Esbriet

(Pirfenidone)

ApprovedSmall molecule

Pirfenidone is used to treat a serious lung disease called idiopathic pulmonary fibrosis (IPF), which causes scarring of the lungs and makes it harder to breathe. It works by slowing down the progression of this disease.[2] Esbriet is currently approved and in use across 52 indications[4].[1]

Esbriet is one of 1108 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

Indications

112

Total Trials

Active Trials

1,107

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute PancreatitisActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Colorectal CarcinomaActive, not recruiting

AsbestosisActive, not recruiting

Bronchiolitis ObliteransApproved

Myocardial FibrosisApproved

NeurofibromatosisActive, not recruiting

Wound HealingActive, not recruiting

Uterine LeiomyomaActive, not recruiting

Lung CancerApproved

Acute PancreatitisPhase 2

Active, not recruiting

Cardiovascular DiseasePreclinical

Active, not recruiting

Colorectal CarcinomaPhase 1/Phase 2

Active, not recruiting

AsbestosisPreclinical

Active, not recruiting

Bronchiolitis ObliteransApproved

Approved

Myocardial FibrosisApproved

Approved

NeurofibromatosisPhase 2

Active, not recruiting

Wound HealingPhase 2

Active, not recruiting

Uterine LeiomyomaPhase 2

Active, not recruiting

Lung CancerApproved

Approved

Showing 10 of 51 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Esbriet

LLegacy Health System

Approved

3 2

Aimovig

Amgen

Preclinical

1 3

Calciferol

Alnylam Pharmaceuticals

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 6

Tricor

JJagotec

Preclinical

1 7

Rayaldee

OOrganon and Co

Preclinical

1 8

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 9

Glucocorticoid

AbbVie

Preclinical

1 10

Nadroparin

GSK

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Idiopathic Pulmonary Fibrosis

NCT06241560

Phase 3Recruiting

Pneumoconiosis

NCT05288179

Q4 2026

Phase 1Not yet recruiting

Drug Interactions

NCT07454291

Phase 1/2Not yet recruiting

Colorectal Carcinoma

NCT06484153

Q1 2027

Phase 1/2Recruiting

Acute Pancreatitis

NCT05350371

Q4 2027

Phase 3Recruiting

Long COVID

NCT06928272

Clinical

Trials by Indication[1]

Idiopathic Pulmonary Fibrosis21 trials

Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 3·NCT01366209·555 enrolled

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 2·NCT01872689·505 enrolled

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT06241560·20 enrolled

Show 18 more trials

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 4·NCT02598193·89 enrolled

Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Completed·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT02136992·160 enrolled

Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).

Completed· Roche logo

Roche·Phase 3·NCT03208933·60 enrolled

Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03047031·21 enrolled

Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

Approved for marketing· Roche logo

Roche··NCT02141087

Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Completed· Roche logo

Roche·Phase 3·NCT00287729·344 enrolled

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

Completed· