Ruboxistaurin Explained

Ruboxistaurin (proposed brand name Arxxant) is an investigational drug for diabetic retinopathy being investigated by Eli Lilly and Company. It is a member of the bisindolylmaleimide family.

In February 2006, Lilly submitted a New Drug Application for ruboxistaurin, and on August 18, 2006, Lilly received an approvable letter from the US FDA for ruboxistaurin,[1] with a request for an additional clinical trial, which would take 5 years to complete.[2] Lilly has not made any further request for approval and ruboxistaurin is not approved by the FDA for any medical use.[3]

Mechanism of action

Ruboxistaurin is an inhibitor of protein kinase C-beta.[4]

External links

Notes and References

  1. Web site: Drugs.com, Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant . 2008-02-15 .
  2. Web site: Drugs.com, Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy . 2008-02-15 .
  3. Web site: Arxxant Approval Status . .
  4. Clarke M, Dodson PM . PKC inhibition and diabetic microvascular complications . Best Pract Res Clin Endocrinol Metab . 21 . 4 . 573–86 . December 2007 . 18054736 . 10.1016/j.beem.2007.09.007.