HONG KONG, June 23, 2026
Ascletis Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for the company’s Phase I clinical trial evaluating ASC35, a once-monthly subcutaneous GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist being developed for the treatment of obesity. The randomized, double-blind, placebo-controlled study will enroll 84 participants with obesity or overweight accompanied by weight-related comorbidities to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35. The study consists of two parts, including a single ascending dose (SAD) evaluation of the company’s proprietary Self-Assembling Lipid Depot (SALD) formulation and a multiple ascending dose (MAD) head-to-head comparison with the FDA-approved once-weekly tirzepatide formulation. The IND clearance marks a significant milestone as Ascletis expands its pipeline of long-acting metabolic disease therapies.
Preclinical Results Demonstrate Strong Weight-Loss Potential
ASC35 was discovered using Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) platform and formulated through the company’s proprietary Ultra-Long-Acting Platform (ULAP) technology. According to preclinical studies, the investigational therapy demonstrated an average half-life approximately six times longer than tirzepatide in non-human primates (NHPs), supporting the potential for once-monthly subcutaneous dosing. In addition, ASC35 achieved approximately 70% to 80% higher drug exposure than tirzepatide in intravenous and subcutaneous studies. In a diet-induced obese (DIO) mouse model, ASC35 produced approximately 71% greater relative body weight reduction than tirzepatide when administered at equal molar doses. Laboratory testing also showed the peptide to be approximately four times more potent than tirzepatide at both the GLP-1R and GIPR targets, highlighting its potential to deliver enhanced efficacy while requiring lower peptide doses.
SALD Platform Designed to Improve Patient Convenience
The investigational SALD formulation is designed to provide sustained drug release through a low-viscosity injectable solution composed of lipids, biocompatible solvents, and the active pharmaceutical ingredient. Following subcutaneous administration, the formulation forms a gel-like depot that gradually degrades within the tissue, releasing the drug over a period of one month or longer. The technology enables administration using a standard injection pen or auto-injector with a fine 29-gauge needle, offering a potentially more convenient treatment option compared with weekly injectable therapies. Researchers also believe the longer half-life and flatter pharmacokinetic profile observed in preclinical studies may improve gastrointestinal tolerability, one of the most common challenges associated with incretin-based obesity treatments. These features could support better patient adherence while addressing the growing demand for long-acting metabolic therapies.
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Ascletis Expands AI-Driven Pipeline for Obesity Therapies
The FDA IND clearance positions Ascletis to begin clinical evaluation of another promising candidate within its expanding obesity pipeline. The company is leveraging its AISBDD, ULAP, and Peptide Oral Transport ENhancement Technology (POTENT) platforms to develop multiple next-generation therapies targeting chronic weight management. According to Founder, Chairman, and CEO Jinzi Jason Wu, Ph.D., the advancement of ASC35 represents an important step toward delivering once-monthly and potentially once-quarterly injectable treatments that combine improved efficacy with greater convenience for patients. As the global obesity market continues to grow rapidly, successful clinical development of ASC35 could strengthen Ascletis’ position in the competitive GLP-1-based therapeutics landscape while offering healthcare providers and patients a differentiated long-acting treatment option for chronic weight management.
Source: Ascletis press release
