【康霈】FDA Submission Completed for Phase 3b Long-Term Follow-up Clinical Trial of CBL-514 for Abdominal Fat Reduction
Key facts
- 【康霈】FDA Submission Completed for Phase 3b Long-Term Follow-up Clinical Trial of CBL-514 for Abdominal Fat Reduction
- 康霈生技 announced on June 3, 2026, the submission of its Phase 3b long-term follow-up clinical trial (CBL-0303) for the injectable drug CBL-514, intended for abdominal fat reduction, to the US FDA.
- Source: PR Times
- Date: June 3, 2026
Direct answer
康霈生技 announced on June 3, 2026, the submission of its Phase 3b long-term follow-up clinical trial (CBL-0303) for the injectable drug CBL-514, intended for abdominal fat reduction, to the US FDA.
- Citation
- 【康霈】FDA Submission Completed for Phase 3b Long-Term Follow-up Clinical Trial of CBL-514 for Abdominal Fat Reduction (June 3, 2026), PR Times
- Source
- PR Times
- Date
- June 3, 2026
康霈生技 announced on June 3, 2026, the submission of its Phase 3b long-term follow-up clinical trial (CBL-0303) for the injectable drug CBL-514, intended for abdominal fat reduction, to the US FDA.
📋 Article Processing Timeline
- 📰 Published: June 3, 2026 at 09:00
- 🔍 Collected: June 4, 2026 at 12:00 (27h 0m after Published)
- 🤖 AI Analyzed: June 7, 2026 at 06:37 (66h 36m after Collected)
1. Date of Occurrence: 2026/06/03
2. Drug Name/Code: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate/severe cellulite
C. Treatment of rare diseases
4. R&D Stages:
A. Phase 1: Completed.
B. Phase 2: Completed.
C. Phase 3: Pivotal trials CBL-0301/CBL-0302 approved in US/Canada. Phase 3b long-term trial CBL-0303 submitted to FDA.
D. NDA: Not yet conducted.
5. Current Status:
On June 3, 2026, the company submitted an IND application to the US FDA for the Phase 3b long-term follow-up clinical trial (CBL-0303) of CBL-514. This trial will enroll subjects who completed one of the pivotal Phase 3 trials to evaluate long-term safety and efficacy maintenance. Subjects may undergo repeat treatment if criteria are met. The trial expects to enroll 300 subjects in the US.
6. Market Situation:
Local fat reduction currently relies on invasive surgery or non-invasive products. Surgery carries higher risks and longer recovery. Non-invasive products have risen in popularity but often face limitations in efficacy or safety concerns. The market for fat reduction remains vast with significant unmet needs.
2. Drug Name/Code: CBL-514
3. Indications:
A. Reduction of subcutaneous fat
B. Improvement of moderate/severe cellulite
C. Treatment of rare diseases
4. R&D Stages:
A. Phase 1: Completed.
B. Phase 2: Completed.
C. Phase 3: Pivotal trials CBL-0301/CBL-0302 approved in US/Canada. Phase 3b long-term trial CBL-0303 submitted to FDA.
D. NDA: Not yet conducted.
5. Current Status:
On June 3, 2026, the company submitted an IND application to the US FDA for the Phase 3b long-term follow-up clinical trial (CBL-0303) of CBL-514. This trial will enroll subjects who completed one of the pivotal Phase 3 trials to evaluate long-term safety and efficacy maintenance. Subjects may undergo repeat treatment if criteria are met. The trial expects to enroll 300 subjects in the US.
6. Market Situation:
Local fat reduction currently relies on invasive surgery or non-invasive products. Surgery carries higher risks and longer recovery. Non-invasive products have risen in popularity but often face limitations in efficacy or safety concerns. The market for fat reduction remains vast with significant unmet needs.
FAQ
What is the brand name of the injectable drug submitted by Kang Pei Biotechnology for FDA review on June 3, 2026?
The brand name of the injectable drug is CBL-514, developed by Kang Pei Biotechnology.
Which company submitted the Phase 3b long-term follow-up clinical trial CBL-0303 to the US FDA on June 3, 2026?
Kang Pei Biotechnology submitted the Phase 3b long-term follow-up clinical trial CBL-0303.
What is the trial number of the Phase 3b long-term follow-up study for CBL-514 submitted on June 3, 2026?
The trial number is CBL-0303, submitted for the Phase 3b long-term follow-up study.
On what date did Kang Pei Biotechnology announce the FDA submission for CBL-514's Phase 3b trial?
Kang Pei Biotechnology announced the FDA submission on June 3, 2026.
What is the intended use of the CBL-514 injectable drug developed by Kang Pei Biotechnology?
CBL-514 is intended for abdominal fat reduction and was submitted for Phase 3b follow-up.