Takeda’s investigational oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) delivered positive topline results in two pivotal Phase 3 trials in adults with moderate-to-severe plaque psoriasis (PsO), meeting all primary and ranked secondary endpoints and supporting its potential as a once-daily oral treatment.

Trial specifics

In data from the Latitude Phase 3 studies (ClinicalTrials.gov Identifiers NCT06088043 and NCT06108544), zasocitinib achieved significantly greater skin clearance than placebo, with more than half of patients reaching PASI 90 (clear or almost clear skin) and about 30% achieving PASI 100 by Week 16 — outcomes that continued to improve through Week 24. The studies also demonstrated superiority over placebo and apremilast across all ranked secondary measures, reinforcing the drug’s robust efficacy profile.

Zasocitinib was generally well-tolerated, with adverse events consistent with previous clinical experience and no new safety signals identified. The safety profile and strong efficacy readouts position the once-daily oral therapy as a promising alternative to existing systemic and injectable treatments for PsO, potentially expanding patient options in a crowded but evolving therapeutic landscape.

Takeda plans to present these findings at upcoming medical congresses and initiate regulatory submissions with the US FDA and other authorities in 2026, underscoring the company’s confidence in zasocitinib’s potential to reshape psoriasis treatment.

The industry context

Tyrosine kinase 2 (TYK2) is a member of the Janus kinase (JAK) family, which mediates intracellular signaling for several cytokines implicated in autoimmune and inflammatory diseases, including psoriasis. TYK2 is particularly important for signaling downstream of interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferons—all of which play key roles in the pathogenesis of plaque psoriasis by promoting Th17 and Th1 immune responses and keratinocyte activation. In addition, genetic variants in TYK2 are associated with altered risk for psoriasis, supporting its functional relevance in disease susceptibility and progression.

Deucravacitinib (BMS-986165, Sotyktu) is the first FDA-approved oral, selective TYK2 inhibitor for moderate-to-severe plaque psoriasis (approved September 2022), demonstrating robust efficacy (PASI 75 in ~60% of patients at 16 weeks) and a favorable safety profile distinct from traditional JAK inhibitors.

The competitive landscape is rapidly evolving: Multiple TYK2 inhibitors (e.g., Takeda’s zasocitinib, Pfizer’s PF-06826647, and others) are in late-stage clinical development, and new oral and biologic agents targeting IL-23, IL-17, and other pathways are raising the efficacy and safety bar.

Standard of care is shifting from broad immunosuppressants and first-generation biologics to highly targeted therapies, including IL-17/23 inhibitors and now oral TYK2 inhibitors, with a focus on patient convenience, safety, and durable skin clearance.