- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC37 was approximately 17 days, 7-fold longer than retatrutide, which supports once-monthly subcutaneous (SQ) dosing in humans.
- ASC37's average in vitro activity was approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively.
- Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 injection is expected in the second quarter of 2026.
HONG KONG, Jan. 20, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/GIPR/GCGR[1] triple peptide agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 injection for the treatment of obesity in the second quarter of 2026.
ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, was discovered and developed in-house utilizing Ascletis' Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. ASC37's average in vitro activity was approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively. ASC37 is engineered for a longer observed half-life (as measured by time to 50% Cmax), compared to once-weekly administered retatrutide, to support once-monthly subcutaneous (SQ) dosing, with injection volume of one milliliter or less. These engineered properties also allow for scalability advantages in manufacturing.
In head-to-head non-human primate (NHP) studies, ASC37 proprietary SQ depot formulations had an average observed half-life of approximately 17 days, 7-fold longer than retatrutide in the standard liquid formulation.
ASC37 injection's superior in vitro potency and longer observed half-life compared to retatrutide demonstrate its potential as a next-generation treatment for obesity.
"With ASC37, we are advancing a potentially more potent, next-generation triple agonist into the clinic which supports once-monthly dosing," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "Expected initiation of our Phase I study in the second half of 2026 will be another step in our comprehensive strategy to improve the treatment options for people with obesity."
Potential Combination Studies with ASC37 Injection
ASC37 injection is being developed as a monotherapy and in combination for the treatment of cardio-metabolic diseases including obesity, diabetes and metabolic dysfunction-associated steatohepatitis (MASH). Ascletis plans to combine ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, with its ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist to treat obesity, diabetes and other metabolic diseases.
Ascletis' AISBDD and ULAP technologies enable the Company to design, optimize and develop multiple once-monthly SQ ultra-long-acting peptides, including ASC35, ASC36 and ASC37. Based on the properties of peptides, the Company can design, through its proprietary ULAP technology, various slow-release constants (k) for peptides in SQ depots to precisely release injected peptides over desired dosing intervals to reduce peak-to-trough ratios and improve clinical outcomes.
[1] GLP-1R: glucagon-like peptide 1 receptor, GIPR: gastric inhibitory polypeptide receptor, GCGR: glucagon receptor
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
[email protected]
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
[email protected]
[email protected]
SOURCE Ascletis Pharma Inc.
