Psoriasis Drug zasocitinib Met Phase 3 Study Goals

Adults with plaque psoriasis may soon have a new once-daily treatment option after positive clinical trial results.

Updated on Sept. 28, 2026 in Arthritis

Isometric editorial illustration of a geometric molecular signaling cluster, representing the cellular mechanism of a new pharmaceutical treatment. — Takeda announced positive results from Phase 3 trials for zasocitinib, a potential new once-daily treatment for moderate-to-severe plaque psoriasis, with an FDA decision expected in 2027. AI Illustration. Upload story photo >

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Takeda announced positive results from two Phase 3 clinical trials for the investigational drug zasocitinib in adults with moderate-to-severe plaque psoriasis. The FDA has accepted the New Drug Application for the treatment under Priority Review, with a target decision date set for the first quarter of 2027.

Why it matters

Psoriasis in difficult-to-treat areas like the scalp and nails often imposes a high burden on patients, creating a critical need for effective therapies. This new treatment could provide a different oral option for managing symptoms in these specific regions.

In two Phase 3 trials involving 693 and 1,108 adults, zasocitinib demonstrated significant skin clearance, with the majority of patients achieving near-complete scalp scores of 0 or 1 at 16 weeks. These findings build on initial clinical data, though long-term safety is still being evaluated.

The players

Takeda

A global pharmaceutical company focused on developing therapies for gastrointestinal, inflammatory, and rare diseases.

FDA

The federal agency responsible for protecting public health by ensuring the safety and efficacy of medical products in the United States.

The details

Zasocitinib functions as a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, a class of medication designed to selectively block specific signaling pathways that drive inflammation in psoriasis. By modulating these intracellular signals, the drug aims to reduce the rapid skin cell turnover characteristic of the condition. Ongoing research in the open-label LATITUDE PsO 3003 study is currently tracking how this mechanism sustains efficacy and tolerability in approximately 2,100 participants over a longer duration.

September 2026: Takeda announced the FDA accepted the new drug application for zasocitinib.
Q1 2027: The FDA target action date for the drug application is scheduled.

Health Landscape

The development of zasocitinib reflects a broader shift toward targeted oral inhibitors for managing inflammatory skin conditions. This drug follows the trajectory of established Phase 3 research programs, including the ongoing LATITUDE PsO 3003 study, as the field seeks to balance systemic symptom control with patient convenience.

If you are managing moderate-to-severe plaque psoriasis, keep an eye on upcoming regulatory updates regarding new oral treatment options. It is worth discussing with your doctor how emerging once-daily therapies might eventually fit into your existing treatment plan.

The takeaway

This development highlights the potential for new oral therapies to address localized psoriasis symptoms like scalp and nail involvement. Talk to your dermatologist about your current disease burden and whether you should monitor for future treatment options as new data becomes available.