Sanofi has decided to stop pursuing amlitelimab for atopic dermatitis (AD), ending plans to seek regulatory approval for the treatment after concluding that the overall clinical evidence did not support further development in the indication.
Amlitelimab, an anti-OX40 ligand monoclonal antibody, entered Sanofi’s pipeline through the company’s 2021 acquisition of Kymab. The drug was once viewed as a significant immunology asset and had been expected to be submitted for approval in AD during the second half of 2026. However, results from late-stage studies increasingly raised questions about its position within the treatment landscape.
Concerns emerged in September 2025 when the phase 3 COAST-1 study met its primary objectives but failed to meet analyst expectations and did not match the efficacy benchmark established by existing therapies. Additional challenges followed in January when another phase 3 trial achieved its primary endpoint but fell short on other important measures. Despite those outcomes, Sanofi initially stated that it intended to pursue regulatory submissions based on the complete body of evidence.
The company has now reversed that position following what it described as an ongoing review of its research pipeline. In announcing the decision, Sanofi said, “Sanofi has determined that the totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD.”
Sanofi noted that the Estuary phase 3 long-term extension study showed sustained clinical responses without relapse among patients aged 12 years and older with moderate-to-severe AD. The study also contributed additional safety information consistent with earlier findings. Nevertheless, the company concluded that the treatment would not provide a meaningful advance over the current standard of care.
As a result, Sanofi will discontinue its broader AD development program for amlitelimab, winding down studies conducted under the OCEANA clinical development program. The decision also ends plans to file the therapy with regulators for the indication.
The company had already narrowed amlitelimab’s development scope before the AD decision. Last year, Sanofi chose not to continue development of the drug in asthma after a phase 2 study failed to meet expectations. The company also no longer lists hidradenitis suppurativa, alopecia areata or scleroderma among the therapy’s active development programs.
One study remains ongoing. Sanofi is continuing a mid-stage clinical trial evaluating amlitelimab in celiac disease, with results expected later in 2026.
The discontinuation comes during a period of leadership changes at the French pharmaceutical company. Paul Hudson was replaced as chief executive officer, and R&D head Houman Ashrafian is also departing the company. Current CEO Belén Garijo has been tasked by Sanofi’s board with reassessing the company’s research strategy and has appointed Paulo Fontoura to succeed Ashrafian.
Sanofi stated that the decision regarding amlitelimab does not affect its full-year 2026 financial guidance. The company also said no additional pipeline changes are being announced alongside the termination of the AD program and that it will provide further updates on its broader corporate strategy at a later date.
Sanofi has announced the discontinuation of Amlitelimab development for atopic dermatitis following a comprehensive review of its Phase 3 clinical program.
The decision to discontinue the development of Amlitelimab for atopic dermatitis marks a significant shift in the competitive landscape of immunology drug development. Late-stage clinical programs require substantial investments of time, resources, and scientific expertise. Even after years of research, pharmaceutical companies may decide to halt development if clinical results do not meet predefined efficacy, safety, or commercial expectations. This announcement reflects the complexity of developing innovative therapies for chronic inflammatory skin conditions.
Overview of the Phase 3 Program
The Phase 3 clinical program was designed to evaluate the long-term safety and effectiveness of Amlitelimab in patients with moderate-to-severe atopic dermatitis. These studies enrolled participants across multiple countries and compared treatment outcomes using established clinical endpoints, including improvements in skin lesions, reduction in itching, and overall quality of life.
While earlier-stage trials demonstrated encouraging results, the complete Phase 3 review led to a strategic reassessment of the program. Companies frequently evaluate not only statistical outcomes but also consistency across studies, patient response rates, safety profiles, and the evolving standard of care before deciding whether to continue development.
Sanofi’s Future Pipeline Strategy
Sanofi continues to invest in a diverse pipeline focused on immunology, rare diseases, oncology, and vaccines. The company stated that strategic portfolio decisions are essential for allocating resources toward programs with the highest likelihood of clinical and commercial success.
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