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Norditropin FlexPro pen

Phase 1

Growth Disorder | Small molecule | Other |Novo Nordisk A/S|Last Updated: Mar 19, 2015

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01943084A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult SubjectsPHASE1 COMPLETED 32 — — Sep 1, 2013Oct 1, 2013Mar 19, 20151 United States
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Study Endpoints
Primary Endpoints
Area under the serum hGH (human growth hormone) concentration-time curve
From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.
Maximum observed serum hGH concentration
Over a 24-hour sampling period
Area under the effect (IGF-I) (insulin-like growth factor-I) curve
From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period
Maximum IGF-I effect (Emax)
Over a 96-hour sampling period
Secondary Endpoints
The frequency of adverse events (AE)
From screening to follow-up period (up to day 23)
Abnormal haematology laboratory parameters
From screening to follow-up period (up to day 23)
Abnormal biochemistry laboratory parameters
From screening to follow-up period (up to day 23)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Norditropin®EXPERIMENTAL -
Genotropin®ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Norditropin® FlexPro® penDRUGAdministered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
Genotropin Pen®DRUGAdministered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I) * Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive) * Considered generally healthy upon completion of medical history, physical examinat...

Countries:United States
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Competitive Landscape -Growth Disorders 4 trials
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO2PHASE3Somapacitan, Norditropin FlexPro
Ascendis Pharma A/SASND1PHASE3Lonapegsomatropin, Somatropin Pen Injector
Harvard Bioscience, Inc.HBIO1NAUndisclosed
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