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Current Issues in Esbriet® (Pirfenidone)

Current Issues in Esbriet® (Pirfenidone)

In October of 2014, the US Food and Drug Administration approved Esbriet® (pirfenidone) for treatment of IPF. A review on ScienceDirect® clarifies issues from clinical practice and clinical trials, offering suggestions for further research.  

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Created in 1974, Esbriet® (pirfenidone) is an oral drug that exhibits multiple effects including anti- fibrotic, anti-inflammatory and antioxidant. It is one of two drugs approved by the US Food and Drug Administration (FDA) for treatment of IPF, currently available in 38 foreign countries.


Masashi Bando, a Japanese-trained pulmonary specialist from Jichi Medical University, reviews use of pirfenidone in IPF research and treatment, identifying important issues.* He explains that it’s important to find a balance in clinical practice between the drug’s effectiveness and side effects, including gastrointestinal and sunlight sensitivity. Bando states that “taken together, management of ADRs [adverse drug reactions] to achieve the maximum benefits after long-term treatment with pirfenidone is an issue that needs to be resolved.”


Bando concludes that exploration is also needed in the following areas to solidify pirfenidone’s role in clinical practice and clinical trials:


·      Optimal time for commencement of treatment with pirfenidone

·      Optimal conditions for treatment with pirfenidone

·      Duration of treatment with pirfenidone

·      How to choose between administration of pirfenidone and OFEV® (nintedanib), the latter being the second FDA-approved drug for IPF treatment

·      Efficacy and safety of combination therapy with N-acetylcysteine (NAC)

·      New clinical uses of pirfenidone:

  Preventing acute exacerbations of IPF (IPF-AE)

  Preventing IPF-AE in the perioperative period

  Postoperative treatment in IPF cases with lung cancer


The full journal article may be found at:


*Bando, M. (2016, September). Pirfenidone: Clinical trials and clinical practice in patients with idiopathic pulmonary fibrosis. Respiratory Investigation, 54(5), 298-304.


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