Ascletis Enters Obesity Race with Once-Monthly Triple-Action Drug

HONG KONG – January 20, 2026 – In a significant move set to intensify the race for next-generation weight-loss therapies, Ascletis Pharma Inc. has announced the selection of a new clinical candidate, ASC37. The drug, a powerful triple-agonist peptide, is engineered for once-monthly subcutaneous injection, a potential game-changer for patient convenience in a market currently dominated by weekly treatments.

The Hong Kong-based biotechnology firm plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026, aiming to begin Phase I human trials for obesity in the latter half of the year. The announcement positions Ascletis as a serious contender in the multi-billion-dollar metabolic disease space, armed with a drug that preclinical data suggests could be more potent and longer-lasting than leading pipeline competitors.

A New Benchmark for Convenience and Potency?

The primary appeal of ASC37 lies in its ambitious dosing schedule. If successful in clinical trials, a once-monthly injection would represent a significant leap forward in user convenience and adherence compared to the once-weekly injections of current market leaders like Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Zepbound (tirzepatide). For the more than one billion people worldwide living with obesity, reducing the frequency of injections from 52 to 12 per year could dramatically improve quality of life and long-term treatment consistency.

ASC37's power comes from its triple-agonist mechanism, simultaneously targeting three key metabolic hormone receptors: the glucagon-like peptide 1 receptor (GLP-1R), the gastric inhibitory polypeptide receptor (GIPR), and the glucagon receptor (GCGR). This multi-pronged approach is designed to synergistically suppress appetite, improve insulin secretion, and increase energy expenditure. While GLP-1 drugs have revolutionized obesity care, and dual GLP-1/GIP agonists have pushed efficacy even further, triple agonists are seen by many as the next frontier.

Ascletis released compelling head-to-head preclinical data comparing ASC37 to retatrutide, Eli Lilly's high-profile triple-agonist currently in late-stage development. According to the company:

• In non-human primate studies, ASC37 demonstrated an average observed half-life of approximately 17 days, which is reportedly seven times longer than retatrutide. This extended half-life is the foundation for the proposed once-monthly dosing regimen in humans.
• In laboratory tests (in vitro), ASC37's activity was approximately five times more potent on the GLP-1 receptor and four times more potent on both the GIP and glucagon receptors compared to retatrutide.

While these early results from lab and animal studies must be validated in extensive human trials, they signal the potential for ASC37 to deliver superior weight loss with a more convenient administration schedule.

Challenging the Titans in a High-Stakes Market

Ascletis is stepping into a fiercely competitive arena. The global market for obesity therapeutics is exploding, driven by unprecedented clinical results and a growing recognition of obesity as a chronic disease. Pharmaceutical giants Eli Lilly and Novo Nordisk currently dominate the landscape, but a wave of innovation is creating opportunities for smaller, agile biotech firms.

ASC37's primary benchmark and direct competitor is Eli Lilly's retatrutide. In its Phase 2 trial, retatrutide demonstrated remarkable efficacy, helping patients achieve an average weight reduction of 24.2% over 48 weeks. Ascletis's claims of superior potency and a longer half-life for ASC37 directly challenge this emerging frontrunner. If ASC37 can replicate or exceed retatrutide's efficacy with the added benefit of monthly dosing, it could carve out a significant niche.

The competitive field also includes other players like Viking Therapeutics, which is developing a dual GLP-1/GIP agonist, and Novo Nordisk, which is advancing its own pipeline with combination therapies like CagriSema. The market is rapidly evolving beyond simple GLP-1 agonists, with a focus on multi-target mechanisms and enhanced convenience, trends that ASC37 is perfectly positioned to address.

Fueled by AI and Advanced Platform Technology

Behind the development of ASC37 are Ascletis's proprietary technology platforms, which the company credits for its ability to design and optimize novel, long-acting therapies in-house. The drug was discovered using its Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies.

The AISBDD platform uses artificial intelligence to analyze protein structures and rapidly design molecules with specific binding properties, dramatically accelerating the early stages of drug discovery. Following design, the ULAP technology is used to engineer the drug for extended release. This platform enables the creation of a subcutaneous depot formulation that slowly and precisely releases the peptide over a desired interval, such as one month. This controlled release is key to maintaining stable drug levels, potentially improving efficacy and safety while minimizing the peaks and troughs associated with more frequent dosing.

ASC37 is a testament to this strategy, but it is not a standalone project. It is part of a broader portfolio of in-house metabolic drug candidates, including once-monthly dual-agonist and amylin agonist peptides. This demonstrates a repeatable, platform-driven approach to innovation in metabolic disease.

"With ASC37, we are advancing a potentially more potent, next-generation triple agonist into the clinic which supports once-monthly dosing," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, in a statement. "Expected initiation of our Phase I study in the second half of 2026 will be another step in our comprehensive strategy to improve the treatment options for people with obesity."

The Long Road from Lab to Clinic

The journey for ASC37 is just beginning. Following the planned IND submission in mid-2026, Ascletis will embark on a multi-year clinical development program. Phase 1 trials will focus on assessing the drug's safety, tolerability, and pharmacokinetic profile in a small number of participants. If successful, the drug will advance to larger Phase 2 and Phase 3 trials to definitively evaluate its efficacy and safety in a broad patient population.

This rigorous process typically takes six to ten years before a drug can be considered for market approval. However, the potential for a best-in-class profile often attracts significant attention and investment along the way.

Looking further ahead, Ascletis is already planning a comprehensive strategy for ASC37. The company intends to develop it not only as a standalone monotherapy but also in combination with other assets in its pipeline, such as ASC36, a once-monthly amylin receptor agonist. Combining different mechanisms of action could offer even more profound benefits for patients with complex cardio-metabolic conditions, including obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). This multifaceted approach underscores the company's long-term commitment to addressing the full spectrum of metabolic disorders.