Gout Clinical Trial Pipeline Expands as 20+ Companies Driving Innovation in Gout Therapeutics | DelveInsight

The gout market is poised for steady growth, driven by the rising prevalence of the disease, increasing awareness, and the launch of novel therapies such as AR-882, Epaminurad, XNW3009, XRx-026, ABP-671, Dapansutrile, D-0120, SAP-001, DYV700, PRX-115, SYNB2081, HP 501, and others addressing unmet needs. Strong demand for effective long-term management and supportive reimbursement policies enhances adoption, while challenges such as generic competition and safety concerns may limit rapid uptake. Overall, innovation and expanding treatment options position the market for sustained expansion.

New York, USA, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Gout Clinical Trial Pipeline Expands as 20+ Companies Driving Innovation in Gout Therapeutics | DelveInsight

The gout market is poised for steady growth, driven by the rising prevalence of the disease, increasing awareness, and the launch of novel therapies such as AR-882, Epaminurad, XNW3009, XRx-026, ABP-671, Dapansutrile, D-0120, SAP-001, DYV700, PRX-115, SYNB2081, HP 501, and others addressing unmet needs. Strong demand for effective long-term management and supportive reimbursement policies enhances adoption, while challenges such as generic competition and safety concerns may limit rapid uptake. Overall, innovation and expanding treatment options position the market for sustained expansion.

DelveInsight’s 'Gout Pipeline Insight 2025' report provides comprehensive global coverage of pipeline therapies for gout across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and competitive landscape dynamics, highlighting the strategies of major pharmaceutical companies to advance the pipeline and capitalize on future growth opportunities. In addition, it includes critical insights into clinical trial benchmarking, partnering and licensing activities, and regulatory pathways involving the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies within the gout domain.

Key Takeaways from the Gout Pipeline Report

• DelveInsight’s gout pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline gout drugs. 
• Key gout companies such as Arthrosi Therapeutics, Ltd, JW Pharmaceutical, Evopoint Biosciences Co., Ltd., XORTX Therapeutics Inc., Atom Therapeutics Co., Olatec Therapeutics LLC, InventisBio, Shanton Pharma, Dyve Biosciences, Protalix BioTherapeutics, Synlogic, Hinova, and others are evaluating new gout drugs to improve the treatment landscape.
• Promising pipeline gout therapies, such as AR-882, Epaminurad, XNW3009, XRx-026, ABP-671, Dapansutrile, D-0120, SAP-001, DYV700, PRX-115, SYNB2081, HP 501, and others, are in different phases of gout clinical trials.
• Notable MoAs in clinical trials include SLC22A12 protein inhibitors, Xanthine oxidase inhibitors, Inflammasome inhibitors, Interleukin 1 beta inhibitors, Interleukin 18 inhibitors, Interleukin inhibitors, NLRP3 protein inhibitors, Urate oxidase replacements, and others.
• 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.
• In September 2025, XORTX Therapeutics Inc. announced the initiation of Investigational New Drug (“IND”) preparation for its lead program, XRx-026, focused on the treatment of gout. In support of this milestone, XORTX has engaged Allucent, a global contract research organization specializing in regulatory and clinical development.
• 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.
• In July 2025, Arthrosi Therapeutics, Inc., announced that it had enrolled more than 50% of patients in the Company's second pivotal Phase III clinical trial (REDUCE 1) evaluating pozdeutinurad (formerly known as AR882) for the reduction of sUA and tophi in gout and tophaceous gout patients.
• In March 2025, Shanton Pharma announced topline data of a Phase IIb study in refractory gout patients with its investigational drug SAP-001 that uses a First-in-Class Mechanism of Action targeting a distinct kidney transporter.
• In March 2025, Arthrosi Therapeutics, Inc., announced that it had dosed the first patient in REDUCE 1, the Company's second pivotal Phase III clinical trial evaluating AR882.
• In December 2024, Atom Therapeutics Co. Ltd announced that the company entered into an exclusive commercialization collaboration agreement with a subsidiary of China Medical System Holdings Ltd (CMS) for lingdolinurad (ABP-671), a novel oral small molecule URAT1 inhibitor for the treatment of chronic gout and hyperuricemia, in mainland China, Hong Kong Special Administrative Region, and Macao Special Administrative Region.
• In August 2024, Arthrosi Therapeutics, Inc., announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to AR882 for the potential treatment of clinically visible tophi in patients with gout.

Request a sample and discover the recent advances in gout drugs @ Gout Pipeline Report

The gout pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage gout drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the gout clinical trial landscape. 

Gout Overview

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.

Find out more about gout drugs @ Gout Treatment

Gout Competitive Landscape

Leading companies such as Arthrosi Therapeutics, Ltd, JW Pharmaceutical, Evopoint Biosciences Co., Ltd., XORTX Therapeutics Inc., Atom Therapeutics Co., Olatec Therapeutics LLC, InventisBio, Shanton Pharma, Dyve Biosciences, Protalix BioTherapeutics, Synlogic, Hinova, and others are currently active in the gout competitive landscape.

Gout drugs that are in the late stage of development include AR-882 (Arthrosi Therapeutics), Epaminurad (JW Pharmaceutical), XRx-026 (XORTX Therapeutics), ABP-671 (Atom Bioscience), Dapansutrile (Olatec Therapeutics), and others. Meanwhile, drugs such as D-0120 (InventisBio), SAP-001 (Shanton Pharma), PRX-115 (Protalix BioTherapeutics), and others are in the mid to early stages of development. 

Learn more about the emerging gout therapies @ Gout Clinical Trials

Gout Therapeutics Assessment

The gout pipeline report proffers an integral view of the emerging gout therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action.

Scope of the Gout Pipeline Report 

• Coverage: Global 
• Gout Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Gout Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Gout Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal
• Gout Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
• Gout Therapeutics Assessment By Mechanism of Action: SLC22A12 protein inhibitors, Xanthine oxidase inhibitors, Inflammasome inhibitors; Interleukin 1 beta inhibitors; Interleukin 18 inhibitors; Interleukin inhibitors; NLRP3 protein inhibitors, Urate oxidase replacements and others.
• Key Gout Companies: Arthrosi Therapeutics, Ltd, JW Pharmaceutical, Evopoint Biosciences Co., Ltd., XORTX Therapeutics Inc., Atom Therapeutics Co, Olatec Therapeutics LLC, InventisBio, Shanton Pharma, Dyve Biosciences, Protalix BioTherapeutics, Synlogic, Hinova, and others.
• Key Gout Pipeline Therapies: AR-882, Epaminurad, XNW3009, XRx-026, ABP-671, Dapansutrile, D-0120, SAP-001, DYV700, PRX-115, SYNB2081, HP 501, and others.

Dive deep into rich insights for new gout treatments, visit @ Gout Drugs

Table of Contents

For further information on the gout pipeline therapeutics, reach out @ Gout Therapeutics

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