Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

Takeda has announced positive topline results for a pair of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1

According to a December 18, 2025, release from the Company, the Latitude studies demonstrated superiority of zasocitinib compared to placebo for the coprimary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24. Of note, the studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.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,” Christophe Weber, president and chief executive officer at Takeda, said in a statement.1 “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 an investigational, next-generation, highly selective oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 as well as other core disease-driving immune pathways. It has > 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data.1,2

Takeda is currently evaluating the safety and efficacy of zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in phase 3 studies in psoriatic arthritis. Additionally, phase 2 studies are ongoing in Crohn’s disease, ulcerative colitis and vitiligo, and being initiated in hidradenitis suppurativa.1,2

The Latitude phase 3 psoriasis studies are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis. The studies were conducted in 21 countries and enrolled 693 and 1108 participants, respectively.1

The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week. Ranked (key) secondary endpoints included comparisons versus placebo at week 16 and apremilast at week 16 and week 24.1

As described in the release from Takeda, zasocitinib met the study’s coprimary endpoints for sPGA 0/1 and PASI 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24 versus placebo. The studies also met all 44 ranked secondary endpoints.1

Zasocitinib was generally well-tolerated, with a safety and tolerability profile consistent with prior studies, including the phase 2b plaque psoriasis study. The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.1

“It is incredibly rewarding and exciting to see our Phase 2 results validated in Phase 3, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24,” Andy Plump, MD, PhD, president of R&D at Takeda, said in a statement.1 “These findings help demonstrate that highly selective inhibition of TYK2, a key mediator of IL-23 and other signaling pathways fundamental to psoriasis, may provide patients with significant reductions in their disease burden, including for many, the possibility of complete skin clearance.”

Takeda detailed plans to present the results at upcoming medical congresses as well as the Company’s intention to submit a New Drug Application with the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 2026.1

References

1. Takeda. 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. 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. Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024;160(10):1066–1074. doi:10.1001/jamadermatol.2024.2701