Caliway Biopharmaceuticals has received the US Food and Drug Administration (FDA) clearance for its CBL-0302 Investigational New Drug (IND) application, enabling a pivotal Phase III clinical trial of CBL-514 for abdominal subcutaneous fat reduction.
This follows the completion of the FDA’s 30-day review period, representing CBL-0302 as the second global Phase III study for CBL-514.
Caliway intends to commence both global pivotal Phase III trials, CBL-0301 and CBL-0302, shortly, with clinical results expected in 2027.
The CBL-0302 trial features a double-blind, placebo-controlled, randomised design and plans to enrol around 320 participants in Australia, Canada, and the US.
It will assess the safety, tolerability, and efficacy of CBL-514 injections. Applications for CBL-0302 are also pending with Health Canada and Australian authorities.
The trial’s primary efficacy endpoints include changes in abdominal subcutaneous fat measured by magnetic resonance imaging (MRI), and improvements on the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS).
These criteria build on prior Phase IIb studies, CBL-0204 and CBL-0205, which successfully met their endpoints.
By using MRI-based measurement, CBL-514 adopts a quantifiable standard in a field that largely relies on subjective visual changes.
This objective approach aims to strengthen the product’s medical value and support its regulatory positioning worldwide.
Meanwhile, Caliway Biopharmaceuticals is progressing with its clinical strategy in the Asia-Pacific. On 19 May, Taiwan TFDA approved CBL-0206, a Phase II study that had already received Australia Human Research Ethics Committee (HREC) approval.
CBL-0206, expected to enrol about 250 participants in Australia and Taiwan, uses a randomised, two-stage, placebo-controlled approach with MRI and abdominal fat rating scale (AFRS) outcomes.
The Asia-Pacific study will provide key data on Asian populations, expanding clinical evidence beyond previous Western-focused trials.
Caliway plans a Phase III application for CBL-0304 in China by the second half of 2026, aiming to establish a comprehensive clinical dataset and advance global regulatory and commercial efforts.
In July 2025, the US FDA cleared Caliway Biopharmaceuticals’ pivotal Phase III trial, SUPREME-01 (CBL-0301), of its investigational drug CBL-514, aimed at large-area localised fat minimisation.
