Ascletis’ ASC37 Triple Agonist Delivers 88% Greater Weight Loss Than Tirzepatide; Monthly Injection and Oral BLA Filings Planned for 2026

Bulletin Express
07/27

Ascletis Pharma Inc. (Ascletis) released pre-clinical data showing its next-generation GLP-1R/GIPR/GCGR triple peptide agonist, ASC37, achieved substantially higher weight reduction than Eli Lilly’s dual agonist tirzepatide in a diet-induced obese (DIO) mouse model.

In an 11-day study, daily subcutaneous doses of 1 nmol/kg produced a 14.10% total body-weight decrease with ASC37 versus 7.50% with tirzepatide—an 88% relative improvement (p = 0.0279). Dose escalation to 10 nmol/kg and 30 nmol/kg generated 30.10% and 41.50% weight-loss, representing 301% and 453% greater reductions than tirzepatide (both p < 0.0001).

ASC37 comprises 41 alpha amino acids, classifying it as a biologic. Ascletis plans to submit Investigational New Drug applications for both a once-monthly self-administration subcutaneous (SQ) formulation and an oral formulation in the third quarter of 2026, followed by biologics license applications (BLAs) after Phase III completion. ASC35, the company’s GLP-1R/GIPR dual peptide agonist with the same amino-acid length, will also follow the BLA route.

Pharmacokinetic data from non-human primate studies show ASC37’s Self-Assembly Lipid Depot (SALD) formulation has an average observed half-life of roughly 17 days, compared with 2.5 days for retatrutide, indicating a seven-fold extension supportive of once-monthly or less frequent dosing.

As a biologic, ASC37 may qualify for 13 years of exemption from U.S. government price negotiations under the Inflation Reduction Act, versus nine years for small molecules, and is not subject to pharmacy compounding pathways.

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