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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR LESINURAD


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All Clinical Trials for Lesinurad

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01493531 ↗ Combining Lesinurad With Allopurinol in Inadequate Responders Completed Ardea Biosciences, Inc. Phase 3 2011-12-01 This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.
NCT01508702 ↗ Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors Completed Ardea Biosciences, Inc. Phase 3 2012-01-01 This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.
NCT01510158 ↗ Combining Lesinurad With Allopurinol in Inadequate Responders Completed Ardea Biosciences, Inc. Phase 3 2012-01-01 This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.
NCT01510769 ↗ Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat Completed Ardea Biosciences, Inc. Phase 3 2012-01-01 This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.
NCT01650246 ↗ Open-Label Lesinurad Monotherapy Extension Study in Gout Completed Ardea Biosciences, Inc. Phase 3 2012-08-01 This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
NCT01744379 ↗ Single and Multiple Dose Study in Japanese Completed Ardea Biosciences, Inc. Phase 1 2012-12-01 This study will explore the safety, tolerability, and serum uric acid lowering effect of lesinurad in healthy Japanese males to allow comparison with the Western population.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lesinurad

Condition Name

Condition Name for Lesinurad
Intervention Trials
Gout 10
Healthy 8
Chronic Kidney Disease (CKD) 1
Tophaceous Gout 1
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Condition MeSH

Condition MeSH for Lesinurad
Intervention Trials
Gout 8
Kidney Diseases 1
Renal Insufficiency, Chronic 1
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Clinical Trial Locations for Lesinurad

Trials by Country

Trials by Country for Lesinurad
Location Trials
United States 257
Australia 20
Canada 20
Poland 20
New Zealand 17
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Trials by US State

Trials by US State for Lesinurad
Location Trials
California 11
Texas 11
Michigan 11
Colorado 8
Arizona 8
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Clinical Trial Progress for Lesinurad

Clinical Trial Phase

Clinical Trial Phase for Lesinurad
Clinical Trial Phase Trials
Phase 4 1
Phase 3 7
Phase 1 11
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Clinical Trial Status

Clinical Trial Status for Lesinurad
Clinical Trial Phase Trials
Completed 18
Terminated 1
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Clinical Trial Sponsors for Lesinurad

Sponsor Name

Sponsor Name for Lesinurad
Sponsor Trials
Ardea Biosciences, Inc. 18
Medpace, Inc. 1
Ironwood Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for Lesinurad
Sponsor Trials
Industry 20
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Lesinurad: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Lesinurad

Lesinurad, marketed under the brand name Zurampic, is a selective uric acid reabsorption inhibitor (SURI) that has been approved for the treatment of hyperuricemia associated with gout. It works by inhibiting the uric acid transporter 1 (URAT1) and organic anion transporter 4 (OAT4), thereby increasing the excretion of uric acid from the renal tubules[5].

Clinical Trials Overview

Phase III Trials: Monotherapy and Combination Therapy

In a significant Phase III study known as LIGHT, lesinurad was evaluated as a monotherapy in patients with gout who were intolerant to or could not take xanthine oxidase inhibitors (XOIs) such as allopurinol or febuxostat. The study demonstrated that lesinurad met its primary endpoint, with a statistically significant higher proportion of patients achieving the serum uric acid (sUA) goal of <6.0 mg/dL at six months compared to those treated with placebo[1].

Additionally, lesinurad has been investigated in combination with XOIs in several other Phase III trials. The CLEAR1 and CLEAR2 trials examined lesinurad in combination with allopurinol in patients who did not achieve target sUA levels on allopurinol alone. Another trial, CRYSTAL, evaluated lesinurad in combination with febuxostat in patients with tophaceous gout[1].

Efficacy and Safety Findings

In the LIGHT study, lesinurad 400 mg monotherapy showed superior sUA lowering compared to placebo, with sustained effects observed up to 18 months in an extension study. However, the treatment was associated with higher rates of treatment-emergent adverse events (TEAEs), particularly renal-related TEAEs and serum creatinine elevations[4].

The combination therapy trials also demonstrated the efficacy of lesinurad when added to allopurinol. The addition of lesinurad to allopurinol was shown to provide additional benefit over allopurinol alone in reducing serum uric acid levels[3].

Market Analysis

Current Market Landscape

The global gout therapeutics market is projected to reach $8.3 billion by 2025, driven by the introduction of new urate-lowering agents, the approval of effective biologics, and an increasing number of patients suffering from chronic gout. Lesinurad, approved in 2015 in the US and in 2016 in the EU, is a key player in this market[2].

