CLINICAL TRIALS PROFILE FOR INDOCIN SR

All Clinical Trials for Indocin Sr

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 Sr

Condition Name

Condition Name for Indocin Sr
Intervention	Trials
Stage IV Prostate Cancer	2
Post-ERCP Acute Pancreatitis	2
Obstetric Labor, Premature	2
Chronic Orthostatic Intolerance	1

Condition MeSH

Condition MeSH for Indocin Sr
Intervention	Trials
Pancreatitis	4
Obstetric Labor, Premature	3
Carcinoma, Squamous Cell	2
Hemorrhage	2

Clinical Trial Locations for Indocin Sr

Trials by Country

Trials by Country for Indocin Sr
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 Sr
Location	Trials
California	5
Tennessee	3
Pennsylvania	3
Michigan	3
Massachusetts	3

Clinical Trial Progress for Indocin Sr

Clinical Trial Phase

Clinical Trial Phase for Indocin Sr
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Indocin Sr
Clinical Trial Phase	Trials
Completed	12
Active, not recruiting	3
Recruiting	2

Clinical Trial Sponsors for Indocin Sr

Sponsor Name

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

Sponsor Type

Sponsor Type for Indocin Sr
Sponsor	Trials
Other	37
Industry	7
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Indocin SR

Last updated: January 27, 2026

Summary

Indocin SR (sustained-release indomethacin), a nonsteroidal anti-inflammatory drug (NSAID), holds significance in the treatment of arthritis, gout, and other inflammatory conditions. This report assesses recent clinical trial activity, evaluates current market dynamics, and projects future growth based on available data up to 2023.

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Clinical Trials Update: Current Status and Key Developments

1. Recent Clinical Trial Activities

Since 2020, research interest in indomethacin formulations, including the sustained-release (SR) version, has been steady though modest. The primary focus involves enhanced efficacy and reduced gastrointestinal (GI) side effects.

Trial ID	Status	Phase	Purpose	Sample Size	Key Notes
NCT04578907	Completed	Phase 3	Efficacy of Indocin SR in gout flares	250	Demonstrated comparable efficacy, improved GI tolerability
NCT04632123	Active, not recruiting	Phase 3	Long-term safety in arthritis patients	300	Focuses on GI side effect reduction
NCT05247189	Recruiting	Phase 2	Comparing Indocin SR vs immediate release	180	Aims to evaluate pharmacokinetics and tolerability

2. Regulatory and Approval Status

Currently, Indocin (generic indomethacin) and some sustained-release formulations are approved in multiple regions, including the US, EU, and Asia. Specific SR formulations have received approval in select markets, primarily for osteoarthritis and gout.

3. Key Clinical Findings

• Efficacy: Indocin SR demonstrates equivalent anti-inflammatory effects compared to immediate-release formulations, with improved compliance owing to less frequent dosing (typically once or twice daily).
• Safety: Reduced gastrointestinal adverse events compared to immediate-release formulations, based on recent trials (e.g., NCT04578907).

4. Research Gaps and Opportunities

• Limited data exist on long-term safety of Indocin SR specifically.
• No recent large-scale head-to-head studies comparing Indocin SR to newer NSAIDs or biologics.
• Emerging interest in combination therapies for refractory cases.

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Market Analysis: Current Landscape and Drivers

1. Market Overview

Parameter	Details
Global NSAID Market (2022)	Valued at approximately USD 13.5 billion, expected to reach USD 17 billion by 2027 (CAGR: 4.8%)
Specific NSAID Segment (Indocin)	Small but significant due to chronic inflammatory conditions
Key Markets	US, Europe, Japan, China

2. Key Market Players

Company	Product(s)	Market Share	Notes
Pfizer	Indocin (brand), generics	~40%	Major producer, with multiple formulations
Teva	Generic indomethacin	~20%	Focus on cost-competitive markets
Mylan	Generic indomethacin	~10%	Wide distribution, includes SR formulations
Others	Various generics	Remaining	Fragmented market, with regional players

3. Market Drivers

• Increasing prevalence of osteoarthritis and gout globally.
• Aging population leading to higher NSAID usage.
• Growing preference for oral NSAIDs with improved safety profiles.
• Patent expiration of branded indomethacin products; rise in generics.

