Idarucizumab
- Generic Name
- Idarucizumab
- Brand Names
- Praxbind
- Drug Type
- Biotech
- CAS Number
- 1362509-93-0
- Unique Ingredient Identifier
- 97RWB5S1U6
- Background
Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an immunoglobulin G1 isotype molecule that binds to and inactivates the oral anticoagulant dabigatran, thereby reversing its anticoagulant effect. As a direct acting oral anticoagulant (DOAC), one of the risks associated with the use of dabigatran includes bleeding, espeically when given to patients at increased risk (elderly, chronic kidney disease, concomitant NSAID or warfarin use, etc).
Approved under the tradename Praxbind (FDA), idarucizumab is indicated for the emergency treatment of dabigatran-associated bleeding in life-threatening or surgically induced situations. Its use is associated with immediate, complete and sustained reversal of the anticoagulant effects of dabigatran.
Idarucizumab protein structure can be viewed below, with disulfide bridges at the following points: H22-H95, H149-H205, H225-L-219, L23-L93, L139-L199.
- Indication
For use in patients treated with Dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
- Associated Conditions
- Anticoagulant effects of dabigatran
Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
- Conditions
- Intracranial Hemorrhage
- Interventions
- First Posted Date
- 2019-08-20
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- University Hospital, Essen
- Target Recruit Count
- 104
- Registration Number
- NCT04062097
- Locations
- 🇩🇪
Klinikum Schön Klinik Bad Aibling SE & Co. KG, Bad Aibling, Germany
🇩🇪Hochtaunuskliniken GmbH, Bad Homburg, Germany
🇩🇪Rhön Klinikum Campus Bad Neustadt, Bad Neustadt An Der Saale, Germany
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
- First Posted Date
- 2017-11-17
- Last Posted Date
- 2025-02-25
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 19
- Registration Number
- NCT03343704
- Locations
- 🇨🇳
Guangdong Provincial People's Hospital, Guangzhou, China
🇨🇳Cardiovascular Institute and Fu Wai Hospital, Beijing, China
🇨🇳Beijing AnZhen Hospital, Beijing, China
Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2019-03-08
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 12
- Registration Number
- NCT03086356
- Locations
- 🇨🇳
Peking University First Hospital, Beijing, China
CU Programme of Idarucizumab for Japanese Patients
- First Posted Date
- 2016-07-13
- Last Posted Date
- 2018-03-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 1
- Registration Number
- NCT02831660
- Locations
- 🇯🇵
Fukuoka Tokushukai Medical Center, Fukuoka, Kasuga, Japan
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
- First Posted Date
- 2016-06-28
- Last Posted Date
- 2020-04-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 1
- Registration Number
- NCT02815670
- Locations
- 🇷🇺
Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan, Kazan, Russian Federation
🇷🇺Regional Clin.Hosp.1,Congen.heart defects&child.Cardiol.dept, Tyumen, Russian Federation
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
- First Posted Date
- 2016-06-14
- Last Posted Date
- 2021-11-18
- Lead Sponsor
- Boehringer Ingelheim
- Registration Number
- NCT02798107
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
- First Posted Date
- 2014-04-07
- Last Posted Date
- 2018-01-05
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 503
- Registration Number
- NCT02104947
- Locations
- 🇺🇸
IU Health Methodist Hospital, Indianapolis, Indiana, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
🇺🇸University of Cincinnati, Cincinnati, Ohio, United States
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2014-01-07
- Last Posted Date
- 2016-02-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 80
- Registration Number
- NCT02028780
- Locations
- 🇯🇵
1321.5.00001 Boehringer Ingelheim Investigational Site, Sumida-ku, Tokyo, Japan
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
- First Posted Date
- 2013-10-07
- Last Posted Date
- 2016-02-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 46
- Registration Number
- NCT01955720
- Locations
- 🇧🇪
1321.2.1 Boehringer Ingelheim Investigational Site, Antwerpen, Belgium
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
- First Posted Date
- 2012-09-20
- Last Posted Date
- 2016-06-23
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 157
- Registration Number
- NCT01688830
- Locations
- 🇧🇪
1321.1.1 Boehringer Ingelheim Investigational Site, Antwerpen, Belgium
Drug Development Updates
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