Takeda’s Oral TYK2 Inhibitor Zasocitinib Delivers Positive Phase 3 Results In Plaque Psoriasis; Shows Strong Efficacy And Skin Clearance

Takeda, a company dedicated to discovering and delivering life-transforming treatments, has reported positive topline results from two pivotal Phase III randomized, double-blind studies evaluating zasocitinib (TAK-279), a next-generation, highly selective oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis.

Both studies met their co-primary endpoints, demonstrating statistically significant superiority over placebo for sPGA 0/1 and PASI 75 at week 16. A significantly higher PASI 75 response was observed as early as week 4, with responses continuing to deepen through week 24. Importantly, all 44 ranked secondary endpoints were also met, including PASI 90, PASI 100, and sPGA 0, versus both placebo and apremilast, highlighting the potential of once-daily zasocitinib to deliver near-complete or complete skin clearance.

“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 chief executive officer at Takeda. “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 was generally well tolerated, with a safety profile consistent with prior clinical experience, including the Phase IIb plaque psoriasis study. The most commonly reported adverse events through week 24 were upper respiratory tract infection, nasopharyngitis, and acne, with no new safety signals identified.

Takeda plans to present the full data set at upcoming medical congresses and intends to begin regulatory submissions, including a New Drug Application to the U.S. FDA, starting in fiscal year 2026.

“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,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “These findings help demonstrate that highly selective inhibition of TYK2, a key mediator of IL-23 and other signalling pathways fundamental to psoriasis, may provide patients with significant reductions in their disease burden, including for many, the possibility of complete skin clearance.”

Beyond plaque psoriasis, zasocitinib is being evaluated in a head-to-head Phase III study versus deucravacitinib, Phase III trials in psoriatic arthritis, and Phase II studies in Crohn’s disease and ulcerative colitis, reflecting Takeda’s broader ambition for TYK2 inhibition across immune-mediated diseases. The reported Phase III results are not expected to materially impact Takeda’s consolidated financial forecast for the fiscal year ending March 31, 2026.