FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis

The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis and granted the application Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is expected in the first quarter of 2027.¹

Zasocitinib is an investigational, once-daily oral tyrosine kinase 2 (TYK2) inhibitor designed to selectively inhibit TYK2-mediated inflammatory signaling. The NDA is supported by data from nearly 3000 patients across the zasocitinib clinical development program, including the pivotal phase 3 LATITUDE PsO 3001 (NCT06088043) and LATITUDE PsO 3002 (NCT06108544) trials.^1,2,3

“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,” Andy Plump, MD, PhD, president of research and development at Takeda, said in the announcement.¹

There remains a need for highly effective oral therapies that also address the diverse and often challenging manifestations of psoriasis — Andy Plump, MD, PhD, president of research and development 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,” Plump continued. “Based on the results across nearly 3,000 patients, zasocitinib has the potential to be a leading oral treatment option in psoriasis.”¹

Phase 3 LATITUDE Results Support Application

LATITUDE PsO 3001 and 3002 were global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies evaluating the efficacy, safety, and tolerability of zasocitinib in adults with moderate-to-severe plaque psoriasis. The trials enrolled 693 and 1108 participants, respectively, and evaluated sPGA 0/1 and PASI 75 responses compared with placebo as co-primary end points at week 16.^2,3

Both studies met their co-primary end points and all ranked secondary end points.¹

At week 16, 71% of patients receiving zasocitinib in LATITUDE PsO 3001 achieved a static Physician Global Assessment (sPGA) score of 0 or 1, indicating clear or almost clear skin, compared with 11% receiving placebo and 32% receiving apremilast. In LATITUDE PsO 3002, corresponding response rates were 69%, 13%, and 30%, respectively.¹

PASI 75 responses at week 16 were also significantly greater with zasocitinib. In LATITUDE PsO 3001, 76% of patients receiving zasocitinib achieved PASI 75 compared with 12% receiving placebo and 37% receiving apremilast. In LATITUDE PsO 3002, rates were 71%, 12%, and 33%, respectively.¹

Higher levels of skin clearance were observed as well. PASI 90 was achieved by 61% and 52% of zasocitinib-treated patients in LATITUDE PsO 3001 and 3002, respectively, compared with 5% and 4% with placebo and 17% and 16% with apremilast. PASI 100 responses were reported in 33% and 25% of patients receiving zasocitinib in the 2 studies.¹

Responses Across High-Impact Sites

The phase 3 program also demonstrated improvements in difficult-to-treat and high-impact areas, including the scalp, nails, palms, and soles.¹

At week 16, scalp-specific PGA 0/1 responses reached 77% with zasocitinib compared with 7% with placebo and 42% with apremilast in LATITUDE PsO 3001. In LATITUDE PsO 3002, rates were 74%, 13%, and 30%, respectively.¹

Among patients evaluated for palmoplantar involvement, 71% of those receiving zasocitinib in LATITUDE PsO 3001 achieved a hands and/or feet PGA score of 0/1 compared with 22% receiving placebo and 44% receiving apremilast. Corresponding rates in LATITUDE PsO 3002 were 69%, 10%, and 43%, respectively.¹

According to Takeda, skin clearance was observed as early as week 4 and continued to increase through week 24 and further through week 52.¹

Safety Findings

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

Longer-term safety, tolerability, and efficacy are also being evaluated in the open-label phase 3 LATITUDE PsO 3003 study (NCT06550076). The study enrolled approximately 2100 adults with moderate-to-severe plaque psoriasis and includes patients receiving zasocitinib for up to 156 weeks.¹

Targeting TYK2 in Psoriasis

TYK2 is an intracellular member of the Janus kinase family involved in inflammatory pathways implicated in psoriasis, including IL-23/IL-17 and type I interferon signaling. Zasocitinib is designed to selectively inhibit TYK2 while minimizing activity against JAK1, JAK2, and JAK3.

According to Takeda, in vitro data demonstrated more than 1-million-fold greater selectivity for TYK2 compared with other JAK enzymes. Zasocitinib is also being evaluated across several other immune-mediated diseases, including psoriatic arthritis, Crohn disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.¹

The European Medicines Agency has also accepted Takeda’s marketing authorization application for zasocitinib for the treatment of moderate-to-severe plaque psoriasis. Takeda also plans to pursue additional regulatory applications globally.

Zasocitinib remains investigational and has not been approved for use by any regulatory authority.¹

References

1. Takeda. U.S. FDA accepts New Drug Application under Priority Review for Takeda’s zasocitinib in moderate-to-severe plaque psoriasis, with potential to redefine oral treatment expectations. Published September 14, 2026. Accessed September 14, 2026.
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. Updated October 24, 2025. Accessed September 14, 2026.
3. A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-Severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period. ClinicalTrials.gov Identifier: NCT06108544. Updated November 20, 2025. Accessed September 14, 2026.