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Clinoril

(sulindac)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sulindac is used to reduce pain, swelling, and stiffness caused by arthritis and other inflammatory conditions. It works by decreasing inflammation in the body to help relieve discomfort.[2] Clinoril is currently approved and in use across 18 indications[4].[1]

Clinoril is one of 438 small molecule programs targeting Familial adenomatous polyposis. It is currently in Approved.

18

Indications

22

Total Trials

1

Active Trials

437

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Familial Adenomatous PolyposisActive, not recruiting

Rheumatic DiseaseActive, not recruiting

Lung CancerActive, not recruiting

Precancerous ConditionApproved

Cutaneous MelanomaApproved

Colon CarcinomaApproved

Desmoid-Type FibromatosisApproved

Malignant Colon NeoplasmApproved

Fragile X SyndromeApproved

Breast CancerActive, not recruiting

Familial Adenomatous PolyposisPhase 3

Active, not recruiting

Rheumatic DiseaseApproved

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

Precancerous ConditionApproved

Approved

Cutaneous MelanomaApproved

Approved

Colon CarcinomaApproved

Approved

Desmoid-Type FibromatosisApproved

Approved

Malignant Colon NeoplasmApproved

Approved

Fragile X SyndromeApproved

Approved

Breast CancerPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Clinoril

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Megace

Bristol-Myers Squibb

Lupron

EEastern Cooperative Oncology Group

MS Contin

HHikma Pharmaceuticals LLC

Zinecard

CChildren's Oncology Group

Cortef

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

Chantix

PPrism Pharmaceuticals

Nubain

AAultman Health Foundation

Apatinib Mesylate

BBukwang Pharmaceutical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Pancreatic Cancer

NCT04207944

Clinical

Trials by Indication[1]

Colorectal Cancer3 trials

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00118365·375 enrolled

Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00062023·12 enrolled

Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01856322·3 enrolled

Melanoma2 trials

Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

Completed·CCancer Trials Ireland·Phase 2·NCT00755976·32 enrolled

Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00841204·50 enrolled

Familial adenomatous polyposis2 trials

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Completed·CCancer Prevention Pharmaceuticals, Inc.·Phase 3·NCT01483144·171 enrolled

Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

Unknown status·RRadboud University Medical Center·Phase 2·NCT00319007·30 enrolled

Breast Cancer2 trials

Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

Completed·FFox Chase Cancer Center·Phase 2·NCT00039520·10 enrolled

Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00245024·30 enrolled

Atorvastatin1 trial

Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00335504·85 enrolled

12 more indications

Desmoid Tumor1 trial

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

Completed·CChildren's Oncology Group·Phase 2·NCT00068419·70 enrolled

AML1 trial

Sulindac for Patients With AML

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT01843179

Pancreatic Cancer1 trial

The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)

Active, not recruiting·—·Phase 2·NCT04207944·100 enrolled

Squamous Cell Carcinoma1 trial

Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

Terminated·MMassachusetts General Hospital·Phase 2·NCT00392665·36 enrolled

Biomarker1 trial

Urinary Biomarker Study With Sulindac and Difluoromethylornithine

Withdrawn·CCancer Prevention Pharmaceuticals, Inc.·Phase 2·NCT01636128

Premalignant Lesion1 trial

A Randomized Study of Sulindac in Oral Premalignant Lesions

Completed·MMemorial Sloan Kettering Cancer Center·N/A·NCT00299195·63 enrolled

Clinical Trial1 trial

A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

Completed·UUniversity of Utah·Phase 2·NCT01187901·92 enrolled

MPA1 trial

Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Completed·MMayo Clinic·N/A·NCT00343629·28 enrolled

Biomarkers1 trial

NSAID Effects on Clinical and Imaging Breast Biomarkers

Completed·SStony Brook University·Phase 2·NCT01761877·114 enrolled

Lung Cancer1 trial

Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00368927·61 enrolled

Colon Cancer1 trial

Sulindac and Plant Compounds in Preventing Colon Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00003365

Unspecified1 trial

The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

Terminated·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00176618·60 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CLINORIL

NDA NDA017911

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for sulindac. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Clinoril drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — sulindac compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for sulindac. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017911). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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