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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

N9-GP · 1 trial · 2 indications

Phase 1 1
NCT03075670A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia BCongenital Bleeding Disorder
COMPLETED15 Analytics
PHASE1COMPLETED
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Congenital Bleeding Disorder
NCT0307567015
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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 to 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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Frequently asked questions about N9-GP

What is N9-GP used for?

N9-GP, also known as nonacog beta pegol, is an investigational drug being studied for the treatment of congenital bleeding disorders, specifically haemophilia B. It is being developed by Novo Nordisk A/S and is currently in Phase 1 clinical development.

What does N9-GP target?

N9-GP is a small molecule designed to address congenital bleeding disorders. While its specific molecular target is not disclosed, it is being investigated as a treatment for haemophilia B, a condition characterized by a deficiency in clotting factor IX.

Who makes N9-GP?

N9-GP is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is currently in Phase 1 clinical trials for the treatment of congenital bleeding disorders, including haemophilia B.

What phase is N9-GP in?

N9-GP is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 1 trial comparing N9-GP with ALPROLIX in patients with haemophilia B has been completed.

What clinical trials is N9-GP in?

N9-GP has been studied in a completed Phase 1 clinical trial with the identifier NCT03075670. This trial compared N9-GP with ALPROLIX in patients with haemophilia B and enrolled 15 male participants aged 18 years and older in the United States, Germany, and Switzerland.

Is N9-GP the same as nonacog beta pegol?

Yes, N9-GP is also known as nonacog beta pegol. This alternative name is used in clinical trial documentation, including the completed Phase 1 study NCT03075670, which evaluated the drug in patients with haemophilia B.