Drugs / TAK-771
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed immunodeficiency 112 1 milestone | |||||
| Filed | Japan (PMDA) | — | immunodeficiency 112 | 2024-02-20 | “In February 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771” halozyme.com ↗ |
| Filed polyneuropathy, inflammatory demyelinating, chronic 1 milestone | |||||
| Filed | Japan (PMDA) | — | polyneuropathy, inflammatory demyelinating, chronic | — | “In August 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771 with ENHANZE®” halozyme.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05150340 | Jan 2022 → Aug 2023 | immunodeficiency disease | Takeda | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAK-771 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05150340 ↗ |
| Modality | Protein / enzyme biologic | “TAK-771 included Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)” NCT05150340 ↗ |
| Route | Subcutaneous | “Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first” NCT05150340 ↗ |