Announced details
Adult patients with moderate-to-severe plaque psoriasis. Development is also under way for psoriatic arthritis, Crohn's disease, ulcerative colitis, non-segmental vitiligo and hidradenitis suppurativa
At Week 16, the sPGA 0/1 response rate was 71% in LATITUDE PsO 3001 and 69% in 3002. PASI 75 response rates were 76% and 71%, respectively
Phase 3 LATITUDE PsO 3001 trial: 693 patients; 3002 trial: 1,108 patients; 3003 trial: approximately 2,100 patients. Number of patients enrolled in the trials
Takeda submitted a new drug application for zasocitinib to the FDA, which accepted and will review it
U.S. drug regulatory authority. Location, representative, capital and year established: Not disclosed
NCT06088043, NCT06108544, NCT06550076. Registration numbers and validity periods: Not disclosed
This NDA submission is not expected to have a material impact on the full-year consolidated earnings forecast for the fiscal year ending March 2027 (fiscal 2026).
The company does not address Contract Value / Offering price.
LATITUDE PsO 3001, 3002 and 3003 trials; ClinicalTrials.gov; American Academy of Dermatology Innovation Academy; and others
| Item | Details |
|---|---|
| Names of Products / Services Covered | Zasocitinib (TAK-279) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | U.S. drug regulatory authority. Location, representative, capital and year established: Not disclosed |
| Relationship with the Company | Takeda submitted a new drug application for zasocitinib to the FDA, which accepted and will review it |
| Launch date | The product is expected to become available for use in the United States following approval. Specific launch date: Not disclosed |
| Applicable area | Adult patients with moderate-to-severe plaque psoriasis. Development is also under way for psoriatic arthritis, Crohn's disease, ulcerative colitis, non-segmental vitiligo and hidradenitis suppurativa |
| Registration number and expiry date | NCT06088043, NCT06108544, NCT06550076. Registration numbers and validity periods: Not disclosed |
| Quantitative Effects | At Week 16, the sPGA 0/1 response rate was 71% in LATITUDE PsO 3001 and 69% in 3002. PASI 75 response rates were 76% and 71%, respectively |
| Usage history | Phase 3 LATITUDE PsO 3001 trial: 693 patients; 3002 trial: 1,108 patients; 3003 trial: approximately 2,100 patients. Number of patients enrolled in the trials |
| Impact on Business Performance | This NDA submission is not expected to have a material impact on the full-year consolidated earnings forecast for the fiscal year ending March 2027 (fiscal 2026). |
| Source | LATITUDE PsO 3001, 3002 and 3003 trials; ClinicalTrials.gov; American Academy of Dermatology Innovation Academy; and others |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The application is based on a comprehensive data package, including major Phase 3 clinical trials, and the FDA accepted it for priority review.