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Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC37 oral tablets, its first oral 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 oral tablets for the treatment of obesity in the second quarter of 2026.
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"- Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability of 4.2%, approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide in the oral SNAC formulation, respectively, in head-to-head non-human primate (NHP) studies.","length":338,"tagName":"p"},{"type":"text","content":"- ASC37 oral tablets' drug exposure, as measured by the area under curve (AUC), was approximately 57-fold of retatrutide's drug exposure in head-to-head NHP studies.","length":173,"tagName":"p"},{"type":"text","content":"- Average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP studies, supporting once daily and less frequent oral dosing. ","length":146,"tagName":"p"},{"type":"text","content":"- ASC37 in vitro activity was approximately 5-, 4- and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively.","length":131,"tagName":"p"},{"type":"text","content":"- Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets is expected in the second quarter of 2026.","length":174,"tagName":"p"},{"type":"text","content":"- The Company will host a conference call in Mandarin at 10:00 a.m. China Standard Time on December 1, 2025. ","length":108,"tagName":"p"},{"type":"text","content":"HONG KONG, Nov. 30, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC37 oral tablets, its first oral 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 oral tablets for the treatment of obesity in the second quarter of 2026.","length":461,"tagName":"p"},{"type":"text","content":"ASC37 oral tablets is the Company's first incretin drug candidate developed with its proprietary Peptide Oral Transport ENhancement Technology (POTENT).","length":156,"tagName":"p"},{"type":"text","content":"ASC37, a GLP-1R, GIPR, and GCGR triple peptide agonist, was discovered and optimized in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). ASC37 in vitro activity was app...