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Ruboxistaurin

Phase 3

Diabetic Neuropathies | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Nov 6, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Ruboxistaurin · 2 trials · 4 indications

Phase 3 2
NCT00044395Treatment for Symptomatic Peripheral Neuropathy in Patients With DiabetesDiabetic Neuropathies
COMPLETED200 Analytics
NCT00044421Treatment of Peripheral Neuropathy in Patients With DiabetesDiabetic Neuropathies
COMPLETED400 Analytics
PHASE3COMPLETED
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Diabetic NeuropathiesUnlock trial analytics
PHASE3COMPLETED
Treatment of Peripheral Neuropathy in Patients With Diabetes
Diabetic NeuropathiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in neuropathic symptoms
Reduction in the progression of DPN measured by composite score

Secondary Endpoints

Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change
Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Ruboxistaurin mesylateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Patients must have type I or type II Diabetes Mellitus. * Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 month...

Countries:United StatesAustraliaBelgiumDenmarkEstoniaGermanyHungaryIsraelSpainCanadaCroatiaFinlandIndiaLithuaniaNetherlandsUnited Kingdom
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Frequently asked questions about Ruboxistaurin

What is Ruboxistaurin used for?

Ruboxistaurin is an investigational small molecule being studied for the treatment of diabetic neuropathies, specifically symptomatic peripheral neuropathy in patients with diabetes. It is being developed by Eli Lilly and Company and has completed Phase 3 clinical trials.

Who makes Ruboxistaurin?

Ruboxistaurin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug is an investigational small molecule intended for the treatment of diabetic neuropathies.

What phase is Ruboxistaurin in?

Ruboxistaurin is in Phase 3 clinical development. Two Phase 3 trials have been completed, each evaluating the drug for the treatment of peripheral neuropathy in patients with diabetes. The drug remains investigational and is not yet approved.

What clinical trials is Ruboxistaurin in?

Ruboxistaurin has been studied in two completed Phase 3 trials. NCT00044395 enrolled 200 participants with diabetic neuropathies, and NCT00044421 enrolled 400 participants with diabetic neuropathies. Both trials were randomized, double-blind, and uncontrolled, with a combined enrollment of 600 participants.

Is Ruboxistaurin the same as any other drug?

Ruboxistaurin is not known by any alternative names. It is a distinct investigational small molecule developed by Eli Lilly and Company for the treatment of diabetic neuropathies. No other names for this drug have been reported.