NDAINTRAVENOUSSOLUTION
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
5/8 — Partial
ANGIOMAX RTU (bivalirudin) by MAIA Biotechnology is thrombin inhibitors [moa]. First approved in 2019.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANGIOMAX RTU (bivalirudin) is a direct thrombin inhibitor administered intravenously as a ready-to-use solution for anticoagulation. It works by selectively and reversibly binding to thrombin, preventing clot formation in patients undergoing percutaneous coronary intervention and other thrombotic conditions. The RTU formulation eliminates the need for reconstitution, improving clinical workflow efficiency.
Peak12.9 years to LOE
Product is in peak commercial phase with established market presence; team size and growth initiatives likely stable to modest.
Mechanism of Action
Thrombin Inhibitors
Pharmacologic Class:
Anti-coagulant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
Started Sep 2014
34 enrolled
Non-ST Elevation Acute Coronary Syndrome
A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
Started Sep 2013
3,232 enrolled
Coronary Artery Disease
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
Started Sep 2008
18 enrolled
Deep Venous Thrombosis
Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI
Started Jun 2007
100 enrolled
Acute Coronary Syndromes
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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.