Caliway Biopharma: FDA Grants Clearance To Proceed With SUPREME-01 Phase 3 Study

(RTTNews) - Caliway Biopharmaceuticals announced that the FDA has granted clearance to proceed with SUPREME-01 or CBL-0301, a global, multicenter, Phase 3 study of CBL-514, the first investigational drug for large-area localized fat reduction. Caliway also plans to submit a Phase 2 IND application to the FDA in fourth quarter of 2025 for the combination of CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity, for the maintenance of weight loss.

Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and Weight management.

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