Barzolvolimab
Anti-KIT monoclonal antibody · also known as CDX-0159
Investigational anti-KIT monoclonal antibody; human studies measure mast-cell depletion in chronic urticaria rather than MCAS.
- How it relates to mast cells
- Mast-cell-mediated condition
- Types of studies cited
- Randomised controlled trial , Cohort study
- Randomised trials in
- chronic spontaneous urticaria
- Approved for
- nothing — Investigational
What this relationship means: Given to people with a condition in which mast cells are central to the disease process, with a human mast-cell effect also measured. This is human evidence, but it is not evidence in MCAS or in a clonal mast cell disorder, and it cannot establish an MCAS outcome.
Mechanism of action
Barzolvolimab is an investigational monoclonal antibody directed at KIT, the receptor through which stem cell factor supports mast-cell development, survival, and activity. It blocks stem-cell-factor-dependent KIT signalling and is designed to reduce mast-cell numbers rather than to block a mediator after release.
An open-label study in chronic inducible urticaria measured skin mast cells by biopsy and serum tryptase after exposure to barzolvolimab. That makes the study more direct than a cell-culture experiment: people received the drug and investigators measured a human mast-cell effect. The population still did not have MCAS.
Published randomised studies and the current phase 3 programmes are in chronic spontaneous urticaria. The separate “mast-cell-mediated condition” tag records that precise middle ground: human mast-cell pharmacology in a relevant condition, without relabelling it as MCAS evidence or as a clonal mast cell disease.
Sources
- Anti-KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria Peer-reviewed study 2023 PMID 36385701 · link checked 21 Aug 2026
- Anti-KIT Barzolvolimab for Chronic Spontaneous Urticaria Peer-reviewed study 2025 PMID 40415544 NCT04538794 · link checked 21 Aug 2026
- Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria Peer-reviewed study 2026 PMID 41747871 NCT05368285 · link checked 21 Aug 2026
- ClinicalTrials.gov record NCT06445023 — barzolvolimab in chronic spontaneous urticaria Trial registry NCT06445023 · link checked 21 Aug 2026
- ClinicalTrials.gov record NCT06455202 — barzolvolimab in chronic spontaneous urticaria Trial registry NCT06455202 · link checked 21 Aug 2026