NDAORALTABLET
Approved
Jan 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
ESBRIET (pirfenidone) by Enterprise Therapeutics is established. Approved for idiopathic pulmonary fibrosis. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ESBRIET (pirfenidone) is an oral pyridone indicated for idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by tissue scarring. The drug works through an established mechanism of action that reduces pulmonary fibrosis progression. Approved in January 2017, ESBRIET is positioned as a foundational therapy in IPF management and represents a key treatment option for patients with this rare, life-threatening condition.
$0.1BPart D
10.9 years to LOEMechanism of Action
established.
Pharmacologic Class:
Pyridone
Indications (1)
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 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
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Started Mar 2023
214 enrolled
Acute Lung InjuryPrevention
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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.