Drugs / Zasocitinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | psoriasis | 2026-09-14 | “The European Medicines Agency (EMA) also accepted Takeda’s new marketing authorization application (MAA) for zasocitinib, initiating the review process for the treatment of...” takeda.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2026-09-14 | “FDA accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis.” takeda.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT06793943 | Jan → Mar 2025 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06111547 | Jun → Jul 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06258265 | Apr → Jun 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06290050 | Mar → May 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05992155 | Sep 2023 → May 2024 | impaired renal function disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05976321 | Sep 2023 → Apr 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05995249 | Aug → Dec 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT07403968 | Jul 2026 → Mar 2028 expected | Crohn disease | Takeda | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07244263 | Jan 2026 → Feb 2028 expected | hidradenitis suppurativa | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT07108283 | Nov 2025 → Oct 2027 expected | vitiligo | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT06764615 | May 2025 → Dec 2029 expected | Crohn disease, ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT06254950 | Mar 2024 → Sep 2026 overdue | ulcerative colitis | Takeda | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06233461 | Mar 2024 → Feb 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT05153148 | Jan 2022 → May 2023 | psoriatic arthritis | Takeda | Completed | Met primary |
| Phase 2 | NCT04999839 | Aug 2021 → Aug 2022 | psoriasis | Takeda | Completed | Met primary |
| Phase 310 trials · 1 met primary | ||||||
| Phase 3 | NCT07752108 | Oct 2026 → May 2027 expected | psoriasis | Takeda | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07286058 | Mar 2026 → Dec 2029 expected | psoriatic arthritis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT07250802 | Dec 2025 → Jan 2033 expected | psoriasis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06973291 | Jul 2025 → Apr 2026 | psoriasis | Takeda | Completed | Met primary |
| Phase 3 | NCT06671496 | Mar 2025 → May 2027 expected | psoriatic arthritis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06671483 | Mar 2025 → May 2027 expected | psoriatic arthritis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06550076 | Sep 2024 → Aug 2029 expected | psoriasis | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06323356 | Mar 2024 → Oct 2025 overdue | generalized pustular psoriasis | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06088043 | Nov 2023 → Jan 2025 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT06108544 | Nov 2023 → Dec 2024 | psoriasis | Takeda | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Takeda | Results Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill takeda.com ↗
Head-to-head LATITUDE Atlas data showed zasocitinib demonstrated statistical superiority to deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8 |
| 2026-09-14 | Takeda | Regulatory 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 takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis. |
| 2026-07-16 | Takeda | Results Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies takeda.com ↗ |
| 2026-06-11 | Takeda | Results Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations takeda.com ↗
In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. |
| 2025-12-18 | Takeda | Results Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). |
| 2023-11-07 | Takeda | Results Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting takeda.com ↗
The study met its primary endpoint with a statistically significant proportion of patients, 53.3% (15 mg) and 54.2% (30 mg), treated with TAK-279 achieving at least an American College of Rheumatology 20 (ACR 20) response compared to 29.2% in the placebo arm at week 12 (p = 0.002). |
| 2023-09-11 | Takeda | Results Takeda Announces Positive Topline Results from Phase 2b Study Evaluating TAK-279, a Highly Selective Oral TYK2 Inhibitor, for the Treatment of Active Psoriatic Arthritis takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) today announced positive topline results from its randomized, double-blind, placebo-controlled, multiple-dose Phase 2b trial evaluating TAK-279, an investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor with next generation selectivity, in people with active psoriatic arthritis. |
| 2023-03-18 | Takeda | Results Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis. |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zasocitinib | “Zasocitinib (TAK-279) is an investigational, once daily, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor.” PMID 42143206 ↗ May 2026 |
| Known as | NDI-034858 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05153148 ↗ |
| Known as | TAK-279 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06550076 ↗ |
| Action | Inhibit | “potent and selective inhibition of TYK2 with zasocitinib” PMID 39167366 ↗ Oct 2024 |
| Modality | Small molecule | — CHEMBL5314423 ↗ |
| Route | Oral | “NDI-034858 oral capsule” NCT05153148 ↗ |
| Target | TYK2 | “potent and selective inhibition of TYK2 with zasocitinib” PMID 39167366 ↗ Oct 2024 |