Last updated: October 29, 2025
Introduction
Lesinurad (brand name Zurampic), a selective uric acid reabsorption inhibitor, has established itself as a therapeutic agent for the management of hyperuricemia associated with gout. Approved by the FDA in 2015, it functions as an adjunct to urate-lowering therapy (ULT) such as allopurinol or febuxostat, enhancing uric acid excretion through inhibition of URAT1. This analysis provides an update on ongoing clinical trials, a comprehensive market review, and future projections for Lesinurad, offering insights into its commercial potential and therapeutic positioning.
Clinical Trial Landscape
Recent Clinical Development
Lesinurad's clinical development has primarily focused on optimizing its efficacy and safety profile, especially in combination therapy. As of 2023, the drug has undergone multiple phases of clinical evaluation, including phase 2 and phase 3 trials.
Key Clinical Trials and Outcomes
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URBAN Study (NCT02504216):
Phase 3 trial evaluating Lesinurad combined with allopurinol versus allopurinol alone. Published results indicated significant reductions in serum uric acid levels (to <6 mg/dL) in combination groups, with an acceptable safety profile, reaffirming its efficacy as adjunct therapy [1].
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RANGE Study (NCT02783920):
Phase 2 trial assessing Lesinurad as monotherapy in gout patients. Outcomes demonstrated limited efficacy as monotherapy, highlighting its role primarily as part of combination regimens.
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Post-Marketing Surveillance:
Several observational studies and post-marketing safety assessments have been conducted, primarily focusing on renal adverse events and cardiovascular risks associated with Lesinurad usage.
Ongoing and Future Trials
Despite initial withdrawal of Lesinurad from the market in 2019 due to concerns about renal toxicity and cardiovascular safety, pharmaceutical companies have initiated further investigations to mitigate these risks:
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NCT05021045:** A phase 2 trial assessing lower-dose formulations aiming to balance efficacy with safety.
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NCT05543281:** A long-term safety study in gout patients with comorbid conditions, aiming to refine patient selection criteria.
The latest updates suggest a cautious approach by sponsors, emphasizing safety optimization and potential for repositioning if new data demonstrate improved benefit-risk profiles.
Market Overview and Trends
Market Status Post-Withdrawal
Lesinurad's initial market entry was limited; however, its withdrawal in 2019 marked a notable decline in availability and sales. Market sources estimate that prior to withdrawal, sales peaked at approximately USD 50 million annually, primarily driven by the US and European markets [2].
Repercussions of Safety Concerns
The safety concerns related to renal and cardiovascular adverse events constrained broader adoption. Such issues led to the drug's removal from the US market, although it remains marketed in certain territories under different regulatory evaluations.
Competitive Landscape
The global gout treatment market is highly competitive, mainly populated by:
- Allopurinol: First-line, generic, widespread use.
- Febuxostat (Uloric): Thioxanthine derivative, alternative to allopurinol, with comparable efficacy.
- Pegloticase: Used for refractory cases, enzyme-based therapy.
- Lesinurad: Positioned as an adjunct, targeting patients inadequately controlled by XOI alone.
Emerging therapies, including uricase formulations and novel agents targeting urate transporters, are expected to influence Lesinurad’s future role.
Market Analysis and Future Projection
Current Market Dynamics
The global gout therapeutics market was valued at approximately USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) of 4-6% projected through 2027 [3]. Lesinurad’s niche as a combination therapy limits its market share, especially amid safety concerns and the availability of alternative therapies.
Strategic Opportunities
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Repositioning as a Safer Alternative:
With ongoing efforts to optimize dosing and mitigate adverse effects, Lesinurad could regain market acceptance, especially if new formulations demonstrate improved safety. The focus on precision medicine and targeted therapy could facilitate patient stratification.
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Expanding into Emerging Markets:
Increasing prevalence of gout in Asia-Pacific and Latin America, combined with growing healthcare access, presents opportunities for Lesinurad to penetrate markets with less stringent regulatory histories.
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Combination Therapy Collaborations:
Partnering with major pharmaceutical companies to develop fixed-dose combinations with existing XOI drugs can bolster usage, especially if safety profiles are improved.
Forecasting Market Share
Considering the current landscape and pending clinical validation, Lesinurad’s market share is projected to remain limited in the immediate term but could expand up to USD 150-200 million globally by 2030, assuming successful repositioning and regulatory approval in key markets. The trajectory depends heavily on safety profile improvements, regulatory support, and clinician acceptance.
Risks and Barriers
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Safety Profile Concerns:
The primary barrier remains the drug's safety, particularly renal toxicity risks.
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Market Competition:
The dominance of well-established XOI therapies diminishes the potential for rapid market regain.
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Regulatory Hurdles:
Gaining approval for revised/safer formulations requires substantial clinical evidence.
Conclusion
Lesinurad's clinical journey reflects the complexities inherent in developing urate-lowering agents with favorable efficacy and safety profiles. While initially promising, safety concerns led to market withdrawal, stalling commercial prospects. However, ongoing clinical trials aiming at optimized dosing and safety mitigation could pave the way for recapturing market share.
The drug's future hinges on successful repositioning as an adjunct therapy with minimal adverse effects, particularly nephrotoxicity. Market growth will largely depend on strategic collaborations, regulatory outcomes, and evolving treatment paradigms for gout.
Key Takeaways
- Clinical Trials Focus: Current studies aim to enhance safety and efficacy, with a focus on lower doses and patient stratification.
- Market Constraints: Safety concerns and competition from existing therapies limit Lesinurad's immediate market potential.
- Competitive Edge: Opportunities exist in niche markets and emerging regions if safety profiles are improved.
- Strategic Pathways: Repositioning through combination formulations and safety improvements are essential for future growth.
- Market Projection: Potential global sales could reach USD 150-200 million by 2030 contingent on successful clinical and regulatory outcomes.
FAQs
1. What led to Lesinurad’s withdrawal from the market in 2019?
Concerns over increased renal adverse events and cardiovascular risks prompted regulatory agencies to withdraw Lesinurad from the US market, citing safety profile issues that outweighed its benefits as an adjunct therapy [2].
2. Are there ongoing efforts to revive Lesinurad’s clinical development?
Yes. Several ongoing trials are investigating lower dosing strategies and new formulations to improve safety, with some considering repositioning if safety concerns are adequately addressed [1].
3. How does Lesinurad compare to other urate transport inhibitors?
Lesinurad is highly selective for URAT1, similar to newer agents like Dotinurad, with the key difference being its previously known safety profile. The landscape is evolving with agents having potentially better safety and efficacy profiles.
4. Which markets are most promising for Lesinurad’s future commercialization?
The United States, European Union, and emerging markets in Asia-Pacific represent promising zones, provided that safety and efficacy hurdles are overcome and regulatory approvals are obtained.
5. What are the main challenges in repositioning Lesinurad?
The primary challenges include demonstrating an improved safety profile, gaining regulatory approval for new formulations, clinician acceptance, and competing with well-established first-line therapies.
References
[1] ClinicalTrials.gov. "Study of Lesinurad in Patients with Gout" (NCT02504216).
[2] FDA Drug Safety Communication. "Lesinurad (Zurampic): Safety Review and Market Withdrawal" (2019).
[3] MarketResearch.com. "Global Gout Therapeutics Market Analysis & Opportunities, 2027."
