Takeda’s Zasocitinib Receives FDA Priority Review for Moderate-to-Severe Plaque Psoriasis Following Positive Phase 3 Results in Nearly 3,000 Patients

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Takeda’s Zasocitinib Receives FDA Priority Review for Moderate-to-Severe Plaque Psoriasis Following Positive Phase 3 Results in Nearly 3,000 Patients

(IN BRIEF) Takeda’s investigational oral TYK2 inhibitor zasocitinib has received FDA Priority Review for the treatment of adults with moderate-to-severe plaque psoriasis, with a PDUFA decision expected in the first quarter of 2027. The NDA is supported by a Phase 3 programme involving nearly 3,000 patients, including the pivotal LATITUDE PsO 3001 and 3002 trials and supportive long-term data from LATITUDE PsO 3003. At Week 16, approximately 70% of zasocitinib-treated patients achieved clear or almost clear skin, while PASI 75 response rates reached 76% and 71% in the two pivotal studies. The programme also demonstrated significant responses in high-impact areas including the scalp, nails, palms and soles, with skin clearance observed as early as Week 4 and continuing through Week 52. Zasocitinib was generally well tolerated, with no new safety signals identified. Takeda is positioning the once-daily therapy as a potential next-generation oral option for psoriasis. The European Medicines Agency has also accepted Takeda’s marketing authorisation application, and the company plans additional global regulatory submissions.

(PRESS RELEASE) OSAKA/ CAMBRIDGE, 14-Sep-2025 — /EuropaWire/ — Takeda has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zasocitinib (TAK-279) under Priority Review 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 being developed as a once-daily treatment. Takeda said its Phase 3 clinical programme demonstrated rapid, durable and consistent improvements in skin clearance, including responses in high-impact and difficult-to-treat areas such as the scalp, nails, palms and soles.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of calendar year 2027.

The regulatory submission is supported by clinical data from nearly 3,000 patients, including the pivotal global Phase 3 LATITUDE PsO 3001 and LATITUDE PsO 3002 studies, as well as supportive long-term data from the open-label LATITUDE PsO 3003 study.

Both pivotal trials were global, multicentre, randomised, double-blind studies comparing zasocitinib with placebo and the active comparator apremilast. Takeda reported that the studies met their co-primary endpoints and all 44 ranked secondary endpoints.

At Week 16, 71% of patients receiving zasocitinib in LATITUDE PsO 3001 achieved a static Physician Global Assessment score of clear or almost clear skin, compared with 11% for placebo and 32% for apremilast. In LATITUDE PsO 3002, the corresponding results were 69% for zasocitinib, 13% for placebo and 30% for apremilast.

For the Psoriasis Area and Severity Index 75 (PASI 75) endpoint, 76% of zasocitinib-treated patients in LATITUDE PsO 3001 achieved at least a 75% improvement at Week 16, compared with 12% for placebo and 37% for apremilast. In LATITUDE PsO 3002, the respective rates were 71%, 12% and 33%.

Deeper levels of skin clearance were also observed. In LATITUDE PsO 3001, 61% of patients achieved PASI 90, compared with 5% for placebo and 17% for apremilast, while 33% achieved complete skin clearance measured by PASI 100, versus 0.7% for placebo and 3% for apremilast.

In LATITUDE PsO 3002, 52% of patients receiving zasocitinib achieved PASI 90 compared with 4% for placebo and 16% for apremilast. PASI 100 was achieved by 25% of zasocitinib-treated patients, versus 1% with placebo and 4% with apremilast.

Takeda also reported meaningful responses in areas of psoriasis that can be particularly difficult to treat. At Week 16, scalp-specific Physician Global Assessment scores of clear or almost clear were achieved by 77% of zasocitinib-treated patients in LATITUDE PsO 3001 and 74% in LATITUDE PsO 3002, compared with 7% and 13% for placebo, respectively.

Results were also reported for nail and palmoplantar psoriasis. In LATITUDE PsO 3001, the least-squares mean change from baseline in the Nail Psoriasis Severity Index was -7.1 for zasocitinib compared with 1.8 for placebo, while LATITUDE PsO 3002 reported changes of -8.6 and -1.4, respectively.

For palmoplantar disease affecting the hands and feet, 71% of zasocitinib-treated patients in LATITUDE PsO 3001 and 69% in LATITUDE PsO 3002 achieved a Physician Global Assessment score of clear or almost clear. These comparisons were not multiplicity-controlled endpoints, and comparisons with apremilast were descriptive.

