Crystalys Therapeutics Raises $130 Million to Advance Phase 3 Development of Dotinurad for Gout

Crystalys Therapeutics has secured $130 million in an oversubscribed Series B financing to accelerate the late-stage clinical development and commercialization preparation of dotinurad, an investigational once-daily oral urate transporter 1 (URAT1) inhibitor for gout. The funding will support the company’s ongoing Phase 3 registration-directed program, including the pivotal RUBY and TOPAZ studies, as well as the Phase 2 AMETHYST trial, while extending operations through multiple anticipated clinical and regulatory milestones.

Dotinurad Targets a Key Treatment Gap in Gout

Dotinurad is a next-generation, once-daily oral URAT1 inhibitor that lowers serum uric acid by blocking urate reabsorption in the kidneys, thereby increasing urinary uric acid excretion. The therapy is being developed as a potential second-line treatment for patients whose disease remains inadequately controlled with conventional urate-lowering therapies.

Despite the availability of xanthine oxidase inhibitors, many patients fail to achieve or maintain the recommended serum uric acid target of below 6 mg/dL, increasing the risk of recurrent flares, chronic inflammation, and tophaceous gout. In the United States and Europe, treatment options between first-line oral therapies and intravenous uricase remain limited, creating a significant unmet medical need.

Phase 3 Program Supports Global Registration

Crystalys’ clinical development program is evaluating dotinurad across a broad spectrum of patients with gout, including individuals with limited treatment options. Although the company did not disclose efficacy or safety findings in this financing announcement, the ongoing registration-directed studies are expected to generate the evidence required to support future regulatory submissions and commercialization.

The new capital will also support manufacturing scale-up, regulatory activities, and commercial launch preparations as the program advances through late-stage development.

Financing Strengthens Path Toward Commercialization

The oversubscribed financing was led by Frazier Life Sciences, with participation from Wellington Management, HBM Healthcare Investments, Soleus Capital, Cormorant Asset Management, Trails Edge Capital Partners, Pivotal bioVenture Partners, KCap Biotechnology Fund, and all existing investors, including Novo Holdings, SR One, Catalys Pacific, Perceptive Xontogeny Venture Funds, Lightstone Ventures, AN Venture Partners, funds managed by abrdn Inc., KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners, and Prebys Ventures Fund.

Crystalys President and Chief Executive Officer James Mackay, Ph.D., said the financing provides the resources needed to advance the company’s late-stage clinical program while supporting regulatory activities and commercial readiness. He added that the investment positions Crystalys to reach multiple clinical and regulatory milestones and advance a potential best-in-class oral treatment option for people living with gout.

Kevin Li, Partner at Frazier Life Sciences, said the investment reflects confidence in dotinurad’s late-stage clinical program, the company’s experienced leadership team, and its potential to address persistent unmet needs in gout management.

Path Forward

With its latest financing completed, Crystalys plans to continue advancing its late-stage clinical development program while expanding regulatory and commercial readiness activities. The company expects the funding to support operations through several upcoming clinical and regulatory milestones as it moves dotinurad toward potential global commercialization.

Reference

Crystalys Therapeutics Announces $130 Million Series B Financing to Advance Global Phase 3 Development and Commercialization of Dotinurad for Gout