Recent Updates
Recently added Catalysts

lasofoxifene

Phase 3

Osteoporosis | Small molecule | Endocrine |Ligand Pharmaceuticals Incorporated|Last Updated: Aug 15, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment9,593
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00163137Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone LossPHASE3 COMPLETED 540 — — May 1, 2003Oct 1, 2005Aug 12, 201172 United States
NCT00141323Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)PHASE3 COMPLETED 8,556 — — Nov 1, 2001Dec 1, 2007Aug 15, 2011201 United States, Argentina +30
NCT00143273Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose EvaluationPHASE2 COMPLETED 497 — — Jun 1, 2004Mar 1, 2006Aug 10, 201117 Japan, South Korea +2
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Spine BMD after 2 years
2 years

Lumbar Spine Bome Mineral Density

New morphometric vertebral fractures
3 years
New cases of breast cancer
5 years
New non-vertebral fractures
5 years
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
12 months

Percent change from baseline in lumbar spine BMD at Month 12

Secondary Endpoints
Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
3 years
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
5 years
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Lasofoxifene 0.25 mgEXPERIMENTALlasofoxifene 0.25 mg/day
raloxifeneACTIVE_COMPARATORraloxifene 60 mg/day
PlaceboPLACEBO_COMPARATORPlacebo
lasofoxifene 0.5 mg/dayEXPERIMENTAL -
lasofoxifene 0.25 mg/dayEXPERIMENTAL -
Lasofoxifene Dose 1EXPERIMENTAL0.05 mg
Lasofoxifene Dose 2EXPERIMENTAL0.25 mg
Lasofoxifene Dose 3EXPERIMENTAL0.5 mg
Interventions
NameTypeDescription
lasofoxifeneDRUGlasofoxifene 0.25mg
raloxifeneDRUGraloxifene 60 mg/day
PlaceboDRUG0 mg/day
Unlock Study Design Details
Eligibility Criteria
Age Range48 Years — 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites72

Inclusion Criteria: * Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: * Presence of metabolic bone disease, fractures, blood clots, or recent cancer. * Any use of selective estrogen receptor ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaCosta RicaCroatiaDenmarkEgyptEstoniaFinlandFranceGermanyHong KongHungaryIndiaIrelandItalyJapanLithuaniaMexicoNorwayPolandRomaniaRussiaSouth AfricaSouth KoreaSpainSwedenTurkey (Türkiye)United KingdomTaiwan
Unlock Eligibility Criteria
Competitive Landscape -Osteoporosis 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Precision BioSciences, Inc.DTIL1NAUndisclosed
SI-BONE, Inc.SIBN1 — Undisclosed
Unlock Competitive Intelligence