Caliway Biopharmaceuticals Receives FDA Approval for CBL-514 Pivotal Phase 3 Study in Fat Reduction

Caliway Biopharmaceuticals Achieves FDA Clearance for Pivotal Study

Caliway Biopharmaceuticals (TWSE 6919) has recently announced a significant milestone in its quest to introduce innovative treatments for fat reduction. The company has secured approval from the U.S. Food and Drug Administration (FDA) to advance its first-in-class lipolysis drug, CBL-514, into a global pivotal Phase 3 study named SUPREME-01. This pivotal step represents a transformative approach to combating abdominal subcutaneous fat and positions CBL-514 as a potential game-changer in aesthetic medicine.

The Path Ahead with SUPREME-01

With the clearance granted, Caliway is set to launch participant recruitment in the United States and Canada in the third quarter of 2025, targeting 300 subjects distributed across 29 clinical sites. This randomized, double-blind, placebo-controlled trial will primarily assess changes in abdominal fat through two key metrics: MRI measurements of abdominal fat volume and self-reported assessments via the Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). These endpoints align with earlier successes in Phase 2b studies (CBL-0204 and CBL-0205), which showcased the potential efficacy of CBL-514.

CBL-514 stands out as a noteworthy candidate; it is recognized as the first investigational drug authorized by the FDA under the 505(b)(1) application pathway aimed specifically at reducing abdominal subcutaneous fat. If clinical trials prove successful, CBL-514 could bridge a crucial gap in therapeutic options—moving beyond traditional aesthetic improvements into more meaningful medical treatment capabilities.

Expansion Plans for CBL-514

In tandem with the SUPREME-01 study, Caliway is preparing to submit regulatory applications for its second pivotal Phase 3 study, SUPREME-02, across the U.S., Canada, and Australia during the same timeframe. The anticipated timeline for topline results from SUPREME-01 spans late 2026 to early 2027, potentially reshaping the landscape of fat reduction treatments.

Moreover, Caliway is exploring additional avenues for CBL-514. By the fourth quarter of 2025, the company plans to file a Phase 2 IND application with the FDA for investigating its combination with Tirzepatide, a GLP-1 receptor agonist recognized for its weight loss benefits. This expansion into the weight management sector could enhance CBL-514's therapeutic breadth, aligning the drug with the burgeoning need for effective obesity treatments.

What is CBL-514?

CBL-514 is the world’s first injectable lipolysis drug designed to target localized fat deposits without adverse systemic effects on critical physiological systems, such as the cardiovascular or central nervous systems. As of May 2025, the drug has successfully completed ten clinical trials, enrolling a total of 520 participants, demonstrating robust efficacy and safety across all measured endpoints.

Caliway is not halting its research efforts; besides abdominal applications, ongoing investigations are underway to evaluate CBL-514's efficacy against moderate-to-severe cellulite and its potential in preventing fat rebound post-weight loss. There's even interest in exploring its formulation variants like CBL-514D for conditions such as Dercum's disease.

Understanding the Abdominal Fat Rating Scale (AFRS)

A critical component in assessing treatment outcomes is the Abdominal Fat Rating Scale (AFRS), a validated tool that measures fat reduction efficacy from both clinician and patient perspectives. By integrating clinical assessments with patient-reported outcomes, Caliway strengthens its commitment to a patient-focused approach in drug development.

Looking Ahead

As Caliway Biopharmaceuticals moves forward with its innovative agenda, the FDA clearance for CBL-514 provides not just a pathway for potential approval but also reaffirms the company’s dedication to addressing and transforming current aesthetic treatment paradigms. With expectations building around the clinical efficacy of CBL-514 in realistically impacting body fat and improving overall wellness, Caliway positions itself at the forefront of biopharmaceutical innovation in aesthetic and weight management solutions.

For those interested in the convergence of biomedical advancements and aesthetic healthcare, keep an eye on Caliway’s developments as it embarks on this promising journey in the pharmaceutical landscape.