Crystalys Therapeutics

Crystalys was co-founded by Catalys Pacific and Novo Holdings and is headquartered in San Diego, California. The leadership team includes President and CEO James Mackay, Ph.D., a veteran with over 40 years in drug development; Chief Medical Officer Nihar Bhakta, M.D.; Chief Operating Officer Ashwin Ram, M.D.; and Executive Director of Operations & Business Development DeAnne Reid. Mackay has a history of leading biotechs, including Ardea Biosciences, which also developed gout treatments. Many of the team members, including Bhakta and Reid, have previous experience in gout drug development from their time at Ardea and Aristea Therapeutics.

The company's core asset is dotinurad, a next-generation, once-daily oral URAT1 inhibitor designed to reduce serum uric acid levels. Dotinurad works by blocking the URAT1 protein in the kidney, which is responsible for the reabsorption of uric acid, thereby increasing its excretion through urine. The drug was originally discovered by Fuji Yakuhin in Japan and is already approved and marketed in Japan, China, the Philippines, and Thailand, where it has been used to treat over 1.2 million patients. Crystalys acquired the U.S. and European rights to dotinurad and aims to position it as a second-line therapy for patients who do not respond adequately to first-line treatments like allopurinol, filling a significant gap in the current market. The FDA has allowed Crystalys to proceed directly to Phase 3 trials, which are expected to yield data in late 2027.