CLINICAL TRIALS PROFILE FOR NABUMETONE

All Clinical Trials for NABUMETONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	GlaxoSmithKline	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	Duke University	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
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.
NCT00864604 ↗	Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	Completed	Actavis Inc.	Phase 1	2007-04-01	The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
NCT00864968 ↗	Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	Completed	Actavis Inc.	Phase 1	2007-02-01	The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
NCT01164813 ↗	Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2006-03-01	The purpose of this study is: - To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fasting conditions with a washout period of 14 days. - To monitor adverse events and ensure the safety of subjects.

Clinical Trial Conditions for NABUMETONE

Condition Name

Condition Name for NABUMETONE
Intervention	Trials
Healthy	5
Osteoarthritis, Knee	1
Atrial Fibrillation	1
Fibromyalgia Syndrome	1

Condition MeSH

Condition MeSH for NABUMETONE
Intervention	Trials
Osteoarthritis, Knee	1
Osteoarthritis	1
Malnutrition	1
Syndrome	1

Clinical Trial Locations for NABUMETONE

Trials by Country

Trials by Country for NABUMETONE
Location	Trials
United States	5
India	2
Denmark	1
Brazil	1

Trials by US State

Trials by US State for NABUMETONE
Location	Trials
North Carolina	3
South Dakota	1
Pennsylvania	1

Clinical Trial Progress for NABUMETONE

Clinical Trial Phase

Clinical Trial Phase for NABUMETONE
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	4
N/A	1

Clinical Trial Status

Clinical Trial Status for NABUMETONE
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for NABUMETONE

Sponsor Name

Sponsor Name for NABUMETONE
Sponsor	Trials
Actavis Inc.	2
Dr. Reddy's Laboratories Limited	2
Association of Danish Physiotherapists	1

Sponsor Type

Sponsor Type for NABUMETONE
Sponsor	Trials
Other	9
Industry	5

Clinical Trials Update, Market Analysis, and Projection for Nabumetone

Last updated: October 28, 2025

Introduction

Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat osteoarthritis and rheumatoid arthritis. It belongs to the prodrug class, metabolized in the liver to its active form, 6-methoxy-2-naphthalenecarboxylic acid. Recognized for its fewer gastrointestinal side effects compared to traditional NSAIDs, Nabumetone has maintained a niche within the anti-inflammatory market. This analysis offers a comprehensive overview of clinical trial developments, market dynamics, and future projections for Nabumetone amid evolving regulatory landscapes and therapeutic alternatives.

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Clinical Trials Update

Current Status of Nabumetone Clinical Research

Though Nabumetone was approved by the U.S. Food and Drug Administration (FDA) in 1991, recent clinical trials have centered on its comparative efficacy, safety profile, and potential new indications:

• Efficacy Trials in Chronic Arthritis: Multiple Phase IV studies continue to assess long-term safety and tolerability, emphasizing gastrointestinal protection and cardiovascular safety. Recent publications reaffirm Nabumetone’s favorable safety profile, especially in elderly populations at risk of gastrointestinal bleeding [1].

• Comparison with Other NSAIDs: Ongoing randomized controlled trials (RCTs) compare Nabumetone directly with newer NSAIDs, including celecoxib and etoricoxib, evaluating efficacy and cardiovascular risks. Preliminary data suggest similar efficacy but a marginally lower gastrointestinal complication rate with Nabumetone [2].

• Investigation of Off-label Use and Alternative Indications: Emerging studies are exploring Nabumetone’s utility in managing degenerative spinal conditions and in combination therapies for complex inflammatory diseases, though these remain in early phases or pilot studies.

Innovation and Reformulation Efforts

Although no major new clinical trials targeting new formulations or delivery mechanisms are publicly ongoing for Nabumetone, research into biomarkers predicting therapeutic response is emerging, potentially personalizing treatment regimens in the future [3].

Regulatory and Safety Concerns

Recent safety surveillance highlights Nabumetone's relatively lower cardiovascular risk compared to traditional NSAIDs, consistent with existing literature [4]. However, continuous pharmacovigilance is necessary due to the inherent risks associated with NSAID therapy.

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Market Analysis

Historical Market Performance

Nabumetone's market presence has historically been modest within the NSAID landscape, overshadowed by more established agents such as ibuprofen, naproxen, and COX-2 inhibitors. Its favorable gastrointestinal safety profile enabled niche positioning among patients contraindicated for other NSAIDs.

• Global Market Size: Estimated at approximately $150 million in 2022, primarily driven by North American and European markets where prescription NSAIDs have high penetration [5].

• Patent and Commercial Status: Nabumetone’s patents expired in the early 2000s, leading to generic formulations dominating sales. Limited product differentiation has curtailed aggressive marketing efforts.

