On October 21, 2025, Urica Therapeutics, Inc., a majority‑owned subsidiary of Fortress Biotech, Inc., announced that Crystalys Therapeutics, Inc. has dosed first patients in its two global Phase 3 trials of dotinurad, a next‑generation, once‑daily oral URAT1 inhibitor for gout. The trials, identified as RUBY (NCT07089875) and TOPAZ (NCT07089888), are randomized, double‑blind, multicenter studies designed to evaluate the safety and efficacy of dotinurad versus an active control arm of allopurinol in adults with hyperuricemia associated with gout and tophaceous gout, respectively. The initiation of patient dosing marks a critical milestone that advances the compound toward potential regulatory approval and commercial launch.
Urica holds a minority equity position in Crystalys and is eligible for a 3% royalty on future net sales of dotinurad. This royalty structure directly ties the success of the Phase 3 trials to Fortress’s future revenue streams, underscoring the material impact of the milestone on the company’s diversified portfolio model. The announcement also highlights the strategic value of Fortress’s subsidiary network, which enables the company to generate potential income through equity holdings and royalty agreements while advancing therapeutic candidates across multiple indications.
The press release confirms that the first patient dosing occurred on the day of announcement, providing clear evidence that the event happened today. This new development is not covered in any prior Fortress Biotech articles and represents a tangible step forward for the company’s portfolio, making it a newsworthy event for investors and stakeholders.
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