SULINDAC · CHARTWELL RX
Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis* Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatu...
Details
- Status
- Discontinued
- First Approved
- 1978-09-27
- Routes
- ORAL
- Dosage Forms
- TABLET
SULINDAC Approval History
What SULINDAC Treats
6 indicationsSULINDAC is approved for 6 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Subacromial Bursitis
- Supraspinatus Tendinitis
- Gouty Arthritis
SULINDAC Boxed Warning
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ]. Sulindac tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings]. Gastrointestinal Risk NSAIDs cause an inc...
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ]. Sulindac tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (see WARNINGS .)
SULINDAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SULINDAC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SULINDAC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SULINDAC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01761877 results posted | 1RO1 CA1615301A1 12-0080-04, 676847 | Ph 2 | completed | NSAID Effects on Clinical and Imaging Breast Biomarkers |
| NCT00841204 results posted | NCI-2009-01115 NCI-2009-01115, UARIZ-08-0841-04 | Ph 2 | completed | Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma |
| NCT01843179 | 12-302 | Ph 2 | withdrawn | Sulindac for Patients With AML |
| NCT01187901 FAPEST results posted | 00039278 P01CA073992 | Ph 2 | completed | A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients |
| NCT01856322 results posted | 130126 13-C-0126 | Ph 2 | terminated | Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer |
| NCT01636128 | UA-UB-101 | Ph 2 | withdrawn | Urinary Biomarker Study With Sulindac and Difluoromethylornithine |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SULINDAC FDA Label Details
Indications & Usage
Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis* Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnin...
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Full clinical data, patents, trials, and competitive landscape for sulindac.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.