Back to discover
Drug

Turoctocog alfa pegol

Approved · EMA
Emerging researchLate-stage development
RxNorm2118568UNII9Y9727LS4D
1
Research papers
1
Regulatory events
Latest activity
beta

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

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

Clinical trial2026-01-06Results posted · ClinicalTrials.gov

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

Clinical trial2025-12-23Results posted · ClinicalTrials.gov

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

Clinical trial2022-12-22Results posted · ClinicalTrials.gov

A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

Clinical trial2020-11-23Results posted · ClinicalTrials.gov

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Clinical trial2020-11-23Results posted · ClinicalTrials.gov

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Clinical trial2020-08-10Results posted · ClinicalTrials.gov

Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials.

Research2020-04-15Haemophilia : the official journal of the World Federation of Hemophilia

Approval: Esperoct (EMA)

Regulatory2019-06-20EMA

Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

Clinical trial2018-10-15Completed · ClinicalTrials.gov

This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.

Clinical trial2017-04-07Completed · ClinicalTrials.gov

A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

Clinical trial2011-04-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Turoctocog alfa pegol
RxNorm CUI
2118568
UNII
9Y9727LS4D
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-06-20
Latest approval
2019-06-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2019-06-20Approval
Approval: Esperoct (EMA)

Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Esperoct can be used for all age groups.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

9 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
9
registered trials across all phases
LATEST COMPLETION 2023
6
Late-stage (III+)
9
Completed
PHASE DISTRIBUTIONn = 9
Phase 13Phase 36

Late-stage studies

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

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1242023

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=362022

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1602020

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=362018

A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1862018

Recent completions

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

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1242023

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=362022

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1602020

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=362018

A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

CompletedPH IIINovo Nordisk A/Sn=1862018

Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

CompletedPH INovo Nordisk A/Sn=502018

Research activity

1 papers

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

Journals, researchers & institutions
Top journals
  • Haemophilia : the official journal of the World Federation of Hemophilia1
Leading researchers
  • Chowdary P1
  • Hampton K1
  • Landorph A1
  • Lentz SR1
  • Meijer K1
  • Neff A1
  • Nemes L1
  • Santagostino E1
Leading institutions
free-text, unnormalised
  • Ampang Hospital1
  • Cleveland Clinic1
  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico1
  • Haemophilia and Thrombosis Center1
  • Katharine Dormandy Haemophilia and Thrombosis Centre1
  • National Haemophilia Centre and Haemostasis Department1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.