ASC36 / Ascletis - LARVOL DELTA

Ascletis Selects Oral Amylin Receptor Peptide Agonist, ASC36, for Clinical Development (PRNewswire) - "In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once-daily dosing for 7 days. ASC36 tablets also reduced food intake significantly. In a head-to-head diet-induced obese (DIO) rat model, ASC36 demonstrated approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively....Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets for the treatment of obesity in the second quarter of 2026."

IND • Preclinical • Obesity

Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development (PRNewswire) - "ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study, while ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study....Co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction....Submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for co-formulation of ASC36 and ASC35 is expected in the second quarter of 2026."

IND • Preclinical • Obesity

Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development (PRNewswire) - "Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026....In a head-to-head diet-induced obese (DIO) rat study, which is well established as being highly predictive of human efficacy, dosed with equal molar concentrations of ASC36 and petrelintide, ASC36 reduced body weight by 10.01%, compared to 5.25% for petrelintide..."

IND • Preclinical • Obesity