Ascletis Files Two FDA IND Applications for Long-Acting Obesity Drug Candidates

Ascletis Pharma Inc. has announced the submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for two long-acting obesity treatment candidates.

The applications cover ASC36, a next-generation peptide amylin receptor agonist designed for once-monthly to once-quarterly injections, and ASC36_35 FDC, a once-monthly fixed-dose combination of ASC36 and the company's GLP-1R/GIPR agonist ASC35.

The company believes these programs could offer a more convenient treatment option by reducing the number of injections required for patients living with obesity.

A single monthly injection instead of weekly dosing

According to Ascletis, many combination obesity treatments currently under development require two separate weekly injections. One example is the combination of eloralintide and tirzepatide, which recently reported strong weight-loss results.

Ascletis says its ASC36_35 FDC is designed differently. Instead of two weekly injections, the company is developing a single monthly subcutaneous injection that targets three important metabolic pathways through the amylin receptor, GLP-1 receptor, and GIP receptor.

The company believes this approach could improve convenience while maintaining strong weight-loss potential.

Preclinical studies showed encouraging weight-loss results

Ascletis reported positive findings from head-to-head diet-induced obese (DIO) rat studies.

According to the company:

• ASC36_35 FDC produced about 51% greater relative body weight reduction compared with the combination of eloralintide and tirzepatide.
• ASC36 monotherapy demonstrated about 91% greater relative body weight reduction than petrelintide.
• ASC36 also achieved approximately 32% greater weight reduction than eloralintide in separate comparisons.

The company noted that DIO rat models have historically shown a good ability to predict weight-loss outcomes in humans.

Long-acting formulation could reduce treatment burden

Both ASC36 and ASC36_35 use Ascletis' Self-Assembling Lipid Depot (SALD) formulation, developed through the company's Ultra-Long-Acting Platform (ULAP).

In non-human primate studies, the ASC36 formulation showed an observed half-life that was about six times longer than eloralintide. These results support the possibility of once-monthly to once-quarterly dosing in future human studies.

The ASC36_35 combination also demonstrated long half-lives for both drug components, supporting the potential for monthly administration.

Stable formulation designed for long-term use

Ascletis said both injectable formulations demonstrated strong chemical and physical stability during preclinical testing.

According to the company, the formulations remained stable at neutral pH without showing aggregation or precipitation caused by fibrillation. This stability is considered important for developing long-acting injectable medicines.

Built on the company's proprietary drug discovery platforms

ASC36 and ASC35 were discovered entirely in-house using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) platform.

The company also developed the long-acting SALD formulations using its proprietary Ultra-Long-Acting Platform technology, which is designed to extend the duration of peptide therapies while reducing dosing frequency.

CEO highlights convenience and efficacy

Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, said the company believes its monthly combination therapy could offer advantages over currently studied treatment combinations.

He noted that while recent studies combining eloralintide and tirzepatide demonstrated strong weight-loss results, patients still required two separate weekly injections.

According to Wu, ASC36_35 FDC combines three validated targets into a single monthly injection and showed stronger weight-loss effects than the comparator combination in preclinical animal studies.

He also said the animal models used have historically been highly predictive of human efficacy.

Builds on recent FDA progress

The latest IND submissions follow another regulatory milestone for Ascletis.

In June 2026, the FDA cleared the company's IND application for ASC35, allowing the start of a Phase I clinical trial evaluating the once-monthly GLP-1R/GIPR dual agonist for obesity.

Ascletis says the new submissions represent another step in expanding its long-acting obesity treatment pipeline.

Expanding pipeline for chronic weight management

Ascletis continues to develop several obesity drug candidates using its proprietary technology platforms.

Its pipeline includes oral and injectable therapies targeting different metabolic pathways, including GLP-1, GIP, glucagon, and amylin receptors. The company aims to develop both first-in-class and best-in-class therapies that improve long-term weight management while reducing treatment burden through less frequent dosing.

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