Once-Daily Pill Zasocitinib Clears Psoriasis at Toughest Sites

Zasocitinib (TAK-279), an investigational once-daily pill, achieved skin clearance rates in moderate to severe plaque psoriasis (PsO) that have historically been limited to injectable biologics, including at hard-to-treat, high-impact sites such as the scalp, nails, palms, and soles, according to new phase 3 data from Takeda.¹

The data, which Takeda plans to submit as part of a package to the FDA and other regulators, was presented at the 2026 American Academy of Dermatology Innovation Academy and showed high rates of skin clearance compared with the placebo. These results could reshape the psoriasis treatment landscape, given that effective options at this level have so far come primarily from injectables.²

What Is Zasocitinib?

Zasocitinib maintains 24-hour inhibition of IL-23 along with other immune pathways that drive psoriasis. The drug shows more than a 1-million-fold greater selectivity for TYK2 than for other Janus kinase (JAK) enzymes, based on in vitro data, potentially allowing for maximal TYK2 inhibition without affecting JAK1, JAK2, or JAK3 signaling. This selectivity profile positions zasocitinib as a potential leading oral option for patients with immune-mediated inflammatory diseases. Zasocitinib remains investigational and is not approved by any regulators.²

Evaluation of Zasocitinib in the LATITUDE Program

Zasocitinib is being evaluated in adults with moderate to severe PsO across 21 countries in the phase 3, randomized, double-blinded LATITUDE PsO 3001 and 3002 trials, which enrolled 693 and 1108 patients, respectively. The trials randomized patients to receive zasocitinib, the FDA-approved oral therapy apremilast (Otezla; Amgen), or placebo. Co-primary end points at week 16 were the proportion of patients treated with zasocitinib who achieved clear or almost clear skin scores according to the static Physician Global Assessment and at least a 75% improvement in the patient’s Psoriasis Area and Severity Index (PASI) score compared with their baseline.² A separate phase 3 trial in the same program, LATITUDE Atlas, compared zasocitinib with deucravacitinib (Sotyktu; Bristol Myers Squibb), an approved oral TYK2 inhibitor.³

At week 16, zasocitinib surpassed both comparators across every end point. About 70% of patients achieved an almost clear or clear score, compared with 11% to 13% on placebo and 30% to 32% on apremilast. On PASI 90, 52% to 61% of zasocitinib patients responded, versus 4% to 5% on placebo and 16% to 17% on apremilast. Complete clearance (PASI 100) was achieved by roughly 25% to 33% of zasocitinib patients, compared with less than 1% on placebo and less than 5% on apremilast. Separation from placebo was evident by week 4, and more than 90% of responders maintained their response through week 60.²

Zasocitinib Targeting Hard-to-Treat Sites

Zasocitinib's benefit extended to sites that are known to be resistant to treatment. Roughly 75% of patients achieved clear or almost-clear scalp skin, outperforming both comparators. Similar improvements were seen on the palms and soles, with roughly 70% of patients seeing palmoplantar psoriasis improvement. Additionally, zasocitinib showed statistically significant improvement over placebo in the nails. These sites carry significant impact on patients’ quality of life, and the consistency of clearance across the body supports a broader treatment benefit rather than one limited to easier-to-treat areas.¹

“Despite advances in psoriasis care, many patients continue to experience persistent symptoms, especially in highly visible or sensitive areas like the scalp—impacting about half of patients with psoriasis—which can disproportionately affect daily life,” Leon Kircik, MD, founder and medical director of Skin Sciences and Physicians Skin Care, principal investigator for the LATITUDE PsO studies, and presenting author, said in a statement.¹ “These findings show that zasocitinib delivered consistently clear skin across the hardest-to-treat areas, including the scalp, nails, palms and soles, reinforcing its potential to become a leading oral treatment option for patients seeking meaningful, whole-body skin clearance.”

Oral vs Injectable Psoriasis Treatment

Until now, most effective psoriasis treatments have been injection-based. Oral options with similar clearance rates represent a meaningful shift for patients who prefer to avoid injections or want simpler dosing. This is reinforced by LATITUDE Atlas, in which zasocitinib reportedly outperformed deucravacitinib on complete skin clearance at week 16. The findings show zasocitinib as an advanced treatment not only compared with placebo and apremilast but also within the oral TYK2 inhibitor class itself.³

Chinwe Ukomadu, MD, PhD, Takeda’s senior vice president and head of the Gastrointestinal & Inflammation Therapeutic Area Unit, said the data from the phase 3 results “…reinforce the potential of our next-generation TYK2 inhibitor to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill.”¹

Zasocitinib’s Safety Profile Consistent With Drug Class

Treatment-emergent adverse events (TEAEs) through week 16 were more common with zasocitinib (62.1%) than with placebo (46.9%) or apremilast (50.5%), but the safety profile remained consistent with the broader drug class.

Commonly reported adverse events were upper respiratory infection (10.1%), acne (6.5%), and nasopharyngitis (6.2%). Serious TEAEs for zasocitinib were low overall (3%) but somewhat higher than with placebo (< 1%) or apremilast (1.5%). Takeda noted that these safety results are consistent with prior phase 2b data, with no new notable safety signals.²

Takeda Plans to Submit to FDA

Trial results suggest the oral TYK2 inhibitor class is in rapid development, with comparable medication now being tested against one another rather than against placebo alone, reinforcing zasocitinib’s potential. With beneficial results, Takeda plans to submit a new drug application for PsO.⁴

References

1. Takeda. Zasocitinib shows consistent skin clearance in phase 3 psoriasis studies. News release. Takeda Pharmaceutical Company Limited. July 16, 2026. Accessed July 28, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-phase-3-psoriasis-skin-clearance/
2. Takeda. Takeda's zasocitinib delivered rapid and durable skin clearance in a convenient once-daily pill, affirming promise to reshape psoriasis care. News release. Takeda Pharmaceutical Company Limited. March 28, 2026. Accessed July 28, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-phase3-clinical-trial-results/
3. Takeda. Takeda's zasocitinib significantly outperforms deucravacitinib in head-to-head phase 3 psoriasis study. News release. Takeda Pharmaceutical Company Limited. June 11, 2026. Accessed July 28, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-outperforms-deucravacitinib-study/
4. Bader K. Zasocitinib shows high skin clearance at hard-to-treat psoriasis sites. Dermatology Times^®. July 16, 2026. Accessed July 28, 2026. https://www.dermatologytimes.com/view/zasocitinib-shows-high-skin-clearance-at-hard-to-treat-psoriasis-sites