Zasocitinib Phase 3 Data Suggests Potential for Once-Daily Psoriasis Pill
Key Takeaways
Takeda announced that TYK2 inhibitor zasocitinib met all primary and 44 ranked secondary endpoints in two phase 3 studies for moderate-to-severe plaque psoriasis.
More than half of the patients achieved near-complete clearance (PASI 90), and 30% achieved complete clearance (PASI 100) by week 16.
The drug was safe and well-tolerated.
Oral TYK2 inhibitor zasocitinib (TAK-279) met all primary and 44 ranked secondary endpoints in two pivotal Phase 3 trials for moderate-to-severe plaque psoriasis, according to a December 18 press release from Takeda.
Results from the studies showed more than 50% of patients achieving PASI 90 and approximately 30% reaching PASI 100 by week 16.
Researchers for the randomized, double-blind studies compared zasocitinib to placebo and apremilast, demonstrating superiority across key efficacy measures with response rates seen early as week 4 and improvement reported through week 24. The TYK2 inhibitor, which selectively targets pathways involving IL-23, was generally well-tolerated. The most common adverse events were upper respiratory tract infections, nasopharyngitis, and acne, consistent with previous studies.
“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, MD, PhD, president of R&D at Takeda, in the news repease. “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 plans to submit a New Drug Application to the FDA in fiscal year 2026. Zasocitinib is also in trials for psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and is undergoing head-to-head evaluation against deucravacitinib.
Source: Takeda press release. December 18, 2025.