BLAINJECTIONINJECTABLEPriority Review
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
Priority Review
PRAXBIND (idarucizumab) by Boehringer Ingelheim. Approved for humanized monoclonal antibody fragment [epc]. First approved in 2015.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRAXBIND (idarucizumab) is a humanized monoclonal antibody fragment that acts as a specific reversal agent for dabigatran, a direct thrombin inhibitor anticoagulant. It binds dabigatran with high affinity, rapidly neutralizing its anticoagulant effects in patients experiencing bleeding or requiring urgent procedures. This is an adjunct therapy used in emergency settings to reverse anticoagulation.
Peak
Peak lifecycle stage with moderate competitive pressure (30%) indicates stable revenue; team size likely optimized but not expanding aggressively.
Mechanism of Action
Pharmacologic Class:
Humanized Monoclonal Antibody Fragment
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Started May 2019
0Hemorrhage
PraxbindTM India PMS Program
Started Dec 2018
5 enrolled
Thromboembolism
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Started Mar 2018
19 enrolled
Hemorrhage
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
Started May 2017
12 enrolled
Healthy Volunteers
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
Started Sep 2016
1 enrolled
Hemorrhage
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.