Ascletis’ ASC36: A New Oral Obesity Treatment on the Horizon
Hong Kong-based Ascletis Pharma Inc. Is poised to enter the obesity treatment market with ASC36, an oral amylin receptor peptide agonist. The company announced on February 10, 2026, its selection of ASC36 for clinical development and plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.
The Promise of Oral Amylin Agonists
Amylin is a hormone naturally produced by the pancreas that works alongside insulin to regulate blood glucose levels and promote feelings of fullness. Amylin receptor agonists have shown promise in weight management, but traditionally have been administered via injection. ASC36 aims to disrupt this paradigm by offering an oral formulation, potentially increasing patient convenience, and adherence.
POTENT Technology: Overcoming Oral Bioavailability Challenges
A major hurdle in delivering peptide drugs orally is their susceptibility to breakdown in the digestive system. Ascletis is tackling this challenge with its proprietary Peptide Oral Transport ENhancement Technology (POTENT). Studies in non-human primates (NHPs) demonstrate POTENT’s effectiveness, achieving absolute oral bioavailability of 6% to 8% with ASC36 tablets. This is a significant step forward for oral peptide delivery.
Impressive Weight Loss Results in Preclinical Trials
Preclinical data reveals ASC36’s potential efficacy. In NHP studies, once-daily dosing of ASC36 oral tablets led to a reduction in indicate body weight of up to 13.2% from baseline over seven days, accompanied by a significant decrease in food intake. In head-to-head studies with other amylin receptor agonists, eloralintide and petrelintide, ASC36 demonstrated superior weight loss in a diet-induced obese (DIO) rat model – approximately 32% and 91% greater relative body weight reduction, respectively.
Scalability and Lower Dosage Potential
Beyond efficacy, ASC36 offers potential manufacturing advantages. The company anticipates that the drug will require a lower dose due to its improved oral bioavailability and efficacy. This could translate to cost savings and increased scalability in production. The elimination half-life of ASC36 oral tablets ranged from 116 to 167 hours in NHP studies, supporting once-daily or less frequent dosing.
ASC36 in Ascletis’ Broader Pipeline
According to Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, ASC36 is one of three key amylin drug candidates in development. The others include an oral small molecule amylin and a once-monthly subcutaneous injectable peptide amylin. Ascletis is leveraging its Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies to build a diverse pipeline addressing metabolic diseases.
Future Trends in Obesity Treatment
ASC36’s development reflects several key trends shaping the future of obesity treatment:
The Rise of Peptide-Based Therapies
Peptide drugs are gaining prominence due to their high specificity and potency. Advances in delivery technologies, like Ascletis’ POTENT, are expanding the possibilities for oral peptide administration, making these therapies more accessible to patients.
Personalized Medicine and Combination Therapies
The potential for co-formulating ASC36 with other peptides, such as GLP-1R/GIPR dual agonists (like ASC35, also in Ascletis’ pipeline), hints at a future of personalized obesity treatment. Combining different mechanisms of action could lead to more effective and tailored therapies.
AI-Driven Drug Discovery
Ascletis’ apply of AISBDD underscores the growing role of artificial intelligence in drug discovery. AI algorithms can accelerate the identification of promising drug candidates and optimize their properties, reducing development time and costs.
Frequently Asked Questions (FAQ)
Q: What is absolute oral bioavailability?
A: It’s the percentage of a drug that reaches the bloodstream after being taken orally, compared to an intravenous dose.
Q: What is POTENT technology?
A: It’s Ascletis’ proprietary technology designed to enhance the oral delivery of peptides.
Q: When is Ascletis expected to submit the IND application to the FDA?
A: In the second quarter of 2026.
Q: What makes ASC36 different from other amylin agonists?
A: ASC36 is an oral formulation, offering potential convenience over injectable options, and has demonstrated superior weight loss in preclinical studies.
Did you know? Amylin works synergistically with insulin to regulate blood sugar and appetite, making it a promising target for obesity and diabetes treatment.
Pro Tip: Staying informed about emerging pharmaceutical developments can empower you to have more informed conversations with your healthcare provider about potential treatment options.
Stay tuned for further updates on ASC36’s clinical development. What are your thoughts on the potential of oral peptide therapies? Share your comments below!
