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Betaxolol

Phase 1

Development of Side Effects From Betaxolol | Small molecule | Other |Smith & Nephew SNATS, Inc.|Last Updated: Jan 3, 2013

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01660620Topical Betaxolol for the Prevention of Retinopathy of PrematurityPHASE1 COMPLETED 23Apr 1, 2011Nov 1, 2011Jan 3, 2013 -
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Study Endpoints
Primary Endpoints
development of apnea and or bradycardia
3 weeks

babies were monitored and HR/RR monitored and recorded by masked observers, periodically

Secondary Endpoints
development of ROP requiring treatment
7 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
betaxololEXPERIMENTALbetaxolol 0.25% 2 per day for 3 weeks
placeboPLACEBO_COMPARATORmasked labeling also 2 per day administration
Interventions
NameTypeDescription
BetaxololDRUG -
topical betaxololDRUGgiven topically
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Eligibility Criteria
Age Range32 Weeks — 32 Weeks
SexALL
Healthy VolunteersNo

Inclusion Criteria: * \<1251 grms birth weight Exclusion Criteria: * ocular defect

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