Taiwanese researchers have developed a groundbreaking drug, CBL-514, which promises to eliminate stubborn fat with a single injection, avoiding the need for surgical procedures. This treatment is set to begin human trials soon and is not only aimed at cosmetic improvements but also at addressing medical conditions such as lipomas (tumors caused by fat accumulation), chronic pain, strokes, and cardiovascular diseases.
Developed by Caliway Pharmaceuticals, CBL-514 represents a paradigm shift in fat reduction treatments. Unlike traditional methods that starve fat cells, CBL-514 directly eliminates them through a process known as adipocyte apoptosis. According to the company, the injection has demonstrated a favorable safety and tolerability profile, allowing for significant localized fat reduction comparable to liposuction.
The mechanism of CBL-514 involves inducing programmed cell death specifically in subcutaneous adipose tissue. Preclinical studies indicate that the drug increases apoptosis mediators, leading to the death of fat cells both in vivo and in vitro. This process effectively reduces fat deposits in targeted areas, such as the abdomen and thighs, without affecting the central nervous, cardiovascular, or respiratory systems.
In recent Phase 2b clinical trials, researchers found that four weeks after treatment, 75% of participants experienced a reduction in abdominal fat by at least one grade on the Abdominal Fat Rating Scale (AFRS). Additionally, 69.6% of those treated with CBL-514 lost at least 150 ml of subcutaneous fat, compared to 0% in the placebo group. Notably, 42.9% of participants achieved their fat loss goals with just one injection.
Currently, the only approved drug for localized fat reduction is ATX-101 (deoxycholic acid injection), which carries serious side effects, including skin necrosis and nerve damage. In contrast, CBL-514 has not shown these adverse effects, even with multiple doses across larger body areas. The most common side effects reported were mild to moderate reactions at the injection site.
If the final trial results confirm the efficacy and safety demonstrated in earlier phases, CBL-514 could become the first commercially available injectable treatment for non-surgical fat elimination. Abdominal fat, particularly in middle-aged individuals, is linked to chronic pain, strokes, and cardiovascular diseases, making a safe and targeted treatment beneficial beyond aesthetic purposes.
CBL-514 received FDA approval as an Investigational New Drug (IND) in 2023 and the European Medicines Agency (EMA) approval a year later. Following the completion of Phase 2b trials, the drug is set to initiate two global Phase 3 clinical trials in the latter half of 2025, with the potential for availability in pharmacies within a year.
Vivian Ling, CEO of Caliway, expressed satisfaction with the FDA’s agreement on the study design and proposed indication, emphasizing confidence in CBL-514’s differentiated value and its potential to redefine standards in aesthetic medicine.