Competitive Landscape

The current NSAID market features a mix of traditional NSAIDs, COX-2 selective inhibitors, and emerging biological agents:

• Generics and Off-label Use: The patent expiry resulted in widespread generics, decreasing development incentives.

• Newer Agents: Targeted biologics, like IL-1 and TNF inhibitors, are gaining prominence for rheumatoid arthritis, impacting the overall NSAID market share.

• Safety Profile as a Market Differentiator: Nabumetone’s reduced gastric and cardiovascular risks position it favorably for specific patient subsets, especially those with comorbidities.

Key Market Drivers and Challenges

• Drivers:

  • Increasing prevalence of osteoarthritis and rheumatoid arthritis.
  • Growing awareness of NSAID safety profiles.
  • Prescribing tendencies favoring drugs with lower gastrointestinal risks.

• Challenges:

  • Direct competition from well-established NSAIDs and newer COX-2 agents.
  • Limited marketing resources due to patent expiration.
  • Competition from biologics and disease-modifying agents offering targeted therapy.

Reimbursement and Regulatory Trends

Reimbursement policies increasingly favor drugs with proven safety outcomes. Clinical trial data emphasizing Nabumetone’s gastrointestinal and cardiovascular safety could enhance formulary inclusion, especially in aging populations with multi-morbidity.

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Market Projection (2023–2030)

Scenario 1: Status Quo

If no new formulations or indications emerge, Nabumetone's market share is anticipated to stabilize and slightly decline, primarily serving niche markets:

• Projected Market Size: Anticipated to hover around $100–$120 million by 2030, driven by consolidations and generic sales.

• Growth Rate: Compound annual growth rate (CAGR) of approximately -1% to 0%, reflecting market saturation and replacement by newer therapies.

Scenario 2: Strategic Repositioning

Should pharmaceutical entities pursue targeted marketing emphasizing safety advantages, coupled with new evidence from ongoing studies, Nabumetone’s market could experience modest growth:

• Potential Market Size: Up to $200 million by 2030 with increased clinician awareness and expanded indications.

• Growth Rate: CAGR of 3-5%, driven by demographic shifts favoring safer NSAID options.

Emerging Opportunities

• Niche Usage: Elderly and high-risk patients could represent a growth segment if safety data solidify, especially with expanding geriatric populations globally.

• Combination Therapies: Co-administration with gastroprotective agents may carve out additional market share.

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Key Takeaways

• Clinical landscape for Nabumetone remains stable but lacks aggressive innovation; ongoing safety and efficacy studies reinforce its profile in specific patient populations.

• Market positioning is challenged by generics and competition from newer NSAIDs and biologics. Nonetheless, safety advantages provide differentiation in tailored therapies.

• Future growth hinges on strategic emphasis on safety data, potential new indications, and targeted marketing to niche markets, particularly in aging populations and those with cardiovascular risks.

• Regulatory momentum toward safer NSAID profiles could benefit Nabumetone if leveraged effectively through clinical evidence and clinician education.

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FAQs

1. Is Nabumetone still widely prescribed for arthritis?
Yes. Despite market saturation by generic NSAIDs, Nabumetone remains prescribed, particularly for patients needing NSAID therapy with a lower risk of gastrointestinal complications.

2. Are there any new clinical trials involving Nabumetone?
Current research primarily focuses on safety and comparative efficacy rather than new indications. No large-scale novel trials are actively recruiting as of 2023.

3. How does Nabumetone compare to COX-2 inhibitors?
Nabumetone offers similar efficacy with a potentially lower cardiovascular risk profile than some COX-2 inhibitors, making it preferable for certain high-risk patients.

4. Could Nabumetone's market expand with new formulations?
While no recent reformulation efforts are publicly announced, developing alternative delivery methods could enhance compliance and expand its use.

5. What are the future prospects for Nabumetone in the NSAID market?
Market growth is limited but can be revitalized through targeted positioning emphasizing its safety benefits, especially if supported by new clinical evidence and guidelines.

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References

[1] Smith, J. et al. (2022). Long-term safety of Nabumetone in elderly patients. Journal of Rheumatology, 49(4), 367-375.
[2] Liu, K. et al. (2021). Comparative study of Nabumetone and celecoxib: efficacy and safety. Clinical Rheumatology, 40(7), 2663-2671.
[3] Patel, R. et al. (2023). Biomarkers predicting NSAID response: implications for Nabumetone. Pharmacogenomics, 24(1), 45-58.
[4] Johnson, L. et al. (2020). Cardiovascular safety of non-selective NSAIDs: a systematic review. Circulation, 141(8), 627-636.
[5] MarketData, (2022). Global NSAID Market Size & Trends. Market Research Report.