News|Articles|September 14, 2026

FDA Grants Priority Review to Zasocitinib for Plaque Psoriasis

Fact checked by: Abigail Brooks, MA

Takeda’s oral TYK2 inhibitor showed rapid skin clearance in phase 3 psoriasis trials as FDA fast-tracks review; decision expected early 2027.

The US Food and Drug Administration (FDA) has accepted Takeda’s new drug application (NDA) for zasocitinib (TAK-279) under Priority Review for adults with moderate-to-severe plaque psoriasis. A regulatory decision is expected during the first quarter of 2027.¹

The application is supported by phase 3 findings from nearly 3000 patients, including the phase 3 LATITUDE PsO 3001 and 3002 clinical trials. In the 2 studies, approximately 70% of patients receiving once-daily zasocitinib achieved clear or almost clear skin at week 16, with improvements observed as early as week 4 and continuing through week 52.¹

Zasocitinib is an investigational, oral, highly selective tyrosine kinase 2 (TYK2) inhibitor. FDA acceptance under Priority Review shortens the agency’s review timeline but does not constitute approval.

“Despite progress in psoriasis care, there remains a need for highly effective oral therapies,” Andy Plump, MD, PhD, president of research and development at Takeda, said in a statement.¹

Phase 3 LATITUDE Results

LATITUDE PsO 3001 and 3002 were global, multicenter, randomized, double-blind, placebo- and active comparator-controlled trials evaluating the efficacy, safety, and tolerability of zasocitinib in adults with moderate-to-severe plaque psoriasis. The trials were conducted across 21 countries and enrolled 693 and 1108 participants, respectively.1-3

The co-primary endpoints were the proportions of patients achieving a static Physician Global Assessment (sPGA) score of 0 or 1 and at least a 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16 compared with placebo.

In LATITUDE PsO 3001, 71% of patients receiving zasocitinib achieved sPGA 0/1 at week 16, compared with 11% receiving placebo and 32% receiving apremilast (P < .001). PASI 75 response rates were 76%, 12%, and 37%, respectively (P < .001).¹

Results were consistent in LATITUDE PsO 3002. At week 16, sPGA 0/1 was achieved by 69% of the zasocitinib group, 13% of the placebo group, and 30% of the apremilast group (P < .001). Corresponding PASI 75 response rates were 71%, 12%, and 33% (P < .001).¹

Zasocitinib also produced higher levels of complete or near-complete skin clearance. PASI 90 response rates were 61% and 52% in the zasocitinib groups across the 2 studies, compared with 4% to 5% with placebo and 16% to 17% with apremilast. PASI 100 was achieved by 33% and 25% of zasocitinib-treated patients, respectively.¹

Responses in High-Impact Areas

Treatment benefits extended to high-impact and difficult-to-treat areas, including the scalp, nails, palms, and soles. At week 16, 77% of zasocitinib-treated patients in LATITUDE PsO 3001 and 74% in LATITUDE PsO 3002 achieved clear or almost clear scalp skin. Rates with placebo were 7% and 13%, respectively.¹

The NDA also includes supportive data from LATITUDE PsO 3003, an open-label phase 3 study assessing long-term safety, tolerability, and efficacy. The study enrolled approximately 2100 participants and includes exposure to zasocitinib 30 mg once daily for up to 156 weeks.⁴

Zasocitinib was generally well tolerated across the phase 3 program, according to Takeda, with no new safety signals identified. The most common adverse events reported in at least 5% of participants across LATITUDE PsO 3001 and 3002 were upper respiratory tract infection (10.1%), acne (6.5%), and nasopharyngitis (6.2%).¹

TYK2 is an intracellular member of the Janus kinase family that mediates inflammatory pathways involved in psoriasis, including interleukin-23/interleukin-17 and type I interferon signaling.

Zasocitinib is designed to maintain 24-hour TYK2 inhibition while minimizing effects on JAK1, JAK2, and JAK3. In vitro studies showed more than 1-million-fold greater selectivity for TYK2 than for the other JAK enzymes, according to Takeda.¹

The European Medicines Agency has also accepted a marketing authorization application for zasocitinib in moderate-to-severe plaque psoriasis. The investigational therapy is additionally being evaluated for psoriatic arthritis, Crohn disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.


References

  1. Takeda. US FDA accepts new drug application under Priority Review for Takeda’s zasocitinib in moderate-to-severe plaque psoriasis. News release. September 14, 2026. Accessed September 14, 2026. https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/
  2. A study about how well TAK-279 works and its safety in participants with moderate-to-severe plaque psoriasis during 52 weeks of treatment. ClinicalTrials.gov identifier: NCT06088043. Accessed September 14, 2026. https://clinicaltrials.gov/study/NCT06088043
  3. A study of TAK-279 in participants with moderate-to-severe plaque psoriasis. ClinicalTrials.gov identifier: NCT06108544. Accessed September 14, 2026. https://clinicaltrials.gov/study/NCT06108544
  4. A study of TAK-279 in participants with moderate-to-severe plaque psoriasis. ClinicalTrials.gov identifier: NCT06550076. Accessed September 14, 2026. https://clinicaltrials.gov/study/NCT06550076

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