Crystalys launches with $205M to bring next-gen gout drug global

Crystalys Therapeutics raised $205M to launch global Phase 3 trials for dotinurad, a gout drug already approved in parts of Asia but not yet tested broadly outside the region.

Why it matters: Gout affects 56M+ people worldwide, and half of those on first-line treatments, like allopurinol, still suffer flare-ups. Current second-line options, like Krystexxa, are limited, expensive, or risky, leaving a major treatment gap. Despite Krystexxa, making $1.2B last year, the drug is costly and requires infusions. This offers a major profit opportunity for dotinurad.

Backstory: Dotinurad, developed in Japan by Fuji Yakuhin and approved since 2020, is already marketed by Eisai in China, the Philippines and Thailand. Dotinurad works by blocking uric acid reabsorption more precisely and gently than older drugs. Crystalys acquired U.S. and European rights last year and convinced the FDA to allow Phase 3 trials based on Asian data.

Dream team: Crystalys is in good hands with their CEO, James Mackay, who previously helped launch the gout drug Zurampic and has experience in administering the creation of this kind of medicine. Alongside the CEO, Crystalys has convinced a top crowd of investors that includes Novo Holdings, SR One, and Catalys Pacific.

Big picture: As demand for better gout therapies grows, Crystalys enters a competitive but underserved space with a safer alternative. The biotech joins others, like Arthrosi, racing to fill the second-line treatment void.