Overview
Turoctocog alfa is a recombinant factor VIII (rFVIII) with a truncated B-domain made from the sequence coding for 10 amino acids from the N-terminus and 11 amino acids from the C-terminus of the naturally occurring B-domain. Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human- or animal-derived materials. During secretion, some rFVIII molecules are cleaved at the C-terminal of the heavy chain (HC) at amino acid 720, and a monoclonal antibody binding C-terminal to this position is used in the purification process allowing isolation of the intact rFVIII. It was developped by Novo Nordisk and FDA approved in October 16, 2013.
Indication
Turoctocog alfa is indicated for the treatment and prophylaxis of bleedings in patients presenting hemophilia A. The treatment with turoctocog alfa is related with its use to control bleeding episodes or as a perioperative management. Hemophilia A is a hereditary hemorrhagic disorder generated by the congenital deficit of the coagulation factor VIII. This disease is manifested as excessive spontaneous or trauma-driven bleeding. The coagulation factor VIII is a robust initiator of thrombin which is later required for the generation of fibrin to form a platelet plug and its gene is expressed in the X chromosome.
Associated Conditions
- Bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/28 | N/A | Recruiting | |||
2020/10/14 | N/A | Completed | |||
2018/07/17 | Phase 3 | Terminated | |||
2018/02/28 | Phase 4 | Completed | |||
2017/06/22 | Phase 2 | Completed | |||
2017/06/07 | N/A | Completed | |||
2016/10/21 | Phase 1 | Completed | |||
2016/10/19 | Phase 3 | Completed | |||
2014/08/04 | N/A | Completed | |||
2014/01/14 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/13/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000IU/VIAL | SIN16110P | INJECTION, POWDER, FOR SOLUTION | 1000 IU/vial | 3/1/2021 | |
| NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2000IU/VIAL | SIN16713P | INJECTION, POWDER, FOR SOLUTION | 2000IU/vial | 2/24/2023 | |
| NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/VIAL | SIN16109P | INJECTION, POWDER, FOR SOLUTION | 250IU/vial | 3/1/2021 | |
| NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IU/VIAL | SIN16111P | INJECTION, POWDER, FOR SOLUTION | 500IU/vial | 3/1/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.