Scientists are testing a new injectable drug, CBL-514, that makes unwanted fat cells in a chosen body area self-destruct. Early trials show the approach can visibly reduce abdominal fat without surgery, because the medicine triggers apoptosis (programmed cell death) rather than merely shrinking the cells.
Two Phase 2b studies found that most volunteers needed only one injection to see a clear drop on a five-point abdominal-fat scale, and no serious side-effects such as nerve injury or skin damage were reported.
After those results, the US FDA has cleared Caliway Biopharmaceuticals to begin two large Phase 3 trials in North America and Australia. If the larger studies confirm both safety and benefit, CBL-514 could be the first drug formally approved to reduce sizable areas of subcutaneous fat, potentially reaching the market within about a year.
Beyond cosmetic use, lowering abdominal fat is linked to lower risks of chronic pain, stroke and heart disease, so a precise, non-surgical method could have wider health value. The same drug is also being explored for cellulite and the rare, painful fat-tumor disorder Dercum’s disease.
Efficacy and Safety of CBL-514 Injection in Reducing Abdominal Subcutaneous Fat: A Randomized, Single-Blind, Placebo-Controlled Phase II Study – Aesthetic Surgery Journal, 4 March 2025.
Open-access clinical paper describing the Phase 2 trial in 76 participants: the treated group showed a much higher chance of losing at least 150 mL of abdominal fat than placebo, with good tolerability.
“Caliway announces FDA clearance of IND application for CBL-514 to proceed with SUPREME-01, the first global pivotal Phase 3 study for reducing abdominal subcutaneous fat.” Company press release, 28 July 2025
Confirms regulatory green light for the Phase 3 programme and outlines study design and timelines.
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