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US-Approved Neupogen

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Feb 23, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

US-Approved Neupogen · 1 trial · 1 indication

Phase 1 1
NCT02923791A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.Healthy Volunteers
COMPLETED256 Analytics
PHASE1COMPLETED
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
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Study Endpoints

Primary Endpoints

The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study.
62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)

Secondary Endpoints

The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;
62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Filgrastim HospiraEXPERIMENTAL -
US-Approved NeupogenACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Filgrastim HospiraBIOLOGICAL5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
US-Approved NeupogenBIOLOGICAL5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Healt...

Countries:United States
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Frequently asked questions about US-Approved Neupogen

What is Neupogen used for?

Neupogen is used for neutropenia, a condition of low white blood cell count. It is also studied in healthy volunteers to assess immune response and pharmacokinetics. The drug is a monoclonal antibody developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development.

Who makes Neupogen?

Neupogen is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is a monoclonal antibody being studied for neutropenia and in healthy volunteers. It is currently in Phase 1 clinical trials.

What phase is Neupogen in?

Neupogen is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The drug is investigational and not yet approved for any indication.

What clinical trials is Neupogen in?

Neupogen has been studied in three completed Phase 1 trials: NCT02766634, NCT02766647, and NCT02923791. These trials evaluated the drug in healthy volunteers and in subjects with neutropenia, with total enrollment of 256 participants across all studies.

Is Neupogen the same as Filgrastim Hospira?

Neupogen is used as a reference product in trials comparing it to Filgrastim Hospira. The trials NCT02766634 and NCT02766647 test Filgrastim Hospira against the already U.S.-approved Neupogen, while NCT02923791 assesses immune response to both products.