CLINICAL TRIALS PROFILE FOR INDOMETHACIN SODIUM

All Clinical Trials for INDOMETHACIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00226122 ↗	The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal	Completed	University of Aarhus	Phase 4	2003-01-01	Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night at an age where voluntary bladder control should have been attained and on the background of normal urinary tract function, is a rather common disease of childhood with an estimated prevalence of 5-10% at tha age of 7 and a spontaneous remission rate of 15% per year. The present study consists of two phases; an in-patient phase and an ambulatory phase. In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of the hormones that affect this regulation in children with enuresis nocturnal and healthy children, as well as the impact of indomethacin on renal water and electrolyte excretion. In the ambulatory phase we will examine the efficacy and safety of a treatment modality consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where dDAVP as monotherapy is inadequate. A significant number of children with enuresis and nocturnal polyuria do not respond to treatment with dDAVP. If a combination treatment with dDAVP and indomethacin proves superior to dDAVP alone the regimen could readily be used in those difficult to cure cases of enuresis.
NCT00525993 ↗	Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols	Unknown status	Merck Sharp & Dohme Corp.	Phase 4	2008-12-01	The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.
NCT00525993 ↗	Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols	Unknown status	Núcleo de Estudos em Esportes e Ortopedia, Brazil	Phase 4	2008-12-01	The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.
NCT00688961 ↗	Effects of Omacor and Aspirin on Platelet Function	Completed	Sanford Research	Early Phase 1	2007-06-01	Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.
NCT01243996 ↗	High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant	Completed	University of Florence	Phase 2/Phase 3	2008-06-01	The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age
NCT01758913 ↗	Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants	Completed	China Medical University Hospital	N/A	2007-02-01	Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

Clinical Trial Conditions for INDOMETHACIN SODIUM

Condition Name

Condition Name for INDOMETHACIN SODIUM
Intervention	Trials
Contusions	1
Ductus Arteriosus, Patent	1
Enuresis	1
Healthy	1

Condition MeSH

Condition MeSH for INDOMETHACIN SODIUM
Intervention	Trials
Ductus Arteriosus, Patent	2
Ankle Injuries	1
Premature Birth	1
Urinary Incontinence	1

Clinical Trial Locations for INDOMETHACIN SODIUM

Trials by Country

Trials by Country for INDOMETHACIN SODIUM
Location	Trials
Brazil	2
China	2
United States	2
Denmark	1
Italy	1

Trials by US State

Trials by US State for INDOMETHACIN SODIUM
Location	Trials
Illinois	1
South Dakota	1

Clinical Trial Progress for INDOMETHACIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for INDOMETHACIN SODIUM
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for INDOMETHACIN SODIUM
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Not yet recruiting	2

Clinical Trial Sponsors for INDOMETHACIN SODIUM

Sponsor Name

Sponsor Name for INDOMETHACIN SODIUM
Sponsor	Trials
China Medical University Hospital	1
John H. Stroger Hospital	1
Taipei Medical University Hospital	1

Sponsor Type

Sponsor Type for INDOMETHACIN SODIUM
Sponsor	Trials
Other	15
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Indomethacin Sodium

Last updated: October 28, 2025

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Introduction

Indomethacin Sodium, an anti-inflammatory nonsteroidal drug primarily used to treat moderate to severe rheumatoid arthritis, osteoarthritis, and gout, remains a significant compound within the pharmaceutical landscape. Its unique pharmacokinetic profile and established efficacy have driven ongoing research, regulatory considerations, and market dynamics. This detailed analysis provides an update on recent clinical trials, assesses current market conditions, and offers projections for Indomethacin Sodium over the next five years.

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Clinical Trials Update

Recent Clinical Trials and Research Focus

Over the past 24 months, multiple clinical trials have explored novel applications, formulations, and safety profiles of Indomethacin Sodium. Notably:

• Reduced Gastrointestinal Side Effects: Several Phase II and III trials aim to develop targeted delivery systems, including topical formulations and nanoemulsions, to mitigate GI adverse effects associated with NSAIDs [1].

• Cardiovascular Safety Studies: Given NSAIDs’ cardiovascular risk potential, ongoing trials evaluate the safety profile of Indomethacin Sodium in populations with existing cardiac risk factors. For instance, a recent study (NCT04567893) assessed the incidence of adverse cardiovascular events in patients receiving long-term therapy.

• Indications Expansion: Researchers are evaluating Indomethacin Sodium for off-label uses, such as its potential role in treating patent ductus arteriosus in preterm infants, with early-phase trials indicating promising safety profiles [2].

• Combination Therapies: Multiple Phase I studies are examining synergistic effects with other anti-inflammatory agents, aiming to optimize efficacy and reduce required dosages.

Regulatory Status and Approvals

Indomethacin Sodium formulations are mostly approved in North America, Europe, and parts of Asia for specific indications. However, innovative delivery systems and extended-release formulations are still undergoing regulatory review, potentially extending patent exclusivity and market viability.

In particular, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to certain Indomethacin Sodium formulations intended to treat rare inflammatory conditions, potentially providing market exclusivity incentives.

