Sanofi Discontinues Amlitelimab in Atopic Dermatitis

Sanofi has discontinued development of its OX40 ligand blocker amlitelimab in atopic dermatitis (AD), abandoning approval efforts for a drug once positioned as a potential successor to blockbuster Dupixent (dupilumab). Announced on 24 July 2026 following a strategic review, the decision reflects Sanofi’s view that the drug would not deliver meaningful improvements over the current standard of care, and lands as OX40 class development suffers repeated setbacks.

Amlitelimab showed efficacy across its Phase III programme but failed to meet its co-primary endpoint in the COAST 2 study (NCT06181435), leading analysts to question whether the wider OX40 class can penetrate the first-line AD market. Sanofi had previously discontinued amlitelimab in asthma, alopecia and hidradenitis suppurativa, narrowing the drug’s franchise potential and increasing pressure on the AD indication. GlobalData’s Tanuj Sircar described the AD discontinuation at the pre-registration stage as surprising, and attributed the move to competitive dynamics in AD and adjacent indications.

The OX40 class has been under sustained pressure. Kyowa Kirin has terminated its OX40 receptor blocker rocatinlimab after some patients developed Kaposi sarcoma, and two patients treated with amlitelimab developed the same rare vascular malignancy. Both pre-filing discontinuations are expected to damage stakeholder perception, though Inmagene’s IMG-007 is in Phase IIb and AbbVie’s continuation of the Apogee-partnered APG990 remains uncertain. Sanofi is expected to redirect investment towards Dupixent and its emerging oral immunology assets, including the Kymera-partnered IRAK4 degrader KT-485 and the Nurix-acquired STAT6 degrader NX-3911. Amlitelimab’s Phase II celiac disease study continues, with a readout expected in the second half of 2026.

The commercial signal is a Dupixent-shaped hole in Sanofi’s immunology strategy as the drug’s patent expiry approaches, and a widening industry doubt over the OX40 class as a whole. Expect Sanofi to double down on Dupixent lifecycle management and oral degrader partnerships, while Regeneron, Pfizer and AbbVie continue jockeying for AD share ahead of the wave of small-molecule entrants.

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