Ascletis Pharma-B announced that its Investigational New Drug (IND) for once-monthly subcutaneous injection of the GLP-1R/GIPR dual-target agonist peptide ASC35 for the treatment of obesity has received FDA approval in the United States. – QQ News

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Zhitong Finance APP News, Ascletis Pharma-B (01672) announced that it has recently received Investigational New Drug (IND) approval from the U. S. Food and Drug Administration (FDA) for its Phase I study of ASC35. ASC35 is a potential best-in-class, once-monthly subcutaneous GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual-target agonist peptide for the treatment of obesity. This Phase I trial is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 in 84 obese (BMI ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²) subjects with weight-related comorbidities, following single-dose and multiple-dose escalation administration. The Phase I trial is divided into two parts. Part A presents a single-dose escalation (SAD) study of the ASC35 self-assembled lipid reservoir (SALD) monthly formulation; Part B presents a head-to-head multi-dose escalation (MAD) study comparing the ASC35 SALD monthly formulation with the FDA-approved telpolide weekly formulation. In vitro studies showed that ASC35 exhibits approximately 4 times stronger agonistic activity against GLP-1R and GIPR than telpolide. Combined with all preclinical studies, ASC35 demonstrates superior efficacy per milligram peptide compared to telpolide. "The FDA approval for clinical trials of ASC35, a monthly formulation developed using our proprietary SALD formulation technology, is an exciting and significant milestone in Ascletis's peptide pipeline for treating obesity. We are currently advancing several peptides for once-monthly to once-quarterly subcutaneous injections into clinical trials, " said Dr. Jinzi Wu, Founder, Chairman, and CEO of Ascletis. "ASC35's exceptional weight loss potential, combined with a more flexible and patient-friendly once-monthly subcutaneous injection method, promises to address a significant unmet need in the rapidly growing obesity market. " Published on June 23,2026 at 18: 06 by a Guangdong finance-related creator.