FDA Clears Caliway’s Trial of CBL-514 for Localised Fat Reduction

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

CBL-514, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. and Canada in Q3 2025.CBL-514 is…

FDA clears Caliway’s CBL-514 for SUPREME-01 study for reducing abdominal subcutaneous fat

Caliway Biopharmaceuticals has announced that the FDA has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multi-centre, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localised fat reduction. This milestone marks a critical step forward in Caliway's global regulatory strategy for CBL-514.SUPREME-01 is a randomised, double-blind, placebo-controlled Phase 3 study. The primary estimand is a multic…

FDA clears Caliway’s trial of CBL-514 for localised fat reduction

The FDA has cleared Caliway Biopharmaceuticals’ pivotal Phase III trial, SUPREME-01 (CBL-0301), of its investigational drug CBL-514.The post FDA clears Caliway’s trial of CBL-514 for localised fat reduction appeared first on Clinical Trials Arena.

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 - PressReach

CBL-514, Caliway’s first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. and Canada in Q3 2025. CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to proceed with a Phase 3 study for the proposed indication of “Reduction of Abdominal Subcutaneous Fat.” Caliway also plan…