Drugs / FK949E
FK949E
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01919008 | Mar → Jun 2012 | major depressive disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01924520 | Nov 2010 → May 2011 | major depressive disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01871987 | Jun → Aug 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01725308 | Feb 2012 → Aug 2015 | bipolar disorder | Astellas Pharma Inc | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT02362412 | Feb 2015 → Feb 2016 | bipolar depression | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01737268 | Oct 2012 → Jun 2016 | bipolar disorder | Astellas Pharma Inc | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-02-27 | Astellas Pharma Inc | Kyowa and Astellas enter into an Agreement for Exclusive Distribution and Promotion of Extended-Release Tablets of Quetiapine Fumarate in Japan astellas.com ↗ |
| 2016-08-09 | Astellas Pharma Inc | Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan astellas.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FK949E | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02362412 ↗ |
| Known as | extended-release formulation of quetiapine | “extended-release formulation of quetiapine” NCT01924520 ↗ |
| Known as | quetiapine | “A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in...” NCT01871987 ↗ |
| Route | Oral | “Taken by mouth (orally).” NCT01725308 ↗ |