
FDA Grants Priority Review to Zasocitinib for Plaque Psoriasis
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
The application is supported by phase 3 findings from nearly 3000 patients, including the phase 3
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
- 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/ - 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 - 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 - 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






















































































































































