Product Description
Simoctocog alfa (human-cl rhFVIII, Nuwiq) is a 4th generation recombinant FVIII (rFVIII), without chemical modification or fusion with any other protein/fragment. Nuwiq is produced in a human embryonic kidney cell line (HEK293F), which ensures human-specific post-translational protein processing. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6595650/)
Mechanisms of Action: FVIII Replacer
Novel Mechanism: Yes
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Chile | Colombia | Croatia | Cyprus | Denmark | Dominican Republic | Estonia | France | Germany | Hungary | Ireland | Italy | Japan | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Portugal | South Africa | Spain | Taiwan | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Octapharma
Company Location: Europe
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Hemophilia A|Injuries/wounds Unspecified|Hemophilia
Phase 3: Hemophilia A|Injuries/wounds Unspecified
Phase 2: Hemophilia A
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04023019 |
MOTIVATE | N/A |
Recruiting |
Hemophilia A |
2028-12-01 |
2020-06-03 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT03344003 |
PREVAIL | N/A |
Terminated |
Hemophilia A |
2020-11-20 |
2024-08-10 |
Patient Enrollment|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 |
|
NCT04592692 |
CL-SelectAte-II-01 | P2 |
Unknown status |
Hemophilia A |
2022-02-28 |
3% |
2023-10-03 |
Primary Endpoints|Treatments|Trial Status |
2018-002776-40 |
2018-002776-40 | P2 |
Completed |
Hemophilia A |
2022-02-18 |
2025-07-09 |
Treatments |
|
NCT04046848 |
SubQ8-01 | P2 |
Terminated |
Hemophilia A |
2022-02-18 |
19% |
2025-02-14 |
Patient Enrollment|Primary Endpoints |
NCT04030052 |
IRB00111805 | P3 |
Withdrawn |
Hemophilia A |
2023-01-19 |
16% |
2024-01-06 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
CTR20171633 |
CTR20171633 | P3 |
Completed |
Hemophilia A |
2020-01-08 |
2025-04-29 |
Patient Enrollment|Treatments |
|
2013-001556-35 |
2013-001556-35 | P3 |
Completed |
Injuries/wounds Unspecified |
2015-01-16 |
2022-03-13 |
Treatments |
|
2009-011055-43 |
2009-011055-43 | P3 |
Completed |
Injuries/wounds Unspecified |
2012-01-31 |
2022-03-13 |
Treatments |
|
2024-516741-39-00 |
MOTIVATE | P4 |
Recruiting |
Injuries/wounds Unspecified |
2029-05-22 |
2025-05-02 |
Treatments |
|
2019-003427-38 |
Treatment of Hemophilia A Patients With FVIII Inhibitors | P4 |
Unknown status |
Hemophilia A |
2029-03-20 |
2025-05-06 |
Treatments|Trial Status |
|
NCT05936580 |
NuDIMENSION | P4 |
Recruiting |
Hemophilia A |
2027-02-01 |
2025-04-23 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT05935358 |
NuPOWER | P4 |
Recruiting |
Hemophilia A |
2026-08-01 |
2025-04-22 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
2018-003869-33 |
OPTI-CLOT: TARGET | P4 |
Active, not recruiting |
Hemophilia |
2025-05-07 |
2022-03-13 |
Treatments |
|
2022-502060-21-00 |
GENA-22 | P4 |
Recruiting |
Unknown |
2025-03-01 |
2025-05-02 |
Treatments |
|
2022-502061-17-00 |
GENA-23 | P4 |
Recruiting |
Unknown |
2025-03-01 |
2025-05-02 |
Treatments |