Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514
PR Newswire
NEW TAIPEI CITY, May 22, 2026
Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track StrategyU.S. FDA Clearance: The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway's second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period.Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC have approved CBL-0206, an Asia-Pacific Phase 2 study of CBL-514, further bolstering Caliway's "global and regional parallel" development strategy.Robust Regulatory Pathway: Parallel advancement of global Phase 3 studies and Asia-Pacific trials aims to solidify CBL-514's regulatory foundation and maximize its long-term commercial potential worldwide.NEW TAIPEI CITY, May 22, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company advancing innovative small-molecule therapies for aesthetic medicine and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CBL-0302 (SUPREME-02). As the second multi-country pivotal Phase 3 clinical study of CBL-514—a first-in-class drug candidate for the reduction of abdominal subcutaneous fat—the IND passed the 30-day review period on May 18.
