{"id":63971,"date":"2026-07-06T07:10:00","date_gmt":"2026-07-06T00:10:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=63971"},"modified":"2026-07-06T07:10:00","modified_gmt":"2026-07-06T00:10:00","slug":"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-formulati","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=63971","title":{"rendered":"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"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

–\u00a0 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.<\/i><\/p>\n

–\u00a0 ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study.<\/i><\/p>\n

–\u00a0 ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection targeting amylin receptor.<\/i><\/p>\n

–\u00a0 ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO rat studies.<\/i><\/p>\n

HONG KONG<\/span>, July 6, 2026<\/span> \/PRNewswire\/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R\/GIPR agonist ASC35, for the treatment of obesity.<\/p>\n

\n<\/div>\n

“Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]<\/sup>. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy.”<\/p>\n

Both ASC36 and ASC35 were discovered in-house utilizing Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.<\/p>\n

In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.<\/p>\n

Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35 FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, the ASC36_35 co-formulation, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide.<\/p>\n

Both ASC36 injection formulation and ASC36_35 FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.<\/p>\n

Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced U.S. FDA IND clearance to initiate a Phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity (Press Release<\/a>), highlighting the Company’s robust clinical execution and the potential of its ULAP technology.<\/p>\n

[1] Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026<\/a>]<\/p>\n

About Ascletis Pharma Inc.<\/b><\/p>\n

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist and ASC37, a GLP-1R\/GIPR\/GCGR triple peptide agonist, ASC39, an eloralintide-like\u00a0potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin RA), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

For more information, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a<\/p>\n

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a><\/p>\n

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

–\u00a0 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.<\/i><\/p>\n

–\u00a0 ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study.<\/i><\/p>\n

–\u00a0 ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection targeting amylin receptor.<\/i><\/p>\n

–\u00a0 ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO rat studies.<\/i><\/p>\n

HONG KONG<\/span>, July 6, 2026<\/span> \/PRNewswire\/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R\/GIPR agonist ASC35, for the treatment of obesity.<\/p>\n

\n<\/div>\n

“Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]<\/sup>. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy.”<\/p>\n

Both ASC36 and ASC35 were discovered in-house utilizing Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.<\/p>\n

In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.<\/p>\n

Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35 FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, the ASC36_35 co-formulation, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide.<\/p>\n

Both ASC36 injection formulation and ASC36_35 FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.<\/p>\n

Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced U.S. FDA IND clearance to initiate a Phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity (Press Release<\/a>), highlighting the Company’s robust clinical execution and the potential of its ULAP technology.<\/p>\n

[1] Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026<\/a>]<\/p>\n

About Ascletis Pharma Inc.<\/b><\/p>\n

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist and ASC37, a GLP-1R\/GIPR\/GCGR triple peptide agonist, ASC39, an eloralintide-like\u00a0potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin RA), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n

For more information, please visit www.ascletis.com<\/a>.<\/p>\n

Contact\uff1a<\/p>\n

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a><\/p>\n

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a><\/p>\n

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