Takeda has released data for its plaque psoriasis (PsO) pill in key secondary endpoints in high-impact areas, supporting a route to potential approval.
In two randomised, multi-centre, double-blind, Phase III trials (NCT06088043 and NCT06108544), zasocitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, demonstrated consistent and high rates of skin clearance across hard-to-treat, high-impact sites, including the scalp, nails, palms and soles, compared with placebo.
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In the two studies, which enrolled adults with moderate-to-severe PsO, 77% and 74% of patients, respectively, with scalp psoriasis treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response versus 7% and 13% who received placebo.
Takeda also pitted its PsO pill against Amgen’s Otezla (apremilast), with 42% and 30% of patients taking the active comparator in the two studies achieving ssPGA 0/1 response at week 16.
With the palms and soles, approximately 70% of patients (71% and 69%) with palmoplantar psoriasis treated with zasocitinib achieved numerically higher rates of hands- and/or feet-specific PGA (hfPGA) 0/1 response, compared to 22% and 10% in the placebo cohort and 44% and 43% in the Otezla arm at week 16.
Zasocitinib also delivered statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo at week 16. Responses were sustained through week 24 in both studies.
Dr Leon Kircik, founder and medical director of Skin Sciences and Physicians Skin Care, Louisville, KY, principal investigator for the LATITUDE PsO studies and presenting author, said: “Despite advances in psoriasis care, many patients continue to experience persistent symptoms, especially in highly visible or sensitive areas like the scalp — impacting about half of patients with psoriasis — which can disproportionately affect daily life. These findings show that zasocitinib delivered consistently clear skin across the hardest-to-treat areas, including the scalp, nails, palms and soles, reinforcing its potential to become a leading oral treatment option for patients seeking meaningful, whole-body skin clearance.”
The secondary endpoint data was presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, taking place in New York City from 16-19 July.
These data build on the topline primary endpoint data announced in December 2025, in which about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) at week 16, with a significantly greater Psoriasis Area and Severity Index (PASI) 75 response rate seen as early as week four and continuing to increase through week 24.
They also build on the Phase III LATITUDE Atlas head-to-head study (NCT06973291), in which zasocitinib demonstrated statistical superiority over Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib). In the study, zasocitinib was superior in the Psoriasis Area and Severity Index (PASI) 100 response rate at week 16, the primary endpoint. More than 35% of zasocitinib patients achieved this endpoint, greater than 2.5 times the response rate for Sotyktu.
The study drug also demonstrated statistical superiority over Sotyktu for all key secondary endpoints, including PASI 90 response and Static Physician’s Global Assessment (sPGA) 0 at week 16.
Sotyktu and AbbVie’s Skyrizi (risankizumab) currently dominate the PsO market in the US. Sotyktu has the same mechanism of action as zasocitinib, while Skyrizi is AbbVie’s blockbuster injected monoclonal antibody (mAb) that inhibits IL-23.
Johnson & Johnson (J&J) is also set to make an impact on the PsO market with its drug Icotyde (icotrokinra), having gained FDA approval in March 2026. J&J said that Icotyde is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.
Icotyde will succeed J&J’s Stelara (ustekinumab), an IL-23 inhibitor approved for PsO treatment that lost core patent exclusivity in 2023. J&J also has Tremfya (guselkumab) on the market in this indication, though, like Skyrizi, the drug is injected.
GlobalData predicts that PsO drug sales across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) will reach $11.56bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterised by itchy, painful, disfiguring and disabling skin lesions that impact a person’s physical, emotional and psychological well-being.
Globally, an estimated 64 million people are living with psoriasis, and about 80%-90% of those have PsO.
Takeda is continuing with its plans to submit a New Drug Application (NDA) for zasocitinib in PsO with the US Food and Drug Administration (FDA) and other regulatory authorities beginning this fiscal year. The drug is also being evaluated in Phase III studies in psoriatic arthritis and Phase II studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).
