Drugs / Ruboxistaurin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Arxxant | diabetic retinopathy | — | “Lilly submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for review of ruboxistaurin mesylate” lilly.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00552227 | Sep 2002 → Jul 2005 | type 2 diabetes mellitus | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02769611 | Jun 2017 → Jan 2022 | heart failure | University of Tennessee | Withdrawn | No outcome recorded Stop: Business |
| Phase 23 trials | ||||||
| Phase 2 | NCT00190970 | Oct 2004 → Nov 2005 | diabetic polyneuropathy | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00482976 | Dec 2003 → Mar 2005 | type 2 diabetes mellitus | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00044148 | Jul 2002 → Apr 2004 | diabetic kidney disease | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00297401 | Mar 2006 → Nov 2007 | type 1 diabetes mellitus | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00266695 | Jan 2006 → Aug 2008 | diabetic retinopathy | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00133952 | Aug 2005 → Jul 2011 | diabetic macular edema | Chromaderm, Inc. | Completed | Missed primary |
| Phase 3 | NCT00090519 | Feb 2004 → Apr 2010 | diabetic retinopathy | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00044421 | Jul 2002 → Oct 2006 | diabetes mellitus, diabetic neuropathy | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00044395 | Jul 2002 → Oct 2005 | diabetic neuropathy, type 1 diabetes mellitus, type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00044408 | Jul 2002 → Oct 2005 | diabetic neuropathy, type 1 diabetes mellitus, type 2 diabetes mellitus | Chromaderm, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00604383 | Mar 2001 → Jun 2005 | diabetic retinopathy | Chromaderm, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT00761852 Comparator | May 1999 → Oct 2007 | type 1 diabetes mellitus, type 2 diabetes mellitus | Brigham and Women's Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2006-11-13 | Eli Lilly and Company | Results Ruboxistaurin Reduced Vision Loss in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy in a New Study lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced results from a three-year phase 3 clinical trial in which ruboxistaurin mesylate (proposed brand name Arxxant(TM), pronounced ark-ZONT) reduced the risk of sustained moderate vision loss by 40 percent when compared to placebo in patients with moderate to severe non-proliferative diabetic retinopathy (DR). |
| 2006-09-29 | Eli Lilly and Company | Regulatory Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy lilly.com ↗
The FDA said it wants additional efficacy data before it will consider approving the molecule for the treatment of moderate to severe nonproliferative diabetic retinopathy. |
| 2006-08-18 | Eli Lilly and Company | Regulatory Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant(TM) (ruboxistaurin mesylate) lilly.com ↗
In its letter, the FDA has requested submission of additional data to support the clinical evidence presented by Lilly in its new drug application (NDA). |
| 2006-06-11 | Eli Lilly and Company | Results Investigational Treatment Ruboxistaurin Demonstrated Promise in Reducing the Occurrence of Vision Loss Caused by Diabetic Retinopathy lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced encouraging results from an analysis of pooled data from two, three-year phase 3 trials that showed ruboxistaurin mesylate reduced the risk of sustained moderate vision loss by 41 percent when compared to placebo in patients with moderate to severe, nonproliferative diabetic retinopathy (DR). |
| 2005-09-12 | Eli Lilly and Company | Results Pilot Study of Ruboxistaurin Showed Favorable Effects on Kidney Damage and Function in People with Type 2 Diabetes and Nephropathy lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced encouraging results from a one-year pilot study examining the effect of ruboxistaurin mesylate in persons with type 2 diabetes and kidney disease (also known as "diabetic nephropathy"). |
| 2005-08-02 | Eli Lilly and Company | Results Lilly Will Submit Ruboxistaurin Mesylate (Arxxant(TM)) to FDA for Treatment of Diabetic Retinopathy in 2005 lilly.com ↗
Eli Lilly and Company announced today that it has completed a Phase 3 clinical trial in which its investigational drug, ruboxistaurin mesylate (proposed brand name Arxxant(TM), pronounced ark-ZONT) reduced the occurrence of vision loss in patients with diabetic retinopathy (DR). |
| 2005-06-12 | Eli Lilly and Company | Results Pilot Study of Ruboxistaurin Showed Favorable Effects on Kidney Damage and Function in People with Type 2 Diabetes and Nephropathy lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced encouraging results from a one-year pilot study examining the effect of ruboxistaurin mesylate in persons with type 2 diabetes and kidney disease (also known as "diabetic nephropathy"). |
| 2004-10-26 | Eli Lilly and Company | Results Data Indicate That Lilly's Ruboxistaurin May Have A Potentially Beneficial Effect on Diabetes-Induced Eye Disease lilly.com ↗
Patients who received 32 mg per day of ruboxistaurin appeared to have better visual acuities (better vision) at equivalent levels of involvement of the center of the macula than placebo-treated patients (data from a trial with approximately 63 patients per treatment group). |
| 2004-09-06 | Eli Lilly and Company | Results Key Study Findings About Diabetic Eye Disease May Lead to Improved Screenings and Treatment for People with Diabetes lilly.com ↗
Visual impairment did not occur until the center of macula was involved. |
| 2004-09-06 | Eli Lilly and Company | Results Data Show Reduced Symptoms of Diabetic Peripheral Neuropathy for Patients Taking Lilly's Ruboxistaurin lilly.com ↗
Eli Lilly and Company announced encouraging results from analyses of prior study data this week for patients with diabetic peripheral neuropathy (DPN). |
| 2004-06-05 | Eli Lilly and Company | Results Key Study Findings About Diabetic Microvascular Complications May Lead to Improved Screenings and Treatment for People with Diabetes lilly.com ↗
Study findings showed significant correlation between the VDT and standardized neurological examination of lower limbs and composite scores of nerve function. |
All press releases naming this drug 11 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ruboxistaurin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00044395 ↗ |
| Known as | Arxxant | ChEMBL registry synonym — accepted as the source's own label CHEMBL91829 ↗ |
| Known as | LY333531 | “The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory...” NCT00190970 ↗ |
| Known as | RBX | “the orally administered PKC beta inhibitor ruboxistaurin (RBX)” PMID 18708615 ↗ Aug 2008 |
| Known as | Ruboxistaurin Mesylate | “We investigate the effects of the isoform-selective PKC-beta inhibitor ruboxistaurin mesylate on neurovascular function and other measures of DPN.” PMID 17392551 ↗ Apr 2007 |
| Known as | Ruboxistaurina | ChEMBL registry synonym — accepted as the source's own label CHEMBL91829 ↗ |
| Known as | Ruboxistaurine | ChEMBL registry synonym — accepted as the source's own label CHEMBL91829 ↗ |
| Action | Inhibit | “oral PKC β inhibitor ruboxistaurin” PMID 23404115 ↗ Mar 20131“Protein kinase C beta inhibitor” CHEMBL91829 ↗ |
| Modality | Small molecule | — CHEMBL91829 ↗ |
| Route | Oral | “Patients received oral placebo (N = 508 total from both studies) or RBX 32 mg/d (N = 520 total).” PMID 23404115 ↗ Mar 2013 |
| Target | PRKCB | “Protein kinase C beta inhibitor” CHEMBL91829 ↗ |