Zasocitinib Hits Phase 3 End Points in Plaque Psoriasis

Today, Takeda announced positive topline results from 2 pivotal phase 3 trials of zasocitinib (TAK-279; Takeda), demonstrating superiority over placebo across key efficacy end points in adults with moderate to severe plaque psoriasis, with rapid and sustained improvements in skin clearance and a safety profile consistent with prior studies.¹

“People living with psoriasis continue to seek safe, effective, and fast-acting oral therapies. These landmark results support zasocitinib’s promise to become a leading oral treatment option that can deliver clear skin for patients with plaque psoriasis,” said Christophe Weber, president and CEO of Takeda, in a statement. “This marks the third positive phase 3 readout from our overarching pipeline this year. Each of these programs—zasocitinib, oveporexton and rusfertide—has potential to transform patient lives, redefine medical practice and deliver significant revenue growth in the future.”

Zasocitinib is a selective oral TYK2 inhibitor that showed promising efficacy and safety in a 2024 phase 2b randomized, double-blind, placebo-controlled trial.² Among 259 adults with moderate to severe plaque psoriasis, up to 48.9% of patients receiving the 30-mg dose achieved a Psoriasis Area and Severity Index (PASI) 75 at week 12 compared with 4.3% on placebo (P < .001), and about one-third achieved complete skin clearance (PASI 100).

The treatment was generally well tolerated, with no serious adverse events associated with broader Janus kinase inhibitors, supporting its potential as a convenient oral option capable of delivering biologic-level responses.

The Latitude phase 3 psoriasis program consisted of 2 global, multicenter, randomized, double-blind, placebo- and active comparator–controlled trials, NCT06088043 and NCT06108544, designed to evaluate the efficacy, safety, and tolerability of zasocitinib in adults with moderate to severe plaque psoriasis.¹ Conducted across 21 countries, the studies enrolled 693 and 1108 participants, respectively.

Patients were randomized to receive zasocitinib, placebo, or the active comparator apremilast. The coprimary end points assessed at week 16 were the proportion of patients achieving a static Physician Global Assessment (sPGA) score of 0/1 and a PASI 75 response compared with placebo. Key secondary end points included additional efficacy comparisons vs placebo at week 16 and vs apremilast at weeks 16 and 24.

Zasocitinib was generally well tolerated, with a safety profile consistent with prior studies, including the phase 2b plaque psoriasis trial. Through week 24, the most common adverse events were upper respiratory tract infection, nasopharyngitis, and acne, and no new safety signals were identified. Clinically meaningful efficacy was observed, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and approximately 30% achieving completely clear skin (PASI 100) at week 16, with response rates continuing to improve through week 24.

Takeda plans to present these findings at upcoming medical congresses and intends to begin submitting a new drug application to the FDA and other regulatory authorities starting in fiscal year 2026. In parallel, zasocitinib is being evaluated in a head-to-head phase 3 study vs deucravacitinib in plaque psoriasis, additional phase 3 studies in psoriatic arthritis, and phase 2 trials in Crohn disease and ulcerative colitis.

These studies help confirm that zasocitinib is a highly effective and well-tolerated oral therapy for adults with moderate to severe plaque psoriasis and support its potential in advancing toward regulatory submission in 2026.

References

1. Takeda’s zasocitinib landmark phase 3 plaque psoriasis data show promise to deliver clear skin in a once-daily pill, catalyzing a new era of treatment. News release. Takeda. December 18, 2025. Accessed December 18, 2025. https://www.takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-once-daily-pill/

2. Steinzor P. TYK2 inhibitor zasocitinib shows high efficacy, safety in moderate to severe psoriasis. AJMC^®. August 28, 2024. Accessed December 18, 2025. https://www.ajmc.com/view/tyk2-inhibitor-zoracitinib-shows-high-efficacy-safety-in-moderate-to-severe-psoriasis