Ascletis Submits IND Application to the U.S. FDA for ASC30_39 FDC, a Potentially First-in-Class Oral Small Molecule Fixed-Dose Combination of GLP-1R Agonist and Selective Amylin Receptor Agonist, for the Treatment of Obesity

-  ASC30_39 FDC, a once-daily oral fixed-dose combination (FDC) tablet of small molecule GLP-1R agonist ASC30 and small molecule selective amylin receptor agonist ASC39, is the first co-formulation of an oral GLP-1 and an oral amylin to reach Investigational New Drug submission.

-  ASC30_39 FDC demonstrated highly favorable pharmacokinetics with excellent oral bioavailability, high drug exposure and a long half-life.

-  ASC30 is a once-daily oral small molecule GLP-1R agonist currently in two global pivotal Phase III studies (AURORA-1 and AURORA-2).

-  ASC39 demonstrated eloralintide-like amylin selectivity (40-fold for hAMY1R over hCTR) and efficacy in preclinical models.

-  ASC30_39 FDC demonstrated excellent compatibility between ASC30 and ASC39, with room temperature stability and a small pill size.

HONG KONG, Nov. 11, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC, a once-daily oral fixed-dose combination (FDC) tablet of small molecule GLP-1R agonist ASC30 and small molecule selective amylin receptor agonist (SARA) ASC39, for the treatment of obesity.

"ASC30_39 FDC is the first co-formulation of an oral GLP-1 and an oral amylin to reach IND submission, combining two validated, complementary mechanisms for weight management in a single once-daily tablet." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "By pairing the potentially best-in-class efficacy and gastrointestinal tolerability of ASC30 with the first eloralintide-like oral small molecule amylin, we believe ASC30_39 FDC has the potential to offer patients a highly differentiated and convenient oral treatment option for obesity."

The IND submission builds upon the recent milestones of Ascletis' oral small molecule portfolio. ASC30 is currently in two global pivotal Phase III studies (AURORA-1 and AURORA-2), enrolling approximately 4,600 participants with obesity or overweight in the U.S., Europe and Canada. Ascletis expects to report topline data from the AURORA Phase III clinical program in the third quarter of 2028. Ascletis recently announced the submission of an IND to the U.S. FDA for ASC39, its oral small molecule selective amylin receptor agonist, for the treatment of obesity.

About ASC30_39 FDC

Both ASC30 and ASC39 were discovered in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) technology. ASC30_39 FDC was developed utilizing Ascletis' proprietary formulation technology and demonstrated excellent compatibility between ASC30 and ASC39, with room temperature stability and a small pill size.

Dosed orally in dogs, ASC30_39 FDC tablets demonstrated excellent oral bioavailability, high drug exposure and a long half-life of up to 12 hours. These key pharmacokinetic parameters of ASC30_39 FDC are consistent with those observed for the respective monotherapies in a head-to-head dog study. (Press Release)

ASC30 is a once-daily oral small molecule GLP-1R agonist currently in two global pivotal Phase III studies (AURORA-1 and AURORA-2), and had a favorable gastrointestinal (GI) tolerability profile with half the rate of vomiting versus orforglipron when both drugs were dosed with weekly titration in non-head-to-head studies. (Press Release)

ASC39 is a potent oral small molecule selective amylin receptor agonist that was 40-fold more selective for human amylin 1 receptor (hAMY1R) over human calcitonin receptor (hCTR) and produced a 6.6% placebo-adjusted body weight reduction after once-daily oral administration for six consecutive days in diet-induced obese (DIO) rats, similar to eloralintide at 5.6%. (Press Release)

About Ascletis Pharma Inc.

Ascletis Pharma Inc. (1672.HK) is a fully integrated biotechnology company focused on discovering, developing and commercializing potentially first-in-class and best-in-class therapeutics for metabolic diseases, including obesity and diabetes. Leveraging its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP) and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has built a wholly in-house pipeline of oral small molecules and peptides targeting GLP-1R, GIPR, GCGR and amylin pathways. Ascletis is advancing a robust pipeline of 15 differentiated assets leveraged from six new molecular entities (three small molecules and three peptides), which are being developed both as monotherapies and in combination. Its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist, is being evaluated in two global Phase III studies in obesity. The Company's pipeline also includes oral small molecule dual and triple agonist fixed-dose combinations, a selective amylin receptor agonist, injectable peptide agonists and combinations spanning dual to quadruple agonism designed for once-monthly to once-quarterly subcutaneous dosing, and oral peptide agonists and combinations designed for once-weekly dosing.

For more information, please visit www.ascletis.com.

Contact:

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
[email protected] 

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
[email protected] / [email protected] 

SOURCE Ascletis Pharma Inc.