Takeda’s closely watched and highly valued dermatology pill zasocitinib has won out in two key phase 3 trials, giving the Japanese pharma confidence to move toward a 2026 approval filing in the U.S.
Early Thursday, Takeda revealed top-line data for two pivotal phase 3 trials of its next-gen, highly selective oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib in adults with moderate to severe plaque psoriasis (PsO).
There was no detailed breakdown (that will come at a later medical conference), but Takeda said both studies showed “superiority of zasocitinib compared to placebo for the co-primary endpoints,” according to a Dec. 18 release.
This includes the static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75 at Week 16, with “significantly greater” PASI 75 responses rate seen as early as Week 4 and continuing to increase through Week 24.
In the sPGA measure, scores between 0 and 4 are logged by physicians to indicate the overall severity of patients' disease. PASI 75, meanwhile, is a key threshold indicating a 75% or greater improvement of the area on patients' bodies affected by psoriasis, as well as their symptom severity.
The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, which Takeda said shows “the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO.”
Safety appeared on the same level as previous trials, with the more common adverse events being upper respiratory tract infections, nasopharyngitis and acne, with “no new safety signals identified,” according to the pharma.
The plan now is to file for a potential approval with the FDA “starting in fiscal year 2026,” the company said. Takeda is looking to take on Bristol Myers Squibb’s first-in-class TYK2 inhibitor Sotyktu, which nabbed a plaque psoriasis green light from the FDA back in 2022. The drug generated $246 million in sales last year.
Zasocitinib is also, in fact, currently in a head-to-head study against Sotyktu in plaque psoriasis, with other phase 3 studies in psoriatic arthritis and phase 2 studies in Crohn’s disease and ulcerative colitis, among other indications, also ongoing.
Speaking at the start of the year at the 2025 J.P. Morgan Healthcare Conference, Takeda’s CEO Christophe Weber said he would plot out a “tactical” launch for the drug should it pass muster with regulators, saying at the time that his company has “learned a lot from BMS’ experience” with marketing Sotyktu.
Takeda expects that zasocitinib, if approved across all indications, could generate peak sales in a range of $3 billion to $6 billion.