Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ruboxistaurin mesylate
Ruboxistaurin · 2 trials · 4 indications
| Name | Type | Description |
|---|---|---|
| Ruboxistaurin mesylate | DRUG | - |
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...
Ruboxistaurin is an investigational small molecule being studied for the treatment of diabetic neuropathies, including peripheral neuropathy in patients with diabetes. It has been evaluated in Phase 3 clinical trials in adults with diabetes mellitus. It is not described as an approved therapy.
Ruboxistaurin targets PRKCB, also known as protein kinase C beta. It acts as an inhibitor of this target. Inhibiting PRKCB is the mechanism under investigation for its effects in diabetic neuropathies, a neurology indication.
Ruboxistaurin is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly sponsored the Phase 3 clinical trials of the drug in diabetic neuropathies.
Ruboxistaurin is in Phase 3 development. It is an investigational drug and is not described as FDA approved. Two Phase 3 trials have been completed, and no trials are currently active.
Ruboxistaurin has been studied in two completed Phase 3 trials: NCT00044421, titled Treatment of Peripheral Neuropathy in Patients With Diabetes, which enrolled 400 patients, and NCT00044395, titled Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes, which enrolled 200 patients. Both were randomized and double blind.
Yes. Ruboxistaurin mesylate is an alternative name for Ruboxistaurin, the small molecule PRKCB inhibitor developed by Eli Lilly and Company for diabetic neuropathies. Both names refer to the same investigational drug.