Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing small-molecule therapies for aesthetic medicine and metabolic diseases, announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), its second multi-country pivotal Phase 3 study for localized fat reduction candidate CBL-514. The IND passed the FDA's 30-day review period on May 18, 2026.
CBL-0302 is a randomized, double-blind, placebo-controlled trial enrolling approximately 320 participants across the United States, Canada, and Australia to evaluate efficacy, safety, and tolerability of CBL-514 injection. Clinical study applications have also been submitted to Health Canada and Australia. The study's primary endpoints include abdominal subcutaneous fat volume change measured objectively by MRI, and abdominal fat level improvement assessed by the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS). This design is supported by previously completed Phase 2b studies (CBL-0204 and CBL-0205).
Caliway plans to initiate both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, in the near term, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
In parallel, the Asia-Pacific Phase 2 study CBL-0206 received approval from Taiwan's TFDA on May 19, 2026, and previously from Australia's Human Research Ethics Committee (HREC). This study will generate safety and efficacy data for Asian demographics, broadening the participant database for future NDA submissions and regional market strategies. Caliway also plans to submit a Phase 3 clinical study application for CBL-0304 in China during the second half of 2026.
CBL-514 is a first-in-class 505(b)(1) small-molecule injectable lipolysis drug designed to induce adipocyte apoptosis without systemic safety risks. To date, 10 clinical trials involving 544 subjects have been completed, meeting all efficacy and safety endpoints. CBL-514 is being developed for non-surgical localized fat reduction and moderate-to-severe cellulite, while a differently formulated counterpart, CBL-514D, is studied for Dercum's disease.
Source: Read the original report | Published: May 22, 2026