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RKI983

Phase 1

Glaucoma | Small molecule | Cardiovascular |Novartis AG|Last Updated: Dec 28, 2007

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 Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00515424Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular HypertensionPHASE1 COMPLETED 90Jul 1, 2007 -Dec 28, 20075 United States
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Study Endpoints
Primary Endpoints
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
Secondary Endpoints
Change in ocular hypertension from Baseline to Day 7.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
RKI983DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension * Females must be post-menopausal or surgically sterile Exclusion Criteria: * Other types of glaucoma * Eye pressure lowering surgeries * A history of or current eye conditions or m...

Countries:United States
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