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...
Ascletis Selects a Next-Generation Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development
- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC37 was approximately 17 days, 7-fold longer than retatrutide, which supports once-monthly subcutaneous (SQ) dosing in humans. - ASC37's average in vitro activity was approximately 5-, 4-, and 4-fold more potent t...
Ascletis Announces U.S. FDA IND Clearance for 13-Week Phase II Study of Its Oral Small Molecule GLP-1, ASC30, in Participants with Diabetes
-The Phase II study for diabetes is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with diabetes. Enrollment is expected to begin in the first quarter of 2026. -ASC30 demonstrated placebo-...
Ascletis Announces Positive Topline Results from U.S. Phase I Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor
- The elimination half-life of ASC50 after a single oral dose was 43, 89, 91, 87, 104, and 85 hours for 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg, respectively, supporting once-daily or potentially once-weekly oral dosing. - ASC50 had strong target engagement after a single oral dose, in...
Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment
-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial. HONG KONG, Dec. 10, 2025 ...
Ascletis' Oral Small Molecule GLP-1, ASC30, Demonstrated Placebo-Adjusted Weight Loss of 7.7% with Better Gastrointestinal Tolerability in Its 13-Week U.S. Phase II Study in Participants with Obesity or Overweight
- ASC30 once-daily tablets showed statistically significant and clinically meaningful dose-dependent placebo-adjusted mean body weight reductions with no observed plateau for weight loss. - ASC30 titrated weekly to target dose demonstrated approximately one-half the rate of vomiting observed w...
Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development
- Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability of 4.2%, approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide in the oral SNAC formulation, respectively, in head-to...
Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development
- Using Ascletis' proprietary Ultra-Long-Acting Platform technology, co-formulation of ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist and ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, demonstrated a comparable pharmacokinet...
Ascletis Presents Full Analysis of Phase Ib Study of ASC30 Oral Tablet, Phase Ib Study of ASC30 Injection, and Preclinical Study of Combination of ASC31 and ASC47 at ObesityWeek® 2025
-Positive data from Phase Ib study of ASC30 oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction; safe and well tolerated with only mild-to-moderate gastrointestinal (GI) adverse events (AEs) across all multiple ascending dose (MAD) cohorts. -Phase Ib study data of ASC...
Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development
-In head-to-head non-human primate (NHP) studies, average observed half-life of ASC36 was approximately15 days, 3-fold longer than petrelintide, which supports once-monthly subcutaneous (SQ) dosing in humans. -ASC36 demonstrated approximately 91% greater relative body weight reduction compared t...
