NDAORALCAPSULEPriority Review
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ESBRIET (pirfenidone) by Enterprise Therapeutics is established. First approved in 2014.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ESBRIET (pirfenidone) is an oral small-molecule antifibrotic agent approved in 2014 for idiopathic pulmonary fibrosis (IPF). It reduces lung fibrosis progression by inhibiting TGF-β and other pro-fibrotic pathways through an established mechanism of action. The drug is administered as oral capsules and represents a foundational therapy in IPF management.
Peak7.2 years to LOE
As a peak-stage product with 7+ years of patent protection, the brand team is likely optimizing market penetration and managing steady-state sales operations.
Mechanism of Action
established.
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
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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.