Product Description
Eftrenonacog alfa (Alprolix™) is a recombinant fusion protein comprising human factor IX (FIX) covalently linked to the constant region (Fc) domain of human IgG1 (i.e. rFIXFc). The presence of the Fc domain extends the terminal half-life (t½) of rFIXFc, permitting prolonged treatment intervals. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28646426/)
Mechanisms of Action: FIX Cleaver
Novel Mechanism: Yes
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Australia | Austria | Belgium | Chile | Colombia | Croatia | Cyprus | Denmark | France | Germany | Hong Kong | Hungary | Iceland | Israel | Italy | Japan | Netherlands | New Zealand | Norway | Portugal | Saudi Arabia | Spain | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Hemophilia A|Hemophilia
Phase 3: Hemophilia A|Hemophilia B
Phase 1: Menorrhagia|Hemophilia A|Hemophilia B
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03901755 |
B-MORE | N/A |
Completed |
Hemophilia B|Hemophilia A |
2024-03-12 |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03055611 |
PREVENT | N/A |
Completed |
Hemophilia B|Hemophilia A |
2022-04-19 |
2022-05-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03655340 |
B-SURE | N/A |
Completed |
Hemophilia A|Hemophilia B |
2022-03-16 |
2023-01-13 |
Primary Endpoints|Treatments |
|
NCT02546622 |
ATHN 2 | N/A |
Completed |
Hemophilia A |
2020-06-30 |
2020-08-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Trial Status |
|
NCT02392156 |
FORWARD | N/A |
Terminated |
Hemophilia B|Hemophilia A |
2015-12-01 |
2019-03-22 |
||
NCT03272568 |
IRB00095067 | P1 |
Completed |
Hemophilia A|Menorrhagia |
2019-12-31 |
2020-10-24 |
Primary Endpoints |
|
NCT00716716 |
SYN-FIXFc-07-001 | P1 |
Completed |
Hemophilia A|Hemophilia B |
2009-10-01 |
2019-03-18 |
Treatments |
|
NCT02234310 |
PUPs B-LONG | P3 |
Completed |
Hemophilia A|Hemophilia B |
2019-08-20 |
2020-08-01 |
Primary Endpoints|Start Date|Treatments |
|
2013-003629-27 |
998HB303 Ireland | P3 |
Completed |
Hemophilia B |
2019-08-20 |
2025-07-02 |
Treatments |
|
2011-003075-11 |
2011-003075-11 | P3 |
Completed |
Hemophilia B |
2017-11-01 |
2022-03-13 |
Treatments |
|
NCT01425723 |
B-YOND | P3 |
Completed |
Hemophilia B|Hemophilia A |
2017-10-01 |
2019-03-22 |
Treatments |
|
2018-003869-33 |
OPTI-CLOT: TARGET | P4 |
Active, not recruiting |
Hemophilia |
2025-05-07 |
2022-03-13 |
Treatments |
|
2022-502921-16-00 |
Sobi.HAEM89-007 | P4 |
Completed |
Hemophilia A |
2023-12-01 |
2025-05-02 |
Treatments |