HONG KONG, July 6, 2026
Ascletis Pharma Inc. has announced the submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for its next-generation obesity therapies, ASC36 and ASC36_35 FDC, marking another significant milestone in the rapidly evolving metabolic disease treatment landscape. The IND applications cover ASC36, a once-monthly to once-quarterly peptide amylin receptor agonist, and ASC36_35 FDC, a potentially first-in-class once-monthly fixed-dose combination (FDC) that combines ASC36 with the peptide GLP-1R/GIPR agonist ASC35. Designed to target three validated obesity pathways—amylin receptor, GLP-1 receptor, and GIP receptor—the investigational therapy aims to deliver superior weight-loss efficacy while significantly reducing injection frequency. The submissions strengthen Ascletis’ expanding obesity pipeline and highlight the company’s continued investment in artificial intelligence-driven drug discovery and ultra-long-acting peptide technologies, two areas attracting substantial attention across the global biopharmaceutical industry.
Triple-Target Therapy Demonstrates Superior Preclinical Weight Loss
According to Ascletis, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction than the co-administration of eloralintide and tirzepatide in head-to-head diet-induced obese (DIO) rat studies, which are widely considered predictive of human efficacy. Unlike current combination approaches requiring two separate weekly injections, the investigational therapy delivers one convenient monthly subcutaneous injection, potentially improving patient adherence while maintaining robust therapeutic activity. The fixed-dose combination simultaneously activates the amylin receptor, GLP-1 receptor, and GIP receptor, providing a comprehensive metabolic approach designed to maximize weight reduction.
In addition, ASC36 monotherapy outperformed leading amylin receptor agonists, achieving approximately 91% greater relative body weight reduction than petrelintide and 32% greater reduction than eloralintide in comparative DIO rat studies. These encouraging preclinical findings position Ascletis among companies pursuing next-generation obesity medicines beyond conventional GLP-1 therapies.
AI-Driven Discovery and Ultra-Long-Acting Technology Power Pipeline
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Both ASC36 and ASC35 were discovered using Ascletis’ proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) platform, enabling rapid identification and optimization of peptide drug candidates. The therapies also utilize the company’s proprietary Ultra-Long-Acting Platform (ULAP) through Self-Assembling Lipid Depot (SALD) formulations, allowing sustained drug release after administration.
In non-human primate studies, the ASC36 SALD formulation demonstrated an observed half-life approximately six times longer than eloralintide, supporting the potential for once-monthly to once-quarterly dosing in humans. Similarly, the ASC36_35 SALD co-formulation maintained prolonged half-lives for both active components, supporting convenient monthly administration. The formulations also demonstrated excellent chemical and physical stability, with no aggregation or precipitation at neutral pH, supporting future large-scale manufacturing and long-term product stability.
FDA IND Submissions Expand Ascletis’ Obesity Development Strategy
The latest IND submissions build upon Ascletis’ recent regulatory success after the U.S. FDA cleared the IND application for ASC35 in June 2026, enabling initiation of a Phase I clinical trial evaluating the company’s once-monthly GLP-1R/GIPR dual agonist for obesity. Together, these regulatory milestones reinforce Ascletis’ strategy of developing first-in-class and best-in-class metabolic therapies that combine artificial intelligence, precision peptide engineering, and ultra-long-acting drug delivery technologies.
As demand for innovative obesity treatments continues to accelerate worldwide, therapies capable of providing greater efficacy with less frequent dosing are becoming increasingly attractive for patients, physicians, and healthcare systems. The FDA review of ASC36 and ASC36_35 FDC will represent an important next step in determining whether these investigational therapies can advance into clinical development and potentially redefine long-term obesity management through monthly injectable precision therapeutics.
Source: Ascletis Pharma press release
