Last reviewed · How we verify
Praxbind (IDARUCIZUMAB)
Idarucizumab reverses dabigatran's anticoagulant effect by binding to it and its metabolites with high affinity.
Praxbind (idarucizumab) is a humanized monoclonal antibody fragment developed by Boehringer Ingelheim, used to treat drug-induced coagulation inhibitor disorder. It is a small molecule modality, FDA-approved in 2015. Praxbind works by binding to and neutralizing the effects of dabigatran, a blood thinner. It is a patented product with no generic manufacturers available. Key safety considerations include the risk of thromboembolic events and hypersensitivity reactions.
At a glance
| Generic name | IDARUCIZUMAB |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Drug class | Humanized Monoclonal Antibody Fragment [EPC] |
| Target | dabigatran and its acylglucuronide metabolites |
| Modality | Monoclonal antibody |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Idarucizumab is designed to reverse the effects of dabigatran, an anticoagulant. It does this by binding to dabigatran and its metabolites more strongly than they bind to thrombin, effectively neutralizing their ability to prevent blood clots.
Approved indications
- Drug-induced coagulation inhibitor disorder
Common side effects
- headache
- constipation
- nausea
Key clinical trials
- This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding (PHASE3)
- Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
- PraxbindTM India PMS Program
- All-Case Surveillance of Prizbind®
- Japanese Pradaxa PMS, Long Term
- Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
- Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots
- Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Praxbind CI brief — competitive landscape report
- Praxbind updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI