Ascletis Announces Initiation of Phase I Study in U.S. for Oral Amylin Receptor Peptide Agonist ASC36 for the Treatment of Obesity
- This trial marks the fourth Phase I peptide study for Ascletis this year. - ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state in non-human primate (NHP) studies utilizing Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT). - ASC36 o...
Ascletis Announces Inclusion in the Hong Kong Stock Connect List under the Shanghai-Hong Kong Stock Connect and the Shenzhen-Hong Kong Stock Connect Programs
HONG KONG, Sept. 7, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that, the ordinary shares of the Company (the "Shares"), which trade on The Stock Exchange of Hong Kong Limited (the "HK Stock Exchange"), have been included in the list of eligible securities under t...
Ascletis Announces First Participant Dosed in a Global Phase III Clinical Program of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 for Chronic Weight Management
- Expected to enroll approximately 4,600 participants with obesity or overweight across two pivotal trials (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada. - Global Phase III clinical program to investigate efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) over 72...
Ascletis Announces Initiation of Two Phase I Studies in U.S. for the Treatment of Obesity: ASC36 Once-Monthly Injection, an Amylin Receptor Peptide Agonist, and ASC36_35FDC Once-Monthly Injection, a Co-Formulation of ASC36 and GLP-1R/GIPR Peptide Agonist ASC35
-ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and ASC35, is a potentially first-in-class drug candidate which targets three validated targets of amylin receptor, GLP-1R and GIPR. -ASC36 is a potentially first-in-class once-monthly to once-quarterly...
Ascletis Announces Initiation of Global Phase III for Oral Small Molecule GLP-1, ASC30 and Positive Preclinical Data for Its First-in-Class Oral Small Molecule GLP-1/GIP/Amylin Fixed-Dose Combination
-Initiated global Phase III program for oral small molecule GLP-1, ASC30, which will enroll approximately 4,600 participants with obesity or overweight across two pivotal trials in the U.S., Europe, and Canada. -Positive preclinical data in non-human primates announced for first-in-class once-da...
Ascletis Announces Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, Demonstrated Superior Weight Loss in a Diet-Induced Obese Mouse Model
-ASC37 demonstrated statistically significant 88% greater relative body weight reduction compared to tirzepatide in the diet-induced obese (DIO) mouse model. -Both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted to the U.S. Food and Drug Administration (FDA...
Ascletis Announces Oral Discussion of ASC36_35 FDC Preclinical Data Demonstrating Superior Weight Loss to Eloralintide/Tirzepatide Combination at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting
- Fixed-dose combination of ASC36 and ASC35 (ASC36_35 FDC) demonstrated superior weight loss compared to eloralintide in combination with tirzepatide in a diet-induced obese (DIO) animal model. HONG KONG, July 23, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that ...
Ascletis Selects for Clinical Development a Fixed-Dose Combination of First-in-Class Oral Small Molecule GIPR Agonist, ASC48, and Oral Small Molecule GLP-1R Agonist, ASC30
- ASC48 is a potentially first-in-class oral small molecule GIPR agonist. - ASC48 demonstrated an EC50 of 1 pM in the hGIPR cAMP activation assay, exhibiting greater potency than tirzepatide (EC50 = 3 pM) and is a selective agonist for GIPR without activity for GLP-1R and GCGR. - ASC48 demonstra...
Ascletis Submits Two IND Applications to U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35
- ASC36_35 FDC, a once-monthly subcutaneous (SQ) injection co-formulation of ASC36 and ASC35, is a potentially first-in-class drug candidate targeting three validated targets of amylin receptor, GLP-1R and GIPR. - ASC36_35 FDC demonstrated approximately 51% greater relative body weight reducti...
Ascletis Announces U.S. FDA IND Clearance for Phase I Study of Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for the Treatment of Obesity
* Phase I trial consists of two parts. Part A is a single ascending dose (SAD) study of ASC35 once-monthly Self-Assembling Lipid Depot (SALD) formulation; Part B is a head-to-head study of multiple ascending doses (MAD) of ASC35 once-monthly SALD formulation compared to the U.S. Food and Drug ...
Ascletis Reinforces Its Differentiated Obesity Portfolio at American Diabetes Association (ADA) 2026 Scientific Sessions, Showcasing ASC30 Clinical Data and Exciting Preclinical Findings from ASC37 and ASC39
HONG KONG, June 8, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the presentation of three key studies at the American Diabetes Association (ADA) 2026 Scientific Sessions (taking place June 5-8, 2026, in New Orleans, Louisiana), highlighting its differentiated portf...
Ascletis to Present Data on Multiple Programs at the 33rd European Congress on Obesity (ECO 2026)
HONG KONG, May 6, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today poster presentations highlighting multiple programs at the 33rd European Congress on Obesity (ECO 2026), taking place May 12-15, 2026 in Istanbul, Türkiye. The presentations include a poster on...
Ascletis to Present Data on Multiple Programs at the American Diabetes Association's 2026 Scientific Sessions
HONG KONG, April 30, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today poster presentations highlighting multiple programs at the American Diabetes Association's (ADA's) 2026 Scientific Sessions, taking place June 5–8, 2026 in New Orleans, Louisiana. The presentat...
Ascletis Completes Enrollment in U.S. Phase II Study of ASC30, an Oral Small Molecule GLP-1R Agonist, for the Treatment of Diabetes
- 13-week U.S. Phase II study is evaluating the efficacy, safety and tolerability of oral small molecule GLP-1R agonist ASC30, a once-daily tablet, in 100 participants with diabetes. - Topline data from the Phase II study are expected in the third quarter of 2026. HONG KONG, April 27, 2026 /PRN...
Ascletis Announces Fixed-Dose Combination of ASC30, Once-Daily Oral Small Molecule GLP-1R Agonist, and ASC39, Once-Daily Oral Small Molecule Amylin-Selective Amylin Receptor Agonist, for Clinical Development
-Fixed-dose combination of ASC30 and ASC39 (ASC30_39 FDC) tablets, dosed orally in dogs, demonstrated comparable pharmacokinetics to those observed in their respective monotherapies in a head-to-head study. The fixed dose combination had excellent oral bioavailability, drug exposure and a half-lif...
Oral Small Molecule Amylin Receptor Agonist ASC39 Demonstrated Eloralintide-like Amylin Selectivity and Efficacy in Preclinical Models
- In a head-to-head cyclic adenosine monophosphate (cAMP) activation assay vs. eloralintide, oral small molecule amylin receptor agonist ASC39 demonstrated similar selectivity and potency to that of eloralintide. EC50 for human amylin 1 receptor (hAMY1R) was 21.4 pM and 21.2 pM for ASC39 and elo...
Ascletis Announces Positive Topline Results from U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule GLP-1R Agonist ASC30 for Obesity
- ASC30 subcutaneous (SQ) depot formulation achieved statistically significant and clinically meaningful placebo-adjusted mean weight loss of 7.5% at week 16 after three monthly doses. - ASC30 SQ depot formulation maintained weight loss for the four months following the third and final mon...
Ascletis Selects Oral Amylin Receptor Peptide Agonist, ASC36, for Clinical Development
- Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state, in non-human primate (NHP) studies. - In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once...
Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne
- Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study - The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously reported placebo-controlled Phase III trial couple...
Ascletis Announces First Participants Dosed in a 13-week U.S. Phase II Study with ASC30, an Oral Small Molecule GLP-1R Agonist for the Treatment of Diabetes
-Topline data from the Phase II study for the treatment of diabetes are expected in the third quarter of 2026. -ASC30 demonstrated placebo-adjusted weight loss of up to 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or o verweight, withbetter gastrointestina...
