CLINICAL TRIALS PROFILE FOR INDOCIN

All Clinical Trials for INDOCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002796 ↗	Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	1997-05-01	Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of giving fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how well it works in treating patients with stage IV colorectal cancer
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	Brooklyn ImmunoTherapeutics, LLC	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	IRX Therapeutics	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.

Clinical Trial Conditions for INDOCIN

Condition Name

Condition Name for INDOCIN
Intervention	Trials
Obstetric Labor, Premature	2
Stage IV Prostate Cancer	2
Post-ERCP Acute Pancreatitis	2
Intraventricular Hemorrhage	1

Condition MeSH

Condition MeSH for INDOCIN
Intervention	Trials
Pancreatitis	4
Obstetric Labor, Premature	3
Carcinoma	2
Adenocarcinoma	2

Clinical Trial Locations for INDOCIN

Trials by Country

Trials by Country for INDOCIN
Location	Trials
United States	44
India	6
Canada	2
Iran, Islamic Republic of	1
United Kingdom	1

Trials by US State

Trials by US State for INDOCIN
Location	Trials
California	5
Massachusetts	3
Kentucky	3
New York	3
Tennessee	3

Clinical Trial Progress for INDOCIN

Clinical Trial Phase

Clinical Trial Phase for INDOCIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for INDOCIN
Clinical Trial Phase	Trials
Completed	12
Active, not recruiting	3
Terminated	2

Clinical Trial Sponsors for INDOCIN

Sponsor Name

Sponsor Name for INDOCIN
Sponsor	Trials
National Cancer Institute (NCI)	3
Brooklyn ImmunoTherapeutics, LLC	3
IRX Therapeutics	3

Sponsor Type

Sponsor Type for INDOCIN
Sponsor	Trials
Other	37
Industry	7
NIH	4

Clinical Trials Update, Market Analysis, and Projection for INDOCIN (indomethacin)

Last updated: May 3, 2026

What is INDOCIN and where is it positioned today?

INDOCIN is the brand name for indomethacin, an oral nonsteroidal anti-inflammatory drug (NSAID) used for inflammatory and pain indications. Clinically, INDOCIN is a long-established product, and today it is supported primarily by ongoing use rather than active, label-expanding late-stage development under new IND submissions.

Core point for decision-makers: market outcomes for indomethacin are driven less by trial breakthroughs and more by (1) generic penetration, (2) guideline-based preference versus newer NSAIDs, and (3) safety/tolerability constraints that affect formulary placement and persistence.

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Is there an active clinical-trials pipeline for INDOCIN?

No reliable, current INDOCIN-specific late-stage clinical-trial dataset can be established from the information available in this prompt. With indomethacin, clinical activity in public registries is often either:

• investigator-initiated comparative studies (dose, formulation, GI risk mitigation),
• small mechanistic studies (non-registration endpoints), or
• trials for new indications where indomethacin acts as a comparator rather than a branded development candidate.

Because this request requires a “clinical trials update” with actionable specifics (trial phase, endpoints, status, timelines), the required trial-level facts cannot be generated without verifiable trial registry records tied to INDOCIN.

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How does indomethacin compete in the NSAID market?

1) Competitive set

Indomethacin competes in a crowded NSAID landscape that includes:

• branded and generic NSAIDs across the same therapeutic class,
• COX-selective and related agents where clinicians prefer a safety profile, and
• opioid-sparing regimens where pain-market dynamics can reduce NSAID share for certain indications.

2) Market structure reality

Indomethacin has a long history of use, which typically results in:

• high generic share,
• low brand premium,
• price pressure and limited incremental commercialization headroom.

Business implication: forecast accuracy depends on channel-level assumptions (retail vs institutional), pricing trends for generics, and guideline adherence by indication. Those details are not available in the prompt.

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What market data is required for a credible forecast and why it cannot be produced here?

A defensible “market analysis and projection” for INDOCIN requires at minimum:

• current sales (units and $) by geography,
• utilization by indication,
• pricing trajectory and generic mix,
• formulary and payer policies by region,
• competitive moves (new generics, shortages, switching).

None of those inputs are provided, and generating them without citations would violate the requirement for hard-data analysis.

Because this response must be complete and accurate, it cannot include numeric market sizing, CAGR projections, or regional outlooks without cited evidence.

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What can be concluded operationally despite the missing market inputs?

Even without a numeric forecast, decision-makers can use an evidence-based commercialization framework that matches how indomethacin performs historically:

Likely drivers

• Generic pricing and reimbursement determine revenue more than brand marketing.
• Safety profile (GI and renal risk considerations for chronic use) affects clinician choice and persistence.
• Institutional formulary rules (step therapy, NSAID preference lists) shape demand.

Likely constraints

• Preference shifts toward other NSAIDs or COX-targeted alternatives where tolerability is favored.
• Chronic use scrutiny increases the burden for GI risk mitigation, reducing broad uptake.

These drivers are structural for the NSAID class and align with indomethacin’s long-standing status, but they do not replace numeric market projections.

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Clinical trial update: what can be delivered without trial registry facts

A compliant update must include items like:

• NCT numbers,
• sponsor types,
• phases,
• recruitment status,
• results reporting dates,
• primary endpoints and effect sizes.

No such trial-level facts are present in the prompt. Under the rules for producing a complete and accurate response, the clinical trial section cannot be populated with fabricated detail.

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Key Takeaways

• INDOCIN is indomethacin, a mature NSAID market with commercialization dominated by generic availability, pricing pressure, formulary placement, and safety constraints.
• A clinical trials update with actionable trial status and readouts cannot be generated from the provided information.
• A market analysis and projection with numeric sizing, CAGR, and regional breakdown cannot be produced without sourced sales, pricing, and payer data.

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FAQs

1) Is INDOCIN still under active late-stage clinical development?

No INDOCIN-specific, phase-based late-stage development facts can be stated from the information provided here.

2) What usually drives indomethacin demand today?

Generic pricing, reimbursement, formulary access, and tolerability-related switching among NSAIDs.

3) Does indomethacin face major market headwinds?

Yes, the class-wide safety profile and competitive substitution by other NSAIDs typically constrain share growth.

4) What would a credible INDOCIN market projection require?

Current sales by geography, indication mix, pricing and generic share trends, channel mix, and payer/formulary dynamics.

5) Can trial activity for indomethacin appear outside branded INDOCIN studies?

Yes. Public trials can include investigator-initiated studies or comparator arms, but INDOCIN-specific updates require registry-linked facts.

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References

[1] ClinicalTrials.gov. (n.d.). Indomethacin studies and results (search and filtering by indomethacin/brand terms). https://clinicaltrials.gov
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and label information for indomethacin-related products. https://www.fda.gov/drugs