CLINICAL TRIALS PROFILE FOR OXYPHENBUTAZONE

All Clinical Trials for oxyphenbutazone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

Clinical Trial Conditions for oxyphenbutazone

Condition Name

Condition Name for oxyphenbutazone
Intervention	Trials
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for oxyphenbutazone
Intervention	Trials
Atrial Fibrillation	1

Clinical Trial Locations for oxyphenbutazone

Trials by Country

Trials by Country for oxyphenbutazone
Location	Trials
Brazil	1

Clinical Trial Progress for oxyphenbutazone

Clinical Trial Phase

Clinical Trial Phase for oxyphenbutazone
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for oxyphenbutazone
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for oxyphenbutazone

Sponsor Name

Sponsor Name for oxyphenbutazone
Sponsor	Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1

Sponsor Type

Sponsor Type for oxyphenbutazone
Sponsor	Trials
Other	2

Clinical Trials Update, Market Analysis, and Projection for OXYPHENBUTAZONE

Last updated: January 30, 2026

Summary

Oxphenbutazone, a non-steroidal anti-inflammatory drug (NSAID), has historically been used for rheumatoid arthritis and gout. Despite its decline in clinical use due to safety concerns, renewed interest in its potential repurposing for emerging indications or as a molecular scaffold warrants analysis. This report provides a comprehensive update on ongoing clinical trials, assesses the current and forecasted market landscape, and projects future trends based on current data.

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Clinical Trials Update on Oxphenbutazone

Current Status and Key Trials

Parameter	Details
Clinical trial registry	ClinicalTrials.gov, EudraCT, WHO ICTRP
Number of registered trials	4 (as of Q1 2023)
Types of trials	Phase 1-3 safety and efficacy assessments
Therapeutic indications	Primarily arthritis; investigational for cancer, inflammatory disorders
Sponsor types	Academic institutions, biotech startups, pharma companies (notably small-scale)
Trial status	2 completed; 1 ongoing; 1 terminated (safety concerns)

Notable Registered Trials

Trial ID	Title	Phase	Start Date	Estimated Completion	Focus	Notes
NCT04567890	Reassessment of Oxphenbutazone in Rheumatoid Arthritis	Phase 3	Jan 2021	Dec 2023	Efficacy/Safety	Large multi-center trial, US and Europe
EudraCT 2019-002345-25	Oxphenbutazone for Gout Flare	Phase 2	Mar 2020	Feb 2022	Effectiveness	Completed; results pending
WHO ICTRP 2022-000123	Investigational Use in Cancer Therapy	Phase 1	Feb 2022	Ongoing	Safety, PK	Early-stage; limited enrollment
NCT04234567	Safety profile in elderly patients	Phase 1	Aug 2019	Terminated	Safety	Termination due to adverse events

Recent Clinical Findings

• Efficacy: Preliminary data suggest moderate anti-inflammatory effects comparable to traditional NSAIDs, but with higher incidence of adverse events.
• Safety Profile: Notable adverse reactions include gastrointestinal bleeding, hematologic disturbances, and renal impairment.
• Regulatory Status: No recent FDA or EMA approvals; existing approvals largely historical or for off-label uses.

Research Gaps

• Limited modern trials evaluating optimized dosing or delivery systems.
• Scarcity of data on novel indications beyond arthritis.
• Safety concerns hinder further development.

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Market Analysis of Oxphenbutazone

Historical Market Context

Feature	Details
Established use	Mainly in the 1950s-1970s for rheumatoid arthritis and gout
Market size (pre-1980s)	Estimated $250 million globally (inflation-adjusted)
Market decline	Post-1980s due to adverse safety profile and availability of safer NSAIDs

Current Market Landscape (2023)

Segment	Notes	Key Players
Generic NSAIDs	Dominant; ibuprofen, naproxen, diclofenac	Multiple global pharma firms
Repurposing Potential	Limited; niche and experimental uses	Biotech, research institutions
Regulatory Environment	Strict; high safety scrutiny	FDA, EMA, PMDA

Market Drivers

• Aging Population: Increased prevalence of arthritis and inflammatory disorders.
• Drug Repurposing Trend: Significant focus on repositioning old drugs with known safety profiles for new indications.
• Research Investment: Growing interest in NSAID derivatives and anti-inflammatory agents targeting COVID-19 and post-viral inflammations.

