Hong Kong – September 03, 2026 -- Ascletis Pharma Inc. has dosed the first participant in a global Phase III program for ASC30, an oral small molecule GLP-1 receptor agonist for chronic weight management, the Hong Kong Stock Exchange-listed biotech confirmed.
Trial enrolls 4,600 participants across three continents
The program comprises two pivotal trials, AURORA-1 and AURORA-2, spanning clinical sites in the U.S., Europe, and Canada. AURORA-1 targets participants with obesity or overweight without type 2 diabetes, while AURORA-2 enrolls those with type 2 diabetes; both trials test 20 mg, 40 mg, and 60 mg maintenance doses against placebo over 72 weeks, with the primary endpoint measuring percentage change in body weight from baseline to Week 72.
Regulatory filings targeted for late 2028 and early 2029
Ascletis expects topline data from the AURORA program in the third quarter of 2028, followed by a New Drug Application submission to the FDA by year-end 2028 and a Marketing Authorisation Application to the EMA in early 2029. The company said its cash position supports operations into 2029, fully funding the program through the planned U.S. and European regulatory submissions.
ASC30 could become the second oral small molecule GLP-1 drug on the market
If approved, ASC30 would be only the second oral small molecule GLP-1 receptor agonist available in the U.S. and Europe. CEO Jinzi Jason Wu said the Phase II weight loss profile, gastrointestinal tolerability, and absence of observed hepatic safety signals support the drug's potential as a category-leading oral therapy.
Pipeline extends to triple-agonist combination candidates
Beyond the AURORA monotherapy program, Ascletis is developing ASC30_48FDC, a tirzepatide-like oral dual agonist combining GLP-1 and GIP targets, ASC30_48_39FDC, a triple agonist fixed-dose combination adding amylin, and ASC30_39FDC, a GLP-1/amylin combination.