BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 5h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEMLIBRA (emicizumab) is a monoclonal antibody indicated for hemophilia A, a bleeding disorder caused by deficiency or dysfunction of clotting factor VIII. It works by bridging factors IX and X to restore hemostatic balance without replacing factor VIII directly. This mechanism represents a paradigm shift in hemophilia treatment, enabling subcutaneous administration rather than intravenous infusions.
Peak
Product is at peak commercial performance (7+ years post-launch) with established market presence; brand teams are focused on market penetration, line extension, and defending against emerging competition in the hemophilia A space.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
Started Sep 2026
5 enrolled
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Started Apr 2026
360 enrolled
Hemophilia A
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
Started Jun 2025
75 enrolled
Von Willebrand Disease, Type 3
A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.
Started May 2025
15 enrolled
Severe Hemophilia A
Real World Use of Emicizumab in Infants and Children Ages 0-3 Years With Hemophilia A
Started Aug 2024
71 enrolled
Hemophilia A
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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.