Takeda's Zasocitinib Redefines Oral Psoriasis Treatment with Phase 3 Superiority

Takeda's once-daily pill zasocitinib has beaten the current leading oral psoriasis drug in a direct head-to-head Phase 3 trial, achieving more than twice the rate of complete skin clearance. Financial Post reported that zasocitinib hit a PASI 100 response — meaning total skin clearance — in over 35% of patients at week 16, compared to roughly 14% for Bristol Myers Squibb's deucravacitinib (Sotyktu). That is a 2.5-times difference in complete clearance.
Takeda says the drug also beat deucravacitinib on every key secondary measure, including PASI 90 and near-total skin clearance scores. According to Ottawa Sun, the company is now on track to file a New Drug Application with the U.S. FDA this fiscal year, putting a potential launch on the horizon for 2027.
The Phase 3 LATITUDE Atlas trial enrolled 606 patients with moderate-to-severe plaque psoriasis. It is the first head-to-head trial ever to pit two TYK2 inhibitors — a class of oral drugs that block a specific inflammation pathway — directly against each other. Deucravacitinib was the first TYK2 inhibitor approved by the FDA, cleared in September 2022, and had been seen as a major step forward for oral psoriasis care.
Zasocitinib pulled ahead quickly. Statistical separation between the two drugs appeared as early as week 8, according to research. Principal investigator Dr. Linda Stein Gold said, "Zasocitinib clearly demonstrated superior skin clearance compared with deucravacitinib, highlighting clinically meaningful differences within the oral treatment class." The drug is taken once a day, which makes it easy for patients to stick to their treatment.
Zasocitinib was generally well tolerated in the trial. Treatment-related side effects occurred in 62.1% of patients through week 16. The most common issues were upper respiratory tract infections (10.1%), nasopharyngitis (6.2%), and acne (6.5%). No new safety signals were found, according to Prince George Post.
That clean safety picture matters because older oral drugs in the JAK inhibitor class carry warnings about blood clots and other serious risks. Zasocitinib was engineered to be more than one million times more selective for TYK2 than for other JAK family members. That tight focus is designed to cut efficacy in while keeping serious side effects out.
Takeda paid $4 billion upfront to acquire zasocitinib from Nimbus Therapeutics in December 2022. That was a huge wager on a molecule that had not yet completed Phase 3 trials. Earlier pivotal studies — LATITUDE-PsO 3001 and 3002 — showed 69–71% of patients reaching near-total skin clearance, far above placebo and the older oral drug apremilast (Otezla). The head-to-head win against Sotyktu now validates that bet, according to Fairview Post.
Takeda CEO Christophe Weber said the data "catalyzes a new era of treatment." Financial analysts noted Takeda's stock has climbed 21% over the past year, driven partly by zasocitinib's pipeline progress. The company now plans to file an NDA with the FDA before March 2027. Beyond psoriasis, zasocitinib is also being tested in Phase 3 for psoriatic arthritis and Phase 2 for Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.
Zasocitinib is not racing alone. Johnson & Johnson recently won FDA approval for Icotyde, an oral IL-23 receptor antagonist that also beat Sotyktu in its own trials. A drug from Alumis called envudeucitinib also posted positive Phase 3 data in early 2026. BMS, for its part, continues to stress its five-plus years of long-term safety data for deucravacitinib — a track record zasocitinib has yet to build, according to The Observer.
Some analysts warn the real battle will be fought with insurance companies, not in clinical trials. Payer access and real-world safety data over years of use will shape which drug wins market share, according to Northern News. Still, a 2.5-times edge in complete skin clearance is a powerful starting point for Takeda's commercial push, especially among the millions of psoriasis patients who want effective treatment without injections.
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