CanPei (6919) Receives Taiwan FDA Approval for Phase 2 Asia-Pacific Clinical Trial of New Drug CBL-514 for Abdominal Fat Reduction
On May 19, 2026, CanPei* announced it has received approval from the Taiwan Food and Drug Administration (TFDA) to conduct a Phase 2 Asia-Pacific clinical trial (CBL-0206) for its new injectable drug, CBL-514, aimed at reducing subcutaneous abdominal fat. The trial will enroll approximately 250 subjects in Taiwan and Australia to gather safety and efficacy data on Asian populations, supporting future New Drug Applications (NDA) and market promotion.
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- 📰 Published: May 20, 2026 at 06:31
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1. Date of Occurrence: May 19, 2026
2. New Drug Name or Code: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate to severe cellulite
C. Treatment of the rare Dercum's disease
4. All Planned R&D Stages:
A. Phase 1 Clinical Trial: Completed.
B. Phase 2 Clinical Trial: Multiple Phase 2 trials, including CBL-0205, are completed. The CBL-0206 trial has received IND approval from both Australia's HREC and Taiwan's TFDA.
C. Phase 3 Clinical Trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the US and Canada. The second pivotal Phase 3 trial, CBL-0302, is approved in the US and has a pending application in Canada.
D. New Drug Application (NDA) review: Not yet initiated.
5. Current R&D Stage:
(1) Application/Approval/Disapproval/Trial Results/Other Major Events:
The company will conduct a Phase 2 clinical trial (CBL-0206) in the Asia-Pacific region, including Taiwan and Australia, for the new drug CBL-514 injection for reducing subcutaneous abdominal fat. This will increase safety and efficacy data for Asian populations to facilitate future NDA submissions and market promotion. The company obtained approval from the Taiwan TFDA to conduct this Phase 2 clinical trial on May 19, 2026. This trial will use MRI to measure changes in subcutaneous abdominal fat volume and the Abdominal Fat Rating Scale (AFRS) to assess improvement in abdominal fat grade as efficacy endpoints. It is expected to enroll approximately 250 subjects in Taiwan and Australia.
A. Clinical Trial Design Overview:
a. Trial Plan Name: A Phase 2, randomized, placebo-controlled clinical trial with a long-term re-treatment design to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous abdominal fat.
b. Trial Purpose: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous abdominal fat.
c. Trial Phase: Phase 2 Clinical Trial
d. Drug Name: CBL-514
e. Claimed Indication: Reduction of subcutaneous abdominal fat
f. Efficacy Endpoints: Measurement of abdominal subcutaneous fat volume change using MRI and assessment of abdominal fat grade improvement using the AFRS.
g. Planned Enrollment: Approximately 250 subjects
B. Statistical Results of Primary and Secondary Endpoints: Not applicable.
C. Future market entry plans if Phase 3 statistical data is known: Not applicable.
D. Results from a single clinical trial are not sufficient to fully reflect the future success or failure of a new drug's development and launch. Investors should exercise caution and judge prudently.
(2) Risks and response measures if approval from the competent authority is not obtained or if trial results are not statistically significant: Not applicable.
(3) Future business direction if approval is obtained or if trial results are statistically significant: Under evaluation by the company.
(4) Accumulated R&D Expenses: To protect the company and its investors, considering future marketing strategies, this information is not disclosed at this time.
6. Next R&D Stage:
CBL-514 for the reduction of subcutaneous abdominal fat (non-surgical fat reduction) is currently in the startup phase of the CBL-0301 clinical trial.
(1) Estimated Completion Time: The actual timeline will be adjusted according to the progress of the clinical trial.
(2) Expected Obligations: None.
7. Market Status:
Currently, over 80% of fat reduction procedures still involve invasive surgical methods, including liposuction and abdominoplasty. Although the fat reduction efficacy of surgery is much more significant than currently available non-surgical products, it is accompanied by many significant side effects, sequelae, and potentially life-threatening risks.
2. New Drug Name or Code: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate to severe cellulite
C. Treatment of the rare Dercum's disease
4. All Planned R&D Stages:
A. Phase 1 Clinical Trial: Completed.
B. Phase 2 Clinical Trial: Multiple Phase 2 trials, including CBL-0205, are completed. The CBL-0206 trial has received IND approval from both Australia's HREC and Taiwan's TFDA.
C. Phase 3 Clinical Trial: The first pivotal Phase 3 trial, CBL-0301, has been approved for execution in the US and Canada. The second pivotal Phase 3 trial, CBL-0302, is approved in the US and has a pending application in Canada.
D. New Drug Application (NDA) review: Not yet initiated.
5. Current R&D Stage:
(1) Application/Approval/Disapproval/Trial Results/Other Major Events:
The company will conduct a Phase 2 clinical trial (CBL-0206) in the Asia-Pacific region, including Taiwan and Australia, for the new drug CBL-514 injection for reducing subcutaneous abdominal fat. This will increase safety and efficacy data for Asian populations to facilitate future NDA submissions and market promotion. The company obtained approval from the Taiwan TFDA to conduct this Phase 2 clinical trial on May 19, 2026. This trial will use MRI to measure changes in subcutaneous abdominal fat volume and the Abdominal Fat Rating Scale (AFRS) to assess improvement in abdominal fat grade as efficacy endpoints. It is expected to enroll approximately 250 subjects in Taiwan and Australia.
A. Clinical Trial Design Overview:
a. Trial Plan Name: A Phase 2, randomized, placebo-controlled clinical trial with a long-term re-treatment design to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous abdominal fat.
b. Trial Purpose: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous abdominal fat.
c. Trial Phase: Phase 2 Clinical Trial
d. Drug Name: CBL-514
e. Claimed Indication: Reduction of subcutaneous abdominal fat
f. Efficacy Endpoints: Measurement of abdominal subcutaneous fat volume change using MRI and assessment of abdominal fat grade improvement using the AFRS.
g. Planned Enrollment: Approximately 250 subjects
B. Statistical Results of Primary and Secondary Endpoints: Not applicable.
C. Future market entry plans if Phase 3 statistical data is known: Not applicable.
D. Results from a single clinical trial are not sufficient to fully reflect the future success or failure of a new drug's development and launch. Investors should exercise caution and judge prudently.
(2) Risks and response measures if approval from the competent authority is not obtained or if trial results are not statistically significant: Not applicable.
(3) Future business direction if approval is obtained or if trial results are statistically significant: Under evaluation by the company.
(4) Accumulated R&D Expenses: To protect the company and its investors, considering future marketing strategies, this information is not disclosed at this time.
6. Next R&D Stage:
CBL-514 for the reduction of subcutaneous abdominal fat (non-surgical fat reduction) is currently in the startup phase of the CBL-0301 clinical trial.
(1) Estimated Completion Time: The actual timeline will be adjusted according to the progress of the clinical trial.
(2) Expected Obligations: None.
7. Market Status:
Currently, over 80% of fat reduction procedures still involve invasive surgical methods, including liposuction and abdominoplasty. Although the fat reduction efficacy of surgery is much more significant than currently available non-surgical products, it is accompanied by many significant side effects, sequelae, and potentially life-threatening risks.