Product Description
Albutrepenonacog alfa (Idelvion®), a fusion protein that genetically fuses recombinant factor IX (rFIX) with recombinant human albumin (rAlbumin), is indicated in the treatment of haemophilia B. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/27988873/)
Mechanisms of Action: FIX Analogue
Novel Mechanism: Yes
Modality: Fusion Protein
Route of Administration: N/A
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Colombia | Croatia | Cyprus | Denmark | Dominican Republic | France | Germany | Hong Kong | Hungary | Ireland | Italy | Japan | Malaysia | Mexico | Morocco | Netherlands | New Zealand | Norway | Portugal | Russia | Spain | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: CSL Behring
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 4: Hemophilia|Hemophilia B|Hemophilia A
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| OPTI-CLOT: TARGET | P4 |
Active, not recruiting |
Hemophilia |
2025-05-07 |
|
| 201907004MIPB | P4 |
Unknown status |
Hemophilia A|Hemophilia B |
2021-11-01 |
|
| ATHN 2 | N/A |
Completed |
Hemophilia A |
2020-06-30 |