TheraRadar
Data updated: May 26, 2026

ESBRIET (pirfenidone)

Trial Activity: Stable 11 active trials
Respiratory Approved 2014-10-15

Esbriet is a pyridone medication used for patients living with idiopathic pulmonary fibrosis (IPF). This drug helps patients with this specific type of lung scarring. It treats the condition even though the exact biological pathway remains a subject of study.

Source: FDA Label • LEGACY PHARMA • Pyridone
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ESBRIET Works

As a pyridone, the specific way this medication works by interacting with the body has not been established. There is currently no confirmed biological target or specific mechanism that explains how it produces its therapeutic effect.

Source: FDA Label

Development Insights

Hoffmann-La Roche conducting 8 trials (18%)
39 indications explored (Broad Platform)
→ idiopathic pulmonary fibrosis (18 trials)
→ healthy (2 trials)
→ idiopathic pulmonary fibrosis (ipf) (2 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
11
Years on Market

Details

Status
Prescription
First Approved
2014-10-15
Patent Cliff
2037
Revenue
$134M (Q4-2022)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

LEGACY PHARMA
Active Ingredient: PIRFENIDONE

ESBRIET Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2014 to 2023
Feb 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label

What ESBRIET Treats

1 indications

ESBRIET is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Idiopathic Pulmonary Fibrosis
Source: FDA Label

ESBRIET Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

JASCAYD
Boehringer Ingelheim
2025 2 indic.
OFEV
Boehringer Ingelheim
2014 3 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ESBRIET

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

JASCAYD
NERANDOMILAST
1 shared
Boehringer Ingelheim
Shared indications:
Idiopathic Pulmonary Fibrosis
OFEV
NINTEDANIB ESYLATE
1 shared
Boehringer Ingelheim
Shared indications:
Idiopathic Pulmonary Fibrosis
YUTREPIA
TREPROSTINIL SODIUM
1 shared
LIQUIDIA TECH
Shared indications:
Idiopathic Pulmonary Fibrosis
📋

Clinical Trial Registry

45 trials
Trial Sponsor ID Phase Status Title
NCT05075161 PIONEER PIONEER 2020-005306-25 Ph 3 recruiting Pirfenidone to Prevent Fibrosis in Ards.
NCT03109288 170083 17-I-0083 Ph 1, Ph 2 recruiting Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
NCT06241560 1305-0035 Ph 2 recruiting A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
NCT05060822 HEC585-P-03 Ph 2 active not recruiting Phase ll Study of HEC585 in Patients With IPF
NCT07082842 HEC585-IPF-301 Ph 3 recruiting Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
NCT06928272 LC-Revitalize Ph 3 recruiting Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study
NCT07454291 ENV-IPF-104 Ph 1 recruiting A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
NCT03177291 MCC-19082 Ph 1 completed Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
NCT06070610 results posted 1305-0034 2023-505522-34-00, U1111-1292-0376 Ph 1 completed A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
NCT03385668 PIRFENIVAS P161001J 2017-002782-22 Ph 2 completed Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies
NCT05321420 ELEVATE LYT-100-2022-204 Ph 2 active not recruiting LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT06253117 PirfenidoneRAP IRB-300012263 HT9425-23-1-0900 Ph 2 recruiting Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
NCT07015398 NAL00-105 Ph 1 completed A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
NCT03902509 RP-F647-201901 Ph 2 completed A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
NCT06224790 PenDaNt 483/RC/KEMU/2022 Ph 4 completed Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy
NCT04971746 GLPG4716-CL-101 2021-001718-12 Ph 1 completed Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects
NCT04461587 ML42227 Ph 2 completed Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
NCT06484153 union-P Ph 1, Ph 2 not yet recruiting Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
NCT04099407 PROMETEO PROMETEO Study Ph 2 completed Pirfenidone and Advanced Liver Fibrosis.
NCT03359863 PIRCLAD results posted 16-20710 Ph 2 completed Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
NCT02689778 1497 Ph 3 completed Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
NCT02958917 results posted HS-3034 Ph 2 terminated Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
NCT02808871 results posted 2017p000062 Ph 2 completed Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
NCT05383131 HEC585-P-04 / CRC-C2032 Ph 1 completed To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
NCT04888715 DW_DWN12088103 Ph 1 completed To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers
NCT03099187 results posted MA39189 2016-002744-17 Ph 2 completed A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
NCT03208933 results posted ML39355 Ph 3 completed Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
NCT02951429 results posted MA29957 2015-005131-40 Ph 2 completed Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
NCT02932566 PIROUETTE 2016CD004 Ph 2 completed The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
NCT03981094 IM027-041 Ph 1 completed A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
NCT02262299 EPOS RH-HJE-2014-09 Ph 2, Ph 3 completed European Trial of Pirfenidone in BOS, A European Multi-center Study
NCT02606877 results posted 1199.229 2015-000732-15 Ph 4 completed A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination
NCT01872689 results posted GB28547 2013-001163-24 Ph 2 completed A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT02598193 results posted MA29895 2015-003280-11 Ph 4 completed Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT02579603 results posted 1199.222 2015-000640-42 Ph 4 completed Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
NCT02648048 ISLAND2 GB29764 2015-003481-81 Ph 1 completed A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
NCT01366209 ASCEND results posted PIPF-016 Ph 3 completed Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT00662038 PIPF-012 results posted PIPF-012 GA29960 Ph 3 completed Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT02525484 GP29830 Ph 1 completed A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
NCT01933334 LOTUSS results posted PSSc-001 Ph 2 completed Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
NCT02707640 results posted WA29976 2012-000564-14 Ph 2 completed A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT02222376 PirDFI DIA-1031-13/14-1 Ph 3 completed Effect of Topic Pirfenidone in Diabetic Ulcers
NCT02408744 Pirfenidona 001 Ph 1, Ph 2 completed Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
NCT02136992 IPF SPH01312 Ph 2 completed Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
NCT07588646 HEC585-P-04/CRC-C2032 Ph 1 completed Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ESBRIET FDA Label Details

Indications & Usage

FDA Label (PDF)

ESBRIET is indicated for the treatment of Idiopathic Pulmonary Fibrosis.

View full patent landscape →
20 OB patents · 8 families · 369 international docs across 47 countries

ESBRIET Patents & Exclusivity

Latest Patent: Mar 2037

Patents (20 active)

US10188637 Expires Mar 28, 2037
US8778947 Expires Aug 30, 2033
US7910610 Expires Jan 8, 2030
US8084475 Expires Jan 8, 2030
US8318780 Expires Jan 8, 2030
US8754109 Expires Jan 8, 2030
US7816383 Expires Jan 8, 2030
US8648098 Expires Jan 8, 2030
US8013002 Expires Jan 8, 2030
US7635707 Expires Apr 22, 2029
US8609701 Expires Apr 22, 2029
US8592462 Expires Apr 22, 2029
US7566729 Expires Apr 22, 2029
US8383150 Expires May 10, 2028
US8420674 Expires Dec 18, 2027
US7767700 Expires Dec 18, 2027
US7696236 Expires Dec 18, 2027
US7988994 Expires Sep 22, 2026
US7767225 Expires Sep 22, 2026
US8753679 Expires Sep 22, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for ESBRIET

Revenue Insights

  • • Q4-2022: $134M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2037
  • • 406 active patents

Trial Analysis

  • • 45 total trials
  • • Stage: Stable

Competitive Landscape

  • • 3 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208780 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment