Drugs / Betrixaban
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Dexxience | — | 2018-09-20 | europa.eu ↗ |
| Approved | US (FDA) | BEVYXXA | — | 2017-06-23 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03346083 | Jul 2018 → Oct 2019 | — | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03397888 | Nov 2017 → Jan 2018 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00999336 | Jul 2009 → Feb 2010 | impaired renal function disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01765868 | Sep → Oct 2007 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01765855 | Sep → Oct 2007 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT03330457 | Aug 2015 → Feb 2016 | hemorrhagic disease | Portola Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01229254 | Sep → Dec 2010 | atrial fibrillation, atrial flutter | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00742859 | Oct 2008 → Aug 2009 | atrial fibrillation | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00375609 | May 2006 → Jan 2007 | venous thromboembolism | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01583218 | Mar 2012 → Dec 2015 | venous thromboembolism | Portola Pharmaceuticals | Completed | Mixed |
| Comparator or background therapy1 trial | ||||||
| — | NCT04684212 Comparator | Jun 2024 | atrial fibrillation, stroke disorder | Brian O'Neill MD | Withdrawn | No outcome recorded Stop: Business |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | betrixaban | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00742859 ↗ |
| Known as | Betrixaban maleate | ChEMBL registry synonym — accepted as the source's own label CHEMBL512351 ↗ |
| Known as | Bevyxxa | “Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)” NCT04684212 ↗ |
| Known as | PRT-054021 | ChEMBL registry synonym — accepted as the source's own label CHEMBL512351 ↗ |
| Action | Inhibit | “Coagulation factor X inhibitor” CHEMBL512351 ↗1“Factor Xa Inhibitor” NCT00375609 ↗ |
| Modality | Small molecule | — CHEMBL512351 ↗ |
| Route | Oral | “Betrixaban 15 mg oral twice daily for 10 to 14 days” NCT00375609 ↗ |
| Target | F10 | “Coagulation factor X inhibitor” CHEMBL512351 ↗ |