EsbrietEsbriet, also known by the generic name of pirfenidone, is an anti-fibrotic drug that is available commercially in the U.S., the United Kingdom, and Asia. It is used to treat mild to moderate cases of idiopathic pulmonary fibrosis (IPF).

History of Esbriet

Esbriet is one of two landmark IPF therapies approved by the U.S. Food and Drug Administration (FDA) in 2014, along with Ofev (nintedanib). Japan was the first country to approve its commercial use in 2008, followed by India in 2010, Europe in 2011, and China in 2013. Because IPF is considered a rare condition, the drug was granted orphan drug status in 2004.

How Esbriet works

The word “idiopathic” means the cause of IPF remains a mystery. Regardless of the causes, there is an aggregation of scar tissue in the lungs likely due to a range of inflammatory reactions in response to primary infections or excess secretion of collagen by fibroblasts and cells. The decrease in oxygen diffusion capacity causes stiffness in the lungs, which can cause discomfort.

Esbriet is an anti-inflammatory and anti-fibrotic drug that reduces inflammation and fibrosis simultaneously. The main mode of action lies in reducing fibroblast secretion and inhibiting TGF-β (which is responsible for excess collagen production), and reducing the secretion of inflammatory mediators like TNF-α and IL-1β. Both pre-clinical and human studies have shown the effectiveness and safety of the drug in terms of tolerance and side effects.

A considerable improvement in the levels of forced expiratory volume (FEV), normalized secretion of pro-inflammatory cytokines, and reduction in the fibrotic lung tissues were some of the highlights of several clinical trials undertaken on a dose-dependent basis. Researchers observed that progression-free survival (a measure of the treatment potential of the drug on the disease) was also increased significantly in these trials.

Other facts about Esbriet

Esbriet is administered orally and is recommended to be taken after food (usually three times daily) to reduce nausea and dizziness in patients. It is mostly metabolized in the liver and excreted in the urine within 24 hours. Mild side effects include nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, indigestion, dizziness, vomiting, decreased or loss of appetite, gastro-esophageal reflux disease (GERD), sinusitis, insomnia, weight loss, and arthralgia.

Post-marketing experience reactions are voluntarily reported from a population of uncertain size, making it difficult to establish a relationship with drug exposure. Many of the adverse reactions reported during post-approval of Esbriet in Japan are consistent with clinical trials and include abdominal discomfort, constipation, diarrhea, gastric disorders, increased blood liver markers, decreased appetite and distortion of the sense of taste, dizziness, somnolence, photosensitivity reaction, itching, and rash. 

Patients with severe liver problems, end-stage kidney disease, those who require dialysis, or who are taking fluvoxamine (a medication used to treat depression and obsessive compulsive disorder) are not advised to take Esbriet. Pregnant women need to consult with their doctors before taking the drug.

Note: Pulmonary Fibrosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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  1. David Maddox says:

    Has anyone taken an ARB along with Esbriet? A recent study in entitled Chronic Activation of the Renin-Angiotensin System Induces Lung Fibrosis indicates that the renin-angiotensin system may be involved in IPF and that inhibition with compounds like Aliskiren to block renin or an angiotensin II receptor antagonist (ARB) might slow the development of IPF, possibly by acting to prevent increases in transforming growth factor-beta much like Espriet. I have developed IPF and will be starting Esbriet very soon and would like to know if it would be safe to combine it with an ARB. The two together might be particularly powerful. Of interest to me is that in my studies of the development of kidney disease in a rat model of obesity one of the early events is an increase in TGF-beta leading to glomerular sclerosis, interstitial fibrosis, and collagen deposition. In other models of kidney disease such as diabetes-induced renal failure angiotensin converting enzyme inhibitors or ARBs can prevent kidney failure. This close link between IPF and kidney disease is of even greater interest to me now that I have IPF. Thank you for your response.

    • Murat Civan says:

      ACE inhibitor is a better choice to prevent progression of fibrosis as bradykinin is the key agent for this action and it accumulates in tissues better with ACE inhibitors(if cough is not prominent). Another important issue is omega-3 fish oil which has some favorable antiinflammatory and wound healing effects as some recent studies suggests that IPF is rather a repair problem. Also some animal studies showed that fibrosis created artificially with bleomycin progresses less in groups taking flaxseed oil which is suggested to improve genetic coded protein products of lung cells. If you are taking medications for hypertension in particular, they should be selected from those of lowering pulmonary vascular tension (i.e. calcium channel blockers or nebivolol-if b-blockers indicated),inhaled n-acetyl cystein and anti gastroesophagial reflux medications are other agents having potential to slow down fibrosis.

  2. As anti-fibrotic drug pirfenidone may slow the IPF progression and although pirfenidone can slow the decline of FVC( the mean lung function indicator in IPF patients).Another treatment superiority of this drug consist of reducing mortality inpatients with IPF who received pirfenidone.

  3. Antoinette M Chatagnier says:

    I am so frustrated I have been to pulmonary specialist since 2010 and everyone has just been so vague and so helpless on my disease. the last one is sending me for a transplant and I am about to get on the list but so frustrated I was never offered any medication at this point.. it is getting worse this year but I would have been a great candidate previously… this is horrible

    • Murat Civan says:

      Pirfenidone got approval in 2014 from FDA and its mortality effect is not clearly declared except slowing FVC decline. Transplatation is the only treatment to improve respiratory functions. In theoretical and laboratory basis actually an important agent (miRNA) was found to reverse fibrosis and miraculous results were reported from the mice experiments however phase 2 trials were stopped due to serious anaphylactic reactions in human subjects. My mother has IPF and i give all potentially beneficial agents including pirfenidone as she is 71 years old and survival after transplantation is simply short at that age

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