Drugs / ASP7374
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | influenza | 2014-05-30 | “submitted an application for marketing approval of recombinant influenza HA vaccine ASP7374 to the Ministry of Health, Labour and Welfare in Japan” astellas.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01393951 | May → Dec 2011 | — | UMN Pharma Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02366962 | Feb → Apr 2015 | influenza | UMN Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01961947 | Oct → Nov 2013 | influenza | UMN Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01961960 | Oct → Nov 2013 | influenza | UMN Pharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01767896 | Oct 2012 → Mar 2013 | influenza | UMN Pharma Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-01-10 | Astellas Pharma Inc | Regulatory Astellas Terminates Agreement with UMN Pharma for Cell Culture Based Influenza Vaccine Programs astellas.com ↗
Astellas will withdraw the application for marketing approval of ASP7374 and discontinue the development of ASP7373. |
| 2014-05-30 | Astellas Pharma Inc | Regulatory Astellas and UMN Announce Submission of Application for Marketing Approval of Recombinant Influenza HA Vaccine ASP7374 in Japan astellas.com ↗
Astellas has submitted an application for marketing approval of recombinant influenza HA vaccine ASP7374 to the Ministry of Health, Labour and Welfare in Japan for the prevention of influenza. |
| 2014-01-15 | Astellas Pharma Inc | Results Astellas and UMN Announce Summary Results in Phase III Clinical Trials of Seasonal Flu Vaccine ASP7374 astellas.com ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-01-10 | Astellas Pharma Inc | Astellas Terminates Agreement with UMN Pharma for Cell Culture Based Influenza Vaccine Programs astellas.com ↗ |
| 2014-05-30 | Astellas Pharma Inc | Astellas and UMN Announce Submission of Application for Marketing Approval of Recombinant Influenza HA Vaccine ASP7374 in Japan astellas.com ↗ |
| 2014-01-15 | Astellas Pharma Inc | Astellas and UMN Announce Summary Results in Phase III Clinical Trials of Seasonal Flu Vaccine ASP7374 astellas.com ↗ |
| 2013-10-21 | Astellas Pharma Inc | Astellas and UMN announce Completion of Administration of Phase III Clinical Trials of Seasonal Flu Vaccine ASP7374 astellas.com ↗ |
| 2011-09-15 | Astellas Pharma Inc | Administration of Seasonal Flu Vaccine ASP7374 Completed in Phase I/II Clinical Trial astellas.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASP7374 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01961947 ↗ |
| Modality | Vaccine | “ASP7374 (cell-culture derived influenza vaccine)” NCT01767896 ↗ |
| Route | Intramuscular | “intramuscular (im) vaccination of ASP7374 dose-3” NCT01393951 ↗ |