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RKI983A

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment276

FDA Designations

No designations recorded

Clinical trial landscape

RKI983A · 1 trial · 2 indications

Phase 1 1
NCT00846989Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular HypertensionGlaucoma
COMPLETED276 Analytics
PHASE1COMPLETED
Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
GlaucomaUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about RKI983A

What is RKI983 used for?

RKI983 is an investigational small molecule being developed for the treatment of glaucoma and ocular hypertension. It is intended for use in patients with primary open-angle glaucoma (POAG) or ocular hypertension, and is administered as an eye drop.

Who makes RKI983?

RKI983 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development.

What phase is RKI983 in?

RKI983 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it is not yet approved by the FDA. The drug remains investigational and is still in the early stages of clinical testing.

What clinical trials is RKI983 in?

RKI983 has one completed clinical trial, NCT00846989, which evaluated the efficacy, tolerability, and safety of RKI983 at 0.05% and 0.10% concentrations compared to Xalatan in patients with POAG or ocular hypertension. The trial enrolled 276 participants in the United States.

Is RKI983 the same as Xalatan?

No, RKI983 is not the same as Xalatan. In the clinical trial NCT00846989, RKI983 was compared against Xalatan as an active control. Xalatan is a prostaglandin analog used to lower intraocular pressure, while RKI983 is a separate investigational compound.