• CBL-514, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. and Canada in Q3 2025.
• CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to proceed with a Phase 3 study for the proposed indication of "Reduction of Abdominal Subcutaneous Fat."
• Caliway also plans to submit regulatory applications for its second global pivotal Phase 3 study, SUPREME-02, in the U.S., Canada, and Australia in Q3 of 2025.

NEW TAIPEI CITY, July 28, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) today announced that theU.S. Food and Drug Administration (FDA) has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multicenter, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localized fat reduction. This milestone marks a critical step forward in Caliway's global regulatory strategy for CBL-514.

Subject recruitment is expected to begin in Q3 2025 at 29 clinical sites across the United States and Canada, with a total of 300 participants randomized 1:1 to receive either CBL-514 or placebo.

SUPREME-01 is a randomized, double-blind, placebo-controlled Phase 3 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.

CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to enter Phase 3 for the proposed indication of "Reduction of Abdominal Subcutaneous Fat." If approved, it may offer a novel therapeutic option beyond traditional aesthetic treatments, which have long been approved solely for "improvement in appearance," potentially offering greater medical value and expanded market opportunities.

Caliway has also completed the Clinical Trial Application (CTA) submission for SUPREME-01 to Health Canada and is preparing to submit the second global pivotal Phase 3 study SUPREME-02 (CBL-0302) in the U.S., Canada, and Australia later this year. The topline results from SUPREME-01 are expected between Q4 2026 and Q1 2027.

In addition, Caliway also plans to submit a Phase 2 IND application to the U.S. FDA in Q4 2025 for the combination of CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity, for the maintenance of weight loss, thereby expanding the therapeutic landscape of CBL-514 and entering the high-demand global weight management market.

With SUPREME-01 now officially cleared to begin by the U.S. FDA, Caliway continues to advance its global development plan, aiming to provide a safe, effective, and innovative fat reduction solution beyond current aesthetic treatment standards.

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.

About AFRS (Abdominal Fat Rating Scale)

AFRS is a five-grade rating scale developed by Caliway and validated in accordance with U.S. FDA guidance and relevant regulations, including the FDA's guideline on Patient-Focused Drug Development. The Clinician Reported-AFRS (CR-AFRS) and the Patient Reported-AFRS (PR-AFRS) are used to assess treatment response based on the physician's evaluation and the participant's self-assessment, respectively.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: https://www.caliwaybiopharma.com/en/

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