CrystalisTherapeutics has secured $130 million in Series B financing to advance late-stage development of its gout therapy, dotinurad, while also supporting preparations for a possible commercial release.
The funding round follows the company’s emergence from stealth in September 2025, when it raised a $205 million Series A financing.
The latest investment was led by Frazier Life Sciences, with new backing from HBM Healthcare Investments, Wellington Management, Soleus Capital and Cormorant Asset Management, alongside several other investors. Existing supporters, including Catalys Pacific, Novo Holdings and SR One, also participated in the financing.
Chief Executive Officer James Mackay said the fundraising was completed remarkably quickly, noting that the sizeable Series A completed last year had attracted considerable attention from investors who had previously chosen not to participate.
The newly raised capital will finance two ongoing registration-directed phase 3 studies, continue the phase 2 Amethyst trial, and help the company build the infrastructure needed for a potential product launch. Crystalys expects the financing to provide sufficient resources to reach several important clinical and regulatory objectives.
Dotinurad is a once-daily oral urate transporter 1 (URAT1) inhibitor that lowers uric acid levels by increasing its excretion through the kidneys. Elevated uric acid can form crystals within joints, triggering the painful inflammation characteristic of gout.
Mackay said that dotinurad is a highly de-risked asset because it has already received regulatory approval in multiple Asian countries. Originally developed by Fuji Yakuhin, the therapy is currently approved in Japan, China, Thailand, Taiwan and the Philippines.
Crystalys obtained global rights to dotinurad from Urica Therapeutics in July 2024. As part of the agreement, Urica received common shares representing 35% of Crystalys’ outstanding equity, along with a 3% royalty on future sales.
Leveraging clinical evidence generated in Asia together with earlier U.S. studies, the company gained regulatory agreement to proceed directly into pivotal development in both the U.S. and Europe. The Phase 3 Ruby trial is having dotinurad go head-to-head with allopurinol in patients with hyperuricemia associated with gout, while the Phase 3 Topaz study is evaluating the same treatments in people with tophaceous gout.
Current FDA-approved urate-lowering therapies include the xanthine oxidase inhibitors febuxostat and allopurinol. Febuxostat carries a boxed warning highlighting an increased risk of cardiovascular death in patients with established cardiovascular disease and is generally reserved for individuals who cannot tolerate allopurinol, fail to respond adequately to it, or are unsuitable candidates for the drug.
Mackay said only about 50% of patients receiving existing first-line therapies achieve recommended treatment targets. For those whose chronic gout remains uncontrolled despite xanthine oxidase inhibitor treatment, Krystexxa, an intravenous therapy administered every two weeks in combination with weekly methotrexate, remains one of the few available options. He said this leaves a substantial unmet need for additional second-line treatments.
Founded in San Diego in 2022, Crystalys was established by Mackay, Catalys Pacific,Novo Holdings and other members of the company’s leadership team. Mackay previously served as chief executive of Aristea Therapeutics, an AstraZeneca spinout that closed in 2023 after safety issues emerged during clinical testing of its lead inflammatory disease candidate.
Crystalis has successfully raised $130 million in a new financing round to support the Phase 3 clinical development of its investigational gout treatment. The investment provides the company with the financial resources needed to complete late-stage studies, expand clinical operations, and prepare for future regulatory submissions if the therapy continues to demonstrate positive results.
Crystalis Secures $130 Million to Advance Phase 3 Development
The latest funding marks an important milestone for Crystalis as it transitions its lead gout therapy into Phase 3 clinical trials. The capital will help accelerate patient enrollment, strengthen global trial execution, and support manufacturing activities required for large-scale clinical studies. Investors continue to show confidence in the company’s ability to address unmet needs in gout treatment
Gout remains a common inflammatory disease affecting millions of people worldwide. Crystalis is developing a therapy designed to improve disease management while addressing limitations associated with current treatment options. If Phase 3 studies confirm earlier clinical findings, the investigational therapy could become an important addition to the growing range of treatments available for patients with chronic gout.
Beyond the lead program, the successful financing also positions Crystalis to continue expanding its broader research pipeline. Strong financial backing enables biotechnology companies to maintain development momentum, attract strategic partnerships, and invest in future innovation across multiple therapeutic areas.
