Hong Kong, July 27, 2026
Ascletis Pharma Inc. announced that its investigational ASC37, a next-generation GLP-1R/GIPR/GCGR triple peptide agonist, achieved statistically significant superior weight loss compared with tirzepatide in a diet-induced obese (DIO) mouse model. After 11 days of treatment at an identical dose of 1 nmol/kg, ASC37 produced an 88% greater relative body weight reduction than tirzepatide. The study also demonstrated dose-dependent weight loss of up to 41.5%, highlighting the therapy’s strong preclinical efficacy. The findings strengthen Ascletis’ efforts to develop long-acting obesity treatments capable of delivering meaningful and sustained weight reduction with less frequent dosing.
Once-Monthly Therapy Designed for Long-Acting Weight Management
ASC37 has been engineered with 41 alpha amino acids, qualifying it as a biologic rather than a small-molecule therapy. According to the company, the investigational drug is being developed in both once-monthly subcutaneous (SQ) and oral formulations, with Investigational New Drug (IND) applications planned for the third quarter of 2026. Following successful clinical development, Ascletis intends to submit Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for both formulations after completion of Phase III clinical trials. Preclinical studies also demonstrated that ASC37’s Self Assembly Lipid Depot (SALD) formulation achieved an average half-life of approximately 17 days in non-human primates, compared with 2.5 days for retatrutide, supporting the potential for once-monthly or even less frequent dosing. This extended duration could improve patient convenience and long-term adherence in chronic obesity management.
Biologic Development Strategy Offers Regulatory Advantages
Ascletis believes ASC37’s biologic classification provides important strategic and commercial advantages. Under the U.S. Inflation Reduction Act, biologic medicines receive 13 years of exemption from government price negotiations, compared with nine years for small-molecule drugs, offering a longer period of market exclusivity. In addition, biologics generally cannot be compounded by third-party pharmacies, reducing the likelihood of lower-cost compounded alternatives entering the market. The company noted that its ASC35 GLP-1R/GIPR dual peptide agonist, which also contains 41 alpha amino acids, will follow the same BLA regulatory pathway, reinforcing its long-term strategy of developing innovative biologic therapies for metabolic diseases.
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Ascletis Expands Next-Generation Obesity Pipeline
The encouraging preclinical results for ASC37 further strengthen Ascletis’ expanding portfolio of next-generation obesity and metabolic disease therapies. Leveraging its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP), and Peptide Oral Transport ENhancement Technology (POTENT), the company is advancing multiple investigational candidates targeting chronic weight management. These include ASC30, ASC35, ASC36, ASC37, ASC39, and several fixed-dose combination programs designed to improve efficacy and patient convenience. While ASC37 remains in the preclinical stage, its superior weight-loss performance, extended half-life, and planned once-monthly dosing position it as a promising candidate in the rapidly evolving obesity treatment landscape, with regulatory submissions expected to begin later in 2026.
Source: Ascletis Pharma press release
