataract1 trial

Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 4·NCT00904904·120 enrolled

Renal Colic1 trial

Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Unknown status·TTehran University of Medical Sciences·Phase 3·NCT01742689·88 enrolled

Interaction1 trial

NSAID Drug Interaction Study

Completed·AArdea Biosciences, Inc.·Phase 1·NCT01884272·24 enrolled

Ovulation1 trial

Three Dimensional Ultrasonographic Detection of Human Ovulation

Recruiting·UUniversity of Saskatchewan·Phase 4·NCT06433453·30 enrolled

Adverse Effect1 trial

Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

Completed·—·Phase 4·NCT03582332·64 enrolled

Age1 trial

A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04821323·10 enrolled

Premature Infants1 trial

Management of Patent Ductus in Premature Infants

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000494

Langerhans Cell Histiocytosis1 trial

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

Recruiting·NNorth American Consortium for Histiocytosis·Phase 2/3·NCT02205762·1,400 enrolled

Gene Therapy1 trial

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT05035407·36 enrolled

ART1 trial

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants

Withdrawn· GSK logo

GSK·Phase 1·NCT05999708

SMA1 trial

Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability

Completed·MMayo Clinic·Phase 1·NCT02603822·25 enrolled

Colorectal Cancer1 trial

Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT00002796·46 enrolled

Orthostatic Intolerance1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Phase 1/2·NCT00262470·150 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Squamous Cell Carcinoma1 trial

IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

Completed·BBrooklyn ImmunoTherapeutics, LLC·Phase 2·NCT02609386·105 enrolled

Breast Cancer1 trial

Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)

Completed·PProvidence Health & Services·Phase 1·NCT02950259·16 enrolled

Exercise1 trial

Blood Brain Flow and Exercise

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT02653638·80 enrolled

Laparoscopic Cholecystectomy1 trial

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

Completed·SSouth Valley University·N/A·NCT04964180·80 enrolled

Asthma1 trial

Electrophilic Fatty Acid Derivatives in Asthma

Completed·SSally E. Wenzel MD·Phase 1·NCT01733485·50 enrolled

Ankylosing Spondylitis1 trial

Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02183168·192 enrolled

Chronic Pancreatitis1 trial

Trial of Indomethacin in Chronic Pancreatitis

Completed·MMayo Clinic·Phase 1/2·NCT04207060·27 enrolled

Brain Injury1 trial

Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury

Completed·HHong Huang·Phase 1/2·NCT02221219·256 enrolled

Sprain1 trial

Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

Completed· GSK logo

GSK·Phase 4·NCT01957215·270 enrolled

Nephrogenic Diabetes Insipidus1 trial

Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

Completed·UUniversity of Colorado, Denver·N/A·NCT00478335·4 enrolled

Melanoma1 trial

Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma

Completed·SSt. Luke's Medical Center·Phase 2·NCT00002535

Gout1 trial

Study Utilizing Rilonacept in Gout Exacerbations

Completed· Regeneron logo

Regeneron·Phase 3·NCT00855920·225 enrolled

Sex Differences1 trial

Brain Blood Flow Responses to Stress: Sex Differences

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06253702·22 enrolled

Vulvar Intraepithelial Neoplasia1 trial

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

Terminated·UUniversity of Southern California·Phase 2·NCT03267680·10 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

Completed·CCEL-SCI Corporation·Phase 3·NCT01265849·928 enrolled

Magnesium Sulfate1 trial

Magnesium Sulfate Versus Indomethacin for Preterm Labor

Terminated·UUniversity of Pennsylvania·Phase 4·NCT00116623

Chemotherapy1 trial

Phase I Platinum Based Chemotherapy Plus Indomethacin

Completed·UUMC Utrecht·Phase 1·NCT01719926·13 enrolled

Orthostatic Hypotension1 trial

Treatment of Orthostatic Hypotension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223691·389 enrolled

Opioid1 trial

Intrathecal Opioid Study

Completed·UUniversity of Witwatersrand, South Africa·Phase 4·NCT02577809·100 enrolled

Premature rupture of membranes1 trial

Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)

Unknown status·TThomas Jefferson University·Phase 2·NCT00466128·116 enrolled

Acetaminophen1 trial

Acetaminophen vs Indomethacin in Treating hsPDA

Terminated·UUniversity of Tennessee·Phase 3·NCT03537144·37 enrolled

Hemorrhage1 trial

Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

Completed·YYale University·Phase 3·NCT00033917·630 enrolled

Head and Neck Cancer1 trial

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

Completed·BBrooklyn ImmunoTherapeutics, LLC·Phase 2·NCT00210470·27 enrolled

Chronic Cough1 trial

Indomethacin for Refractory Chronic Cough

Unknown status·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 3·NCT03662269·84 enrolled

