idarucizumab
Trade name: praxbind
mAbapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Oct 16, 2015
Idarucizumab, sold under the brand name Praxbind, is a monoclonal antibody used as a reversal agent for dabigatran. — Wikipedia
Clinical trial activity
8 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
4
Phase 3
4
Phase 4
0
Earliest trial started Sep 1, 2012 (NCT01688830)
Timeline
2010s
- Jan 1, 2012
Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)
- May 28, 2015
Orphan Drug Designation
- Oct 16, 2015
Boehringer Ingelheim — Earliest FDA Approval
- Oct 16, 2015
Boehringer Ingelheim — Marketing Organization
- Oct 16, 2015
Boehringer Ingelheim — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- DabigatranINHIBITOR
Dabigatran inhibitor
- DabigatranSEQUESTERING AGENT
Dabigatran sequestering agent
Approval history
- approvedAcceleratedBreakthroughOct 16, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaIdarucizumab ↗
- NCATS97RWB5S1U6 ↗
- ChEMBLCHEMBL3544996 ↗
Also known as
- adabi-fab
- bi 655075
- bi-655075
- bi-655075
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- idarucizumab
- praxbind
- praxbind
- praxbind
- praxbind
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03343704 | Phase 3 | Mar 26, 2018 | Boehringer Ingelheim |
| NCT03086356 | Phase 1 | May 10, 2017 | Boehringer Ingelheim |
| NCT02815670 | Phase 3 | Sep 7, 2016 | Boehringer Ingelheim |
| NCT02831660 | Phase 3 | Jul 1, 2016 | Boehringer Ingelheim |
| NCT02104947 | Phase 3 | May 1, 2014 | Boehringer Ingelheim |
| NCT02028780 | Phase 1 | Jan 1, 2014 | Boehringer Ingelheim |
| NCT01955720 | Phase 1 | Sep 1, 2013 | Boehringer Ingelheim |
| NCT01688830 | Phase 1 | Sep 1, 2012 | Boehringer Ingelheim |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Boehringer Ingelheim | For profit | 8 | 8 | 2 | 2012 |
1 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Boehringer Ingelheim | For profit | MKTG | Oct 16, 2015 |
| Boehringer Ingelheim | For profit | NDA | Oct 16, 2015 |