Crystalys Raises $130 Million to Advance Gout Drug Development

Crystalys Therapeutics has secured $130 million in an oversubscribed Series B financing round to support the late-stage clinical development and commercialization of its lead gout treatment candidate, dotinurad, as the company moves closer to potential regulatory milestones.

The financing was led by Frazier Life Sciences, with participation from several new and existing healthcare-focused investment firms, reflecting strong investor confidence in the company’s lead program and long-term growth strategy.

Crystalys said the funding will be used to advance the global clinical development of dotinurad, prepare for potential commercialization, and provide the company with sufficient operational funding through multiple anticipated clinical and regulatory milestones.

Dotinurad is a once-daily oral URAT1 inhibitor being developed as a next-generation treatment for gout. The investigational medicine is designed to lower uric acid levels in patients while offering the potential for improved safety and efficacy compared with currently available therapies.

Gout is a common form of inflammatory arthritis caused by the buildup of uric acid crystals in the joints, leading to severe pain, swelling, and inflammation. While several treatments are available, many patients either fail to achieve recommended uric acid targets or cannot tolerate existing medications, creating an ongoing need for safer and more effective treatment options.

Crystalys is currently evaluating dotinurad in a comprehensive late-stage clinical development program that includes two ongoing Phase 3 registration-directed studies, known as RUBY and TOPAZ, as well as the Phase 2 AMETHYST trial.

Together, the studies are designed to evaluate the therapy across a broad range of gout patients, including individuals who have limited treatment options because of intolerance or inadequate response to current therapies. The company believes these trials will provide the clinical evidence needed to support future regulatory submissions while helping define the medicine’s potential role in the treatment landscape.

James Mackay, Ph.D., President and Chief Executive Officer of Crystalys Therapeutics, said the successful financing marks an important milestone as the company enters the next phase of development.

“We are delighted to have the support of this strong syndicate of new investors alongside all of our existing investors as we advance dotinurad through late-stage clinical development and prepare for commercialization,” Mackay said.

He added that the new funding strengthens Crystalys’ ability to continue advancing the RUBY, TOPAZ, and AMETHYST studies while positioning the company to achieve key clinical, regulatory, and commercial milestones.

“Our goal is to bring what we believe could become a best-in-class treatment option to people living with gout,” Mackay said.

Kevin Li, Partner at Frazier Life Sciences, said the investment reflects confidence in both the company’s leadership team and the potential of dotinurad.

“We are pleased to support Crystalys at this important stage of growth,” Li said. “The company has established a strong foundation around a late-stage clinical asset that has the potential to address significant unmet needs in gout. Combined with an experienced management team, we believe Crystalys is well positioned to make a meaningful impact for patients while advancing toward commercialization.”

The financing round attracted participation from a broad group of life sciences investors, including Wellington Management, HBM Healthcare Investments, Soleus Capital, Cormorant Asset Management, Trails Edge Capital Partners, Pivotal bioVenture Partners, and several existing shareholders such as Novo Holdings, SR One, Lightstone Ventures, Longwood Fund, Alexandria Venture Investments, and others.

The strong investor participation underscores growing interest in therapies targeting gout, a disease that affects millions of people worldwide and continues to present treatment challenges despite available medications.

With fresh capital in place, Crystalys plans to accelerate its late-stage clinical program, expand commercialization preparations, and continue working toward regulatory approval of dotinurad. If successful, the investigational therapy could offer patients a new once-daily oral treatment that addresses persistent unmet needs in gout management through improved efficacy and safety.