Belly Fat Removal Drug Passes Final Stage Before FDA Approval

What if you could inject a drug directly into a “problem area”—like your belly—to kill fat cells and reduce fat deposits in that specific area? That’s what a new drug from Taiwan’s Caliway Pharmaceuticals offers: the world’s first injection that causes programmed cell death in a target area, like your belly or thighs.

The drug, called CBL-514, is a small molecule compound that induces apoptosis of adipocytes (fat cells), killing them instead of “starving” them, allowing for rapid reduction of subcutaneous fat deposits in specific areas in just a few weeks after a single dose. It is currently being tested in three ways:

• non-surgical fat reduction,
• treatment of Dercum's disease (in which painful fatty tumors form throughout the body),
• cellulite treatment.

“When administered subcutaneously, CBL-514 demonstrated a favorable safety and tolerability profile, providing significant localized fat reduction without surgery and producing results comparable to liposuction,” Caliway said.

While the drug is being studied for a variety of uses, the main focus - and the one expected to hit the market first - is non-surgical reduction of problematic abdominal fat.

CBL-514 has already successfully completed two Phase 2 studies (CBL-0204 and CBL-0205) and is preparing to conduct two pivotal global Phase 3 clinical trials in the second half of 2025.

In a recent Phase 2 study of CBL-0205, 75% of participants had at least one point reduction in abdominal fat on the Abdominal Fat Rating Scale (AFRS) after 4 weeks of a single injection. This allowed the drug to pass the FDA’s threshold for efficacy, despite safety and tolerability having been demonstrated in a previous study.

To date, the only drug approved for localized fat reduction is ATX-101 (deoxycholic acid injection), which has been shown to be effective in eliminating fat in small areas, but is associated with serious side effects such as skin necrosis, ulcers, nerve damage, and infection. CBL-514 has not been shown to cause any of these complications, even with multiple doses administered over much larger areas of the body.

In the latest study, more than 75% of participants achieved their target amount of fat reduction after one or two injections, and the average fat reduction was more than twice as high. These results were consistent with the results of the first phase 2 study, published in December 2024, which reported that 76.7% of 107 participants improved their scores by at least one point on the five-point AFRS scale. And three-quarters of those participants achieved the result with just one injection.

“CBL-514 is a new class of lipolysis-inducing drug that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous fat in the treatment area without any systemic side effects on the central nervous system, cardiovascular system and respiratory system,” the company noted. “Our preclinical studies have shown that CBL-514 activates the apoptosis mediators caspase-3 and the Bax/Bcl-2 ratio, and then induces adipocyte apoptosis in vivo and in vitro.”

While the drug has an obvious aesthetic use—non-surgical body sculpting—it may also have broader benefits. Abdominal fat, particularly in middle-aged and older adults, is associated with a number of serious health conditions, including chronic pain, stroke, and cardiovascular disease. While CBL-514 doesn’t directly target the deeper visceral fat in this area, it can reduce subcutaneous fat by more than 25%, reducing the risk of chronic disease and positively impacting visceral fat, which is difficult to treat.

Until now, there has been no safe, localized, non-surgical method for reducing body fat.

In 2023, the FDA approved CBL-514 as an investigational new drug (IND). A year later, the European Medicines Agency (EMA) also approved it, granting orphan drug status for the treatment of Dercum's disease.

In May, the company received approval to move into the final stage of clinical trials; the first phase of Phase 3 will take place in the U.S. and Canada, and the second phase will take place in the U.S., Canada, and Australia. Both studies are already recruiting participants. The first cohort of Phase 3 will include about 300 participants at nearly 30 clinical sites in North America.

“We are pleased to have reached agreement with the FDA on the study design and indication,” said Vivian Lin, CEO of Caliway. “The agency agreed that the indication of ‘abdominal fat reduction’ reinforces our confidence in the unique value of CBL-514 and its potential to change the standard of care in aesthetic medicine.”

If the drug proves effective in these large studies, it could hit the market within 12 months.

The results of the latest phase II clinical trial were published in the Aesthetic Surgery Journal.