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N9-GP

Phase 1

Congenital Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: May 26, 2023

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03075670A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia BPHASE1 COMPLETED 15 — — Mar 7, 2017Dec 8, 2017May 26, 202312 United States, Germany +1
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Study Endpoints
Primary Endpoints
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
From time 0 (dosing) up to 240 hours post-dose

Calculated based on plasma FIX activity measured in blood

Secondary Endpoints
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
At 30 minutes
Terminal half-life (t½)
From time 0 (dosing) up to 240 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
N9-GPEXPERIMENTAL -
ALPROLIX®ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
N9-GPDRUGA single dose of 50 IU/kg for intravenous (i.v.) injection
ALPROLIX®DRUGA single dose of 50 IU/kg for intravenous (i.v.) injection
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Eligibility Criteria
Age Range18 Years — 70 Years
SexMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Male, aged 18-70 years (both inclusive) at the time of signing informed consent * Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records * History of more than 150 exposures days to any factor IX containin...

Countries:United StatesGermanySwitzerland
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