According to DelveInsight, more than 10 prominent companies are actively developing over 12 therapeutic candidates for the treatment of Hyperuricemia.
Hyperuricemia Overview:
Hyperuricemia is characterized by abnormally high levels of uric acid in the blood—typically exceeding 6 mg/dL in women and 7 mg/dL in men—and affects approximately 38 million people in the United States. Its global prevalence continues to rise, largely driven by increasing adoption of Western diets and sedentary lifestyles. While many individuals with hyperuricemia remain asymptomatic, the condition can progress to gout or kidney stone formation. It results from either excessive uric acid production or impaired excretion and is often associated with high cellular turnover, renal dysfunction, and various metabolic disorders. Additionally, hyperuricemia has been linked to an increased risk of cardiovascular disease, obesity, hypertension, and chronic kidney disease.
The primary cause of hyperuricemia is an imbalance between uric acid production and elimination. Uric acid, a metabolic byproduct of purine breakdown, is mainly excreted by the kidneys. When renal function is compromised—due to reduced glomerular filtration, decreased tubular secretion, or increased reabsorption—uric acid tends to accumulate in the bloodstream. Roughly two-thirds of uric acid is cleared through the kidneys, with the remainder eliminated via the gastrointestinal tract. Factors contributing to elevated uric acid levels include high-purine diets, rapid cellular breakdown (as observed in rhabdomyolysis or hemolysis), and the use of certain medications.
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"Hyperuricemia Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Hyperuricemia Therapeutics Market.
Key Takeaways from the Hyperuricemia Pipeline Report
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DelveInsight’s Hyperuricemia pipeline report highlights a dynamic landscape, with over 10 active companies developing more than 12 therapeutic candidates for the treatment of Hyperuricemia.
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Takeda’s gout medication Uloric (febuxostat) has been officially discontinued in the United States following cardiovascular safety concerns and the issuance of a black box warning in 2019. The FDA has listed it in its drug shortage database, and the medication will remain available to wholesalers only until March 31, 2026, to allow sufficient time for patient transition.
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In March 2025, Takeda submitted a Type B meeting package to the FDA and awaited feedback by April 26, 2025, to finalize the next steps toward NDA submission via the 505(b)(2) pathway.
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Leading companies in the Hyperuricemia space—including Arthrosi Therapeutics, Shanton Pharma Pte. Ltd., Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., Shenyang Sunshine Pharmaceutical Co., Ltd., and Intelligem Therapeutics Australia Pty Ltd—are actively advancing novel therapies to enhance treatment outcomes.
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Promising drug candidates currently under development include AR882, ABP-671, SAP-001, and others, which show potential to redefine the future of Hyperuricemia management.
Hyperuricemia Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Hyperuricemia Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hyperuricemia treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Hyperuricemia market.
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Hyperuricemia Emerging Drugs
AR882: Arthrosi Therapeutics
AR882 is a novel therapeutic candidate designed to treat hyperuricemia, especially in patients with gout. It functions as a highly selective and potent Uric Acid Transporter 1 (URAT1) inhibitor—a crucial transporter responsible for uric acid reabsorption in the kidneys. By blocking URAT1 activity, AR882 enhances uric acid excretion via urine, thereby reducing serum uric acid levels. This precision mechanism offers potential benefits in mitigating hyperuricemia-related complications such as gout flares and tophi formation. The drug is currently in Phase III clinical development for hyperuricemia treatment.
ABP-671: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
ABP-671 is a Urate Transporter 1 (URAT1) inhibitor that reduces uric acid reabsorption in the kidneys. Administered as a once-daily oral monotherapy, it lowers serum uric acid (sUA) levels by enhancing urinary excretion. This helps prevent and reduce tophi formation and decreases the frequency of gout attacks. By maintaining optimal sUA levels, ABP-671 may also mitigate risks associated with hyperuricemia-related complications, including diabetes, cardiovascular disease, and kidney dysfunction. In recent clinical studies, the drug achieved promising results, with approximately 93% and 77% of participants reaching sUA levels below 6 mg/dL and 5 mg/dL, respectively. ABP-671 is currently in Phase III clinical development for the treatment of hyperuricemia.
Hyperuricemia Companies
More than 10 leading companies are currently engaged in developing therapies for hyperuricemia, with Arthrosi Therapeutics advancing a drug candidate that has reached the most progressed stage—Phase III clinical development.
DelveInsight’s report covers around 75+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Hyperuricemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Hyperuricemia Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Hyperuricemia Pipeline Therapeutic Assessment
• Hyperuricemia Assessment by Product Type
• Hyperuricemia By Stage
• Hyperuricemia Assessment by Route of Administration
• Hyperuricemia Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Hyperuricemia Current Treatment Patterns
4. Hyperuricemia - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Hyperuricemia Late-Stage Products (Phase-III)
7. Hyperuricemia Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Hyperuricemia Discontinued Products
13. Hyperuricemia Product Profiles
14. Hyperuricemia Key Companies
15. Hyperuricemia Key Products
16. Dormant and Discontinued Products
17. Hyperuricemia Unmet Needs
18. Hyperuricemia Future Perspectives
19. Hyperuricemia Analyst Review
20. Appendix
21. Report Methodology
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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