NDAORALTABLET
Approved
Jan 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ESBRIET (pirfenidone) by Enterprise Therapeutics is established. First approved in 2017.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ESBRIET (pirfenidone) is an oral pyridone small molecule approved in 2017 for idiopathic pulmonary fibrosis (IPF), a rare, progressive lung disease with limited treatment options. It works through established anti-fibrotic and anti-inflammatory mechanisms to slow disease progression. The drug is taken as tablets and represents a standard-of-care option in IPF management.
$0.093BPart D
Peak10.8 years to LOEProduct is at peak commercial maturity with ~9,200 annual claims; expect stable team size and focus on market maintenance and patient adherence programs.
Mechanism of Action
established.
Pharmacologic Class:
Pyridone
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
Started Mar 2026
20 enrolled
Idiopathic Pulmonary Fibrosis
A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer
Started Dec 2025
48 enrolled
Colorectal Cancer (CRC)
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
Started Jun 2025
132 enrolled
Healthy Participants
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Started Jul 2024
25 enrolled
To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal CarcinomaTo Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal CancerCombination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
Started Nov 2023
14 enrolled
Healthy
Worked on ESBRIET at Enterprise Therapeutics? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.