In the modern landscape of obesity and metabolic pharmacology, GLP-1 receptor agonists such as Semaglutide (Wegovy/Ozempic) and dual GIP/GLP-1 agonists like Tirzepatide (Zepbound/Mounjaro) have revolutionized weight management. Patients routinely achieve 15% to 22% total body weight reduction through appetite suppression and delayed gastric emptying.However, clinical endocrinologists and researchers face a persistent challenge: the post-GLP-1…
Biopharma Research Team
CBL-514 vs Kybella (Deoxycholic Acid): Apoptosis vs Necrosis ComparedIn the realm of non-surgical fat reduction and localized lipolytic injectables, the search for an effective, minimally invasive alternative to surgical liposuction has spanned decades. For years, deoxycholic acid (marketed as Kybella in the United States and Belkyra globally) has stood as the primary FDA-cleared injectable…
Phase 2/3 Clinical Trials & Research SummaryCBL-514 is a novel first-in-class small molecule investigational drug designed to induce targeted reduction of subcutaneous and visceral fat through adipocyte apoptosis (programmed fat cell death). Unlike traditional lipolytic agents or invasive procedures that result in indiscriminate tissue necrosis, CBL-514 selectively activates apoptotic pathways in fat cells, while…
Clinical results from Caliway's CBL-0204 Phase 2b study of its fat reduction drug candidate CBL-514 for localized fat reduction have been accepted by the Aesthetic Surgery Journal (ASJ), a leading academic journal in aesthetic medicine and plastic surgery.Following the publication of CBL-16001 Phase 2a results in 2022 and CBL-0202 Phase 2 results in 2025, this marks…
CBL-514, when combined separately with two leading GLP-1R-based weight-loss therapies, semaglutide and tirzepatide, demonstrated enhanced weight loss, attenuated post-discontinuation weight regain, and greater reductions in subcutaneous and visceral fat in animal studies. The presentation also marked the first disclosure at an international congress of CBL-514’s potential to improve liver metabolic indicators. Preclinical data on…
U.S. FDA Clearance: The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway’s second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period.Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline…
TAIPEI, June 4, 2026 – Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company focused on breakthrough aesthetic and local fat reduction therapeutics, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CBL-0303, a Phase 3b long-term follow-up study of CBL-514 for abdominal subcutaneous…
Caliway’s research team comprises experts with deep knowledge and experience in drug discovery, business development, and regulatory affairs. We develop innovative new strategies with high safety to address medical conditi…
In Caliway, the diseases we are targeted on affect millions of people, often in their most productive years. We are on a mission to combine science, medicine, and advocacy with improving people’s lives suffering from illnesses or life-thr…
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