Pirfenidone: an anti-fibrotic therapy for progressive kidney disease

Expert Opin Investig Drugs. 2010 Feb;19(2):275-83. doi: 10.1517/13543780903501539.


Importance of the field: Many chronic diseases of various etiologies lead to fibrosis and organ dysfunction. Despite many advances in medicine in recent years, options to slow the progression of fibrotic diseases have remained limited. The recent availability of pirfenidone, an antifibrotic and anti-inflammatory investigational agent, thus offers a new hope for treating progressive fibrotic diseases.

Areas covered in this review: This review provides concise review of the available data regarding the mechanism and pharmacokinetics of pirfenidone and preclinical and clinical data regarding efficacy and safety in fibrotic diseases of the kidney. It also reviews results of clinical trials involving pirfenidone in other fibrotic diseases.

What the reader will gain: The review will provide in-depth review of pirfenidone with a renal focus.

Take home message: Because many of the available clinical trials have been small and/or uncontrolled, conclusive evidence regarding efficacy and safety of pirfenidone is lacking, particularly in patients with renal or hepatic dysfunction. Larger studies are needed to better understand long-term efficacy and safety of this medication in various patient populations.

Publication types

  • Research Support, N.I.H., Intramural
  • Review

MeSH terms

  • Animals
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacology
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Chronic Disease / drug therapy
  • Clinical Trials as Topic
  • Disease Models, Animal
  • Disease Progression
  • Drug Evaluation
  • Fibrosis / chemically induced
  • Fibrosis / drug therapy*
  • Humans
  • Kidney / pathology*
  • Kidney Diseases / drug therapy*
  • Pyridones / adverse effects
  • Pyridones / pharmacokinetics
  • Pyridones / pharmacology
  • Pyridones / therapeutic use*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Pyridones
  • pirfenidone