Takeda has posted phase 3 data on an autoimmune asset it acquired for $4 billion, laying down a marker ahead of a fight for market share with companies including Bristol Myers Squibb and Johnson & Johnson.
In December, Takeda reported two phase 3 trials of its TYK2 inhibitor, zasocitinib, in adults with moderate to severe plaque psoriasis met their primary endpoints. The Japanese drugmaker later teased bits of the data, revealing that more than 50% of patients had a 90% improvement on the PASI scale and that about 30% of participants had clear skin, but it kept the full dataset under wraps.
Saturday, Takeda used the 2026 American Academy of Dermatology (AAD) Annual Meeting to provide a closer look at the results. Zasocitinib’s PASI 90 rates were 61.3% and 51.9% at Week 16 of the two trials, versus 5% and 4% for placebo and 16.8% and 15.9% for apremilast. Amgen sells apremilast as Otezla.
Takeda reported rates of PASI 100, which indicates clear skin, of 33.4% and 25.2% in people treated with zasocitinib at Week 16. The figures for placebo were 0.7% and 1.1%. On apremilast, 2.9% and 4.3% of patients met the PASI 100 criteria. Zasocitinib beat the controls by similar margins on the sPGA psoriasis symptom scale, providing strong evidence that the molecule is more effective than placebo and Otezla.
If approved, zasocitinib will compete with more efficacious therapies than placebo and Otezla. BMS sells a TYK2 inhibitor, Sotyktu, and Alumis has positive phase 3 data on a molecule that hits the target. J&J and Protagonist Therapeutics recently won FDA approval for an IL-23 receptor antagonist, Icotyde, that beat BMS’ Sotyktu in a phase 3 trial.
With the caveat that cross-trial comparisons can be unreliable, zasocitinib appears to have an advantage over Sotyktu. BMS reported PASI 90 rates of 32% to 42% and PASI 100 rates of 10% to 14% in its phase 3 program.
J&J and Alumis look to pose more of a threat to Takeda. The FDA approved (PDF) Icotyde based on two phase 3 trials in adults that reported PASI 90 rates of up to 55% and PASI 100 rates of up to 32% at Week 16. Alumis, which is also presenting data at AAD Saturday, said in its topline release that, averaged across its two trials, about 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24.
Andrew Plump, M.D., Ph.D., president of R&D at Takeda, discussed how zasocitinib compares to Alumis’ envudeucitinib at a TD Cowen event in early March. Lacking Alumis’ full data, Plump said it is hard to say how the molecules shape up, but he named dosing as an area Takeda has “considerable differentiation.” Zasocitinib is taken once a day, while envudeucitinib is taken twice a day.
J&J’s Icotyde is taken once a day but must be swallowed on an empty stomach. Patients need to take the drug with water when they wake up and wait 30 minutes before eating because of the molecule’s food effect. Alumis saw no clinically significant food effect in a study of envudeucitinib. Plump said there is no food effect with zasocitinib, something he predicted will be “quite important for this class.”
A lot is resting on how the molecules’ strengths and weaknesses translate into market share. Takeda has forecast peak potential zasocitinib revenue of $3 billion to $6 billion in psoriasis and psoriatic arthritis, reflecting a belief that the candidate is as good or better than any other oral drug that is approved or coming to market in the near future.
Takeda is on track to seek regulatory approvals in its 2026 financial year, which starts in April.
