Last reviewed · How we verify
Turoctocog alfa pegol (N8-GP)
Turoctocog alfa pegol is a recombinant human coagulation factor VIII with extended half-life achieved through PEGylation, which replaces deficient clotting factor in hemophilia A patients.
Turoctocog alfa pegol is a recombinant human coagulation factor VIII with extended half-life achieved through PEGylation, which replaces deficient clotting factor in hemophilia A patients. Used for Hemophilia A (prevention and treatment of bleeding episodes).
At a glance
| Generic name | Turoctocog alfa pegol (N8-GP) |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | Recombinant coagulation factor VIII (pegylated) |
| Target | Coagulation factor VIII |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
The drug is a pegylated (polyethylene glycol-conjugated) version of recombinant factor VIII that functions as a replacement therapy for patients with hemophilia A who lack functional factor VIII. The PEGylation modification extends the drug's circulating half-life compared to standard recombinant factor VIII, reducing dosing frequency and improving patient convenience. Factor VIII is essential for the intrinsic coagulation pathway, enabling thrombin generation and clot formation.
Approved indications
- Hemophilia A (prevention and treatment of bleeding episodes)
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10) (PHASE3)
- Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A (PHASE3)
- A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
- Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
- An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct
- A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A (PHASE3)
- 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 (PHASE3)
- Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Turoctocog alfa pegol (N8-GP) CI brief — competitive landscape report
- Turoctocog alfa pegol (N8-GP) updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI