CLINICAL TRIALS PROFILE FOR CLINORIL

All Clinical Trials for CLINORIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	Chao Family Comprehensive Cancer Center	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	National Cancer Institute (NCI)	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00005882 ↗	Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps	Completed	University of California, Irvine	Phase 3	1998-07-01	This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
NCT00062023 ↗	Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2003-06-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer. PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.
NCT00062023 ↗	Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer	Terminated	M.D. Anderson Cancer Center	Phase 2	2003-06-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer. PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.
NCT00068419 ↗	Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor	Completed	National Cancer Institute (NCI)	Phase 2	2004-02-01	This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.
NCT00068419 ↗	Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor	Completed	Children's Oncology Group	Phase 2	2004-02-01	This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

Clinical Trial Conditions for CLINORIL

Condition Name

Condition Name for CLINORIL
Intervention	Trials
Precancerous Condition	5
Colorectal Cancer	2
Desmoid Tumor	1
Familial Adenomatous Polyposis	1

Condition MeSH

Condition MeSH for CLINORIL
Intervention	Trials
Precancerous Conditions	5
Colorectal Neoplasms	3
Lung Neoplasms	1
Carcinoma, Non-Small-Cell Lung	1

Clinical Trial Locations for CLINORIL

Trials by Country

Trials by Country for CLINORIL
Location	Trials
United States	30
United Kingdom	2
Canada	2
Belgium	1
Netherlands	1

Trials by US State

Trials by US State for CLINORIL
Location	Trials
California	5
Arizona	4
Minnesota	3
Ohio	2
Massachusetts	2

Clinical Trial Progress for CLINORIL

Clinical Trial Phase

Clinical Trial Phase for CLINORIL
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	6

Clinical Trial Status

Clinical Trial Status for CLINORIL
Clinical Trial Phase	Trials
Completed	7
Terminated	1
Unknown status	1

Clinical Trial Sponsors for CLINORIL

Sponsor Name

Sponsor Name for CLINORIL
Sponsor	Trials
National Cancer Institute (NCI)	8
University of California, Irvine	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for CLINORIL
Sponsor	Trials
NIH	8
Other	5
Industry	1

Clinoril (Sulindac): Clinical-Stage Status, Market Assessment, and Forecast

Last updated: May 6, 2026

What is Clinoril (sulindac) and what phase is it in?

Clinoril is the brand name for sulindac, an oral NSAID used for pain and inflammation associated with musculoskeletal conditions and specific inflammatory disorders. It is an established medicine and is not in active late-stage development based on available publicly indexed clinical trial records.

Clinical development status

• Therapeutic category: NSAID
• Regulatory status: Marketed drug (brand: Clinoril)
• Clinical trial activity (public registries): No current evidence of a major, sponsor-led Phase 3 or Phase 2b/3 program for new pivotal indications for sulindac under the Clinoril brand in the commonly used public trial registries.

Are there current clinical trials involving sulindac?

Publicly indexed trial listings for sulindac are sparse and, where present, typically relate to:

• small mechanistic or pharmacology studies,
• historical comparisons,
• drug-drug interaction or formulation questions,
• or studies in narrower populations rather than broad label-expansion programs.

Implication for investors/R&D: sulindac/Clinoril behaves like a mature, off-patent asset from a development-engine standpoint rather than a pipeline candidate.

What patents or IP structure typically constrain upside?

Clinoril is an older NSAID. For established NSAIDs, brand economics are usually driven by:

• generic substitution once patents expire,
• limited remaining protection outside new formulations,
• and market-share competition rather than monopoly pricing.

Net effect: forecast upside tends to be limited unless a company controls a validated, label-expanding or lifecycle-improving IP position (for example, a patent-protected formulation, new dosing regimen, or new compliant use in a defined population).

Market analysis: Who buys Clinoril and where does demand come from?

Clinoril is used across NSAID-treated indications, with demand shaped by:

• local prescribing practices,
• payer formularies and step therapy,
• relative price vs. generics,
• safety positioning versus other NSAIDs.

Demand drivers

• Chronic musculoskeletal pain management continues to support steady baseline demand for NSAIDs.
• Formulary preference for generics compresses net pricing over time.
• Safety perception among prescribers influences share among NSAIDs (GI, renal, and cardiovascular risk management).

Key competitive set

Clinoril competes primarily with:

• generic NSAID tablets and capsules (broad class competition),
• other NSAIDs with entrenched clinician familiarity,
• and, in some settings, COX-2 selective or combination therapies depending on local guideline adoption.

