[Canpep*] Company's New Drug CBL-514 Injection for Abdominal Subcutaneous Fat Reduction, Second Pivotal Phase 3 Trial (CBL-0302) Clears US FDA IND 30-Day Review, Trial to be Initiated
Biotech firm Canpep Inc. announced that its second pivotal Phase 3 clinical trial (CBL-0302) for the novel drug CBL-514, targeting the reduction of abdominal subcutaneous fat, has passed the U.S. FDA's 30-day IND review period without comment. This approval allows the company to initiate the crucial late-stage trial, a significant milestone toward potential commercialization.
📋 Article Processing Timeline
- 📰 Published: May 18, 2026 at 09:00
- 🔍 Collected: May 19, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: May 19, 2026 at 08:17 (17 min after Collected)
1. Date of occurrence: 2026/05/18
2. Name/code of new drug: CBL-514
3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Dercum's disease
4. All planned development stages:
A. Phase 1: Completed.
B. Phase 2: Multiple Phase 2 trials including CBL-0205 completed. CBL-0206 approved by Australia HREC, application submitted to Taiwan TFDA.
C. Phase 3: First pivotal Phase 3 trial CBL-0301 approved in the US and Canada. Second pivotal Phase 3 trial CBL-0302 approved in the US, application submitted in Canada.
D. New Drug Application (NDA): Not yet initiated.
5. Current development stage:
(1) The second multi-national, multi-center pivotal Phase 3 clinical trial CBL-0302 (SUPREME-02) for the New Drug Application (NDA) of CBL-514 injection for reducing abdominal subcutaneous fat, passed the U.S. FDA's 30-day IND review period on May 18, 2026, with no comments, and the CBL-0302 trial will be initiated. The trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grade as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia.
A. Clinical trial design:
a. Trial Name: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (SUPREME-02).
b. Purpose: To evaluate the efficacy, safety, and tolerability of CBL-514.
c. Phase: Phase 3
d. Drug Name: CBL-514
e. Indication: Reduction of abdominal subcutaneous fat
f. Endpoints: Primary efficacy endpoints are change in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade assessed by PR-AFRS.
g. Subjects: Approximately 320.
(2) Other details: Not applicable.
6. Next development stage:
(1) Expected completion time: To be adjusted according to trial progress.
(2) Expected obligations: None.
7. Market status: The fat reduction market still has significant unmet needs.
8. Other matters: None.
9. New drug development is lengthy, costly, and not guaranteed to succeed, posing risks to investors. Please invest prudently.
2. Name/code of new drug: CBL-514
3. Indications: A. Reduction of subcutaneous fat B. Improvement of moderate to severe cellulite C. Treatment of rare disease Dercum's disease
4. All planned development stages:
A. Phase 1: Completed.
B. Phase 2: Multiple Phase 2 trials including CBL-0205 completed. CBL-0206 approved by Australia HREC, application submitted to Taiwan TFDA.
C. Phase 3: First pivotal Phase 3 trial CBL-0301 approved in the US and Canada. Second pivotal Phase 3 trial CBL-0302 approved in the US, application submitted in Canada.
D. New Drug Application (NDA): Not yet initiated.
5. Current development stage:
(1) The second multi-national, multi-center pivotal Phase 3 clinical trial CBL-0302 (SUPREME-02) for the New Drug Application (NDA) of CBL-514 injection for reducing abdominal subcutaneous fat, passed the U.S. FDA's 30-day IND review period on May 18, 2026, with no comments, and the CBL-0302 trial will be initiated. The trial will use MRI to measure changes in abdominal subcutaneous fat volume and the Patient Report-Abdominal Fat Rating Scale (PR-AFRS) to assess improvement in abdominal fat grade as primary efficacy endpoints. It is expected to enroll 320 subjects in the US, Canada, and Australia.
A. Clinical trial design:
a. Trial Name: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat (SUPREME-02).
b. Purpose: To evaluate the efficacy, safety, and tolerability of CBL-514.
c. Phase: Phase 3
d. Drug Name: CBL-514
e. Indication: Reduction of abdominal subcutaneous fat
f. Endpoints: Primary efficacy endpoints are change in abdominal subcutaneous fat volume measured by MRI and improvement in abdominal fat grade assessed by PR-AFRS.
g. Subjects: Approximately 320.
(2) Other details: Not applicable.
6. Next development stage:
(1) Expected completion time: To be adjusted according to trial progress.
(2) Expected obligations: None.
7. Market status: The fat reduction market still has significant unmet needs.
8. Other matters: None.
9. New drug development is lengthy, costly, and not guaranteed to succeed, posing risks to investors. Please invest prudently.