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Raj Chovatiya, MD, PhD, explains where oral TYK2 inhibitor zasocitinib may fit in psoriasis treatment after the FDA accepted its NDA under priority review.
The US Food and Drug Administration (FDA) has accepted Takeda's new drug application for zasocitinib, an investigational oral tyrosine kinase 2 (TYK2) inhibitor, under priority review for adults with moderate to severe plaque psoriasis.¹˒² A decision is expected in the first quarter of 2027.¹
Raj Chovatiya, MD, PhD, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago, Illinois, spoke with HCPLive about how the agent could fit into a crowded treatment landscape.
The filing rests on the phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) trials. A static Physician Global Assessment (sPGA) score of 0 or 1 at Week 16 was reached by 71% and 69% of zasocitinib-treated patients, versus 11% and 13% on placebo and 32% and 30% on apremilast (Otezla) (P <.001 for each).¹
Chovatiya noted psoriasis already has more than a dozen treatment options, including many biologics and oral agents such as apremilast, deucravacitinib (Sotyktu), and icotrokinra. He said the first priority remains moving every patient with moderate to severe disease beyond topical therapy to a targeted advanced treatment, whether injectable or oral.
The oral-versus-biologic debate has long favored biologics on efficacy alone, according to Chovatiya. Newer agents, including next-generation TYK2 inhibitors and small peptides, are narrowing the gap in the proportion of patients reaching relatively clear skin. Clinicians can offer a different route based on patient preference.
Chovatiya said oral medications feel familiar to many patients, which may lower the barrier for those naive to systemic therapy. He suggested zasocitinib could draw in patients entering the systemic-ready phase, along with those with limited but particularly burdensome disease areas. Scalp-specific PGA scores of 0 or 1 reached 77% and 74% with zasocitinib across the two trials.¹
Zasocitinib was generally well tolerated, and Takeda reported no new safety signals. Adverse events in at least 5% of patients included upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), and acne (6.5%).¹
Chovatiya described the potential quality-of-life effect of high clearance rates as substantial. Patients hesitant about biologics could gain a chance to clear their skin, resume daily function, and feel more confident about their appearance. He added the clearance rates show what may be possible, given the large gap among untreated patients.
Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.
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