New Belly Fat Injection May Replace Liposuction: Fast Results, No Surgery

What is CBL‑514?

CBL‑514 is a first‑in‑class injectable developed by Taiwan’s Caliway Biopharma. Unlike traditional cosmetic treatments that shrink or remove fat mechanically, CBL‑514 induces apoptosis—programmed death—directly in fat cells by upregulating proteins like caspase‑3 and Bax/Bcl‑2. It’s designed for targeted fat loss in specific areas without the need for surgery.

When did the trials happen and what did they show?

• Phase 2b trials (CBL‑0204 & CBL‑0205):

• One study (CBL‑0205) saw 54.2% of participants lose ≥20% of abdominal fat volume within four weeks—zero in placebo group

• Average fat volume loss was 166.6 mL versus a 15.7 mL gain in placebo
  

• Over 75% showed at least one-grade improvement on a clinician-rated abdominal fat scale (AFRS), compared to just ~27% for placebo

• Results from the earlier CBL‑0204 showed ≥1-grade improvements in over 80% of participants.

• Safety & tolerance:
  Mild to moderate injection-site reactions were the most common adverse effect. No serious systemic side effects reported
• Preclinical support & pain-related data:
  Animal studies confirmed upregulation of fat‑death pathways. In rare Dercum’s disease, CBL‑514 reduced painful lipomas by ≥50% in over 64% and cut pain by nearly 5 points on a 10‑point scale

Why it matters

1. Non‑surgical alternative to lipo: Results rival liposuction (~183 mL fat removal) but without the recovery, anesthesia, or scars 

2. Rapid and localized: Most improvements visible within weeks of a single treatment—no long downtime.

3. Beyond aesthetics: Targeted reduction of subcutaneous abdominal fat may impact metabolic health and chronic disease risk 

4. Regulatory momentum:

• FDA granted IND approval in mid‑2023 and accepted Phase 2b and End‑of‑Phase‑2 (EOP2) findings 

• EMA gave orphan drug status for Dercum’s disease in late 2024

• An End‑of‑Phase‑2 meeting with FDA was successful in May 2025

Phase 3 on the horizon

Two global pivotal Phase 3 trials are set to start in the second half of 2025 across the U.S., Canada, and Australia, aiming to enroll ~600 participants 
If outcomes remain consistent, CBL‑514 could be FDA‑approved within about 12 months.

Who could benefit?

• Individuals seeking non-surgical body contouring without downtime or risk of anesthesia.

• Patients with localized stubborn fat (belly, love handles).

• People with rare fat disorders like Dercum’s disease or cellulite.

• Potentially as a maintenance tool after systemic weight loss, e.g., GLP‑1 therapy. Early data suggests it helps prevent fat rebound

Tags

CBL‑514, injectable fat loss, aesthetic medicine, non‑surgical lipo, Phase 3 trials UAE, FDA approval