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TV-1106

Phase 2

Growth Hormone Deficiency | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Dec 10, 2021

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_CONTROLLEDDMC
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01811576Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone DeficiencyPHASE2 COMPLETED 52Mar 31, 2013Aug 5, 2013Dec 10, 202123 United States, Czechia +7
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Study Endpoints
Primary Endpoints
Insulin-like growth factor I (IGF-I) concentration change from baseline
Baseline to Week 12
Secondary Endpoints
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Baseline to Week 12
Safety Parameters
78 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
recombinant human growth hormoneACTIVE_COMPARATORDaily subcutaneous dose
TV-1106EXPERIMENTALTitration dose levels of TV-1106
Interventions
NameTypeDescription
TV-1106DRUG -
Recombinant human growth hormoneDRUGSubcutaneous once daily
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Eligibility Criteria
Age Range23 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator. * Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either a...

Countries:United StatesCzechiaGermanyGreeceHungaryIsraelSerbiaSlovakiaSlovenia
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