Caliway Biopharmaceuticals (TWSE:6919), a Taiwan-based clinical-stage biopharmaceutical company, announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for a new clinical study of CBL-514, a first-in-class drug candidate for the reduction of abdominal subcutaneous fat.

The IND application for CBL-0302 (SUPREME-02), Caliway's second multi-country pivotal Phase 3 study for CBL-514, successfully passed the FDA's 30-day review period.

Caliway is planning to start both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, in the near term, with clinical results anticipated in 2027.

The randomised, double-blind, placebo-controlled study is planned to enrol around 320 participants across the United States, Canada, and Australia to evaluate the efficacy, safety, and tolerability of the CBL-514 injection. Clinical study applications for the product have also been submitted to Health Canada and Australia.