Drugs / Idarucizumab
Idarucizumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PRAXBIND | — | 2018-04-12 | fda.gov ↗ |
| Approved | EU (EMA) | Praxbind | — | 2015-11-20 | europa.eu ↗ |
| Approved | US (FDA) | PRAXBIND | — | 2015-10-16 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03086356 | May → Sep 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02028780 | Jan → Aug 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01955720 | Sep 2013 → May 2014 | hemorrhagic disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01688830 | Sep 2012 → Nov 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03343704 | Mar 2018 → Jul 2020 | hemorrhagic disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02815670 | Sep 2016 → Oct 2019 | hemorrhagic disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02831660 | Jul → Sep 2016 | hemorrhagic disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02104947 | May 2014 → Jul 2016 | hemorrhagic disease | Boehringer Ingelheim | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Idarucizumab | “Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers” PMID 26088268 ↗ Jun 2015 |
| Known as | Adabi-fab | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544996 ↗ |
| Known as | BI 655075 | “A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients...” NCT02104947 ↗3“A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated...” NCT03343704 ↗ “BI 655075 (Idarucizumab)” NCT02028780 ↗ |
| Known as | Praxbind | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544996 ↗ |
| Modality | Monoclonal antibody | “Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment” PMID 28230262 ↗ Apr 2017 |
| Route | Intravenous | “following intravenous administration” NCT02028780 ↗ |