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turoctocog alfa pegol

Phase 3

Haemophilia A | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Jan 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05082116Efficacy 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 COMPLETED 36 — — Sep 27, 2021Dec 28, 2022Jan 6, 202611 China
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Study Endpoints
Primary Endpoints
Number of Bleeding Episodes Per Year (Annualised Bleeding Rate)
From start of treatment (Week 0) until Week 28

Number of bleeding episodes per year (Annualised Bleeding Rate) data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.

Secondary Endpoints
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
From start of treatment (Week 0) until Week 28
Number of Injections Needed to Treat Bleeding Episodes
From start of treatment (Week 0) until Week 28
Consumption of N8-GP for Prophylaxis
From start of treatment (Week 0) until Week 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
N8-GP prophylaxisEXPERIMENTALAll patients will receive prophylaxis with 50 IU/kg N8-GP every 4 days for a treatment period of at least 28 weeks (with the possibility of switching to twice-weekly dosing during the treatment period at the discretion of the investigator).
Interventions
NameTypeDescription
turoctocog alfa pegol (N8-GP)DRUGN8-GP will be injected into a vein (intravenous injections) every 4 days in at least 28 weeks
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Eligibility Criteria
Age Range12 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Male Chinese patient with severe congenital haemophilia A with a...

Countries:China
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