Takeda Reported Positive Psoriasis Drug Trial Results

The FDA has accepted a New Drug Application for the oral psoriasis treatment zasocitinib.

Updated on Sept. 28, 2026 in Arthritis

Isometric editorial illustration of a laboratory petri dish with a structured crystal, symbolizing medical innovation and clinical research. — Takeda announced successful phase 3 clinical trial results for its oral psoriasis treatment, zasocitinib, with the FDA granting Priority Review. AI Illustration. Upload story photo >

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Takeda has announced successful results from two phase 3 clinical trials for zasocitinib, an investigational oral tyrosine kinase 2 inhibitor. The FDA has now accepted the drug's application for Priority Review.

Why it matters

Psoriasis in sensitive areas like the scalp and nails presents unique treatment challenges and significant patient burden. Zasocitinib is being evaluated as a once-daily treatment option for those with moderate-to-severe plaque psoriasis.

In phase 3 trials, 77% of patients in trial 3001 and 74% in trial 3002 achieved scalp-specific Physician Global Assessment scores of 0 or 1. Trial 3001 and 3002 enrolled 693 and 1,108 adults, respectively.

The players

Takeda

This is a global pharmaceutical company focused on creating treatments for various medical conditions, including psoriasis.

FDA

This federal agency is responsible for protecting public health by regulating the safety and efficacy of new drug applications.

The details

The drug is a once-daily oral tyrosine kinase 2 inhibitor tested against placebo and apremilast. Results also showed mean shifts from baseline in the Nail Psoriasis Severity Index of -7.1 in trial 3001 and -8.6 in trial 3002.

Takeda announced the FDA's acceptance of the new drug application in September 2026.
The FDA has scheduled a target action date for the drug application in the first quarter of 2027.

The Big Picture

This drug trial progression follows the clinical data collection patterns established by the LATITUDE PsO 3003 study. The results provide a new benchmark for oral therapies aiming to treat complex plaque psoriasis cases.

Patients dealing with moderate-to-severe plaque psoriasis may eventually gain access to a new once-daily oral medication. This development could offer a new treatment alternative for those who struggle with symptoms on the scalp and nails.

The takeaway

The successful trial results for zasocitinib highlight the ongoing efforts to address the challenges of treating plaque psoriasis in visible areas. Patients should discuss new treatment options with their healthcare provider as these therapies move through regulatory approval.