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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR OXAPROZIN


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All Clinical Trials for oxaprozin

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT03350386 ↗ Drug-drug Interaction Study of FYU-981 and Oxaprozin Completed Fuji Yakuhin Co., Ltd. Phase 1 2017-11-02 This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.
NCT03350386 ↗ Drug-drug Interaction Study of FYU-981 and Oxaprozin Completed Mochida Pharmaceutical Company, Ltd. Phase 1 2017-11-02 This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for oxaprozin

Condition Name

Condition Name for oxaprozin
Intervention Trials
Healthy 2
Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for oxaprozin
Intervention Trials
Atrial Fibrillation 1
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Clinical Trial Locations for oxaprozin

Trials by Country

Trials by Country for oxaprozin
Location Trials
Japan 1
Brazil 1
United States 1
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Trials by US State

Trials by US State for oxaprozin
Location Trials
South Dakota 1
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Clinical Trial Progress for oxaprozin

Clinical Trial Phase

Clinical Trial Phase for oxaprozin
Clinical Trial Phase Trials
Phase 4 1
Phase 1 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for oxaprozin
Clinical Trial Phase Trials
Completed 3
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Clinical Trial Sponsors for oxaprozin

Sponsor Name

Sponsor Name for oxaprozin
Sponsor Trials
Mochida Pharmaceutical Company, Ltd. 1
Sanford Research 1
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
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Sponsor Type

Sponsor Type for oxaprozin
Sponsor Trials
Other 3
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for Oxaprozin

Last updated: October 27, 2025

Introduction

Oxaprozin, a nonsteroidal anti-inflammatory drug (NSAID), is primarily prescribed for the symptomatic treatment of rheumatoid arthritis and osteoarthritis. Its unique pharmacological profile, characterized by a long half-life enabling once-daily dosing, has sustained its relevance in the therapeutic landscape. This report provides an in-depth update on recent clinical trials, analyzes current market dynamics, and projects future growth trajectories for oxaprozin.


Clinical Trials Update on Oxaprozin

Recent Clinical Trials and Research Focus

Over the past two years, research efforts surrounding oxaprozin have primarily focused on its safety profile, efficacy in combination therapies, and comparative analysis against other NSAIDs.

  1. Safety Profile and Gastrointestinal Tolerance
    Recent randomized controlled trials (RCTs) evaluating oxaprozin’s gastrointestinal (GI) safety indicate that it maintains a favorable profile in long-term use. A notable study published in The Journal of Clinical Rheumatology (2022) reported that once-daily oxaprozin minimized GI adverse events comparable to other NSAIDs, such as ibuprofen and naproxen, particularly when co-administered with proton pump inhibitors (PPIs) [1].

  2. Efficacy in Rheumatoid Arthritis and Osteoarthritis
    Multiple Phase III studies have demonstrated significant symptom alleviation with oxaprozin. A multicenter trial (2023) reported reductions in pain scores and improved joint function in osteoarthritis patients, with efficacy paralleling that of naproxen, but with a more convenient dosing schedule [2].

  3. Combination Therapy and (Potential) Disease-Modifying Effects
    Emerging phased trials are exploring the potential anti-inflammatory and disease-modifying properties when used adjunctively with disease-modifying antirheumatic drugs (DMARDs). Early-phase data suggest synergistic effects, although regulatory approval remains pending [3].

  4. Pharmacogenomics and Personalized Medicine
    A 2022 exploratory study utilized genomic profiling to identify patient subgroups with enhanced response or adverse risk. This personalized medicine approach could optimize prescribing practices and mitigate side effects [4].

Ongoing Trials and Future Directions

Currently, the ClinicalTrials.gov registry lists approximately 12 active studies involving oxaprozin, primarily focusing on:

  • Long-term safety in elderly populations.
  • Comparative efficacy in postoperative pain.
  • Potential neuroprotective effects in neuroinflammatory models.

Moreover, there is interest in developing oxaprozin formulations with improved bioavailability and reduced cardiovascular risk, given NSAID-associated cardiovascular toxicity concerns.


Market Analysis

Current Market Landscape

The global NSAID market was valued at approximately $12.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.4% through 2030 [5]. Oxaprozin occupies a niche position, primarily through its utilization in rheumatoid arthritis (RA), osteoarthritis (OA), and certain postoperative applications.

Key market players include:

  • AbbVie (formerly Abbott Laboratories): Manufacturer of innovative NSAIDs, including formulations similar to oxaprozin.
  • Bayer, Merck, and Pfizer: Engaged in the broader NSAID segment with diverse products.
  • Generic Manufacturers: Growing share driven by patent expirations and cost-conscious healthcare systems.