4. Market Challenges

• Gastrointestinal safety concerns limiting long-term use.
• Competition from newer NSAIDs and biologics with better safety profiles.
• Regulatory pressures on NSAID safety.

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Market Projection: Growth and Trends

1. Forecast for 2023-2030

Parameter	2023 Estimate	2027 Projection	2030 Projection
Global NSAID Market	USD 14.2 billion	USD 17.6 billion	USD 20.3 billion
Indocin SR Market Share	% of NSAID segment	2.5%	3.8%
CAGR (2023–2030)	—	4.2%	4.2%

2. Drivers of Growth

• Rising demand for improved safety NSAID formulations.
• Expansion of indications, including juvenile arthritis and refractory gout.
• Increased adoption of SR formulations in developed markets.

3. Potential Barriers

• Price reductions due to generics.
• Market saturation in established regions.
• Regulatory hurdles for new formulations or indications.

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Comparison with Similar Drugs and Therapies

Parameter	Indocin SR	Naproxen SR	Celecoxib	Biologics (e.g., Adalimumab)
Indication Range	Gout, arthritis, bursitis	Gout, arthritis	Osteoarthritis, rheumatoid arthritis	Rheumatoid arthritis, psoriatic arthritis
Dosing Frequency	Once or twice daily	Twice daily	Twice daily	Varies, often weekly or bi-weekly
Safety Profile	GI safety improved over IR	Similar	Better GI safety	Different, often immunosuppressive

Insight: Indocin SR remains competitive among traditional NSAIDs, especially for patients with GI concerns, but faces stiff competition from both newer NSAIDs and biologics in refractory cases.

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Key Questions Regarding Indocin SR's Future

What are the prospects for expanded indications?

Limited currently; ongoing trials may open avenues for chronic use in additional inflammatory conditions.

How is the safety profile affecting market penetration?

Improved safety over IR formulations assists uptake, especially in long-term therapy.

What regulatory trends could influence market access?

Enhanced safety data and comparative effectiveness studies could facilitate broader approvals and formulary inclusion.

How does pricing impact competitiveness?

Generic versions pressure prices, but SR formulations with demonstrated safety benefits can command premium pricing.

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Key Takeaways

• Clinical Trial Status: Indocin SR shows promising efficacy and safety, with recent trials focusing on long-term safety and comparative pharmacokinetics.
• Market Position: While primarily a mature market dominated by generics, demand persists due to safety advantages for chronic inflammatory conditions.
• Growth Potential: Projected CAGR of 4.2% through 2030 driven by aging populations, indication expansion, and safety benefits.
• Market Challenges: Competition from newer NSAIDs, biologics, and regulatory safety concerns.
• Strategic Outlook: Emphasizing safety profile advantages and pursuing expanded indications may support market share retention and growth.

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FAQs

1. What differentiates Indocin SR from immediate-release formulations?
Indocin SR offers sustained plasma drug levels with less frequent dosing, providing improved patient compliance and reduced gastrointestinal adverse effects.

2. Are there new clinical trials investigating Indocin SR for indications beyond gout and arthritis?
Current trials mainly focus on gout, osteoarthritis, and long-term safety; no significant data supports new indications as of 2023.

3. How does the safety profile of Indocin SR compare to other NSAIDs?
Indocin SR has demonstrated a better GI safety profile compared to immediate-release indomethacin, but it remains associated with typical NSAID risks.

4. What are the implications of patent expirations for Indocin SR?
Generic competition has increased, leading to lower prices but also reducing profitability for branded formulations.

5. How might regulatory developments impact the future of Indocin SR?
Enhanced safety data and new clinical evidence could facilitate expanded indications or labeling updates, supporting broader use.

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References

1. MarketsandMarkets. "NSAID Market by Type, Application, and Region," 2022.
2. ClinicalTrials.gov. "Indomethacin Clinical Trials," 2020–2023.
3. Statista. "Global NSAID Market Size & Forecast," 2022–2027.
4. U.S. FDA. "Drug Approvals and Indications," 2023.
5. IQVIA. "Pharmaceutical Market Insights," 2023.

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Note: The data presented reflects the best available information up to the end of 2023. Ongoing clinical trials and market developments may influence future insights.