How fast is the market changing?

NSAID demand is stable-to-moderate in most markets, but economics degrade structurally due to:

• pricing pressure from generics,
• periodic guideline updates that shift prescriber choice,
• substitution to alternative NSAIDs when tolerability or dosing convenience is favored.

For sulindac specifically, market performance generally tracks:

• generic price erosion,
• region-by-region formulary access,
• and inclusion or exclusion in payer preferred lists.

Market forecast: What trajectory should be modeled?

Given the mature status, the most realistic model for Clinoril is:

• volume stability to modest decline tied to generics and substitution dynamics,
• continued net price compression as competitive pressure persists,
• low likelihood of step-change revenue without a new, protected indication or meaningful lifecycle IP.

Base case revenue trajectory model (framework)

Use the following components in a revenue build (product-level, brand-equivalent economics):

Forecast driver	Direction for mature NSAID	Typical impact magnitude
Net price	Down	Moderate-to-high
Unit volumes	Flat to down	Low-to-moderate
Market share	Depends on formulary access	Low
Mix (tied to prescriber behavior)	Slightly negative	Low

Bottom line: model incremental revenue growth as unlikely. The expected path is declining or flat nominal revenue with margin pressure.

Scenario projection (5-year horizon)

Because Clinoril is an established NSAID, scenario projection should focus on pricing and share rather than pipeline events.

Base case

• Net revenue: low-to-flat decline annually
• Rationale: ongoing generic competition and formulary pressure

Downside case

• Net revenue: faster decline
• Rationale: formulary exclusions, stronger substitution to competing NSAIDs

Upside case

• Net revenue: stabilization
• Rationale: temporary payer contracting improvements or regional supply advantages

What near-term catalysts could change the forecast?

For mature drugs like sulindac, catalysts are typically not Phase 3 readouts. Instead, they are:

• regulatory or label maintenance events that preserve access,
• new formulation releases with acceptable payer acceptance,
• public health guideline changes that alter NSAID selection patterns.

With no evidence of a major new pivotal program, catalysts that create step-change economics are limited.

What are the key risks to the market outlook?

Commercial risks

• Generic pricing pressure remains the primary risk to net revenue.
• Payer formulary dynamics can rapidly shift share across NSAIDs.
• Safety communications and risk-awareness can reduce use in riskier populations.

Regulatory risks

• NSAID class-level restrictions or changing labeling can affect uptake.
• Supply chain or manufacturing changes can affect availability in certain regions.

Investment and R&D interpretation

If the goal is R&D

• sulindac is unlikely to be an efficient place to fund major late-stage trials unless tied to a specific protected program with measurable differentiation (new indication, controlled-release, or a highly defined biomarker-driven population).
• Most plausible R&D returns come from lifecycle strategy (formulation, dosing optimization, or combination strategies that can be protected).

If the goal is market exposure

• Treat Clinoril as a cash-flow asset rather than a pipeline growth story.
• Profitability depends more on contract pricing, distribution, and net-to-gross management than on clinical differentiation.

Key Takeaways

• Clinoril (sulindac) is a mature NSAID with no clear evidence of an active, late-stage pivotal development program in public registries.
• Market economics are structurally constrained by generic substitution and payer formulary pressure.
• Forecast modeling should emphasize declining net price and stable-to-declining volumes, with limited upside absent lifecycle IP, formulation differentiation, or a new protected indication.
• Primary risks are commercial (pricing/share) and safety/guideline-driven utilization shifts, not trial-driven catalysts.

FAQs

1. Is Clinoril currently in Phase 3 development?
   No clear evidence supports active Phase 3 pivotal development for sulindac/Clinoril under public listings.

2. What drives Clinoril sales in the near term?
   Payer formulary access, generic pricing levels, and prescriber preference among NSAID options.

3. Why is upside limited for mature sulindac products?
   Competitive substitution and persistent net price compression after generic entry dominate revenue dynamics.

4. What would materially improve the revenue outlook?
   A protected lifecycle strategy that improves differentiation and preserves payer access, or a label expansion with enforceable IP.

5. What risk matters most for forecasting?
   Net-to-gross changes from contracting and formulary inclusion versus exclusion across regions.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] FDA. Drug Approval Package: Sulindac (Clinoril). https://www.accessdata.fda.gov/
[3] EMA. EPAR: Sulindac (where applicable by documentation availability). https://www.ema.europa.eu/
[4] Drugs@FDA. Search results and labeling history for sulindac/Clinoril. https://www.accessdata.fda.gov/scripts/cder/daf/