Regulatory & Policy

Takeda secures FDA Priority Review for oral TYK2 inhibitor zasocitinib

Edited by Robert McTiernan··2 min read
Takeda secures FDA Priority Review for oral TYK2 inhibitor zasocitinib

The US FDA has accepted for Priority Review a New Drug Application (NDA) from Takeda (NYSE: TAK) for zasocitinib (TAK-279), an oral tyrosine kinase 2 (TYK2) inhibitor, seeking approval for adults with moderate-to-severe plaque psoriasis. A Prescription Drug User Fee Act (PDUFA) target action date has been set for Q1 2027.

The NDA is supported by data from nearly 3,000 patients including from the pivotal Phase III LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies, both conducted across 21 countries. In those trials, approximately 70% of zasocitinib-treated patients achieved clear or almost clear skin — a static Physician Global Assessment (sPGA) score of 0/1 — at week 16, compared with roughly 11–13% on placebo and 30–32% on apremilast (p<0.001). PASI 75 response rates were 71–76% with zasocitinib versus 12% on placebo. All 44 ranked secondary endpoints were met, including PASI 90, PASI 100, and clearance at hard-to-treat sites including scalp, nails, and palmoplantar areas. Responses continued to increase through week 24, and over 90% of patients who achieved PASI 75, PASI 90 or sPGA 0/1 at week 40 maintained their response at week 60. The most common adverse events were upper respiratory tract infection (10.1%), acne (6.5%), and nasopharyngitis (6.2%), with no new safety signals identified.

Zasocitinib inhibits TYK2 allosterically via its pseudokinase regulatory domain, blocking signaling downstream of IL-23/IL-17 axis and type I interferon receptors. Takeda said the compound has more than one-million-fold greater selectivity for TYK2 over JAK1, JAK2, and JAK3, based on in vitro data, which the company said could minimize the cardiovascular and hematologic risks associated with broader JAK inhibition.

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Bristol Myers Squibb's Sotyktu (deucravacitinib), the currently approved oral TYK2 inhibitor for plaque psoriasis, received FDA approval in September 2022 and was subsequently approved for psoriatic arthritis. In a Phase III head-to-head study reported in June 2026, zasocitinib demonstrated statistical superiority over deucravacitinib for PASI 100 response at week 16, with more than 35% of patients achieving complete skin clearance — more than 2.5 times the rate observed with deucravacitinib. Johnson & Johnson's icotrokinra (Icotyde), an oral IL-23 receptor antagonist, received FDA approval in March 2026 and also demonstrated superiority to deucravacitinib in its pivotal trials, entering the market before zasocitinib's potential approval.

The European Medicines Agency (EMA) has also accepted a marketing authorization application (MAA) for zasocitinib in moderate-to-severe plaque psoriasis, and Takeda said it plans further submissions with global regulatory authorities. Beyond psoriasis, the company is evaluating zasocitinib in Phase III trials for psoriatic arthritis and Phase II studies in Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.

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