Recent Updates
Recently added Catalysts

RKI983A

Phase 1

Glaucoma | Small molecule | Cardiovascular |Novartis AG|Last Updated: Dec 19, 2020

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment276
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00846989Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular HypertensionPHASE1 COMPLETED 276Jan 1, 2009Apr 1, 2009Dec 19, 202029 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Mean reduction of the daily average intraocular pressure (IOP) .
from Baseline to Day 29
Secondary Endpoints
Mean IOP reduction at each assessment time-point
from Baseline to Day 8, 15, 22 and 29
Mean reduction of the daily average IOP
from Baseline to Days 8, 15 and 22
Frequency of adverse events
4 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RKI983ADRUGRKI983 0.05 % twice daily
LatanoprostDRUGLatanoprost 0.005 % once a day
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception * Clinical diagnosis of POAG or OH * For study eyes not previously treated with anti-glaucoma medications * IOP must be ≥ 22 mm Hg at least at tw...

Countries:United States
Unlock Eligibility Criteria