Ascletis Advances Obesity Pipeline With Two FDA IND Filings for Long-Acting Injectable Candidates

As reported on PharmaBiz, Ascletis Pharma has announced the submission of two Investigational New Drug (IND) applications to the US Food and Drug Administration (FDA) for experimental obesity treatments designed to reduce dosing frequency. The candidates include ASC36, a long-acting amylin receptor agonist intended for monthly to quarterly administration, and ASC36_35 FDC, a fixed-dose combination that pairs ASC36 with the company’s dual GLP-1/GIP receptor agonist, ASC35, in a single once-monthly injection.

The submissions mark another step in Ascletis’ efforts to develop next-generation obesity therapies that may offer prolonged activity and greater convenience compared with currently available treatments requiring weekly administration.

Focus on Longer-Acting Obesity Treatments

ASC36 is an amylin receptor-targeting peptide developed using Ascletis’ proprietary artificial intelligence-assisted drug discovery platform. The company says the therapy is formulated using its Self-Assembling Lipid Depot (SALD) technology, part of its Ultra-Long-Acting Platform (ULAP), with the goal of supporting monthly or even quarterly subcutaneous dosing.

ASC36_35 FDC combines ASC36 with ASC35, a peptide that activates both GLP-1 and GIP receptors. By engaging three metabolic pathways—amylin, GLP-1, and GIP—the combination is designed to enhance weight-loss effects while maintaining a convenient once-monthly injection schedule.

Preclinical Data Suggest Extended Duration

According to Ascletis, non-human primate studies showed that the ASC36 SALD formulation achieved an observed half-life roughly six times longer than that reported for eloralintide, indicating the potential for significantly less frequent dosing. Similar studies of the ASC36_35 combination also demonstrated extended half-lives for both components, supporting the feasibility of monthly administration.

The company noted that both formulations remained chemically and physically stable at neutral pH, with no evidence of aggregation or precipitation associated with peptide fibrillation.

Weight-Loss Results in Animal Models

Ascletis highlighted encouraging findings from diet-induced obesity (DIO) rat studies. In comparative testing, ASC36 monotherapy produced substantially greater reductions in body weight than two other amylin-based therapies, petrelintide and eloralintide.

For the combination candidate, ASC36_35 FDC demonstrated stronger weight-loss effects than the combined use of eloralintide and tirzepatide in head-to-head animal studies. Company executives pointed to these results as evidence that simultaneous activation of amylin, GLP-1, and GIP pathways could provide enhanced efficacy.

However, it is important to note that these findings are based on preclinical research, and the safety and effectiveness of either candidate in humans remain to be established through clinical trials.

Building on Recent Regulatory Progress

The newly submitted IND applications follow a recent regulatory milestone for Ascletis’ obesity program. In June 2026, the FDA cleared an IND application for ASC35, allowing the company to begin a Phase I clinical study evaluating the once-monthly injectable candidate in people with obesity.

Ascletis believes the latest filings further validate its investment in long-acting drug delivery technologies and expand a pipeline that includes multiple investigational therapies targeting metabolic diseases.

Broader Obesity Portfolio

Beyond ASC36 and ASC35, Ascletis is developing several other obesity-focused candidates, including:

ASC30, an oral and injectable GLP-1 receptor agonist.
ASC37, a triple agonist targeting GLP-1, GIP, and glucagon receptors.
ASC39, an oral small-molecule amylin receptor agonist.
ASC30_39 FDC, a fixed-dose combination of GLP-1 and amylin receptor agonists for chronic weight management.

With the two new FDA submissions, Ascletis is seeking to position itself among companies pursuing longer-acting obesity therapies that could potentially improve patient convenience while maintaining robust weight-loss efficacy. Human clinical data will ultimately determine whether these promising preclinical results translate into meaningful therapeutic benefits.