2026/05/04 Gilva Therapeutics’GV-100 Phase 1 Clinical Trial Application Approved in Australia

Gilva Therapeutics INC. announces that its lead drug candidate, GV-100, has received approval for its Phase 1 clinical trial application in Australia and will proceed into clinical evaluation in healthy participants. The study is a randomized, double-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic profile of GV-100 in healthy participants. The trial will include single ascending dose, multiple ascending dose, food-effect, and drug-drug interaction evaluations.
GV-100 is an orally available, structurally innovative small-molecule HDAC6 inhibitor developed by Gilva Therapeutics, with a primary focus on autosomal dominant polycystic kidney disease (ADPKD) and other diseases with significant unmet medical needs. ADPKD is one of the most common inherited kidney diseases and may lead to progressive kidney enlargement, declining kidney function, and ultimately end-stage kidney disease. Approval of the Phase 1 clinical trial application in Australia represents an important milestone in the development of GV-100 and marks its transition into clinical-stage development.
Gilva Therapeutics will continue to advance the clinical execution of GV-100 and support its future clinical development in ADPKD and potential global partnership opportunities.