May 28, 2026 – BioDuro congratulates Gilva Therapeutics on receiving approval in Australia to initiate a Phase I clinical trial for GV-100, a novel oral selective HDAC6 inhibitor for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
According to Gilva, GV-100 demonstrated promising efficacy and safety in preclinical studies and represents a differentiated therapeutic approach targeting HDAC6-related disease pathways.
BioDuro has established a broad collaboration with Gilva spanning discovery through CMC. For the GV-100 IND-enabling program, BioDuro provided services including API process development and production, pre-formulation studies, and integrated project management.
The successful advancement of GV-100 into clinical development underscores the strong collaboration between the two companies and BioDuro's capabilities in supporting IND-enabling development programs toward global markets.
For more information about Gilva's announcement, please visit: Gilva Therapeutics Official News Release
About BioDuro
BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.
About Gilva Therapeutics
Gilva Therapeutics is a Taiwan-based biopharmaceutical company focused on the development of innovative small molecule therapies for unmet medical needs, particularly in rare diseases. The company's development platform combines drug discovery expertise with translational and clinical development capabilities to advance differentiated therapeutic candidates.
Media Enquiries
Christina Coby
Associate Director, Marketing, BioDuro
Email: christina.coby@bioduro.com
Mobile: +1 (619) 414 7409
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