Pharma giant Takeda has said its experimental oral psoriasis drug zasocitinib met all major goals in two pivotal Phase 3 trials, delivering rapid and sustained skin clearance and strengthening the company’s late-stage pipeline.

 

The randomized, double-blind studies showed zasocitinib beat placebo on both co-primary endpoints — static Physician Global Assessment (sPGA) 0/1 and PASI 75 — at week 16 in adults with moderate-to-severe plaque psoriasis. Patients began seeing significant improvement as early as week four, with response rates continuing to rise through week 24.

 

The drug also cleared a demanding slate of 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0, outperforming both placebo and the active comparator apremilast. The results suggest a once-daily pill could deliver complete or near-complete skin clearance for many patients.

 

“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.”

 

Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies. The most common side effects through week 24 were upper respiratory tract infection, nasopharyngitis and acne, and no new safety concerns were identified.

 

“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, president of R&D at Takeda. 

 

“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.”

 

The company expects to begin submitting a New Drug Application to the U.S. Food and Drug Administration and other regulators starting in fiscal year 2026.

 

Zasocitinib is also being tested head-to-head against deucravacitinib in plaque psoriasis, in Phase 3 studies for psoriatic arthritis, and in Phase 2 trials for Crohn’s disease and ulcerative colitis. Takeda said the Phase 3 results do not materially change its full-year forecast for the fiscal year ending March 31, 2026.