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rhPTH

Phase 1

Osteoporosis | Small molecule | Endocrine |GSK plc|Last Updated: Oct 19, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00532077A Study to Evaluate the Effects of SB-751689 or rhPTH(1-34) on Excretion of Calcium and Phosphate in WomenPHASE1 COMPLETED 40Aug 1, 2007Jan 1, 2008Oct 19, 20105 United States
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Study Endpoints
Primary Endpoints
renal fractional clearance of calcium and phosphate
over 1 month
Secondary Endpoints
renal fraction clearance of electrolytes, cAMP, safety measures, and serum biomarkers
over 1 month
urinary excretion of sodium, magnesium, potassium, bicarbonate, and chloride
Albumin-adjusted serum calcium levels
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
rhPTH(1-34)DRUG -
SB-751689 100 mgDRUG -
SB-751689 400 mgDRUG -
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Eligibility Criteria
Age Range40 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Healthy postmenopausal women 40 to 65 years of age, inclusive, meeting at least one of the following: Postmenopausal defined by the STRAW criteria of 12 months of spontaneous amenorrhea with serum FSH levels = 40 mIU/mL; History of bilateral oophorectomy (with or without hyste...

Countries:United States
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Competitive Landscape -Osteoporosis 8 trials