BLASubcutaneousInjectablePriority Review
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
5/8 — Partial
Priority Review
ALHEMO (concizumab) by Novo Nordisk is tissue factor pathway inhibitor antagonists [moa]. Approved for tissue factor pathway inhibitor antagonist [epc]. First approved in 2024.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALHEMO (concizumab) is a monoclonal antibody antagonist of Tissue Factor Pathway Inhibitor (TFPI) approved in December 2024 by Novo Nordisk. It is administered via subcutaneous injection to restore hemostasis in patients with bleeding disorders. Concizumab works by blocking TFPI, thereby enhancing the intrinsic coagulation pathway.
Growth
Early-stage product in growth phase with established reimbursement pathway (HCPCS J7173); commercial infrastructure scaling underway.
Mechanism of Action
Tissue Factor Pathway Inhibitor Antagonists
Pharmacologic Class:
Tissue Factor Pathway Inhibitor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
Started May 2025
30 enrolled
Haemophilia A, Haemophilia B
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
Started Aug 2024
23 enrolled
Haemophilia AHaemophilia B
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors
Started Mar 2022
153 enrolled
Haemophilia A and B With and Without Inhibitors
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
Started Nov 2019
156 enrolled
Haemophilia A Without InhibitorsHaemophilia B Without Inhibitors
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors
Started Oct 2019
134 enrolled
Haemophilia A With InhibitorsHaemophilia B With Inhibitors
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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.