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Jump to Key Points The FDA has accepted a new drug application under priority review for zasocitinib, an oral, once-daily tyrosine kinase 2 (TYK2) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adults, according to the manufacturer.
A regulatory decision is expected in the first quarter of 2027.
The filing was supported by findings from the LATITUDE PsO 3001 and 3002 trials, in which zasocitinib, also known as TAK-279, reached all primary and secondary endpoints, according to a news release from Takeda. The studies were conducted in 21 countries.
According to the release, the LATITUDE PsO 3001 study randomly assigned 693 adults with moderate-to-severe plaque psoriasis to receive zasocitinib, apremilast, or placebo. By week 16, 71% of patients taking zasocitinib achieved a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) compared with 32% for apremilast and 11% for placebo (P < .001). In addition, 76% of those taking zasocitinib achieved a Psoriasis Area and Severity Index (PASI) 75 response, compared with 37% for apremilast and 12% for placebo, also at week 16.
- FDA priority review granted for oral once-daily TYK2 inhibitor zasocitinib.
- Indication: moderate-to-severe plaque psoriasis in adults.
- Decision expected Q1 2027; NDA supported by LATITUDE PsO 3001/3002.
- Week 16 efficacy: sPGA 0/1 69%-71%; PASI 75 71%-76%.
- Common AEs: URTI 10.1%, nasopharyngitis 6.2%, acne 6.5%; no new safety signals.
In the larger LATITUDE PsO 3002 study, which randomly assigned 1108 adults to the same three treatment groups, 69% of patients taking zasocitinib achieved a sPGA 0/1 compared with 30% of those on apremilast and 13% of those on placebo (P < .001). PASI 75 was met by 71% of those taking zasocitinib vs 33% of those on apremilast and 12% for placebo (P < .001).
Among secondary endpoints, by week 16, 33% and 25% of patients taking zasocitinib achieved PASI 100 in the 3001 and 3002 trials, respectively, significantly outperforming apremilast (3%-4%) and placebo (0.7%-1.0%).
According to the Takeda release, zasocitinib was generally well tolerated, with no new safety signals identified. The most common adverse events were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), and acne (6.5%).
Takeda also is evaluating the safety and efficacy of zasocitinib in phase 3 studies for psoriatic arthritis and in phase 2 studies for Crohn’s disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.
Scott Harris has covered dermatology for more than a decade. He lives near Washington, DC.
