Ascletis Pharma Selects ASC35 as Once-Monthly GLP-1/GIP Dual Agonist Candidate for Obesity Treatment

Ascletis Pharma Inc. (HKEX: 1672) has unveiled ASC35, a next-generation GLP-1/GIP dual peptide agonist designed for once-monthly subcutaneous dosing in obesity treatment.
The company expects to file an IND with the U.S. FDA in Q2 2026.

Engineered for Potency and Duration

Discovered through Ascletis’ AI-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP), ASC35 combines extended half-life with high potency.

• In vitro, ASC35 was ~4× more potent than tirzepatide for both GLP-1R and GIPR activation.
• In non-human primate (NHP) studies, ASC35’s half-life was ~14 days — 6× longer than tirzepatide.
• ASC35 showed 70–80% higher drug exposure (AUC) than tirzepatide via both I.V. and S.Q. routes.

These results support once-monthly dosing in humans with sub-1 mL injection volumes—a strong patient convenience advantage.

Translating Preclinical Data to Human Potential

The NHP-to-human pharmacokinetic scaling suggests ASC35 may achieve a 30-day half-life or longer in humans. Its flatter PK profile could also mean fewer gastrointestinal side effects, a common issue with current incretin therapies.

Superior Weight Loss in Preclinical Models

In head-to-head DIO mouse studies, ASC35 outperformed tirzepatide significantly:

 “The preclinical characterization of ASC35 suggests best-in-class efficacy with once-monthly dosing and a more flexible titration schedule.”

• Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis.

Expanding the Metabolic Pipeline

Ascletis plans to develop ASC35 both as a monotherapy and in combinations for obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH).

Planned combinations include:

• ASC35 + ASC36: GLP-1R/GIPR dual agonist + amylin receptor agonist
• ASC35 + ASC47: GLP-1R/GIPR dual agonist + THRβ agonist for adipose targeting

Both ASC36 and ASC47 are once-monthly injectable peptides developed on the ULAP platform.

The Bigger Picture

With superior half-life, bioavailability, and potency, ASC35 positions Ascletis at the forefront of next-generation incretin therapeutics, aiming to challenge weekly GLP-1s like tirzepatide with a monthly, longer-acting alternative.

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