Lingdolinurad (ABP-671) for Chronic Gout
ABP-671 is a next-generation, highly selective oral urate transporter 1 (URAT1) inhibitor under global Phase 3 clinical trials for treatment of chronic gout. Phase 3 clinical trials to treat general gout, refractory gout and tophaceous gout patients also have been initiated. In addition, a Phase 2 clinical trial to treat hyperuricemia in chronic kidney disease (CKD) patients also has been initiated.
Positive Phase 2 Trial Results
ABP-671 has been evaluated in clinical trials across multiple regions worldwide, with more than 1,000 patients enrolled in total.
In a Phase 2a clinical trial in Australia, twice-daily administration of ABP-671 at 2 mg resulted in target sUA levels of < 6 mg/dL, < 5 mg/dL, and < 4 mg/dL in 100%, 100%, and 86% of patients with chronic gout, respectively (Figure 1). In a multi-country Phase 2b clinical trial, conducted primarily in the U.S., ABP-671 was compared with placebo and to a treat-to-target regimen of allopurinol at doses of up to 800 mg. ABP-671 demonstrated significantly greater overall benefit than allopurinol. In the ABP-671 treatment groups a higher proportion of patients achieved target sUA levels of 6 mg/dL, 5 mg/dL and 4 mg/dL compared with the allopurinol group. Compared with placebo, ABP-671 reduced the risk of acute gout flares by 67.3% while allopurinol was only able to reduce acute gout flares by 12.2%. During the 6-month treatment period, dissolution, reduction of tophi size was observed in patients that presented with tophi at the start of treatment.
In a China Phase 2b trial, after 8 weeks of treatment, 92% of subjects receiving ABP-671, 2 mg twice daily, achieved sUA levels < 6.0 mg/dL, significantly higher than the 52% observed in the febuxostat 40 mg group (Figure 1). In addition, during 24 weeks of treatment with ABP-671, 2 mg twice daily, complete dissolution of tophi was observed in some subjects (Figure 2).
The three global Phase 3 studies in patients with gout will evaluate ABP-671 monotherapy, a add-on study in refractory gout and in tophaceous gout. In China, a separate monotherapy phase 3 study in gout patients is ongoing and data readout is expected in Q3/2027.
Figure 1: sUA Target Rate Reduction for Phase 2b Clinical Trials in China and Australia
Figure 2: Tophi Dissolution in the Phase 2b Clinical Trial in China
Safety Profiles
ABP-671 has demonstrated a favorable safety profile in Phase 1 and Phase 2 studies in healthy participates and patients with gout in the United States, China, and Australia. Most adverse events were Grade 1 (mild). No serious adverse events were reported with ABP-671 at the tested doses. ABP-671 is primarily excreted in its original form and does not form the similar metabolites associated with the liver toxicity of benzbromarone. To date, no cardiovascular events and clinically hepatotoxicity were observed.
Market Opportunity of Gout Treatment
The global gout patient population increased from 58.3 million in 2021 to 69.0 million in 2025 and is expected to further increase to 82.9 million by 2030. Now in the U.S., gout affects approximately 10–12 million adults and is the most common inflammatory arthritis.
According to market forecast data from Frost & Sullivan, the global gout therapeutics market grew from $2.9 billion in 2021 to $3.2 billion in 2025 and is expected to increase significantly to $7.7 billion by 2030. In the U.S., the gout drug market increased from $1.6 billion in 2021 to $1.8 billion in 2025 and is expected to further grow to $4.1 billion in 2030.
Commercialization of Lingdolinurad in China
Atom Therapeutics and China Medical System Holdings (CMS) have entered into an exclusive commercialization agreement for ABP-671, under which CMS has obtained exclusive commercialization rights for the product in Mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region.
Leveraging CMS’s strong market access capabilities and well-established network of hospitals, retail pharmacies, and online pharmacy channels, the partnership is expected to facilitate the commercialization and launch of ABP-671 and accelerate its market penetration in major cities as well as second- and third-tier cities in the CMS commercialization territories.
References
- Dalbeth N, Gosling AL, Gaffo A, et al. Gout. Lancet. 2021 May 15;397(10287):1843-1855.
- Ghang B, Kim J, Kang T, et al. Ten-year cardiovascular risk changes and major adverse events in gout patients. Rheumatology (Oxford). 2026;65(1):keaf322.
- Ghang BZ, Lee JS, Choi J, et al. Increased risk of cardiovascular events and death in the initial phase after discontinuation of febuxostat or allopurinol: another story of the CARES trial. RMD Open. 2022 Jun;8(2):e001944.
- Kang E, Han KD, Song GG, et al. Increased risk of atrial fibrillation in young adults with gout: a nationwide cohort study. Front Cardiovasc Med. 2026;13:1862887.
- Cipolletta E, Zverkova Sandström T, Rozza D, et al. Treat-to-target urate-lowering treatment and cardiovascular outcomes in patients with gout. JAMA Intern Med. 2026;186(3):332-342
- Ebstein E, Forien M, Norkuviene E, et al. Ultrasound evaluation in follow-up of urate-lowering therapy in gout: the USEFUL study. Rheumatology (Oxford). 2019 Mar 1;58(3):410-417.