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 |
---|---|---|---|---|---|
2021/03/30 | Phase 2 | Withdrawn | Healx Limited | ||
2020/09/09 | Phase 2 | Completed | Alison Stopeck | ||
2019/12/23 | Phase 2 | Active, not recruiting | |||
2013/05/17 | Phase 2 | Terminated | |||
2013/04/30 | Phase 2 | Withdrawn | |||
2013/01/07 | Phase 2 | Completed | |||
2012/07/10 | Phase 2 | Withdrawn | |||
2011/12/01 | Phase 3 | Completed | |||
2010/11/23 | Phase 3 | Withdrawn | |||
2010/08/24 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
A-S Medication Solutions | 50090-4976 | ORAL | 200 mg in 1 1 | 4/22/2019 | |
State of Florida DOH Central Pharmacy | 53808-0799 | ORAL | 150 mg in 1 1 | 4/13/2010 | |
Bryant Ranch Prepack | 71335-0413 | ORAL | 200 mg in 1 1 | 1/27/2022 | |
A-S Medication Solutions | 50090-2093 | ORAL | 200 mg in 1 1 | 4/26/2021 | |
PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-771 | ORAL | 200 mg in 1 1 | 1/4/2019 | |
Proficient Rx LP | 71205-648 | ORAL | 200 mg in 1 1 | 3/1/2022 | |
Major Pharmaceuticals | 0904-7335 | ORAL | 200 mg in 1 1 | 7/28/2023 | |
Actavis Pharma, Inc. | 0591-5660 | ORAL | 200 mg in 1 1 | 5/22/2023 | |
PD-Rx Pharmaceuticals, Inc. | 72789-374 | ORAL | 200 mg in 1 1 | 1/25/2024 | |
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 |
---|---|---|---|---|---|
Sulindac Capsules | 国药准字H20010624 | 化学药品 | 胶囊剂 | 5/7/2020 | |
Sulindac Tablets | 国药准字H20033535 | 化学药品 | 片剂 | 2/3/2020 | |
Sulindac Tablets | 国药准字H33021627 | 化学药品 | 片剂 | 4/7/2020 | |
Sulindac Tablets | 国药准字H10940091 | 化学药品 | 片剂 | 4/21/2020 |
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. |
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