Skip to Content

Arxxant Approval Status

  • FDA approved: No
  • Brand name: Arxxant
  • Generic name: ruboxistaurin mesylate
  • Company: Eli Lilly and Company
  • Treatment for: Diabetic Retinopathy

Arxxant (ruboxistaurin mesylate) is an investigational specific protein kinase C beta (PKC beta) inhibitor for the treatment of diabetic retinopathy.

In August 2006, Lilly announced the receipt of an Approvable Letter from the from the U.S. Food and Drug Administration (FDA), advising the company that it will require efficacy data from an additional Phase 3 study before it will consider approving the molecule.

Development Status and FDA Approval Process for Arxxant

Sep 29, 2006Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
Aug 18, 2006Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant
Aug  2, 2005Lilly Will Submit Arxxant to FDA in 2005

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.