OSAKA, Japan and CAMBRIDGE, Mass., March 28, 2026
Takeda announced positive results from its Phase 3 LATITUDE clinical trials evaluating zasocitinib (TAK-279), a next-generation oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. The data, presented at the American Academy of Dermatology (AAD) 2026 Annual Meeting, demonstrate that the once-daily oral therapy achieved rapid and durable skin clearance with a favorable safety profile, positioning it as a potential leading oral treatment option in psoriasis care.
Phase 3 Data Shows Rapid and Durable Skin Clearance
The LATITUDE PsO Phase 3 studies, conducted globally across multiple centers, showed that zasocitinib delivered strong efficacy outcomes, with approximately 70% of patients achieving clear or almost clear skin (sPGA 0/1) at week 16. This represents a significant improvement compared to placebo and the active comparator apremilast, reinforcing the drug’s competitive advantage in the psoriasis treatment landscape.
In addition, over 60% of patients achieved PASI 90, indicating near-complete skin clearance, while a substantial proportion also reached complete clearance (PASI 100). Importantly, the therapy demonstrated rapid onset of action, with significant responses observed as early as week 4, highlighting its ability to deliver early and meaningful clinical benefits.
Durability of response was another key strength, with more than 90% of patients maintaining treatment response through week 60, underscoring the potential for long-term disease control in chronic inflammatory conditions like psoriasis.
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Favorable Safety Profile Supports Long-Term Use
Zasocitinib was generally well tolerated across Phase 3 studies, with a safety profile consistent with earlier clinical trials and no new safety signals identified. The most common adverse events included upper respiratory tract infections, nasopharyngitis, and acne, all of which were manageable and aligned with expectations for therapies in this class.
Serious adverse events remained low, further supporting the drug’s suitability for long-term use in chronic disease management. The high selectivity of zasocitinib for TYK2 over other JAK pathways is believed to contribute to its improved safety profile, minimizing off-target effects while maintaining strong efficacy.
This balance between efficacy and safety is critical in psoriasis treatment, where patients often require lifelong therapy, making tolerability a key factor in treatment adherence and overall outcomes.
Oral Therapy Poised to Transform Psoriasis Treatment
Zasocitinib represents a next-generation approach to treating immune-mediated inflammatory diseases, offering the convenience of a once-daily oral therapy compared to injectable biologics. This is particularly significant as current high-efficacy treatments often require injectable administration, which can impact patient preference and adherence.
By targeting TYK2-mediated signaling pathways, the drug addresses core immune drivers of psoriasis, including IL-23 and other inflammatory mediators, positioning it as a precision-targeted therapy. The strong Phase 3 data suggest that zasocitinib could reshape the treatment paradigm, providing patients with an effective, safe, and convenient alternative.
Takeda is preparing for regulatory submissions starting in fiscal year 2026, indicating that the therapy is approaching a critical stage in its development. If approved, zasocitinib could become a first-in-class oral TYK2 inhibitor with best-in-class efficacy, significantly expanding treatment options for millions of patients worldwide.
The Phase 3 results for zasocitinib (TAK-279) highlight a major advancement in psoriasis treatment, demonstrating rapid, durable, and clinically meaningful skin clearance alongside a favorable safety profile. With its once-daily oral dosing and strong efficacy outcomes, zasocitinib is poised to become a transformational therapy in dermatology, reinforcing the role of biopharma innovation in addressing chronic immune-mediated diseases.
Source: Takeda press release
