The gout therapeutics landscape is experiencing unprecedented expansion with more than 20 pharmaceutical companies actively developing over 25 pipeline drugs to address significant unmet medical needs in this painful inflammatory arthritis condition. According to DelveInsight's comprehensive pipeline analysis, the robust development activity spans multiple clinical stages and employs diverse therapeutic mechanisms to improve treatment outcomes for gout patients.
Recent Clinical Achievements Drive Pipeline Momentum
Several companies have achieved notable clinical milestones in recent months, demonstrating the accelerating pace of gout drug development. In September 2025, Atom Therapeutics Co., Ltd announced that its global Phase IIb/III clinical trial of lingdolinurad (ABP-671), a novel orally administered URAT1 inhibitor, achieved its primary endpoint with significant efficacy in lowering serum uric acid (sUA) levels and demonstrated good safety and tolerability in the treatment of patients with chronic gout.
XORTX Therapeutics Inc. also made significant progress in September 2025, announcing the initiation of Investigational New Drug (IND) preparation for its lead program, XRx-026, focused on the treatment of gout. The company has engaged Allucent, a global contract research organization specializing in regulatory and clinical development, to support this milestone.
FDA Recognition Validates Therapeutic Potential
The U.S. Food and Drug Administration has recognized the therapeutic potential of several gout pipeline candidates through Fast Track designations. In July 2025, Shanton Pharma announced that the FDA had designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy. This designation followed the company's announcement of topline data from a Phase IIb study in refractory gout patients, demonstrating SAP-001's first-in-class mechanism of action targeting a distinct kidney transporter.
Similarly, Arthrosi Therapeutics received FDA Fast Track Designation for AR882 (now known as pozdeutinurad) in August 2024 for the potential treatment of clinically visible tophi in patients with gout. The company has made substantial progress with its pivotal Phase III clinical trial program, announcing in July 2025 that it had enrolled more than 50% of patients in the REDUCE 1 trial evaluating pozdeutinurad for the reduction of sUA and tophi in gout and tophaceous gout patients.
Diverse Mechanisms Target Multiple Disease Pathways
The expanding pipeline encompasses a wide range of therapeutic approaches, reflecting the complex pathophysiology of gout. Notable mechanisms of action in clinical trials include SLC22A12 protein inhibitors, xanthine oxidase inhibitors, inflammasome inhibitors, interleukin 1 beta inhibitors, interleukin 18 inhibitors, interleukin inhibitors, NLRP3 protein inhibitors, and urate oxidase replacements.
Late-stage development candidates include AR-882 from Arthrosi Therapeutics, Epaminurad from JW Pharmaceutical, XRx-026 from XORTX Therapeutics, ABP-671 from Atom Bioscience, and Dapansutrile from Olatec Therapeutics. Mid to early-stage programs feature D-0120 from InventisBio, SAP-001 from Shanton Pharma, and PRX-115 from Protalix BioTherapeutics, among others.
Strategic Partnerships Accelerate Development
Commercial partnerships are playing a crucial role in advancing pipeline programs. In December 2024, Atom Therapeutics Co. Ltd announced an exclusive commercialization collaboration agreement with a subsidiary of China Medical System Holdings Ltd (CMS) for lingdolinurad (ABP-671) in mainland China, Hong Kong Special Administrative Region, and Macao Special Administrative Region.
Market Drivers Support Sustained Growth
The gout market is positioned for steady growth, driven by the rising prevalence of the disease, increasing awareness, and the launch of novel therapies addressing unmet needs. Strong demand for effective long-term management and supportive reimbursement policies enhance adoption potential. However, challenges such as generic competition and safety concerns may limit rapid uptake of new therapies.
Gouty arthritis, commonly called gout, is a painful and prevalent type of inflammatory arthritis that typically affects just one joint at a time, most often the big toe. The condition is marked by periods of intense symptoms called flares, followed by symptom-free intervals known as remission. If left unmanaged, recurrent episodes can progress to chronic gouty arthritis, a more severe and damaging form of the disease. Although gout has no permanent cure, it can be successfully controlled through medications and lifestyle modifications.
The comprehensive pipeline development across multiple companies and therapeutic approaches represents a significant advancement in addressing the substantial unmet medical needs in gout treatment, positioning the market for sustained expansion as these novel therapies progress through clinical development and toward potential commercialization.
