STOCKHOLM, Sweden, June 11OSAKA, Japan and CAMBRIDGE, Massachusetts, June 11, 2026, 2026
Takeda has announced positive topline results from its pivotal Phase 3 LATITUDE Atlas study, demonstrating that zasocitinib (TAK-279) significantly outperformed deucravacitinib across all primary and key secondary endpoints in adults with moderate-to-severe plaque psoriasis. The investigational, once-daily oral TYK2 inhibitor achieved superior rates of complete skin clearance, rapid clinical responses, and durable efficacy while maintaining a favorable safety profile consistent with previous studies. The landmark head-to-head trial positions zasocitinib as a potential next-generation oral therapy capable of redefining treatment expectations for millions of people living with plaque psoriasis worldwide. The findings also strengthen Takeda’s plans to pursue regulatory submissions beginning this fiscal year and further expand its growing inflammation and immunology portfolio.
Phase 3 Study Demonstrates Superior Skin Clearance Over Deucravacitinib
The LATITUDE Atlas Phase 3 trial enrolled 606 adults with moderate-to-severe plaque psoriasis and directly compared once-daily oral zasocitinib with deucravacitinib, one of the leading TYK2 inhibitors currently available. The study successfully met its primary endpoint, showing statistically significant superiority for PASI 100 response rates, a stringent measure representing complete skin clearance. More than 35% of patients treated with zasocitinib achieved complete skin clearance by Week 16, exceeding the response rate observed with deucravacitinib by more than 2.5-fold. In addition to the primary endpoint, zasocitinib demonstrated superiority across all key secondary endpoints, including PASI 90 response rates and Static Physician’s Global Assessment (sPGA) 0, further highlighting its robust efficacy profile.
Researchers also reported separation between treatment groups as early as Week 8, indicating a rapid onset of action that could provide meaningful benefits for patients seeking faster disease control. These findings represent one of the most significant comparative efficacy results reported within the oral psoriasis treatment class to date.
Next-Generation TYK2 Inhibitor Shows Strong Clinical Promise
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Zasocitinib is an investigational highly selective and potent oral TYK2 inhibitor designed to maintain continuous suppression of key inflammatory pathways involved in psoriasis, including the IL-23/IL-17 axis and type I interferon signaling. Unlike broader Janus kinase inhibitors, zasocitinib demonstrates exceptional selectivity for TYK2, potentially enabling powerful anti-inflammatory activity while minimizing effects on related JAK pathways associated with safety concerns. According to Takeda, the therapy offers more than one-million-fold selectivity for TYK2 compared with other JAK family enzymes. Investigators noted that this highly targeted mechanism may help deliver both rapid and durable disease control while preserving a favorable safety profile.
Importantly, no new safety signals were identified in the Phase 3 study, and the overall tolerability profile remained consistent with previous clinical investigations. The combination of high efficacy, convenient once-daily oral dosing, and encouraging safety findings positions zasocitinib as a potentially transformative treatment option in the competitive psoriasis market.
Regulatory Filings Planned as Takeda Expands Inflammation Pipeline
The positive head-to-head data build upon earlier Phase 3 results presented at the American Academy of Dermatology Annual Meeting and reinforce Takeda’s confidence in advancing zasocitinib toward regulatory approval. The company confirmed that it remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration and additional global regulatory agencies beginning this fiscal year. Beyond plaque psoriasis, Takeda is evaluating zasocitinib across multiple immune-mediated diseases, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and vitiligo, reflecting the broad therapeutic potential of TYK2 inhibition. Psoriasis affects an estimated 64 million people worldwide, with plaque psoriasis accounting for approximately 80% to 90% of cases.
For many patients, the disease causes significant physical discomfort, emotional distress, and reduced quality of life. If approved, zasocitinib could establish a new benchmark for oral psoriasis treatment by delivering levels of skin clearance traditionally associated with injectable biologics while offering the convenience of an oral therapy. The latest results further strengthen Takeda’s position in immunology and support the company’s strategy of developing innovative therapies capable of transforming patient outcomes across chronic inflammatory diseases.
Source: Takeda press release
