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An Open-Label, Randomized Phase 2a Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

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Trial Profile

An Open-Label, Randomized Phase 2a Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs CBL-514 (Primary)
  • Indications Adiposis dolorosa; Pain
  • Focus Therapeutic Use
  • Sponsors Caliway Biopharmaceuticals

    • Most Recent Events

    • 25 Apr 2024 According to a Caliway Biopharmaceuticals media release, U.S. FDA granted Orphan Drug Designation based on the CBL-0201DD Phase 2 study results for Dercum's disease in February 2024.
    • 14 Feb 2024 According to a Caliway Biopharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment based based on Caliway's preclinical and CBL-0201DD Phase 2 (NCT05387733) clinical study results.
    • 13 Sep 2023 Primary endpoint (Efficacy of CBL-514 following injection into lipomas or nodules of participants with Dercums disease.) has been met, according to a Caliway Biopharmaceuticals Media Release.

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