Hong Kong, China, November 11, 2026
Ascletis Pharma Inc. has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC, an investigational once-daily oral fixed-dose combination therapy being developed for the treatment of obesity. The experimental medicine combines two small-molecule compounds, ASC30, a glucagon-like peptide-1 receptor (GLP-1R) agonist, and ASC39, a selective amylin receptor agonist. The combination is designed to bring together two complementary biological pathways involved in appetite regulation, metabolic control and body weight management in a single oral tablet. According to the company, ASC30_39 FDC is the first co-formulation of an oral GLP-1 agonist and an oral amylin agonist to reach the IND submission stage. This development represents an important milestone in the advancement of next-generation oral obesity treatments, potentially offering an alternative to injectable weight-management therapies if clinical studies demonstrate favorable safety and efficacy.
ASC30 and ASC39 Combine Two Weight Management Mechanisms
The development of ASC30_39 FDC focuses on combining two therapeutic mechanisms that could complement each other in treating obesity. ASC30 is an investigational, once-daily oral small-molecule GLP-1 receptor agonist designed to activate pathways associated with appetite regulation, glucose metabolism and weight reduction. GLP-1 receptor agonists have become an important therapeutic approach in obesity and type 2 diabetes management because of their ability to influence appetite and metabolic functions. The second component, ASC39, is an oral small-molecule selective amylin receptor agonist developed to target the amylin signaling pathway. Amylin is a hormone involved in regulating appetite, satiety and food intake. By activating amylin-related pathways, ASC39 is intended to complement the effects of GLP-1 receptor activation. The combination aims to deliver the potential benefits of both mechanisms through a convenient once-daily tablet. Ascletis reported that ASC39 demonstrated approximately 40-fold selectivity for the human amylin 1 receptor (hAMY1R) over the human calcitonin receptor (hCTR) in preclinical testing. In diet-induced obese rat models, once-daily oral administration for six consecutive days produced a 6.6% placebo-adjusted reduction in body weight. These findings provide preliminary evidence supporting the compound’s biological activity, although animal results cannot establish clinical effectiveness in humans.
Favorable Pharmacokinetic Findings Support Development
The company reported encouraging formulation and pharmacokinetic findings for ASC30_39 FDC. In preclinical studies involving dogs, the combination tablet demonstrated excellent oral bioavailability, high drug exposure and a half-life of up to 12 hours. These pharmacokinetic characteristics were consistent with those observed for the individual compounds in comparative studies. Ascletis also highlighted the compatibility of ASC30 and ASC39 within the fixed-dose formulation. The combination demonstrated room-temperature stability and a relatively small tablet size, which could support convenient storage, handling and daily administration. The formulation was developed using the company’s proprietary technology to maintain compatibility between the two active pharmaceutical ingredients. Both compounds were discovered internally using Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) technology. This approach uses artificial intelligence and structural biology principles to support the identification and development of potential drug candidates. The company is applying its proprietary discovery and formulation capabilities to advance a broader pipeline of oral small molecules and peptide-based treatments targeting metabolic diseases.
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Phase III ASC30 Programme Strengthens Obesity Pipeline
The IND submission builds on the progress of Ascletis’ broader oral obesity development programme. ASC30 is currently being evaluated in two global pivotal Phase III clinical trials, AURORA-1 and AURORA-2. Together, these studies are expected to enroll approximately 4,600 participants with obesity or overweight across the United States, Europe and Canada. The programme is designed to evaluate the long-term efficacy, safety and tolerability of once-daily oral ASC30 in different patient populations, including individuals with and without type 2 diabetes. The company expects to report topline results from the AURORA Phase III programme in the third quarter of 2028. Ascletis has also recently submitted a separate IND application for ASC39 as a standalone oral amylin receptor agonist for obesity, further expanding its clinical development strategy. According to Jinzi Jason Wu, Ph.D., Founder, Chairman and Chief Executive Officer of Ascletis, the combination brings together two complementary mechanisms in a single daily oral formulation, with the potential to provide a differentiated treatment option for people living with obesity. The latest submission highlights the growing pharmaceutical industry focus on oral obesity medications and combination-based metabolic therapies. However, ASC30_39 FDC remains investigational, and its safety and efficacy in humans have not yet been established. The FDA IND submission is a regulatory development milestone, not marketing approval. Future clinical evaluation will be necessary to determine whether this combination can provide meaningful weight-management benefits and become a viable treatment option.
Source: Ascletis Pharma press release