Market Segments and Growth

The gout therapeutics market is segmented into various drug classes, with nonsteroidal anti-inflammatory agents (NSAIDs) currently holding the highest market share due to their high penetration, low cost, and efficient pain relief. However, the urate-lowering agents segment, which includes lesinurad, is expected to grow at the highest rate over the coming years. This growth is attributed to the increasing adoption of new drugs, growing investment by key players, and the expected entry of various new therapies[2].

Competitive Landscape

Lesinurad competes in a market dominated by several major pharmaceutical companies, including Takeda Pharmaceutical, Novartis, Savient Pharmaceuticals, AstraZeneca, and others. The approval of combination therapies like Duzallo (lesinurad/allopurinol) has further strengthened AstraZeneca's position in the gout therapeutics market[2].

Regulatory Approvals and Labeling

FDA and EU Approvals

Lesinurad was approved by the U.S. FDA in December 2015 and by the European Commission in February 2016 for use in combination with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with XOI monotherapy alone[2][5].

Combination Therapy Approval

In August 2017, the FDA approved Duzallo, a fixed-dose combination tablet of lesinurad and allopurinol, for the treatment of gout-related hyperuricemia in patients with uncontrolled gout. This approval was based on clinical studies that demonstrated the additional benefit of lesinurad when added to allopurinol[3].

Mechanism of Action and Pharmacokinetics

Inhibition of URAT1 and OAT4

Lesinurad works by inhibiting the activity of URAT1 and OAT4, which are responsible for the reuptake of uric acid from the renal tubules. This inhibition increases the excretion of uric acid, thereby reducing serum uric acid levels[5].

Pharmacokinetic Profile

Lesinurad is rapidly absorbed, reaching maximum plasma concentrations within 1–4 hours following administration. It has a mean steady-state volume of distribution of approximately 20 L and is primarily eliminated with an elimination half-life of about 5 hours[5].

Key Takeaways

  • Clinical Efficacy: Lesinurad has demonstrated significant efficacy in reducing serum uric acid levels both as a monotherapy and in combination with xanthine oxidase inhibitors.
  • Market Growth: The gout therapeutics market is expected to grow substantially, with urate-lowering agents like lesinurad driving this growth.
  • Regulatory Approvals: Lesinurad and its combination therapy, Duzallo, have received approvals from regulatory bodies in the US and EU.
  • Mechanism of Action: Lesinurad inhibits URAT1 and OAT4, increasing uric acid excretion and reducing serum uric acid levels.
  • Safety Profile: While effective, lesinurad is associated with renal-related adverse events and serum creatinine elevations.

FAQs

What is lesinurad used for?

Lesinurad is used for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with xanthine oxidase inhibitor monotherapy alone.

How does lesinurad work?

Lesinurad works by inhibiting the uric acid transporters URAT1 and OAT4, thereby increasing the excretion of uric acid from the renal tubules.

What are the key clinical trials for lesinurad?

Key clinical trials include the LIGHT study for monotherapy and the CLEAR1, CLEAR2, and CRYSTAL trials for combination therapy with xanthine oxidase inhibitors.

What are the common side effects of lesinurad?

Common side effects include renal-related adverse events, serum creatinine elevations, and other treatment-emergent adverse events.

Is lesinurad available as a combination therapy?

Yes, lesinurad is available as a combination therapy with allopurinol under the brand name Duzallo, which was approved by the FDA in 2017.

Sources

  1. AstraZeneca Press Release: "AstraZeneca announces top-line results from phase III monotherapy study of lesinurad in gout patients intolerant to xanthine oxidase inhibitors" - December 13, 2013.
  2. Business Wire: "Gout Therapeutics Market to Reach $8.3 Billion by 2025 - Key Vendors are Takeda Pharmaceutical, Novartis, Savient Pharmaceuticals, AstraZeneca, GlaxoSmithKline, Merck, Teijin Pharma, Regeneron --- Research and Markets" - April 28, 2017.
  3. FDA Document: "209203Orig1s000 - Duzallo (lesinurad/allopurinol) Fixed-Dose Combination Tablets" - August 15, 2017.
  4. PubMed: "Lesinurad 400 mg monotherapy demonstrated superior sUA lowering compared with placebo, with sustained effects for up to 18 months" - December 1, 2017.
  5. DrugBank Online: "Lesinurad: Uses, Interactions, Mechanism of Action" - Accessed January 1, 2025.

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