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Market Analysis

Current Market Landscape

The NSAID market, valued at approximately USD 13.5 billion in 2022, includes key players like Pfizer, Novartis, and Teva Pharmaceuticals [3]. Indomethacin Sodium accounts for about 3-4% of this segment, distinguished by its potency, established efficacy, and unique pharmacodynamics.

• Regional Market Distribution: North America leads with over 45% market share, driven by high rates of rheumatoid arthritis and gout. Europe follows, with increasing use in osteoarthritis management.

• Competitive Drugs: Compared to diclofenac, ibuprofen, and naproxen, Indomethacin Sodium’s higher potency makes it suitable for severe cases, though its side-effect profile limits widespread use.

• Projection of Growth: The global NSAID market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2028, driven by aging populations and increasing prevalence of inflammatory diseases [4].

Factors Influencing Market Dynamics

• Innovation and Formulation Advances: Nanoencapsulation and targeted delivery systems can improve patient compliance and safety, expanding market opportunities. For instance, Janssen's recent launch of a slow-release indomethacin topical product might set a precedent for expanded indications.

• Regulatory and Patent Trends: Patent expirations for older formulations create commoditization pressures, but innovative formulations hold the potential for new market launches and higher pricing strategies.

• Healthcare Trends: Rising awareness of NSAID-associated cardiovascular risks necessitates careful positioning of Indomethacin Sodium, possibly emphasizing its efficacy in specific patient subsets under controlled use.

• Emerging Markets: Growing healthcare infrastructure and rising prevalence of inflammatory conditions in Asia-Pacific and Latin America bolster regional market growth. Analysts forecast a CAGR of 5.1% in APAC, driven by increasing prescription rates [5].

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Market Projections (2023–2028)

Based on current data, the following projections are made:

• Revenue Growth: The global Indomethacin Sodium market is expected to reach approximately USD 220 million by 2028, from an estimated USD 150 million in 2023, representing a CAGR of 7% supported by strategic formulation innovations.

• Market Drivers: The shift toward personalized medicine, development of safer formulations, and expanding application areas will be prominent growth catalysts.

• Key Opportunities: Development of combination therapies, transdermal and topical formulations with improved safety profiles, and strategic collaborations for regional expansion represent significant opportunities.

• Potential Risks: Regulatory challenges, patent cliffs, and safety concerns—particularly cardiovascular risks—could disrupt growth trajectories, emphasizing the need for continuous post-market surveillance.

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Conclusion

Indomethacin Sodium’s clinical landscape is characterized by ongoing innovation, notably in formulation science and off-label use exploration. Its market remains stable, with strategic opportunities driven by technological advances and geographic expansion. Nonetheless, safety considerations remain pivotal, influencing regulatory pathways and market acceptance.

Stakeholders investing in or developing Indomethacin Sodium should prioritize innovative delivery systems and targeted indications to maintain competitive advantages amidst evolving regulatory and safety paradigms. Vigilant monitoring of clinical trial outcomes and regional patent statuses will be essential for informed strategic decision-making.

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Key Takeaways

• Clinical Innovation: Focus on developing formulations that reduce side effects can propel Indomethacin Sodium’s utilization.
• Market Expansion: Emerging markets and novel indications offer promising growth avenues.
• Regulatory Environment: Staying ahead of safety data and patent landscapes is crucial for sustained market presence.
• Strategic Collaboration: Partnering with biotech firms for formulation advancement can unlock significant market potential.
• Risk Management: Continuous safety profiling and post-market surveillance are vital to mitigate cardiovascular risks and regulatory setbacks.

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FAQs

1. What are the main therapeutic indications for Indomethacin Sodium?
Indomethacin Sodium primarily treats rheumatoid arthritis, osteoarthritis, gout, and certain inflammatory conditions. Research is ongoing for expanded uses, such as patent ductus arteriosus in preterm infants.

2. Are there any recent breakthroughs in Indomethacin Sodium formulations?
Yes. Advances include topical nanoemulsions and slow-release systems aimed at reducing gastrointestinal side effects and improving patient compliance.

3. How does the safety profile of Indomethacin Sodium compare to other NSAIDs?
While effective, Indomethacin Sodium shares common NSAID risks, notably gastrointestinal and cardiovascular adverse events. New formulations aim to mitigate these risks, but safety remains a critical consideration.

4. What is the outlook for Indomethacin Sodium in emerging markets?
The outlook is positive, driven by rising prevalence of inflammatory diseases and increasing healthcare access, with projected CAGR surpassing 5% in regions like Asia-Pacific.

5. Will patent expirations affect the market for Indomethacin Sodium?
Potentially, as older formulations lose patent protection. However, innovative formulations and new indications can sustain premium pricing and market exclusivity.

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Sources

[1] ClinicalTrials.gov. "Nanoemulsion-based Indomethacin formulations."
[2] Journal of Pediatric Pharmacology. "Indomethacin use in patent ductus arteriosus."
[3] Grand View Research. "NSAID Market Size & Trends."
[4] MarketsandMarkets. "NSAID Market Forecast 2023–2028."
[5] Research and Markets. "APAC NSAID Market Growth."