Caliway Biopharmaceuticals has received Investigational New Drug (IND) clearance from the US Food and Drug Administration for its phase 3 clinical study called CBL-0302, also known as SUPREME-02.
This is an important milestone for the company because CBL-0302 is the second global pivotal phase 3 study for CBL-514, the company’s lead drug candidate designed to reduce abdominal subcutaneous fat without surgery.
The IND application successfully completed the FDA’s 30-day review period on May 18.
CBL-514 is a first-in-class injectable small-molecule drug being developed for localized fat reduction.
The drug works by causing adipocyte apoptosis, which means it helps destroy fat cells in targeted body areas. According to the company, no major systemic safety risks have been identified so far, and the treatment has shown good tolerability during clinical studies.
Caliway is developing CBL-514 for several conditions, including:
The company is also studying another formulation called CBL-514D for additional diseases, including Dercum’s disease.
The newly approved study, CBL-0302, will use a randomized, double-blind, placebo-controlled design. Around 320 participants are expected to join the study across the United States, Canada, and Australia.
The trial will evaluate three main things:
Caliway has also submitted clinical study applications for this study in Canada and Australia.
At the same time, the company plans to launch another global phase 3 study called CBL-0301. Both studies are expected to begin soon, with clinical data anticipated in 2027.
One thing that makes CBL-514 different from many aesthetic treatments currently available in the market is the way the results are being measured.
The primary efficacy endpoints for CBL-0302 include:
Most aesthetic drugs and devices today are approved mainly based on appearance improvement. Caliway is trying to use measurable MRI-based fat reduction data instead.
The company believes this objective approach can strengthen the medical value and market position of CBL-514 globally.
The phase 3 programme is supported by earlier phase 2b clinical studies known as CBL-0204 and CBL-0205.
According to the company, both studies successfully met all primary efficacy endpoints.
So far, CBL-514 has been tested in 10 clinical trials involving 544 participants, and the company says all efficacy and safety goals have been achieved.
Alongside the global phase 3 programme, Caliway is also expanding clinical development in the Asia-Pacific region.
On May 19, the Taiwan Food and Drug Administration approved CBL-0206, a phase 2 study for Asian populations.
The study had already received approval from Australia’s Human Research Ethics Committee (HREC).
CBL-0206 is expected to enroll around 250 participants from Taiwan and Australia.
The study uses a randomized and placebo-controlled design with two stages:
The study will also use MRI scans and abdominal fat rating scales to measure treatment results.
Most earlier studies for CBL-514 mainly involved Western populations.
With CBL-0206, Caliway wants to collect more safety and efficacy data from Asian participants. This can help the company prepare stronger future NDA submissions and support regional commercialization plans.
The additional data may also help with future licensing partnerships in international markets.
Caliway is also preparing to expand the programme into China.
The company plans to submit a phase 3 clinical study application for CBL-0304 in China during the second half of 2026.
This strategy shows that the company is trying to build a broader global regulatory and commercial presence for CBL-514.
Caliway Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative small-molecule therapies.
The company is listed on the Taiwan Exchange under TWSE-6919 and is working mainly in aesthetic medicine and metabolic disease treatments.
Caliway’s goal is to develop new therapies that can offer better treatment options in both medical aesthetics and other disease areas.
The FDA IND clearance for CBL-0302 marks another major step forward for Caliway and its injectable fat reduction drug CBL-514.
With global phase 3 trials preparing to start across multiple countries, the company is moving closer to potential commercialization. The use of MRI-based measurements and broader international clinical studies may also help differentiate CBL-514 in the competitive aesthetic medicine market.