Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment

Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment

PR Newswire

NEW TAIPEI CITY, Aug. 25, 2026

FDA IND Clearance for CBL-0201WR—Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in combination with tirzepatide.U.S. IRB Approval for Pivotal Phase 3 Trial SUPREME-01 (CBL-0301)—The protocol amendment for the pivotal Phase 3 clinical trial SUPREME-01 has been approved by the North American central Institutional Review Board (IRB) in the US, officially initiating subject enrollment.CBL-514 "Visceral Fat Reduction" Data Selected for EASD Oral Presentation—Breakthrough research demonstrating CBL-514's efficacy in reducing visceral fat has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 30, 2026 (local time).NEW TAIPEI CITY, Aug. 25, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment.