PARIS, France, July 24, 2026
Sanofi announced that it has discontinued the clinical development of amlitelimab for moderate-to-severe atopic dermatitis (AD) and will not submit the investigational therapy for global regulatory review. The decision follows a comprehensive strategic assessment of the company’s research pipeline, concluding that the overall efficacy and safety data generated during clinical development do not support continued advancement of amlitelimab for this indication. Although the investigational OX40-ligand (OX40L) monoclonal antibody demonstrated sustained clinical responses and a favorable long-term safety profile in the Phase 3 ESTUARY extension study, Sanofi determined that the therapy would not provide a meaningful improvement over the current standard of care available to patients with atopic dermatitis. The company confirmed that this decision does not affect its financial guidance for 2026 and reaffirmed its commitment to developing innovative treatments for immune-mediated diseases.
Phase 3 Data Showed Durable Response but Limited Clinical Advantage
Sanofi’s decision was supported by findings from the ESTUARY Phase 3 long-term extension study, which evaluated amlitelimab in patients aged 12 years and older with moderate-to-severe atopic dermatitis. The study demonstrated that patients maintained long-term clinical responses without disease relapse, while the safety profile remained consistent with previous clinical findings. Despite these encouraging outcomes, the company concluded that the totality of evidence did not demonstrate sufficient clinical differentiation compared with currently available therapies for atopic dermatitis. As treatment options for AD continue to expand rapidly, Sanofi determined that amlitelimab would not offer enough additional benefit to justify regulatory submission or commercialization. The company stated that complete clinical results, including data from the ESTUARY program, will be presented at an upcoming medical conference to provide the scientific community with further insights into the therapy’s performance.
Strategic Pipeline Focus Remains on Immune-Mediated Diseases
The discontinuation reflects Sanofi’s ongoing strategy to prioritize pipeline programs capable of delivering significant therapeutic advances for patients. While ending development in atopic dermatitis, the company emphasized that it remains committed to addressing the unmet medical needs associated with inflammatory skin diseases, recognizing the complexity and diversity of immune pathways involved in AD. Sanofi also expressed its appreciation to the patients, caregivers, investigators, and clinical research teams who participated in the amlitelimab development program. The company will work closely with investigators, clinical trial sites, and regulatory authorities to ensure the orderly wind-down of ongoing atopic dermatitis studies while providing appropriate care transitions for enrolled participants. This patient-centered approach aims to maintain continuity of care throughout the study closure process.
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Amlitelimab Development Continues in Celiac Disease
Although the atopic dermatitis program has been discontinued, amlitelimab continues to be evaluated in other immune-mediated diseases. The investigational antibody targets OX40 ligand (OX40L), a key immune regulator involved in the initiation of T-cell-mediated inflammation, using a mechanism designed to reduce inflammation without depleting T cells. Sanofi confirmed that the Phase 2 clinical trial evaluating amlitelimab in celiac disease remains ongoing, with results expected during the second half of 2026. The company believes this program may still provide valuable insights into the therapeutic potential of OX40L inhibition in autoimmune disorders. By refining its research priorities while continuing to invest in innovative immunology programs, Sanofi aims to strengthen its long-term pipeline and focus resources on therapies with the greatest potential to deliver meaningful clinical benefits for patients worldwide.
Source: Sanofi press release
