Drug intelligence / Profile preview

FB-317

Development stage
Preclinical
Lead developer
Fountain Biopharma
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

FB-317 is a humanized monoclonal antibody biosimilar of omalizumab, developed by Fountain Biopharma for the treatment of IgE-mediated allergic conditions such as allergic asthma and chronic urticaria. As a biosimilar to Xolair, FB-317 functions by binding to circulating free serum immunoglobulin E (IgE) at the same epitope that interacts with the high-affinity IgE receptor (FcεRI). By sequestering free IgE, the drug prevents its binding to receptors on the surface of mast cells and basophils, thereby inhibiting the release of inflammatory mediators and reducing the allergic cascade. It is intended to provide a more accessible therapeutic option for patients with severe persistent asthma and chronic spontaneous urticaria.

Other names
Omalizumab biosimilar
02

Targets

IgE (Immunoglobulin E)

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