Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats idiopathic pulmonary fibrosis (IPF). Sold as Esbriet. Every FDA application for this active ingredient: 2 branded and 24 generic.
As of Nov 14, 2026, FDA lists 26 applications for Pirfenidone (sold as Esbriet), first approved Oct 15, 2014, with 0 new uses approved and 0 published complete response letters.
First approved: Oct 15, 2014
Applications: 26
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $182M
First approved in the EU: Feb 28, 2011
First approved in Japan: Oct 16, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 72 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Pirespa, new ingredientA drug containing a new active ingredient indicated for the treatment of idiopathic pulmonary fibrosis. · Shionogi & Co., Ltd. · Oct 16, 2008 · Review report
Clinical Trials
34 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Accord Hlthcare
Sandoz
Alembic
Apotex
Aurobindo Pharma