Product Description
GlycoPEGylated human recombinant factor VIII (FVIII). (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8918113/)
Mechanisms of Action: FVIII Analogue
Novel Mechanism: Yes
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Australia | Austria | Belgium | Colombia | Croatia | Denmark | Germany | Hungary | Israel | Italy | Japan | Netherlands | Norway | Peru | Portugal | Spain | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Novo Nordisk
Company Location: BAGSVAERD DENMARK G7 00000
Company CEO: Lars Fruergaard Jorgensen
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Algeria, Argentina, Australia, Austria, Bulgaria, Canada, China, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Romania, Spain, Taiwan, Thailand, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Blood Coagulation Disorders|Hemophilia A|Hemostatic Disorders|Injuries/wounds Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
pathfinderâ¢6 | P3 |
Completed |
Hemostatic Disorders|Blood Coagulation Disorders|Hemophilia A |
2023-06-07 |
|
pathfinder10 | P3 |
Active, not recruiting |
Injuries/wounds Unspecified |
2023-05-14 |
|
Pathfinder10 | P3 |
Completed |
Hemophilia A |
2022-12-28 |
|
JapicCTI-142577 | P3 |
Active |
Hemophilia A |
2021-11-13 |