With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
Takeda’s oral drug candidate zasocitinib significantly eased disease severity in two late-stage plaque psoriasis studies, setting the Japanese pharma up to challenge Bristol Myers Squibb in this indication.
“The oral psoriasis segment is projected to exceed $5B by 2030,” analysts at Jefferies told investors in a Thursday note, explaining that patients are partial to pills over injectables. In this area, zasocitinib’s “strong efficacy and safety profile de-risk regulatory approval,” the firm continued. Takeda expects to file a new drug application for zasocitinib at the start of its 2026 fiscal year, which begins in April.
Takeda acquired zasocitinib from Nimbus Therapeutics for $4 billion at the end of 2022, outcompeting “almost every biopharmaceutical company” to get it, according to Andy Plump, Takeda’s head of research and development.
Across the two Phase III LATITUDE studies, Takeda enrolled more than 1,800 adults with moderate to severe plaque psoriasis. Both studies compared zasocitinib with placebo and Amgen’s Otezla. Data were sparse in the pharma’s Thursday release, in which it noted that “on average about 30 percent” of treated patients achieved completely clear skin, or a score of 100 on the Psoriasis Area and Severity Index (PASI).
Meanwhile, “more than half” of patients hit PASI 90, indicating clear or almost clear skin.
Despite the lack of details, Jefferies said that zasocitinib “demonstrated best-in-class Ph3 results,” which in turn point to its “potential to redefine the oral psoriasis market.”
Zasocitinib is an AI-designed molecule, something which trial organizers said helped make its targeting “1.7 million times” more selective than other drugs for psoriasis. After a reshuffle of pipeline priorities and dropping its entire cell therapy program this fall, Takeda re-upped a pact with AI-discovery firm Nabla Bio to refill its early pipeline.
With zasocitinib, Takeda is stepping up to Bristol Myers Squibb and its oral tyrosine kinase inhibitor Sotyktu, which was approved in September 2022 for plaque psoriasis. Sotyktu made $246 million worldwide for BMS last year, a 45% year-on-year increase.
Takeda is running a Phase III head-to-head study that compares zasocitinib against Sotyktu in moderate to severe plaque psoriasis. The trial is expected to be completed in July next year.
Aside from Sotyktu, Takeda’s zasocitinib will also be going up against Johnson & Johnson’s icotrokinra, which in March this year hit a 50% PASI 90 response. Truist in its note said that zasocitinib appears “comparable” to icotrokinra, however noting that J&J’s molecule “has first mover advantage with PDUFA expected sometime in 2026.”
