2026. 04
Date： 2026.04.20 -
Caliway Completes U.S. FDA IND Submission for SUPREME-02, the Second Global Pivotal Phase 3 Study of CBL-514. Advancing Dual-Track Global Phase 3 Clinical Development
- Caliway has completed the U.S. FDA IND submission for SUPREME-02 (CBL-0302), the second global multi-national, multi-center pivotal Phase 3 study of CBL-514 for reduction of abdominal subcutaneous fat, progressing on schedule according to the Company’s development plan.
- SUPREME-02 is expected to enroll approximately 320 subjects across the United States, Canada, and Australia, and will utilize the optimized AFRS scale together with MRI as primary efficacy assessment tools. Along with SUPREME-01, the first global pivotal Phase 3 study already cleared by the FDA, it will form a key Phase 3 clinical data foundation for CBL-514’s future New Drug Application (NDA).
- With two global pivotal Phase 3 studies advancing in parallel, CBL-514’s global regulatory pathway continues to progress steadily.
New Taipei City, April 20, 2026 – Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company advancing innovative small-molecule therapies in aesthetic medicine, metabolic diseases, and other unmet medical needs, announced that it has formally completed the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) submission for SUPREME-02 (CBL-0302), the second global multi-national, multi-center pivotal Phase 3 study of its first-in-class large-area localized fat reduction drug candidate, CBL-514, for reduction of abdominal subcutaneous fat. This marks another important step forward in Caliway’s global Phase 3 clinical development program for CBL-514.
SUPREME-02 is a randomized, double-blind, placebo-controlled study expected to enroll approximately 320 subjects across the United States, Canada, and Australia to evaluate the efficacy, safety, and tolerability of CBL-514 Injection for reduction of abdominal subcutaneous fat. The primary efficacy endpoints include: (1) objective measurement of abdominal subcutaneous fat volume change by MRI, and (2) subject self-assessment of abdominal fat grade improvement using the optimized PR-AFRS scale (Patient-Reported Abdominal Fat Rating Scale).
The Company noted that both pivotal Phase 3 studies will adopt the optimized AFRS scale. This is expected to enhance interpretability for both subjects and investigators and improve overall clinical data quality, reflecting Caliway’s quality-first clinical development strategy and its approach to advancing multi-national clinical programs in parallel, with the goal of supporting future NDA submissions across major markets and enhancing the likelihood of regulatory success.
In addition, the Phase 3 study designs and primary efficacy endpoints are supported by results from Caliway’s previously completed Phase 2b studies, CBL-0204 and CBL-0205, both of which met their primary endpoints, providing a solid clinical data foundation.
SUPREME-02, together with SUPREME-01 (CBL-0301), constitutes Caliway’s global pivotal Phase 3 program for the indication of “reduction of abdominal subcutaneous fat.” With the completion of the IND submission for SUPREME-02, Caliway’s global pivotal Phase 3 clinical program for this indication is further strengthened. The two pivotal Phase 3 studies will advance in parallel and jointly serve as the clinical data foundation for CBL-514’s future NDA submission.
Currently, Kybella, the only FDA-approved injectable drug for localized fat reduction, is indicated solely for the treatment of submental fat (double chin), representing small-area applications. There is currently no approved injectable drug for the reduction of large-area subcutaneous fat. By incorporating MRI-measured abdominal fat volume change as a primary efficacy endpoint, CBL-514 differentiates itself from existing aesthetic drugs and devices, which have historically been approved primarily under the framework of “Improvement in Appearance.”
If successfully developed and approved, CBL-514 has the potential to become the first 505(b)(1) fat reduction drug indicated for “reduction of abdominal subcutaneous fat,” addressing an unmet medical need while enhancing both clinical value and global market potential.
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 with no systemic safety risks identified and good tolerability.To date, 10 clinical trials with a total of 544 subjects have been completed with all efficacy and safety endpoints met.
CBL-514 is being developed across multiple indications, including reduction of subcutaneous fat (non-surgical localized fat reduction) and moderate-to-severe cellulite. 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.