Crystalys Therapeutics Advances Phase 3 Trials of Dotinurad for the Treatment of Gout with Dosing of First Patient

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Crystalys Therapeutics Advances Phase 3 Trials of Dotinurad for the Treatment of Gout with Dosing of First Patient

San Diego, October 21, 2025

Crystalys Therapeutics Inc, (Crystalys), a clinical-stage biopharmaceutical company focused on transforming the treatment of gout by leveraging Japan’s pharmaceutical innovation with global expertise announced the initiation of global Phase 3 trials of dotinurad, a once-daily oral URAT1 inhibitor, with dosing of the first patients. Crystalys is one of AN Venture Partners’ portfolio companies.

The new trials will evaluate dotinurad’s safety and efficacy in patients with gout who have not responded adequately to first-line therapies, aiming to address significant unmet needs in the US and Europe. Dotinurad has already demonstrated robust safety and efficacy in extensive studies and is approved in Japan, China, the Philippines, and Thailand.

For the full announcement, please see Crystalys Therapeutics’ press release here.

 
About Crystalys Therapeutics

Crystalys Therapeutics is a clinical-stage biopharmaceutical company based in San Diego, California, focused on transforming the treatment of gout. The company’s lead candidate, dotinurad, is a next-generation, once daily oral, URAT1 inhibitor in clinical development as a second-line therapy aimed to reduce uric acid, gout flares and tophi. Dotinurad was invented by Fuji Yakuhin and has obtained regulatory approval in Japan, China, the Philippines and Thailand. With best-in-class potential for both safety and efficacy, dotinurad is supported by clinical data from multiple Asian markets where it is approved. Crystalys is advancing dotinurad in global Phase 3 trials toward regulatory approval and commercial launch.

For more information, visit www.crystalystx.com and follow us on X and LinkedIn.

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