betrixaban
Trade name: bevyxxa
Approved
Jun 23, 2017
Betrixaban is an anticoagulant drug which acts as a direct factor Xa inhibitor. Betrixaban is now being developed by Portola Pharmaceuticals. Oral, once-daily Factor Xa inhibitor anticoagulant that directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. U.S. Food and Drug Administration granted Fast Track designation to betrixaban for extended-duration prevention of venous thromboembolism (VTE; blood clots) in acute medically ill patients (i.e., those who are hospitalized for serious medical conditions, such as heart failure, stroke, infection and pulmonary disease). Has the potential to become the first oral Factor Xa inhibitor anticoagulant approved for hospital-to-home prevention of VTE in acute medically ill patients. — NCATS
Clinical trial activity
11 trials · 7 clinical orgs · 1 marketing orgs
Earliest trial started May 1, 2006 (NCT00375609)
Timeline
2000s
- Jan 1, 2006
Portola Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2007
Portola Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2012
Portola Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Jun 23, 2017
Portola Pharmaceuticals — Earliest FDA Approval
- Jun 23, 2017
Portola Pharmaceuticals — NDA Secondary Org
- Jun 23, 2017
Portola Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- Coagulation factor XINHIBITOR
F10 inhibitor
Approval history
- approvedPriority reviewFast trackJun 23, 2017
Chemistry & pharmacology
SMILES
COC1=CC=C(NC(=O)C2=CC=C(C=C2)C(=N)N(C)C)C(=C1)C(=O)NC3=CC=C(Cl)C=N3- Mol. weight
- 451.905 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaBetrixaban ↗
- NCATS74RWP7W0J9 ↗
- ChEMBLCHEMBL512351 ↗
Also known as
- betrixaban
- betrixaban
- betrixaban
- betrixaban
- betrixaban
- betrixaban
- betrixaban
- betrixaban
- bevyxxa
- bevyxxa
- n-(5-chloropyridin-2-yl)-2-(4-(n,n-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide
- prt054021
- prt054021
- prt054021
- prt054021
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03346083 | Phase 1 | Jul 18, 2018 | Portola Pharmaceuticals |
| NCT03397888 | Phase 1 | Nov 16, 2017 | Portola Pharmaceuticals |
| NCT02596100 | Phase 1 | Sep 1, 2015 | Portola Pharmaceuticals |
| NCT03330457 | Phase 2 | Aug 30, 2015 | Portola Pharmaceuticals |
| NCT01583218 | Phase 3 | Mar 1, 2012 | Portola Pharmaceuticals |
| NCT01229254 | Phase 2 | Sep 1, 2010 | Merck, Portola Pharmaceuticals |
| NCT00999336 | Phase 1 | Jul 1, 2009 | Merck, Portola Pharmaceuticals |
| NCT00742859 | Phase 2 | Oct 1, 2008 | Instituto Cardiovascular de Rosario, Argentina, J. W. Goethe University, Lankenau Hospital, McMaster University, Portola Pharmaceuticals, University of Toronto |
| NCT01765855 | Phase 1 | Sep 1, 2007 | Portola Pharmaceuticals |
| NCT01765868 | Phase 1 | Sep 1, 2007 | Portola Pharmaceuticals |
| NCT00375609 | Phase 2 | May 1, 2006 | Portola Pharmaceuticals |
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Portola Pharmaceuticals | For profit | 11 | 10 | 3 | 2006 |
| Merck | For profit | 2 | 1 | 2 | 2009 |
| Instituto Cardiovascular de Rosario, Argentina | Academic/Hospital | 1 | 0 | 1 | 2008 |
| J. W. Goethe University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Lankenau Hospital | Academic/Hospital | 1 | 0 | 1 | 2008 |
| McMaster University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Toronto | Academic/Hospital | 1 | 0 | 1 | 2008 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Portola Pharmaceuticals | For profit | NDA2 | Jun 23, 2017 |
| Portola Pharmaceuticals | For profit | NDA | Jun 23, 2017 |