TheraRadar
Data updated: May 26, 2026

CLINORIL (sulindac)

Trial Activity: Declining
Immunology Approved 1978-09-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

National Cancer Institute (NCI) conducting 2 trials (33%)
11 indications explored (Broad Platform)
→ inflammation (1 trials)
→ cancer (1 trials)
→ pain (1 trials)
1
Indication
--
Phase 3 Trials
47
Years on Market

Details

Status
Discontinued
First Approved
1978-09-27
Routes
ORAL
Dosage Forms
TABLET

Companies

Merck
Active Ingredient: SULINDAC

CLINORIL Approval History

1979
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Original
New Indication
New Form
Label Update
108 FDA actions from 1978 to 2010
Dec 2010 SUPPL
Label · Labeling
FDA Letter Label
Jun 2010 SUPPL
Label · Labeling
FDA Letter Label
Mar 2009 SUPPL
Label · Labeling
FDA Letter Label

What CLINORIL Treats

1 FDA approvals

Originally approved for its first indication in 1978 .

  • Other (1)
📋

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NCT01843179 12-302 Ph 2 withdrawn Sulindac for Patients With AML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NCT01636128 UA-UB-101 Ph 2 withdrawn Urinary Biomarker Study With Sulindac and Difluoromethylornithine
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

CLINORIL FDA Label Details

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Data Sources

FDA Approval: NDA017911 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment