Clinical results from Caliway's CBL-0204 Phase 2b study of its fat reduction drug candidate CBL-514 for localized fat reduction have been accepted by the Aesthetic Surgery Journal (ASJ), a leading academic journal in aesthetic medicine and plastic surgery.
Following the publication of CBL-16001 Phase 2a results in 2022 and CBL-0202 Phase 2 results in 2025, this marks…
CBL-514, when combined separately with two leading GLP-1R-based weight-loss therapies, semaglutide and tirzepatide, demonstrated enhanced weight loss, attenuated post-discontinuation weight regain, and greater reductions in subcutaneous and visceral fat in animal studies. The presentation also marked the first disclosure at an international congress of CBL-514’s potential to improve liver metabolic indicators.
Preclinical data on…
U.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…
TAIPEI, June 4, 2026 – Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company focused on breakthrough aesthetic and local fat reduction therapeutics, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CBL-0303, a Phase 3b long-term follow-up study of CBL-514 for abdominal subcutaneous…