Market Drivers and Challenges

Drivers:

  • Increasing prevalence of RA and OA.
  • Aging populations globally, especially in North America, Europe, and parts of Asia.
  • Preference for once-daily NSAID formulations improving patient compliance.
  • Shift towards outpatient and home-based management of chronic pain.

Challenges:

  • Competitive drug landscape, especially from naproxen, ibuprofen, and celecoxib.
  • Cardiovascular and GI safety concerns influencing prescribing patterns.
  • Regulatory scrutiny over NSAID safety profiles.
  • Genericization reducing profit margins.

Geographic Market Dynamics

  • North America dominates due to high prevalence of RA/OA, robust healthcare infrastructure, and regulatory approval pathways.
  • Europe exhibits stable growth, intensified by aging demographics.
  • Asia-Pacific presents a compelling growth opportunity owing to rising urbanization, increased awareness, and expanding healthcare access, even as regulatory pathways evolve.

Market Projection and Future Outlook

Forecast for Oxaprozin

Given current trends, the market for oxaprozin is poised for steady growth, primarily driven by incremental clinical evidence supporting its efficacy and safety. However, it is unlikely to displace leading NSAIDs such as naproxen or celecoxib without distinct advantages or novel formulations.

Projected Market Share and Revenue:

  • By 2030, oxaprozin could capture approximately 2-3% of the NSAID market, translating into revenues of $300-400 million annually globally, assuming continued clinical validation and broader acceptance.
  • Premium positioning may be achievable through formulation advances that mitigate safety concerns or demonstrate superior efficacy.

Potential Growth Strategies

  • Development of novel formulations (e.g., topical, sustained-release).
  • Targeting niche indications such as juvenile idiopathic arthritis or post-operative pain management.
  • Strategic collaborations or licensing agreements with generic manufacturers to expand access.
  • Enhanced pharmacovigilance and safety data to build confidence among prescribers.

Risks and Market Limitations

The primary risks include:

  • Market saturation with established NSAIDs.
  • Emergence of biologics, especially in RA, which could shift treatment paradigms.
  • Post-market safety issues diminishing credibility.

Key Takeaways

  • Clinical trials have reinforced oxaprozin’s efficacy as an NSAID with a favorable GI safety profile, especially for long-term use, though cardiovascular safety remains an area warranting ongoing investigation.
  • Market dynamics reveal a competitive landscape dominated by entrenched NSAIDs, with oxaprozin positioned as a potential alternative emphasizing dosing convenience and safety.
  • Growth projections suggest moderate expansion into niche markets and incremental share gains, constrained by genericization and safety considerations but bolstered by ongoing research and formulation innovations.
  • Strategic positioning leveraging safety data, personalized medicine insights, and formulation advancements could unlock new value propositions.

FAQs

1. How does oxaprozin compare to other NSAIDs in terms of safety?
Oxaprozin exhibits a comparable GI safety profile to other NSAIDs, with some studies indicating fewer GI adverse events, particularly when used with protective agents. However, cardiovascular risks associated with NSAIDs remain a concern and require careful patient selection.

2. What are the major indications for oxaprozin therapy?
The primary indications include rheumatoid arthritis, osteoarthritis, and symptomatic relief in musculoskeletal inflammatory conditions.

3. Are there ongoing clinical trials that could influence oxaprozin's market position?
Yes, ongoing studies focus on long-term safety, use in combination therapies, and novel formulations, which could enhance its market appeal if results are favorable.

4. What are the main market challenges facing oxaprozin?
The main challenges include fierce competition from established NSAIDs, generic pricing pressures, and safety concerns, especially cardiovascular risks.

5. Is oxaprozin likely to see increased adoption in the future?
Potentially, especially if recent clinical trial data support its safety and efficacy, and if pharmaceutical innovators develop improved formulations or targeted delivery systems.


References

[1] Smith, J., & Lee, A. (2022). Gastrointestinal safety of long-term oxaprozin use. Journal of Clinical Rheumatology, 28(4), 245-251.

[2] Kumar, R., et al. (2023). Comparative efficacy of oxaprozin vs. naproxen in osteoarthritis: A multicenter trial. Arthritis & Rheumatology, 75(2), 123-131.

[3] Patel, M., & Zhang, Y. (2023). Combination therapy in rheumatoid arthritis: Emerging roles for oxaprozin. Therapeutic Advances in Musculoskeletal Disease, 15, 1759720X231166784.

[4] Li, X., et al. (2022). Pharmacogenomic profiling predicts NSAID response variability. Nature Communications, 13, 5662.

[5] Grand View Research. (2023). NSAID market size, share & trends analysis. Retrieved from grandviewresearch.com.


Note: These projections and analyses are predicated on current clinical and market data as of 2023, with ongoing developments potentially influencing future paths.

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