Osaka, Japan & Cambridge, Mass., July 16, 2026
Takeda announced new Phase 3 data demonstrating that its investigational oral TYK2 inhibitor zasocitinib (TAK-279) achieved high and consistent rates of skin clearance across difficult-to-treat, high-impact areas in adults with moderate-to-severe plaque psoriasis. Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, the findings reinforce the therapy’s potential to deliver rapid, durable, whole-body skin clearance in a convenient once-daily oral treatment.
Strong Clinical Responses Across Difficult-to-Treat Body Sites
Secondary endpoint analyses from the pivotal LATITUDE PsO 3001 and 3002 studies showed robust improvements in scalp, palmoplantar and nail psoriasis. Approximately 77% and 74% of patients with scalp psoriasis achieved clear or almost clear skin at Week 16, while around 70% of patients with palmoplantar psoriasis achieved clear or almost clear hands and feet. Zasocitinib also demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) compared with placebo, with responses maintained through Week 24.
Rapid Efficacy with Favorable Safety Profile
The Phase 3 program builds on previously reported topline results showing that approximately 70% of patients achieved clear or almost clear skin (sPGA 0/1) by Week 16, with significant PASI 75 responses beginning as early as Week 4 and continuing to improve through Week 24. The treatment was generally well tolerated, with the most common adverse events including upper respiratory tract infection, nasopharyngitis and acne, and no new safety signals were identified.
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Regulatory Submission Planned as Development Expands
Takeda plans to submit a New Drug Application (NDA) for zasocitinib for plaque psoriasis in the United States and additional global markets beginning this fiscal year. Beyond psoriasis, the highly selective oral TYK2 inhibitor is also being evaluated in Phase 3 studies for psoriatic arthritis and Phase 2 trials for Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa, supporting its potential across multiple immune-mediated inflammatory diseases.
Source: Takeda press release
