Drugs / turoctocog alfa pegol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hemophilia B leyden 1 milestone | |||||
| Filed | EU (EMA) | — | hemophilia B leyden | 2018-02-27 | “a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for N8-GP” novonordisk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Esperoct | — | 2019-06-20 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02994407 | Jan 2017 → Oct 2018 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02920398 | Oct 2016 → Apr 2017 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01205724 | Sep 2010 → Apr 2011 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT05082116 | Sep 2021 → Dec 2022 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT03528551 | Apr 2018 → Dec 2020 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02137850 | Jun 2014 → Jun 2023 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01731600 | Feb 2013 → Sep 2014 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01489111 | Aug 2012 → Dec 2018 | congenital hematological disorder, hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01480180 | Jan 2012 → Dec 2018 | hemophilia A | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2019-06-20 | Novo Nordisk A/S | Regulatory Esperoct® (turoctocog alfa pegol, N8-GP) approved in the EU novonordisk.com ↗
Bagsværd, Denmark, 20 June 2019 – Novo Nordisk today announced that the European Commission has granted marketing authorisation for Esperoct® for the treatment of adolescents (≥12 years of age) and adults with haemophilia A. |
| 2019-04-26 | Novo Nordisk A/S | Regulatory 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 ↗
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of Esperoct® (turoctocog alfa pegol, N8-GP) recommending marketing authorisation for the treatment of adolescents and adults with haemophilia A. |
| 2019-02-19 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval of ESPEROCT® (turoctocog alfa pegol, N8-GP) novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for ESPEROCT® for the treatment of adults and children with haemophilia A. |
| 2018-02-27 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for langtidsvirkende faktor VIII (N8-GP) i USA og EU til behandling af hæmofili A novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt registreringsansøgning til de amerikanske sundhedsmyndigheder (FDA) og Det Europæiske Lægemiddelagentur (EMA) for N8-GP, et faktor VIII-præparat med forlænget halveringstid til behandling af mennesker med hæmofili A. |
| 2018-02-27 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A novonordisk.com ↗
Novo Nordisk today announced the submission of a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for N8-GP, an extended half-life factor VIII for treatment of people with haemophilia A. |
| 2015-11-18 | Novo Nordisk A/S | Results Novo Nordisks kapitalmarkedsdag 2015 novonordisk.com ↗
De rapporterede data understøtter yderligere, at den langtidsvirkende rekombinante faktor VIII, N8-GP (turoctocog alfa pegol), forekommer at have en sikker og veltolereret profil, og at 95% af milde til moderate blødninger kan behandles med 1-2 infusioner. |
| 2015-11-18 | Novo Nordisk A/S | Results Highlights to be presented at Novo Nordisk's Capital Markets Day 2015 novonordisk.com ↗
The reported data provide additional support that the long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol), appears to have a safe and well-tolerated profile, and that 95% of mild to moderate bleeds can be managed with 1-2 infusions. |
| 2014-03-19 | Novo Nordisk A/S | Results Positive results from first phase 3 trial with N8-GP, a long-acting factor VIII for treatment of haemophilia A novonordisk.com ↗
Bagsværd, Denmark, 19 March 2014 - Novo Nordisk today announced the completion of pathfinder(TM)2, the first phase 3 trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for haemophilia A patients. |
All press releases naming this drug 9 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | turoctocog alfa pegol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02994407 ↗ |
| Known as | Esperoct | “N8-GP (turoctocog alfa pegol; Esperoct® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard...” PMID 32544297 ↗ Sep 20201“N8-GP (turoctocog alfa pegol; Esperoct® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII).” PMID 32940955 ↗ Sep 2020 |
| Known as | N8-GP | “Evaluate the pharmacokinetics (PK), immunogenicity, safety, and preliminary efficacy of s.c. administration of turoctocog alfa pegol (s.c. N8-GP) in adult or adolescent...” PMID 31618804 ↗ Nov 20192“N8-GP (turoctocog alfa pegol; Esperoct® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard...” PMID 32544297 ↗ Sep 2020 “turoctocog alfa pegol (N8-GP)” NCT05082116 ↗ |
| Modality | Protein / enzyme biologic | “N8-GP is a recombinant factor VIII (FVIII)” PMID 23398640 ↗ Apr 2013 |
| Route | Intravenous | “Single dose (low) administered intravenously (into the vein)” NCT01205724 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL5315071 ↗ |