Sulindac

Overview

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) of the arylalkanoic acid class that is marketed by Merck under the brand name Clinoril. Like other NSAIDs, it may be used in the treatment of acute or chronic inflammatory conditions. Sulindac is a prodrug, derived from sulfinylindene, that is converted in vivo to an active sulfide compound by liver enzymes. There is evidence from some studies that sulindac may be associated with fewer gastrointestinal side effects than other NSAIDs, except for the cyclooxygenase-2 (COX-2) inhibitor drug class. This may be due to the sulfide metabolite undergoing enterohepatic circulation thus maintaining constant blood levels of the compound without inducing gastrointestinal effects, where the drug is excreted in the bile and then reabsorbed from the intestines. While its full mechanism of action is not fully understood, sulindac is thought to primarily mediate its action by inhibiting prostaglandin synthesis by inhibiting COX-1 and COX-2.

Indication

For acute or long-term use in the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis), and acute gouty arthritis.

Associated Conditions

Ankylosing Spondylitis (AS)
Colorectal Adenomas
Gout
Osteoarthritis (OA)
Rheumatoid Arthritis
Tendonitis exacerbated
Acute Subacromial bursitis
Acute supraspinatus tendinitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40	2021/03/30	NCT04823052	Phase 2	Withdrawn	Healx Limited
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer	2020/09/09	NCT04542135	Phase 2	Completed	Alison Stopeck
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)	2019/12/23	NCT04207944	Phase 2	Active, not recruiting	Duke University
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer	2013/05/17	NCT01856322	Phase 2	Terminated	National Cancer Institute (NCI)
Sulindac for Patients With AML	2013/04/30	NCT01843179	Phase 2	Withdrawn	Massachusetts General Hospital
NSAID Effects on Clinical and Imaging Breast Biomarkers	2013/01/07	NCT01761877	Phase 2	Completed	Stony Brook University
Urinary Biomarker Study With Sulindac and Difluoromethylornithine	2012/07/10	NCT01636128	Phase 2	Withdrawn	Cancer Prevention Pharmaceuticals, Inc.
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)	2011/12/01	NCT01483144	Phase 3	Completed	Cancer Prevention Pharmaceuticals, Inc.
A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)	2010/11/23	NCT01245816	Phase 3	Withdrawn	Cancer Prevention Pharmaceuticals, Inc.
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients	2010/08/24	NCT01187901	Phase 2	Completed	University of Utah

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sulindac	A-S Medication Solutions	50090-4976	ORAL	200 mg in 1 1	4/22/2019
Sulindac	State of Florida DOH Central Pharmacy	53808-0799	ORAL	150 mg in 1 1	4/13/2010
SULINDAC	Bryant Ranch Prepack	71335-0413	ORAL	200 mg in 1 1	1/27/2022
SULINDAC	A-S Medication Solutions	50090-2093	ORAL	200 mg in 1 1	4/26/2021
SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-771	ORAL	200 mg in 1 1	1/4/2019
SULINDAC	Proficient Rx LP	71205-648	ORAL	200 mg in 1 1	3/1/2022
SULINDAC	Major Pharmaceuticals	0904-7335	ORAL	200 mg in 1 1	7/28/2023
Sulindac	Actavis Pharma, Inc.	0591-5660	ORAL	200 mg in 1 1	5/22/2023
SULINDAC	PD-Rx Pharmaceuticals, Inc.	72789-374	ORAL	200 mg in 1 1	1/25/2024
SULINDAC	Epic Pharma, LLC	42806-011	ORAL	200 mg in 1 1	12/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-SULIN TAB 200MG	Apotex Inc	00778362	Tablet - Oral	200 MG	12/31/1988
APO-SULIN TAB 150MG	Apotex Inc	00778354	Tablet - Oral	150 MG	12/31/1988
CLINORIL TAB 150MG	merck frosst canada & cie, merck frosst canada & co.	00456888	Tablet - Oral	150 MG / TAB	12/31/1979
SULINDAC-150 TAB 150MG	PRO DOC LIMITEE	00808628	Tablet - Oral	150 MG	12/31/1989
NU-SULINDAC TAB 150MG	nu-pharm inc	02042576	Tablet - Oral	150 MG	12/31/1994
SULINDAC-200 TAB 200MG	PRO DOC LIMITEE	00808636	Tablet - Oral	200 MG	12/31/1989
CLINORIL TAB 200MG	merck frosst canada & cie, merck frosst canada & co.	00432369	Tablet - Oral	200 MG / TAB	12/31/1979
NU-SULINDAC TAB 200MG	nu-pharm inc	02042584	Tablet - Oral	200 MG	12/31/1994
TEVA-SULINDAC	teva canada limited	00745596	Tablet - Oral	200 MG	12/31/1988
PENTA-SULINDAC	pentapharm ltd.	02239163	Tablet - Oral	150 MG / TAB	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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