Drug intelligence / Profile preview

amlitelimab

Development stage
Phase 3
Lead developer
Sanofi
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Amlitelimab is a fully human, non-depleting monoclonal antibody that targets and blocks OX40 ligand (OX40L), a key immune regulator expressed on antigen-presenting cells. By inhibiting the interaction between OX40L and its receptor OX40 on activated T cells, amlitelimab modulates the immune response without depleting T cells. This mechanism aims to restore balance between pro-inflammatory and regulatory T cells, offering potential therapeutic benefit in various immune-mediated diseases. Amlitelimab is being developed primarily for moderate-to-severe atopic dermatitis (currently in Phase 3 trials), with additional clinical development ongoing or planned for asthma (Phase 2), hidradinits suppurativa (Phase 2), alopecia areata (Phase 2), interstitial lung disease secondary to systemic sclerosis (Phase 2b platform trial), celiac disease, and scleroderma. The drug is administered subcutaneously and has shown sustained efficacy with durable off-drug responses in clinical studies[1][4][5][6][7].

Other names
amlitelimab
02

Targets

TNFSF4 (Tumor necrosis factor ligand superfamily member 4)

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