GLP - 1R agonist

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Innovent Receives U.S. FDA Approval for IND Application of Oral GLP-1R Agonist IBI3032
Prnewswire· 2025-08-05 00:00
SAN FRANCISCO and SUZHOU, China, Aug. 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to initiate a Phase 1 clinical trial of IBI3032, the co ...
Ascletis Announces Positive Interim Results from Its U.S. Phase Ib Trial with ASC30, a Potentially First-in-Class Subcutaneous Injection Small Molecule GLP-1R Agonist
Prnewswire· 2025-03-31 11:00
Core Insights - Ascletis Pharma Inc. announced positive interim results from a Phase Ib study of ASC30, a small molecule GLP-1 receptor agonist, demonstrating a 36-day half-life for its ultra-long-acting subcutaneous injection formulation in patients with obesity [2][4][8] - The oral tablet formulation of ASC30 showed a potential best-in-class weight loss of 6.3% after four weeks of treatment [5] Group 1: Study Results - The Phase Ib study involved three ultra-long-acting subcutaneous injection formulations of ASC30, with one formulation achieving a 36-day half-life, supporting less frequent administration [3][4] - The study included eight patients receiving the ASC30 formulation and two on placebo, indicating a well-structured clinical trial design [3] Group 2: Safety Profile - ASC30 SQ injection was well tolerated, with no serious adverse events reported and the majority of gastrointestinal-related adverse events being mild [6] - No significant elevations in liver enzymes or abnormal findings in laboratory tests were observed, indicating a favorable safety profile [6] Group 3: Product Development - ASC30 is designed for both once-daily oral and once-monthly subcutaneous administration, providing flexibility in treatment options for obesity [7][9] - The formulation is stable around neutral pH, allowing for potential co-formulation with other drugs, which could enhance its therapeutic applications [4] Group 4: Market Implications - The once-monthly injection could significantly reduce the number of devices and cartridges needed compared to weekly injectables, potentially improving patient compliance and convenience [8] - The unique properties of ASC30 as a small molecule GLP-1R biased agonist position it favorably in the obesity treatment market [9][10]