Takeda announced that its oral TYK2 inhibitor Zasocitinib met all 44 ranked secondary endpoints in a Phase III study of moderate‑to‑severe plaque psoriasis, including 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100). The study also confirmed the primary endpoint of PASI 75, with more than half of participants achieving PASI 90 and roughly 30% reaching PASI 100 by week 16, a level of efficacy that exceeds most existing oral and injectable options.
The drug’s selective inhibition of TYK2 over other JAK enzymes is expected to reduce off‑target effects, and its once‑daily oral dosing offers a convenient alternative to biologic injections. In a head‑to‑head study, Zasocitinib is being compared with Bristol Myers Squibb’s Sotyktu (deucravacitinib), another TYK2 inhibitor, to establish relative efficacy and safety in the competitive psoriasis market.
Zasocitinib’s success is a key component of Takeda’s strategy to offset expected revenue declines from generic competition to its ulcerative colitis drug Entyvio. The company acquired the candidate from Nimbus Therapeutics for a $4 billion upfront payment and up to $2 billion in milestones, and the drug was discovered with the help of artificial intelligence, underscoring Takeda’s investment in AI‑driven drug discovery. Beyond psoriasis, the company is exploring Zasocitinib in psoriatic arthritis, inflammatory bowel disease, vitiligo, and hidradenitis suppurativa, potentially broadening its market reach.
Takeda plans to file for regulatory approval in the United States and the European Union in fiscal year 2026. Management estimates that, if approved, Zasocitinib could generate peak sales of up to $5 billion, positioning it as a significant revenue driver in Takeda’s portfolio.
Chief Executive Officer Christophe Weber said, “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. This marks the third positive Phase III readout from our overarching pipeline this year, and each of these programs has the potential to transform patient lives, redefine medical practice and deliver significant revenue growth in the future.”
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