Drug

Turoctocog alfa

Approved medicine

ClassCoagulation factor VIII exogenous proteinResearchOngoing clinical research

Also known as Novoeight, antihemophilic factor(FVIII)rec,B-domain truncated.

RxNorm1737557 ChEMBLCHEMBL2108286UNII969NZA3X9T

Research papers

Coagulation factor VIII

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

Clinical trial2021-11-16Results posted · ClinicalTrials.gov

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A

Clinical trial2020-11-30Results posted · ClinicalTrials.gov

Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

Clinical trial2020-07-27Results posted · ClinicalTrials.gov

Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients With Moderate or Severe Haemophilia A in India

Clinical trial2020-04-17Results posted · ClinicalTrials.gov

Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

Clinical trial2019-06-19Terminated · ClinicalTrials.gov

Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Clinical trial2017-07-27Results posted · ClinicalTrials.gov

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Clinical trial2017-06-20Completed · ClinicalTrials.gov

A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

Clinical trial2017-03-17Results posted · ClinicalTrials.gov

Impact of severe haemophilia A on patients' health status: results from the guardian(™) 1 clinical trial of turoctocog alfa (NovoEight(®) ).

Research2015-02-12Haemophilia : the official journal of the World Federation of Hemophilia

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.

Research2014-10-02Haemophilia : the official journal of the World Federation of Hemophilia

Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics.

Research2013-05-08Haemophilia : the official journal of the World Federation of Hemophilia

Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy.

Research2013-05-07Haemophilia : the official journal of the World Federation of Hemophilia

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Turoctocog alfa

Aliases & brands

Novoeightantihemophilic factor(FVIII)rec,B-domain truncated

RxNorm CUI

1737557

ChEMBL ID

CHEMBL2108286

UNII

969NZA3X9T

Primary mechanism

Coagulation factor VIII exogenous protein

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Coagulation factor VIII

F8 · P00451

EXOGENOUS PROTEINCoagulation factor VIII exogenous protein

Clinical trials

13 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2020

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 13

Phase 15Phase 21Phase 36Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients With Moderate or Severe Haemophilia A in India

CompletedPH IVNovo Nordisk A/Sn=602019

Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

TerminatedPH IIINovo Nordisk A/Sn=12019

Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=682018

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=602018

Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=2142016

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

CompletedPH IINovo Nordisk A/Sn=362020

Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients With Moderate or Severe Haemophilia A in India

CompletedPH IVNovo Nordisk A/Sn=602019

Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=682018

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=602018

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

CompletedPH INovo Nordisk A/Sn=352017

Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=2142016

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20132015

Most influential

Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy.

Haemophilia : the official journal of the World Federation of Hemophilia · 2013 · 69 cites

Haemophilia : the official journal of the World Federation of Hemophilia · 2013 · 49 cites

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.

Haemophilia : the official journal of the World Federation of Hemophilia · 2015 · 43 cites

Impact of severe haemophilia A on patients' health status: results from the guardian(™) 1 clinical trial of turoctocog alfa (NovoEight(®) ).

Haemophilia : the official journal of the World Federation of Hemophilia · 2015 · 7 cites