Drugs / TAK-003
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asymptomatic dengue 1 milestone | |||||
| Filed | EU (EMA) | — | asymptomatic dengue | 2021-03-25 | “the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003)” takeda.com ↗ |
| Filed dengue disease 1 milestone | |||||
| Filed | US (FDA) | — | dengue disease | 2022-11-22 | “FDA has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate.” takeda.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01511250 | Nov 2011 → Apr 2016 | — | Takeda | Completed | No outcome recorded |
Press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAK-003 | “The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy.” PMID 40099800 ↗ Mar 2025 |
| Known as | TDV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01511250 ↗ |
| Modality | Vaccine | “Takeda's tetravalent dengue vaccine (TDV) (previously DENVax)” NCT01511250 ↗ |
| Route | Subcutaneous | “administered subcutaneously” NCT01511250 ↗ |