ArticleDrug design, development and therapy2025
A Phase I Dose-Escalation Study of the Pharmacokinetics, Pharmacodynamics, and Safety of a Single Oral Dose of Tigulixostat.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Aim: Tigulixostat is a promising selective xanthine oxidase inhibitor under clinical development for the treatment of hyperuricemia. The aim of this study was to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of tigulixostat, along with its primary active metabolite, GD-MET-1, following single oral administration in healthy Chinese subjects. Methods: A single center, open-label, dose-escalation study was conducted in healthy Chinese subjects who received single oral doses of tigulixostat ranging from 25 to 300 mg. Serial blood and urine samples were collected for PK and PD analysis. Safety was monitored throughout the study. Results: Thirty subjects were enrolled, with six subjects per dose group. Tigulixostat exhibited dose-proportional increases in both maximum plasma concentration (C Conclusion: These findings demonstrate that tigulixostat exhibits approximately dose-proportional PK, with linear elimination and predictable exposure across the 25-300 mg range. A dose-dependent reduction in serum uric acid was observed up to 200 mg, with a plateau effect at 300 mg. The PK profile of GD-MET-1 indicated lower systemic exposure and less consistent dose proportionality compared with the parent compound, suggesting a supportive rather than dominant role in PD activity. The favorable safety and tolerability profile reinforces tigulixostat's potential as a novel therapeutic agent for the management of hyperuricemia.
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