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: No
Modality: Fusion Protein
Route of Administration: N/A
FDA Designation: *
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
Company: CSL Behring
Company Location: Eastern America
Company Founding Year: 1904
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, France, Germany, Greece, Italy, Poland, Spain
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Hemophilia|Hemophilia B
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2022-500221-33-01 |
EFC17574 (ATLAS-NEO) | P3 |
Recruiting |
Hemophilia |
2028-03-01 |
2025-05-02 |
Treatments |
|
NCT06399289 |
CSL654_3004 | P3 |
Completed |
Hemophilia B |
2026-07-07 |
18% |
2026-07-24 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/20/2022 |
News Article |
Global rHu Albumin Market to surpass US$ 182.5 Million by 2030, Says Coherent Market Insights (CMI) |
|
10/01/2021 |
News Article |
Thermo Fisher Scientific Opens Biologics Manufacturing Site in Lengnau, Switzerland |
|
06/08/2021 |
News Article |
Global Hemophilia B Market Insight, Epidemiology and Market Forecast Report 2021-2030 - ResearchAndMarkets.com |
|
07/03/2020 |
News Article |
IDELVION® Becomes First and Only Factor IX Therapy with 21-Day Prophylactic Dosing |