CLINICAL TRIALS PROFILE FOR INDOCIN

All Clinical Trials for INDOCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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
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.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	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
Breast Neoplasm	1

Condition MeSH

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

Clinical Trial Locations for INDOCIN

Trials by Country

+

−

Trials by Country for INDOCIN
Location	Trials
United States	44
India	6
Canada	2
Denmark	1
Singapore	1

Trials by US State

+

−

Trials by US State for INDOCIN
Location	Trials
California	5
Tennessee	3
Pennsylvania	3
Michigan	3
Massachusetts	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
Recruiting	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

Indocin: Clinical Trials, Market Analysis, and Projections

Introduction to Indocin

Indocin, also known as indomethacin, is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to treat pain, inflammation, and fever. It is particularly effective in managing conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Clinical Trials and Recent Developments

While Indocin itself is not a new drug and has been on the market for several decades, there are ongoing studies and analyses related to its use and efficacy.

Current Studies and Uses

There are no major clinical trials specifically focused on Indocin that are currently in the phases of initiation or completion, as it is an established medication. However, ongoing research often involves comparing Indocin with newer NSAIDs or other therapeutic agents to assess relative efficacy and safety.

Safety and Efficacy

Historical and ongoing studies continue to affirm the efficacy of Indocin in treating inflammatory conditions. However, its use is also associated with well-documented side effects, such as gastrointestinal issues and renal impairment, which are common with NSAIDs[3].

Market Analysis

Global Market Size and Growth

The global market for indomethacin, as part of the broader NSAID market, is subject to various factors influencing its growth.

• Market Size: The global indomethacin market size was valued at a significant amount in 2023, with a projected compound annual growth rate (CAGR) through 2031. The exact figures are not provided in the sources, but the market is expected to grow steadily due to the ongoing demand for anti-inflammatory medications[3].

• Segment Analysis: The market is segmented based on type, application, and geography. The segments that are expected to be most lucrative in the near future include the treatment of rheumatoid arthritis and other inflammatory conditions, particularly in regions with aging populations and increasing healthcare access[3].

Regional Analysis

• Developed Countries: In developed countries, the adoption of new treatments and the lifecycle of patents influence the market. While generics and biosimilars compete with branded NSAIDs, the demand for effective anti-inflammatory medications like indomethacin remains stable[5].

• Pharmerging Countries: In pharmerging countries, especially China, there is an expected increase in the use of new original medicines post-COVID-19. This trend could impact the market for indomethacin, although the growth might be slower compared to other therapeutic areas[5].

Competitive Landscape

The NSAID market is highly competitive, with several established and new players. Indocin faces competition from other NSAIDs, as well as from newer classes of anti-inflammatory drugs. The market dynamics are influenced by the launch of new medicines, patent expiries, and changes in demand and use patterns[5].

Projections to 2025

Global Medicine Spending

The global medicine market, including NSAIDs like indomethacin, is expected to grow at a CAGR of 3-6% through 2025, reaching a total market size of about $1.6 trillion. This growth is driven by the adoption of new treatments, offset by patent lifecycles and competition from generics and biosimilars[5].

Specific Therapy Areas

In the context of inflammatory conditions, the spending on new brands is projected to continue at historically high levels. However, the overall growth in the NSAID segment may be moderate due to the availability of generic options and the emergence of new therapeutic modalities[5].

Economic and Regulatory Factors

The pharmaceutical market, including the segment for indomethacin, is influenced by economic and regulatory factors. The IPO market, deal-making activities, and access to capital are expected to improve in 2025, which could impact the overall pharmaceutical landscape[2].

Key Takeaways

• Established Efficacy: Indocin remains an effective treatment for inflammatory conditions, with a well-documented safety and efficacy profile.
• Market Growth: The global indomethacin market is expected to grow steadily, driven by ongoing demand and increasing healthcare access in various regions.
• Competitive Landscape: The market is highly competitive, with competition from other NSAIDs and newer therapeutic agents.
• Economic and Regulatory Factors: The pharmaceutical market, including the segment for indomethacin, is influenced by economic and regulatory trends that are expected to shape the industry in 2025.

FAQs

What is Indocin used for?

Indocin, or indomethacin, is used to treat pain, inflammation, and fever associated with conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Are there any ongoing clinical trials for Indocin?

There are no major clinical trials specifically focused on Indocin currently in the phases of initiation or completion, as it is an established medication.

How does the global market for indomethacin look?

The global market for indomethacin is expected to grow steadily, driven by ongoing demand and increasing healthcare access, particularly in pharmerging countries.

What are the main factors influencing the market for indomethacin?

The market is influenced by the launch of new medicines, patent expiries, competition from generics and biosimilars, and changes in demand and use patterns.

What is the projected growth rate for the global medicine market through 2025?

The global medicine market, including NSAIDs like indomethacin, is expected to grow at a CAGR of 3-6% through 2025.

Sources

1. Cognitive Market Research: Indometacin Indomethacin Market Report 2024 (Global Edition)
2. Evaluate Pharma: Evaluate Releases 2025 preview for pharma market
3. IQVIA: Global Medicine Spending and Usage Trends: Outlook to 2025