FDA Priority Review Granted to Zasocitinib for Moderate to Severe Psoriasis

Published on: September 14, 2026

Phase 3 data show zasocitinib use led to clear or almost clear skin in around 70% of patients by Week 16, setting up an FDA decision in early 2027.

Frequently Asked Questions:

What is zasocitinib being evaluated for?
Zasocitinib is under FDA priority review for adults with moderate-to-severe plaque psoriasis, based on phase 3 data from the LATITUDE PsO program.
How does zasocitinib work?
Zasocitinib is an oral, highly selective TYK2 inhibitor that blocks IL-23 and other core inflammatory pathways involved in psoriasis without affecting JAK1, 2, or 3 signaling.
What did the LATITUDE PsO trials show?
Both LATITUDE PsO 3001 and 3002 met their co-primary endpoints at week 16, with roughly 70% to 76% of zasocitinib-treated patients achieving sPGA 0/1 or PASI 75, respectively, versus placebo and apremilast.

The US Food and Drug Administration (FDA) has accepted Takeda's new drug application under priority review for zasocitinib, an oral tyrosine kinase 2 (TYK2) inhibitor for adult patients living with moderate-to-severe plaque psoriasis, based on phase 3 data spanning nearly 3000 individuals.¹

A Prescription Drug User Fee Act (PDUFA) target action date is slated for the first quarter of 2027.¹ The filing rests on the phase 3 LATITUDE PsO 3001 and 3002 trials, supported by long-term findings resulting from the open-label LATITUDE PsO 3003 study.¹ The European Medicines Agency (EMA) has also separately accepted a marketing application for zasocitinib, resulting in a parallel EU review.¹

"Based on results across nearly 3000 patients, zasocitinib has the potential to be a leading oral treatment option in psoriasis," Andy Plump, MD, PhD, president of research and development at Takeda, said in a statement.

Zasocitinib Phase 3 Efficacy in Moderate-to-Severe Psoriasis

During the phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) trials, researchers randomized 693 and 1108 adult patients living with moderate-to-severe psoriasis across 21 countries to zasocitinib, placebo, or apremilast in a double-blind design. They met both co-primary endpoints at Week 16.² A static Physician Global Assessment (sPGA) score of 0 or 1 was attained by 71% and 69% of zasocitinib-treated subjects across the pair of trials, versus 11% and 13% on placebo and 32% and 30% on apremilast (P <.001 for each).²

Psoriasis Area and Severity Index 75 (PASI 75) responses reached 76% and 71% with zasocitinib, compared with 12% for placebo and 37% and 33% for apremilast (P <.001 for each).² Clearance appeared by Week 4 and continued through Week 52.¹

Zasocitinib Safety Results and High-Impact Site Clearance

Complete clearance rates also favored zasocitinib, with PASI 90 being attained by 61% and 52% of patients across the two trials, versus single-digit placebo rates (P <.001 for each).² High-impact, hard-to-treat sites responded as well, including scalp-specific PGA 0/1 rates of 74% to 77% (P <.001).²

Zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies and a lack of new safety signals, according to Takeda’s release.¹ Adverse events (AEs) in at least 5% of patients across both trials included upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), and acne (6.5%).¹

The company also highlighted its studying of zasocitinib in phase 3 psoriatic arthritis research and phase 2 programs spanning vitiligo, Crohn's disease, ulcerative colitis, and hidradenitis suppurativa.¹

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

References

Takeda. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis. Published September 14, 2026. Accessed September 14, 2026. https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/.
Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine kinase 2 inhibition with zasocitinib (TAK-279) in psoriasis: a randomized clinical trial. JAMA Dermatol. 2024;160(10):1066-1074. doi:10.1001/jamadermatol.2024.2701.

FDA Priority Review Granted to Zasocitinib for Moderate to Severe Psoriasis

Frequently Asked Questions:

Zasocitinib Phase 3 Efficacy in Moderate-to-Severe Psoriasis

Zasocitinib Safety Results and High-Impact Site Clearance

Takeda. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis. Published September 14, 2026. Accessed September 14, 2026. https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/.

Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine kinase 2 inhibition with zasocitinib (TAK-279) in psoriasis: a randomized clinical trial. JAMA Dermatol. 2024;160(10):1066-1074. doi:10.1001/jamadermatol.2024.2701.