Caliway Biopharmaceuticals has announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), marking another milestone in the global clinical development of CBL-514, the company’s first-in-class injectable drug candidate designed for reducing abdominal subcutaneous fat.

The IND clearance follows the successful completion of the FDA’s 30-day review process on May 18 and paves the way for the launch of Caliway’s second multinational pivotal phase 3 clinical study for CBL-514. The company stated that both global phase 3 studies, CBL-0301 and CBL-0302, are expected to begin in the near term, with clinical results anticipated in 2027.

CBL-0302 has been designed as a randomized, double-blind, placebo-controlled study and is expected to enroll approximately 320 participants across the United States, Canada and Australia. The trial will evaluate the efficacy, safety and tolerability of CBL-514 injections for abdominal fat reduction. Clinical study applications have also been submitted to regulatory authorities in Canada and Australia.

According to the company, the study’s primary efficacy endpoints include objective measurement of abdominal subcutaneous fat volume through MRI scans, along with improvement assessments using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS). Caliway noted that the trial design and endpoints are supported by findings from its earlier phase 2b studies, CBL-0204 and CBL-0205, which successfully achieved all primary endpoints.

The company stated that the use of MRI-based fat volume measurement as a primary endpoint differentiates CBL-514 from many currently available aesthetic therapies and devices, which often rely largely on subjective appearance-based evaluations. Caliway believes this data-driven approach could strengthen the product’s clinical positioning and global commercial potential.

Alongside its global phase 3 programme, the company is also expanding its regional clinical strategy in Asia-Pacific markets. On May 19, the Taiwan Food and Drug Administration approved CBL-0206, a phase 2 clinical study for CBL-514 involving participants in Taiwan and Australia. The study had earlier received approval from Australia’s Human Research Ethics Committee.

CBL-0206 is expected to enroll around 250 participants and follows a randomized, placebo-controlled, two-stage study design. The trial will generate additional safety and efficacy data among Asian populations, supporting future regulatory submissions and commercialisation strategies across global markets.

Caliway also revealed plans to submit a phase 3 clinical study application for CBL-0304 in China during the second half of 2026 as part of its broader international expansion strategy.

CBL-514 is being developed as a 505(b)(1) first-in-class small-molecule injectable therapy that induces adipocyte apoptosis to reduce localized subcutaneous fat without identified systemic safety risks. The drug candidate is currently being evaluated for multiple indications, including non-surgical localized fat reduction and moderate-to-severe cellulite treatment.

The company stated that a total of 10 clinical trials involving 544 participants have been completed to date, with all efficacy and safety endpoints successfully achieved.

Caliway Biopharmaceuticals, listed on the Taiwan Exchange, focuses on the discovery and development of innovative small-molecule therapies for aesthetic medicine and other therapeutic areas.