Ascletis Gains FDA Clearance for Once-Monthly Obesity Peptide
Tuesday, June 23rd, 2026 - Ascletis Pharma announced it has received U.S. Food and Drug Administration clearance of its Investigational New Drug application to begin a Phase I study of ASC35, a once-monthly injectable dual GLP-1/GIP receptor agonist for obesity. The company said the trial will evaluate the peptide's safety, tolerability, and pharmacokinetics in healthy volunteers.
Trial Design
The Phase I study consists of two parts, according to company announcements. Part A is a single ascending dose (SAD) study of ASC35 formulated as a Self-Assembling Lipid Depot (SALD) for subcutaneous administration. Part B will assess multiple doses. The SALD technology is designed to enable once-monthly dosing, a potential advantage over currently available weekly GLP-1-based therapies.
Clinical Context
ASC35 joins a crowded field of incretin-based obesity treatments. Currently approved GLP-1 drugs such as semaglutide (Novo Nordisk's Wegovy) and the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly's Zepbound) require weekly injections. Several companies are pursuing longer-acting formulations, including once-monthly candidates, though none have reached late-stage clinical testing.
Regulatory Landscape
The FDA clearance comes amid heightened regulatory scrutiny of peptide products. The agency recently declared the tirzepatide shortage resolved, narrowing the pathway for compounding pharmacies to produce copycat versions. The European Medicines Agency also adopted a new guideline for synthetic peptide development in December 2025, effective this year, providing more explicit chemistry, manufacturing, and controls requirements for the therapeutic class.
Pipeline Competition
Multiple companies are advancing next-generation obesity peptides. Oryn Therapeutics announced Tuesday it is expanding its leadership team to advance its Orynotide macrocyclic peptide platform for immune reprogramming in inflammatory and autoimmune conditions. Separately, a Phase I trial published in Nature Communications tested a mutant KRAS peptide vaccine combined with dual checkpoint blockade in metastatic colorectal cancer, showing the breadth of peptide therapeutic applications beyond metabolic disease.
Related Reading
- Medriva's regulatory tracker for compounded GLP-1 policies: /tracker/
- Clinical review methodology: /clinical-review-methodology/
