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Blosozumab

Phase 1

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Jul 16, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02109042A Study of Blosozumab (LY2541546) in Postmenopausal Female ParticipantsPHASE1 COMPLETED 15Apr 1, 2014Jul 1, 2014Jul 16, 20182 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
Predose and daily up through 7 days postdose

The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.

PK: Area Under the Concentration Curve of Blosozumab
Predose and daily up through 7 days postdose

The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BlosozumabEXPERIMENTALWeekly SC injections of blosozumab for 6 weeks.
Interventions
NameTypeDescription
BlosozumabDRUGAdministered subcutaneously
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Eligibility Criteria
Age Range60 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Part A: Overtly healthy PMP females * Part B: PMP women who are currently taking oral bisphosphonates * Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2) Exclusion Criteria: * Show evidence of human immunodeficiency virus (HIV) inf...

Countries:United States
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