COVID-191 trial

Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19

Unknown status·PPerseverance Research Center, LLC·Phase 1/2·NCT04344457·80 enrolled

Microcirculation1 trial

Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers

Completed·UUniversity Hospital, Angers··NCT00152724·85 enrolled

Hypoxia1 trial

Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

Completed·UUniversity of Calgary·Phase 1/2·NCT01280006·12 enrolled

Enuresis1 trial

The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal

Completed·UUniversity of Aarhus·Phase 4·NCT00226122·56 enrolled

Pain1 trial

Comparison of No Premedication, Rectal Indomethacin Suppository, and Paracervical Block for Pain Reduction During Hysterosalpingography: A Prospective Randomized Three-Arm Controlled Trial

Not yet recruiting·BBalikesir University·Phase 3·NCT07792668·180 enrolled

Metabolic Syndrome1 trial

Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

Not yet recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT07218653·72 enrolled

Unspecified2 trials

Human Cerebral Blood Flow Regulation

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04265053·110 enrolled

The Effect of Dehydration on Intestinal Permeability

Completed·ÖÖrebro University, Sweden·N/A·NCT03620825·20 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

INDOCIN

NDA NDA016059

Feb 23, 1982

INDOCIN SR

NDA NDA018185

Apr 20, 1984

INDOMETHACIN

NDA NDA018858

May 4, 1984

INDOMETHACIN

NDA NDA018730

May 18, 1984

INDOMETHACIN

NDA NDA018851

Jul 31, 1984

INDOMETHACIN

NDA NDA018690

Aug 6, 1984

INDOMETHACIN

NDA NDA018829

Aug 13, 1984

INDOCIN

NDA NDA017814

Nov 23, 1984

INDOMETHACIN

NDA NDA018806

Jan 30, 1985

INDOCIN

NDA NDA018878

Oct 10, 1985

INDOCIN

NDA NDA018332

Mar 17, 2010

INDOMETHACIN

NDA NDA022536

Feb 24, 2014

TIVORBEX

NDA NDA204768

Sources

References

[1]
ClinicalTrials.gov — 113 trial records for Indomethacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Indocin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Indomethacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Indomethacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204768). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Indocin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Cosette Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCosette Pharmaceuticals, Inc.

Patent Landscape[6]

Patent Cliff

Apr 23, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9089471Apr 23, 2030

8734847Apr 23, 2030

8992982Apr 23, 2030

Indocin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q4 2029

Trials by Indication[1]

Pancreatitis23 trials

Indomethacin13 trials

Preterm Labor7 trials

Patent ductus arteriosus7 trials

Acute Pancreatitis4 trials

Function3 trials

Treatment2 trials

Embryo Transfer2 trials

Prostate Cancer2 trials

Arthritis2 trials

Alzheimer's Disease1 trial

Bleeding1 trial

Cataract1 trial

Renal Colic1 trial

Interaction1 trial

Ovulation1 trial

Adverse Effect1 trial

Age1 trial

Premature Infants1 trial

Langerhans Cell Histiocytosis1 trial

Gene Therapy1 trial

ART1 trial

SMA1 trial

Colorectal Cancer1 trial

Orthostatic Intolerance1 trial

Papilloma1 trial

Squamous Cell Carcinoma1 trial

Breast Cancer1 trial

Exercise1 trial

Laparoscopic Cholecystectomy1 trial

Asthma1 trial

Ankylosing Spondylitis1 trial

Chronic Pancreatitis1 trial

Brain Injury1 trial

Sprain1 trial

Nephrogenic Diabetes Insipidus1 trial

Melanoma1 trial

Gout1 trial

Sex Differences1 trial

Vulvar Intraepithelial Neoplasia1 trial

Efficacy and Safety1 trial

Magnesium Sulfate1 trial

Chemotherapy1 trial

Orthostatic Hypotension1 trial

Opioid1 trial

Premature rupture of membranes1 trial

Acetaminophen1 trial

Hemorrhage1 trial

Head and Neck Cancer1 trial

Chronic Cough1 trial

COVID-191 trial

Microcirculation1 trial

Hypoxia1 trial

Enuresis1 trial

Pain1 trial

Metabolic Syndrome1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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