Zasocitinib (TAK-279) - (LATITUDE PsO)

September 14, 2026: Takeda (TAK) said the FDA accepted, under Priority Review, its NDA for zasocitinib (TAK-279), an oral TYK2 inhibitor, for adults with moderate-to-severe plaque psoriasis; the PDUFA target action date is in Q1 2027. The EMA also accepted the MAA.

The filing is supported by Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544), where co-primary and all 44 ranked secondary endpoints were met, plus long-term supportive data from open-label LATITUDE PsO 3003 (NCT06550076). At week 16, sPGA 0/1 was achieved by 71% vs 11% placebo and 32% apremilast in PsO 3001, and 69% vs 13% placebo and 30% apremilast in PsO 3002 (p<0.001). PASI 75 was 76% vs 12% placebo and 37% apremilast in PsO 3001, and 71% vs 12% placebo and 33% apremilast in PsO 3002 (p<0.001). PASI 90 reached 61%/52%; PASI 100 reached 33%/25%; scalp ssPGA 0/1 reached 77%/74%. In PsO 3002, PASI 75 at week 4 was 17% vs 4% for placebo (p<0.001).

Takeda said zasocitinib was generally well tolerated, with common adverse events of upper respiratory tract infection (10.1%), acne (6.5%), and nasopharyngitis (6.2%), and no new safety signals.