Recent Updates
Recently added Catalysts

Tibolone

Phase 3

Osteoporosis | Small molecule | Endocrine |Organon & Co.|Last Updated: Feb 3, 2022

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 Trials1
Total Enrollment4,534
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00519857Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)PHASE3 COMPLETED 4,534Jul 1, 2001Aug 1, 2006Feb 3, 2022 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral)
3 years
Secondary Endpoints
Bone mineral density of lumbar vertebrae (L1-L4) and left proximal femur for total hip density measured by means of dual-energy X-ray absorptiometry (DXA).
3 years
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORTibolone
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
TiboloneDRUG1.25 mg p.o, once daily for 3 years
PlaceboDRUGTablet p.o, once daily for 3 years
Unlock Study Design Details
Eligibility Criteria
Age Range60 Years — 85 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Voluntary written informed consent, and who were willing and able to make reasonable efforts to observe all clinical trial requirements were to be enrolled * Subjects were to be postmenopausal (naturally or surgically) women, from 60 to 85 years of age (inclusive) at entry * S...

Unlock Eligibility Criteria
Competitive Landscape -Osteoporosis 8 trials