Ascletis Pharma, a biotechnology company based in Hangzhou, China, has submitted two Investigational New Drug (IND) applications to the US Food and Drug Administration (FDA) for innovative obesity treatments.
The applications cover ASC36, a potentially first-in-class once-monthly to once-quarterly subcutaneous (SQ) injection targeting the amylin receptor, and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 and ASC35 that targets three validated pathways: the amylin receptor, glucagon-like peptide-1 receptor (GLP-1R), and glucose-dependent insulinotropic polypeptide receptor (GIPR).
Both candidates use Self-Assembling Lipid Depot (SALD) formulations developed in-house through Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
Commenting on the development, Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, said that while the combination of eloralintide and tirzepatide recently achieved 29 per cent weight loss at Week 32, it requires two separate weekly injections. In contrast, ASC36_35 FDC, which targets the amylin receptor, GLP-1R and GIPR, requires only a single once-monthly injection.
Wu added that in a head-to-head diet-induced obese (DIO) rat study, ASC36_35 FDC demonstrated approximately 51 per cent greater relative body weight reduction than the co-administration of eloralintide and tirzepatide, noting that these animal models are considered highly predictive of human efficacy.
Both ASC36 and ASC35 were discovered using Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD).
In non-human primate studies, the SALD formulation of ASC36 showed an observed half-life approximately six times longer than eloralintide, supporting the potential for once-monthly to once-quarterly administration in humans. The ASC36_35 FDC SALD co-formulation also demonstrated prolonged half-lives for both components, supporting once-monthly dosing in humans.
Preclinical studies have also highlighted the candidates’ efficacy. In head-to-head DIO rat studies, ASC36 monotherapy achieved approximately 91 per cent greater relative body weight reduction than petrelintide and 32 per cent greater reduction than eloralintide. Meanwhile, the ASC36_35 co-formulation outperformed the combination of eloralintide and tirzepatide by approximately 51 per cent in relative body weight reduction.
According to the company, both formulations demonstrated excellent chemical and physical stability, with no aggregation or precipitation caused by fibrillation at neutral pH.
The two new IND submissions build on the recent progress of ASC35. In June 2026, Ascletis received U.S. FDA clearance to begin a Phase I clinical trial evaluating ASC35 as a once-monthly subcutaneous treatment for obesity.
