Dive Brief:
- Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.
- Takeda didn’t provide detailed data, but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla.
- Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.
Dive Insight:
Sotyktu was the first TYK2 inhibitor to gain Food and Drug Administration approval. But it hasn’t yet become the kind of seller Bristol Myers once hoped. The drug recorded $291 million in revenue in 2025 and, with an expected clearance coming in psoriatic arthritis, Bristol Myers recently revealed plans to no longer promote Sotyktu in dermatology in many markets.
Polling by some analysts has suggested that many dermatologists prefer injectable biologics due to Sotyktu’s lower efficacy. Takeda, then, may have to convince doctors that zasocitinib is clearly better if it hopes to draw patients away from effective shots like AbbVie’s Skyrizi and J&J’s Tremfya.
The company, for its part, has been optimistic about zasocitinib’s chances. On a May earnings call with analysts, CEO-elect Julie Kim claimed the drug is “poised to be a leading oral treatment option” with the potential to “significantly expand” the growing market for psoriasis pills.
“When you look at the market, oral treatments are already the fastest-growing segment, with the number of patients on advanced oral therapy expected to triple over the next decade,” Kim told analysts.
The study results disclosed Thursday could help Takeda’s case. In the head-to-head trial, zasocitinib helped 35% of the people who took it achieve a measure called PASI 100, a benchmark of complete skin clearance with no visible lesions. That figure was 2.5-times better than Sotyktu, a statistically significant difference that met the study’s main goal. Takeda didn’t state the exact number associated with Sotyktu, but in Bristol Myers’ clinical trials, up to 14% of trial enrollees hit the PASI 100 mark.
Zasocitinib was also statistically better than Sotyktu on all secondary endpoints, which included partial skin clearance measures such as PASI 90 and PASI 75. The PASI 100 rate would fall short of what’s been seen in testing of Skyrizi and Tremfya, although zasocitinib hasn’t been evaluated directly against those drugs.
“As expectations for oral therapies continue to rise, these findings support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option in plaque psoriasis,” said Linda Stein Gold, the director of dermatology clinical research at Henry Ford Health and a lead trial investigator, in a statement.
An equally important trial readout is expected for zasocitinib in inflammatory bowel disease later this year. Two TYK2 drugs, including Sotyktu, have failed studies in people with ulcerative colitis or Crohn’s disease.
