Sanofi has discontinued its development of the OX40L-targeting therapy amlitelimab for atopic dermatitis following a pipeline review.
Sanofi has announced it will discontinue the clinical development of amlitelimab for
The July 24 decision has occurred despite positive long-term results from the company’s phase 3 SHORE and COAST development programs for amlitelimab.2 The move by Sanofi follows an internal strategic review the research pipeline. Now, the company will no longer pursue global regulatory submissions for amlitelimab in the atopic dermatitis treatment space.
Amlitelimab was designed as a fully human monoclonal antibody, inhibiting the OX40 ligand (OX40L), an immune signaling molecule involved in the early activation of T-cell–mediated inflammation.2 The selective blocking of this pathway without depleting T cells was done to modulate immune responses upstream in the inflammatory cascade.
In the company’s announcement, they described the determination to discontinue as based upon an assessment of the overall efficacy and safety data of the drug collected throughout this development program.1 Although results from the ongoing ESTUARY phase 3 long-term extension trial suggested patients aged 12 years and older maintained clinical responses over time without relapse, Sanofi decided the medication would not provide a meaningful improvement compared with currently available options for moderate-to-severe disease.
The company noted that the study also continued to support the therapy’s emerging safety profile, consistent with observations from earlier clinical trials. Additional analyses from ESTUARY and the broader amlitelimab clinical development program are expected to be presented at a future scientific meeting.
Despite its discontinuation of the investigational drug’s development in atopic dermatitis, the company emphasized the substantial unmet need within the eczema treatment space. They pointed to the biologic heterogeneity of atopic dermatitis, pointing to diverse immune pathways contributing to disease development and progression, underscoring the continued need for additional therapeutic approaches for patients whose disease remains inadequately controlled.
Additionally, Sanofi acknowledged the contributions of the patients, caregivers, investigators, and study personnel who took part in the amlitelimab clinical program. They stated it will work alongside investigators, clinical sites, and regulatory authorities to responsibly conclude ongoing atopic dermatitis research. The company also plans to ensure appropriate transition plans for enrolled participants.
The announcement is not expected to impact Sanofi's financial outlook for 2026, with the company confirming its previously issued full-year guidance remains unchanged. While amlitelimab’s development in atopic dermatitis has ended, the drug remains under investigation in other diseases. Sanofi confirmed that its phase 2 clinical trial assessing the medication in celiac disease is continuing, with topline findings slated for the second half of 2026.
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