Sanofi Halts Development of Amlitelimab for Atopic Dermatitis

Sanofi announced it will no longer pursue amlitelimab, an anti‑OX40 ligand monoclonal antibody, for the treatment of atopic dermatitis (AD). The company concluded that the totality of efficacy and safety data from its Phase 3 COAST‑1 trial and a subsequent study did not support further development or filing for regulatory approval. The decision also ends the broader AD development program for the drug, which had been expected to be submitted for approval in the second half of 2026.

The move comes as Sanofi, now led by CEO Belen Garijo, reassesses its immunology pipeline. Earlier in the year the firm halted development of amlitelimab for asthma after a Phase 2 failure and has already removed the drug from programs for hidradenitis suppurativa, alopecia areata and scleroderma. One study of amlitelimab remains ongoing, but all worldwide regulatory submissions for the eczema indication have been withdrawn.