Takeda said skin clearance was visible as early as Week 4, continued to improve through Week 24 and was sustained and further improved through Week 52. In LATITUDE PsO 3002, PASI 75 at Week 4 was achieved by 17% of patients receiving zasocitinib compared with 4% of those receiving placebo.

Across the pivotal studies, zasocitinib was generally well tolerated and no new safety signals were 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 at 10.1%, acne at 6.5% and nasopharyngitis at 6.2%.

Andy Plump, M.D., Ph.D., President of Research and Development at Takeda, said that although psoriasis treatment has advanced, there remains a need for effective oral therapies capable of addressing the varied manifestations of the disease, including high-impact areas such as the scalp.

He said the Phase 3 programme demonstrated rapid and durable skin clearance across different patient groups and difficult-to-treat sites, adding that the results from nearly 3,000 patients suggest zasocitinib could become an important oral treatment option if approved.

Regulatory reviews expand beyond the United States

Takeda has also submitted zasocitinib for regulatory review in Europe. The European Medicines Agency (EMA) has accepted the company’s Marketing Authorisation Application (MAA) for the treatment of moderate-to-severe plaque psoriasis.

The company plans to submit further applications to regulatory authorities globally as it works to make the investigational therapy available to psoriasis patients in additional markets, subject to regulatory approval.

Takeda said the NDA submission is not expected to have a significant impact on its consolidated financial forecast for the fiscal year ending 31 March 2027.

If approved by the FDA following Priority Review, zasocitinib could become available to eligible patients after regulatory approval. The therapy remains investigational and is not currently approved for the treatment of plaque psoriasis.

About Plaque Psoriasis

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.7,8,14 Globally, an estimated 66.4 million people are living with psoriasis, and about 80-90% of those have plaque psoriasis.15-17 Persistent itch, the appearance and location of skin lesions — especially in highly visible or high-impact sites — and related comorbidities, like psoriatic arthritis, play a major role in reducing quality of life and can lead to significant impacts on daily living.8,12-14 Psoriasis is also a heterogeneous disease driven by complex, interconnected immune pathways, genetics and environmental factors that differ across patients and over time, leading to variability in disease course, symptoms and treatment response.18-22

About Zasocitinib (TAK-279)

Zasocitinib is an investigational, next-generation, highly selective and potent oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.23-27 It has the potential to be a leading oral treatment option for people living with psoriasis that may deliver rapid and durable skin clearance in a convenient once-daily pill.1-2 Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data.23-24 Takeda is currently evaluating the safety and efficacy of zasocitinib in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.28-33 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.

About Tyrosine Kinase 2 (TYK2) Inhibitors

TYK2 is a central mediator of core inflammatory pathways in psoriasis — IL-23/IL-17 axis and type I interferon signaling — making it a promising target as inhibition of a single pathway may not fully control disease for every patient.22,26,34. TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.22-23 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes such as lipid metabolism and hematopoiesis.22-23 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, is a promising therapeutic approach to target immune-mediated inflammation.27

About the Phase 3 LATITUDE PsO 3001 and 3002 Studies

The Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) 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.6-7 The studies were conducted in 21 countries, with LATITUDE PsO 3001 enrolling 693 participants and LATITUDE PsO 3002 enrolling 1,108 participants, respectively. The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week 16.6-7 Ranked secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).6-7

About the Phase 3 LATITUDE PsO 3003 Study

The LATITUDE PsO 3003 (NCT06550076) study is a Phase 3, multicenter, open-label study evaluating the long-term safety, tolerability and efficacy of zasocitinib in adults with moderate-to-severe plaque psoriasis.4 The study enrolled approximately 2,100 participants and consists of two parts.4 In Part A (de novo cohort), adult patients who had not been exposed to zasocitinib before received zasocitinib 30 mg once daily for up to 52 weeks.4 Patients who completed Part A or the treatment period in the Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies received zasocitinib for up to 156 weeks in Part B.4 The primary endpoint was the number of zasocitinib-treated patients with treatment-emergent and serious adverse events.4 Secondary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response.4

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Contacts

Investor Relations:

Christopher O’Reilly
takeda.ir.contact@takeda.com

Media Relations:

Tsuyoshi Tada (Tokyo)
toiawase_kouhou@takeda.co.jp

Jennifer Henesey (Boston)
Media_Relations@takeda.com

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References

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SOURCE: Takeda Pharmaceutical Company Limited

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