Gannex, a wholly owned company of Ascletis Pharma Inc (HKEX: 1672), announced on Wednesday that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application and initiation of global development of ASC41 oral tablet, a liver-targeted prodrug.
The product is a selective thyroid hormone receptor beta (THR-beta) agonist.
The approval was based on efficacy and safety data from the phase one randomised, double-blind, placebo controlled single- and multiple-ascending dose study in 65 patients completed in China and commercially ready oral tablet formulation developed with in-house proprietary technology.
The approval allows the firm to commence clinical trials in the United States.
Krystal Biotech receives FDA approval for updated VYJUVEK label
Renalytix signs collaboration agreement with Tempus AI to expand KidneyIntelX.dkd access
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA