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
| 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 |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2018-04-17 | Boehringer Ingelheim | Regulatory FDA Provides Full Approval to Praxbind, Specific Reversal Agent for Pradaxa prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate). |
| 2017-11-13 | Boehringer Ingelheim | Results New RE-VERSE AD™ Analyses Provide Additional Insights on Impact of Idarucizumab (Praxbind®) in Pradaxa® Patients with Gastrointestinal Bleeding or Needing Emergency Surgery prnewswire.com ↗
Of the 137 patients enrolled with a GI bleed, complete reversal of the anticoagulant effect of Pradaxa was observed in more than 95 percent of patients. |
| 2017-07-11 | Boehringer Ingelheim | Results Final Phase III Study Results Reinforces Safety and Efficacy of Praxbind® as Reversal Agent for Pradaxa® Patients in Emergency Situations prnewswire.com ↗
The study shows that idarucizumab, marketed in the U.S. as Praxbind®, was able to immediately reverse the anticoagulant effect of Pradaxa® (dabigatran etexilate mesylate) in patients in emergency situations. |
| 2017-05-03 | Boehringer Ingelheim | Regulatory Anvisa aprova agente reversor de anticoagulante oral que traz maior tranquilidade para pacientes em caso de emergências prnewswire.com ↗
A Boehringer Ingelheim anuncia a aprovação pela ANVISA do Praxbind® (idarucizumabe), indicado para pacientes tratados com o anticoagulante oral Pradaxa® (etexilato de Dabigatrana). |
| 2016-11-15 | Boehringer Ingelheim | Results Updated Phase III Results Reinforce Safety and Efficacy of Praxbind® (idarucizumab) in Urgent Situations prnewswire.com ↗
Of note, reversal was evident immediately after administration of idarucizumab. |
| 2016-04-02 | Boehringer Ingelheim | Results Interim Phase III Data Show Praxbind® (idarucizumab) Reverses Dabigatran (Pradaxa®) in Emergency Situations prnewswire.com ↗ |
| 2015-11-09 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Praxbind® (idarucizumab) Analyses on Reintroduction of Antithrombotic Therapy after Reversal of Dabigatran prnewswire.com ↗
An interim analysis of data from the ongoing phase III RE-VERSE AD™ trial showed reinitiation of alternative antithrombotic therapy was possible any time after idarucizumab use. |
| 2015-10-16 | Boehringer Ingelheim | Regulatory FDA Approves Praxbind® (idarucizumab), Specific Reversal Agent for Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). |
| 2015-09-01 | Boehringer Ingelheim | Results New Analysis Shows Idarucizumab* Enables Rapid Initiation of Emergency Surgery in Dabigatran-Treated Patients prnewswire.com ↗
Results from an interim analysis of the Phase III RE-VERSE AD™ study demonstrate that 5g of idarucizumab enabled emergency surgery to be initiated rapidly in urgent situations involving patients treated with dabigatran (Pradaxa ® dabigatran etexilate mesylate). |
| 2015-06-22 | Boehringer Ingelheim | Results Idarucizumab* Reverses the Anticoagulant Effect of Dabigatran Within Minutes in Patient Study prnewswire.com ↗
Results from an interim analysis of the Phase III RE-VERSE AD™ patient study demonstrate that 5 g of idarucizumab* immediately reversed the anticoagulant effect of dabigatran (Pradaxa ® dabigatran etexilate mesylate) in patients requiring urgent anticoagulant reversal. |
| 2015-06-16 | Boehringer Ingelheim | Results Phase I Data Published in The Lancet Show Boehringer Ingelheim's Idarucizumab* Reverses Anticoagulant Effects of Dabigatran prnewswire.com ↗
Results showed that idarucizumab immediately and completely reversed dabigatran-induced anticoagulation and no procoagulant effects were found when measured by a specific assay. |
| 2015-04-23 | Boehringer Ingelheim | Regulatory FDA Grants Priority Review to Boehringer Ingelheim's Biologics License Application for Idarucizumab* prnewswire.com ↗ |
| 2015-03-02 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Submits Biologics License Application to FDA for Idarucizumab*, Investigational Specific Reversal Agent for Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA), requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa ® (dabigatran etexilate mesylate). |
| 2014-12-08 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Reverses Anticoagulant Effects of Dabigatran (PRADAXA®) in Middle-Aged, Elderly and Renally Impaired Volunteers prnewswire.com ↗
Further, anticoagulation was restored when volunteers were re-dosed with dabigatran 24 hours after idarucizumab was administered. |
| 2014-11-18 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Restores Wound-Site Formation of Fibrin, a Key Component of Blood Clotting, in Healthy Volunteers Given Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. |
| 2014-08-25 | Boehringer Ingelheim | Results Pradaxa® (dabigatran etexilate mesylate) Data to be Presented at European Society of Cardiology Congress 2014 prnewswire.com ↗
Dabigatran-induced anticoagulant and bleeding effects can be reversed with both prothrombin complex concentrates and a specific antidote |
| 2014-06-26 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's Investigational Antidote for Pradaxa® (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to idarucizumab*, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate). |
All press releases naming this drug 22 releases
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 ↗ |