Takeda’s once-daily oral plaque psoriasis (PsO) drug has met all its endpoints in two pivotal trials, with the company set to seek approval from the US Food and Drug Administration (FDA) in 2026.
In the randomised, multi-centre, double-blind, Phase III trials (NCT06088043 and NCT06108544), zasocitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, met all its primary and secondary endpoints in adults with moderate-to-severe PsO.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The studies, which were both placebo-controlled and active comparator-controlled, demonstrated superiority of zasocitinib compared to placebo in both static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 after 16 weeks of treatment, with PASI 75 response rate seen as early as week four and continuing to increase through week 24.
The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO.
The drug was generally well-tolerated, with adverse events (AEs) remaining consistent with prior studies, such as upper respiratory tract infection, nasopharyngitis and acne.
Takeda R&D president Dr Andy Plump said: “It is incredibly rewarding and exciting to see our Phase II results validated in Phase III, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataBased on the trials, Takeda plans to submit a new drug application (NDA) to the FDA and other regulatory authorities in 2026. The data will also be presented at an upcoming medical congress.
Zasocitinib is also being evaluated in a head-to-head study against Bristol Myers Squibb’s Sotyktu (deucravacitinib) in plaque psoriasis, Phase III studies in psoriatic arthritis and Phase II studies in Crohn’s disease and ulcerative colitis, among other indications.
According to Takeda, results from the Phase III studies have no significant impact on the full-year consolidated forecast for the fiscal year ending in March 2026.
Both zasocitinib and Sotyktu, the latter of which was approved in September 2022, have the same molecular target. GlobalData’s patient-based forecast estimates Sotyktu will reach blockbuster status in 2025. In 2030, sales are expected to reach $2.17bn.
Meanwhile, zasocitinib sales, according to the same patient-based forecast, are expected to reach $1.28bn in 2030.
Johnson & Johnson (J&J) is also hoping to make an impact on the PsO market, with its investigational drug icotrokinra, which is showing potential as a standard of care (SoC) medication.
J&J has submitted an NDA to the FDA for approval of the drug and is awaiting a regulatory decision.
This comes as 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 Pharmaceutical Technology.
