Drugs / turoctocog alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | NovoEight | — | 2013-11-13 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT02941354 | Oct 2016 → Jun 2017 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01692925 | Dec 2012 → Mar 2013 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01365520 | Jun → Sep 2011 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01238367 | Nov 2010 → Oct 2011 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00837356 | Mar → Oct 2009 | hemophilia A | Novo Nordisk A/S | Completed | Met primary |
| Phase 36 trials | ||||||
| Phase 3 | NCT03588741 | Jun 2018 → Jun 2019 | hemophilia A | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT02938585 | Dec 2016 → Mar 2018 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01493778 | Sep 2012 → Aug 2017 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01138501 | Jun 2010 → Nov 2011 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00984126 | Oct 2009 → Jun 2016 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00840086 | Apr 2009 → Sep 2011 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03449342 | Mar 2018 → Mar 2019 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03196297 Background | Aug 2017 → Jun 2018 | hemophilia A, vascular hemostatic disease | Novo Nordisk A/S | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-06-20 | Novo Nordisk A/S | Esperoct® (turoctocog alfa pegol, N8-GP) approved in the EU novonordisk.com ↗ |
| 2019-04-26 | Novo Nordisk A/S | Novo Nordisk receives positive opinion from the European regulatory authorities for Esperoct® (turoctocog alfa pegol, N8-GP) for the treatment of haemophilia A novonordisk.com ↗ |
| 2019-02-19 | Novo Nordisk A/S | Novo Nordisk receives US FDA approval of ESPEROCT® (turoctocog alfa pegol, N8-GP) novonordisk.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | turoctocog alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01238367 ↗ |
| Known as | NN-7008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108286 ↗ |
| Known as | NNC 0155-0000-0004 | “a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A” NCT01365520 ↗ |
| Known as | NovoEight | “Long-term patterns of safety and efficacy of bleeding prophylaxis with
turoctocog alfa (NovoEight(® ) ) in previously treated patients with severe
haemophilia A: interim...” PMID 26058730 ↗ Jun 20153“Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.” PMID 25273984 ↗ Oct 2014 “Turoctocog alfa (NovoEight(®)) is a human recombinant coagulation factor VIII (rFVIII) for the treatment of patients with hemophilia A.” PMID 25495795 ↗ Feb 2015 “Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A” NCT02941354 ↗ |
| Action | Restore | “Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prophylaxis and treatment of bleeding episodes” PMID 23647704 ↗ May 2013 |
| Modality | Protein / enzyme biologic | “Turoctocog alfa is an approved B-domain truncated recombinant factor VIII concentrate” PMID 26679394 ↗ Dec 2015 |
| Route | Intravenous | “home treatment with self-injection i.v.” NCT00840086 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL2108286 ↗ |