2025. 06
Date： 2025.06.29 -
Caliway Completed FDA IND Submission for Global Pivotal Phase 3 Study SUPREME-01 of CBL-514 for Fat Reduction, Advancing NDA on Schedule
- Caliway has submitted the Investigational New Drug (IND) application to the U.S. FDA for SUPREME-01 (CBL-0301), the first global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, with a planned enrollment of 300 subjects.
- The primary estimand is a multicomponent responder endpoint with abdominal fat volume change measured by MRI and abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). The study design was agreed upon with the FDA at the EOP2 meeting.
- Subject recruitment for SUPREME-01 (CBL-0301) is expected to begin in the U.S. and Canada in Q3 2025.
New Taipei City, June 29 2025 –Caliway Biopharmaceuticals (TWSE: 6919) today announced the submission of the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its first global, multicenter, pivotal Phase 3 study SUPREME-01 (CBL-0301) of CBL-514, the first investigational drug for large-area localized fat reduction. The study, with its design agreed with the FDA during the End-of-Phase 2 (EOP2) meeting, will serve as the pivotal trial to support the future New Drug Application (NDA). SUPREME-01 Phase 3 is expected to enroll approximately 300 participants across nearly 30 clinical sites in the U.S. and Canada to evaluate the efficacy, safety, and tolerability of CBL-514 in reducing abdominal subcutaneous fat. Caliway also plans to submit the IND application for the second global Phase 3 study, SUPREME-02 (CBL-0302), later this year.
SUPREME-01 Phase 3 is a randomized, double-blind, placebo-controlled study. The primary estimand is a multicomponent responder endpoint, comprising: (1) abdominal fat volume change measured by MRI, and (2) abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). These endpoints were previously evaluated and met in Caliway’s completed Phase 2b studies, CBL-0204 and CBL-0205.
During the EOP2 meeting held in April 2025, the FDA agreed to the proposed indication “Reduction of Abdominal Subcutaneous Fat” for NDA filing. If approved, CBL-514 would become the world’s first 505(b)(1) lipolysis drug to seek regulatory approval with this specific indication, moving beyond the conventional “improvement in appearance” claims typically associated with aesthetic treatments. It also marks the first regulatory submission for a non-surgical large-area fat reduction drug candidate.
Caliway expects to initiate subject recruitment for SUPREME-01 Phase 3 in Q3 2025. As global demand for body contouring continues to rise rapidly, surgical liposuction carries high risks and side effects, while non-surgical alternatives offer limited efficacy with lingering safety concerns. CBL-514 aims to fill this critical unmet medical need by providing a novel, precise, and safer solution with efficacy comparable to liposuction
About CBL-514
CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, 10 clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met.Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and Weight management (to reduce post-weight-loss fat rebound). CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum’s disease and more.