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AAE581

Phase 2

Osteoporosis | Small molecule | Endocrine |Novartis AG|Last Updated: May 8, 2012

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment836
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00170911Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.PHASE2 COMPLETED 160Mar 1, 2005 -Nov 2, 2011 -
NCT00100607Safety and Efficacy of AAE581 in Postmenopausal Women With OsteoporosisPHASE2 COMPLETED 676Feb 1, 2004Sep 1, 2005May 8, 2012 -
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Study Endpoints
Primary Endpoints
Change of lumbar spine(L1-L4)BMD at 12 months
Safety of 12 month treatment
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses
Secondary Endpoints
Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months
Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months
Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AAE581DRUG -
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Eligibility Criteria
Age Range50 Years — 75 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Low spine Bone Mineral Density * 0 to 1 prevalent fracture in non lumber spine Exclusion Criteria: * History or presence of any bone disease other than osteopenia /osteoporosis * Previous treatment with other anti-osteoporosis agent(Wash out required) * Evidence of vitamin D...

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Competitive Landscape -Osteoporosis 8 trials