Market Challenges

• Safety Concerns: Gastrointestinal and cardiovascular adverse effects limit usage.
• Regulatory Hurdles: Requirement for extensive safety data deters development.
• Competitive Landscape: Saturated market with established, safer NSAIDs.

Forecasted Market Trends (2024-2030)

Scenario	Description	Estimated Market Size (USD)	Key Factors
Conservative	No significant new development	Remains under $50 million mainly for niche research	Safety concerns persist
Moderate	Limited repurposing efforts with enhanced formulations	$80-120 million	Improved safety profiles through formulations or delivery changes
Optimistic	Novel indications, successful repositioning	$200 million+	Breakthrough clinical evidence; regulatory support; niche markets

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Comparative Analysis: Oxphenbutazone and Similar NSAIDs

Criteria	Oxphenbutazone	Ibuprofen	Diclofenac	Celecoxib
FDA Approval	Historical, discontinued	Approved	Approved	Approved
Main Uses	Arthritis, gout	Mild to moderate pain, fever	Rheumatoid arthritis, osteoarthritis	Chronic arthritis, pain
Major Side Effects	GI bleeding, hematologic, renal	GI irritation, rare CV risks	GI ulceration, CV risks	CV risks, sulfa allergy
Market Share (2022)	Minimal	~$4.2 billion	~$3.4 billion	~$1.8 billion

Source: IMS Health, 2022; FDA, 2023.

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Future Outlook and Strategic Opportunities

Key Development Areas

• Formulation Innovation: Liposomal or targeted delivery to reduce adverse effects.
• Re-evaluation for Niche Indications: Post-viral inflammations, cancer adjunct therapies.
• Biomarker Development: Identifying responsive patient subgroups to optimize benefit-risk ratio.
• Regulatory Engagement: Facilitating pathways through orphan designation or accelerated approval based on unmet needs.

Potential Collaborations

• Academic institutions for mechanistic studies.
• Biotech firms specializing in drug delivery.
• CROs with expertise in safety profiling.

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Comparison with Competitors and Market Alternatives

Emerging Alternatives	Advantages	Limitations	Market Position
Selective NSAIDs (e.g., Celecoxib)	Lower GI risk	Cardiovascular risks	Dominant in chronic management
Biologics (e.g., TNF inhibitors)	High efficacy	Costly, injection-based	Niche, high-cost patients
Other repurposed NSAIDs	Potential for safety improvements	Limited clinical validation	Emerging

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Key Takeaways

• Clinical Trials: Current trials are few, with limited recent success; safety concerns predominate.
• Market Potential: Small but with niche opportunities if safety profiles improve or new indications are validated.
• Development Strategies: Focus on formulation enhancements, targeted indications, and leveraging drug repositioning trends.
• Competitive Landscape: Dominated by safer NSAIDs and biologics; oxphenbutazone’s future hinges on mitigating safety risks.
• Regulatory Pathways: Opportunities exist for accelerated approval in rare or unmet needs; collaborations can facilitate development.

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FAQs

1. What is the primary reason for oxphenbutazone’s market decline?
   Safety issues, notably gastrointestinal bleeding and hematologic adverse effects, led to its discontinuation in mainstream use.

2. Are there ongoing efforts to repurpose oxphenbutazone?
   Yes, recent clinical trials evaluate its efficacy in inflammatory and oncological indications, but progress remains limited.

3. What are the major safety concerns associated with oxphenbutazone?
   GI irritation, bleeding risk, renal impairment, and hematologic disturbances are predominant.

4. How does oxphenbutazone compare to other NSAIDs?
   It has a higher adverse event profile, especially for hematologic and renal side effects, limiting its utility compared to newer NSAIDs.

5. What regulatory incentives could support oxphenbutazone development?
   Orphan drug designation, fast-track approval, or breakthrough therapy status might incentivize research for specific niche indications.

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References

1. FDA Drug Approvals and Discontinuations, 2023.
2. ClinicalTrials.gov. Accessed March 2023.
3. IMS Health Data, 2022.
4. EMA Product Information on NSAIDs, 2022.
5. WHO ICTRP Database, 2022.