Ascletis Files Two FDA INDs for Once-Monthly Obesity Drugs Targeting Amylin, GLP-1R, and GIPR
The filings build on preclinical data showing stronger weight loss and longer half-lives, while Ascletis says ASC36_35 may need only one monthly injection.
- Ascletis Pharma Inc. recently submitted two Investigational New Drug applications to the U.S. Food and Drug Administration for obesity candidates ASC36 and ASC36_35 FDC.
- Both candidates utilize Ascletis' Ultra-Long-Acting Platform technology and Self-Assembling Lipid Depot formulations, enabling once-monthly to once-quarterly subcutaneous administration.
- In head-to-head diet-induced obese rat studies, ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight reduction versus petrelintide and eloralintide, while ASC36_35 FDC showed 51% greater reduction.
- "ASC36_35 FDC requires only one monthly injection," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, highlighting the co-formulation's convenience advantage.
- These submissions follow recent Phase I clearance for ASC35 in June 2026, advancing Ascletis' metabolic pipeline developed through Artificial Intelligence-Assisted Structure-Based Drug Discovery technology.
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36 Articles
Ascletis Submits Two IND Applications to U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35 | Taiwan News | Jul. 6, 2026 08:10
Jul. 6, 2026 08:10
Williamson Herald
Ascletis Submits Two IND Applications to the U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35
ASC36_35 FDC, a once-monthly subcutaneous (SQ) injection co-formulation of ASC36 and ASC35, is a potentially first-in-class drug candidate targeting three validated targets of amylin receptor, GLP-1R and GIPR.ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the…
Ascletis files two FDA INDs for once-monthly obesity drugs targeting amylin, GLP-1R, and GIPR
HONG KONG, July 6, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. "…
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