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  • Acceptance is based on pivotal Phase 3 data demonstrating rapid, durable and consistent skin clearance, including in high-impact sites, in a convenient once-daily pill
  • Results from nearly 3,000 patients support potential for next-generation TYK2 inhibitor to redefine oral treatment expectations in psoriasis
  • The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027

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OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis. Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.1-3Addressing unmet needs in psoriasis treatment
“Despite progress in psoriasis care, there remains a need for highly effective oral therapies that also address the diverse and often challenging manifestations of psoriasis, including involvement of high-impact sites like the scalp,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Our Phase 3 data demonstrated rapid and durable skin clearance across various patient types and in high-impact and hard-to-treat areas. Based on the results across nearly 3,000 patients, zasocitinib has the potential to be a leading oral treatment option in psoriasis.”

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Article contentPhase 3 clinical data supporting the zasocitinib NDA for moderate-to-severe plaque psoriasis
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The NDA filing is supported by a comprehensive data package including the pivotal global Phase 3 LATITUDE PsO 3001 (

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) and 3002 (

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) studies, in which all primary and ranked secondary endpoints were met.

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The submission also included supportive data from LATITUDE PsO 3003 (

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), an open-label study to evaluate zasocitinib’s long-term safety, tolerability and efficacy.

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Zasocitinib data demonstrated:

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  • Statistically significant and clinically meaningful improvements across multiple measures of skin clearance and symptom relief, with about 70% of patients achieving clear or almost clear skin (sPGA 0/1) at week 16.
  • Rapid and durable skin clearance for the majority of patients, with clearance observed as early as week 4 and increasing through week 24 and further through week 52.
  • High levels of skin clearance across hard-to-treat and high-impact sites, including the scalp, nails, palms and soles, which can result in reduced quality of life for patients.5
  • Zasocitinib was generally well tolerated, with a safety profile consistent with previous studies. No new safety signals were identified.

Article contentNext steps for zasocitinib
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The European Medicines Agency (EMA) also accepted Takeda’s new marketing authorization application (MAA) for zasocitinib, initiating the review process for the treatment of moderate-to-severe plaque psoriasis. Takeda plans to submit additional applications for plaque psoriasis with global regulatory authorities to bring zasocitinib to people living with psoriasis worldwide.

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The NDA filing has no significant impact on the full year consolidated financial forecast for the fiscal year ending March 31, 2027.

Article content Q&A:
Article contentWhat specific data supports the zasocitinib FDA acceptance?
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The NDA filing is supported by the pivotal Phase 3 LATITUDE PsO 3001 (

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) and 3002 (

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) studies, in which the co-primary and all 44 ranked secondary endpoints were met.

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The studies are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis.

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Co-primary and select secondary endpoints at week 16 included:

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Co-primary Endpoints and Select Secondary Endpoints at Week 16

LATITUDE PsO 3001 Results

LATITUDE PsO 3002 Results

static Physician Global Assessment (sPGA) 0/1

71% zasocitinib vs 11% placebo and 32% apremilast (p<0.001)

69% zasocitinib vs 13% placebo and 30% apremilast (p<0.001)

Psoriasis Area and Severity Index (PASI) 75

76% zasocitinib vs 12% placebo and 37% apremilast (p<0.001)

71% zasocitinib vs 12% placebo and 33% apremilast (p<0.001)

Select Secondary

Endpoints at Week 16

PASI 90

61% zasocitinib vs 5% placebo and 17% apremilast (p<0.001)

52% zasocitinib vs 4% placebo and 16% apremilast (p<0.001)

sPGA 0

40% zasocitinib vs 0.7% placebo and 8% apremilast (p<0.001)

34% zasocitinib vs 1% placebo and 7% apremilast (p<0.001)

PASI 100

33% zasocitinib vs 0.7% placebo and 3% apremilast (p<0.001)

25% zasocitinib vs 1% placebo and 4% apremilast (p<0.001)

Scalp-specific PGA (ssPGA) 0/1

77% zasocitinib vs 7% placebo and 42% apremilast (p<0.001)

74% zasocitinib vs 13% placebo and 30% apremilast (p<0.001)

Nail Psoriasis Severity Index (NAPSI), Least-squares mean change from baseline

-7.1 zasocitinib vs 1.8 placebo (p<0.001)

-8.6 zasocitinib vs -1.4 placebo (p<0.001)

Palmoplantar (hands and/or feet response) PGA (hfPGA) 0/1*

71% zasocitinib vs 22% placebo and 44% apremilast*

69% zasocitinib vs 10% placebo and 43% apremilast*

PASI 75 at Week 4

N/A

17% zasocitinib vs 4% for placebo (p<0.001)

Most Common Adverse Events (≥5%)

Upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%), with no new safety signals identified**

*Not a multiplicity controlled secondary endpoint. Comparisons with apremilast are descriptive and should be interpreted accordingly.

**Sample size adjusted incidence proportion across the two studies.

Article contentWhen could zasocitinib become available to patients?
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Zasocitinib is currently under FDA Priority Review, with a decision anticipated in the first quarter of 2027. If approved, zasocitinib could become available to appropriate patients after FDA approval.

Article contentAbout Plaque Psoriasis
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Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring and disabling skin lesions that impact one’s physical, emotional and psychological wellbeing.

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Globally, an estimated 66.4 million people are living with psoriasis, and about 80-90% of those have plaque psoriasis.