CBL-514 / Caliway Biopharmaceuticals - LARVOL DELTA

Efficacy and safety of CBL-514 for Dercum disease lipomas: A randomized phase 2a study. (PubMed, JAAD Int) - No abstract available

Journal • P2a data • Genetic Disorders • Metabolic Disorders • Pain • Rare Diseases • Rheumatology

Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies (PRNewswire) - "CBL-0201WR is a randomized, placebo-controlled Phase 2 study to be conducted at multiple centers in the United States. The study is expected to enroll approximately 120 subjects with obesity (BMI > 30) or overweight (BMI > 27) with comorbidities. The study will evaluate the efficacy, safety, and tolerability of CBL-514 in combination with Zepbound (tirzepatide, a dual GLP-1/GIP receptor agonist, Eli Lilly)."

IND • New P2 trial • Obesity

Caliway Biopharmaceuticals Presents Preclinical Research Supporting a Multi-Mechanism Approach to Weight Management at TMASO 2025 (PRNewswire) - "Under the specific conditions of the animal model, the combination group demonstrated statistically significant differences compared with incretin monotherapy across multiple parameters, including: Body-weight reduction: –21.8% (combination) vs –14.5% (monotherapy); Post-treatment weight regain: +25.2% vs +55.9% after incretin withdrawal; Subcutaneous fat reduction: –43.5% vs –15.4%; Visceral fat reduction: –41.6% vs –8.9%."

Preclinical • Obesity

"A Systematic Review of Injectable Lipolytic agents for Non-Submental Fat Reduction". (PubMed, Plast Reconstr Surg) - "Injectable lipolytic agents offer a promising, minimally invasive alternative for fat reduction in non-submental regions. However, further clinical trials are needed to standardize treatment protocols, evaluate long-term efficacy, and assess the cost-effectiveness of combining injectables with other weight management strategies. Expanding FDA approval for additional indications remains a potential future direction."

Journal • Aesthetic Medicine • Obesity

Caliway Met Dual Milestones... (PRNewswire) - "Caliway (6919) has been added to the Taiwan component of the MSCI Global Standard Index, effective after market close on August 26, 2025, marking recognition from the international capital market. CBL-514's global pivotal Phase 3 study SUPREME-01, following U.S. FDA clearance, has now also received approval from Health Canada. The study is expected to begin recruitment in Q3 2025 across the U.S. and Canada, targeting 300 participants."

Commercial • New P3 trial • Obesity

A Phase 3 Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd.

New P3 trial

A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Caliway Biopharmaceuticals Co., Ltd. | N=30 ➔ 20

Enrollment change • Rare Diseases

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 (PRNewswire) - "Caliway Biopharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multicenter, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localized fat reduction...Subject recruitment is expected to begin in Q3 2025 at 29 clinical sites across the United States and Canada, with a total of 300 participants randomized 1:1 to receive either CBL-514 or placebo...Caliway has also completed the Clinical Trial Application (CTA) submission for SUPREME-01 to Health Canada and is preparing to submit the second global pivotal Phase 3 study SUPREME-02 (CBL-0302) in the U.S., Canada, and Australia later this year. The topline results from SUPREME-01 are expected between Q4 2026 and Q1 2027....Caliway also plans to submit a Phase 2 IND application to the U.S. FDA in Q4 2025 for the combination of CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity..."

IND • New P3 trial • P3 data: top line • Metabolic Disorders • Obesity