Canopus* (6919) Submits Phase 3 Clinical Trial Application in Australia for New Drug CBL-514 for Abdominal Fat Reduction
Taiwanese biopharmaceutical company Canopus* announced that on May 20, 2026, it completed the submission of its second multinational, pivotal Phase 3 clinical trial (CBL-0302) application to Australia's Human Research Ethics Committee (HREC). The trial for its new drug candidate, CBL-514 injection, aims to reduce abdominal subcutaneous fat and is planned to enroll approximately 320 subjects across the United States, Canada, and Australia.
📋 Article Processing Timeline
- 📰 Published: May 21, 2026 at 06:31
- 🔍 Collected: May 21, 2026 at 06:31 (0 min after Published)
- 🤖 AI Analyzed: May 21, 2026 at 06:56 (24 min after Collected)
On May 20, 2026, Taiwanese biopharmaceutical company Canopus* (stock code: 6919) announced a significant milestone for its new drug candidate, CBL-514 injection. The company has successfully submitted an application to Australia's primary regulatory body, the Human Research Ethics Committee (HREC), to conduct its second multinational, multi-center pivotal Phase 3 clinical trial (CBL-0302, named SUPREME-02) for the reduction of abdominal subcutaneous fat.
CBL-514 is a drug under development for reducing subcutaneous fat, improving moderate to severe cellulite, and treating the rare Dercum's disease. The development program is progressing, with Phase 1 trials already completed. Multiple Phase 2 trials have also been concluded, and a new Phase 2 trial (CBL-0206) has been approved for execution in Australia and Taiwan.
Regarding Phase 3 trials, the first pivotal study (CBL-0301) has been approved in the United States and Canada. The CBL-0302 trial, now submitted in Australia, has already received approval in the US and is currently under review in Canada.
The CBL-0302 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of CBL-514. It plans to enroll approximately 320 subjects across the United States, Canada, and Australia. The primary efficacy endpoints will measure the change in abdominal subcutaneous fat volume using MRI and assess the improvement in fat grading via the Patient Report-Abdominal Fat Rating Scale (PR-AFRS).
The company advises that the success of a new drug cannot be determined by a single clinical trial result and that investors should exercise caution. Future business plans are currently under evaluation, and cumulative R&D expenses are not being disclosed at this time to protect marketing strategy and shareholder interests.
Currently, over 80% of fat reduction procedures are invasive surgeries like liposuction. While effective, these procedures carry risks of significant side effects. Consequently, non-surgical methods such as cryolipolysis, ultrasound, and injectable lipolysis agents have rapidly gained popularity. However, many existing non-surgical options are often considered to have limited efficacy. CBL-514 is positioned to potentially fill this gap as a new treatment option.
CBL-514 is a drug under development for reducing subcutaneous fat, improving moderate to severe cellulite, and treating the rare Dercum's disease. The development program is progressing, with Phase 1 trials already completed. Multiple Phase 2 trials have also been concluded, and a new Phase 2 trial (CBL-0206) has been approved for execution in Australia and Taiwan.
Regarding Phase 3 trials, the first pivotal study (CBL-0301) has been approved in the United States and Canada. The CBL-0302 trial, now submitted in Australia, has already received approval in the US and is currently under review in Canada.
The CBL-0302 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of CBL-514. It plans to enroll approximately 320 subjects across the United States, Canada, and Australia. The primary efficacy endpoints will measure the change in abdominal subcutaneous fat volume using MRI and assess the improvement in fat grading via the Patient Report-Abdominal Fat Rating Scale (PR-AFRS).
The company advises that the success of a new drug cannot be determined by a single clinical trial result and that investors should exercise caution. Future business plans are currently under evaluation, and cumulative R&D expenses are not being disclosed at this time to protect marketing strategy and shareholder interests.
Currently, over 80% of fat reduction procedures are invasive surgeries like liposuction. While effective, these procedures carry risks of significant side effects. Consequently, non-surgical methods such as cryolipolysis, ultrasound, and injectable lipolysis agents have rapidly gained popularity. However, many existing non-surgical options are often considered to have limited efficacy. CBL-514 is positioned to potentially fill this gap as a new treatment option.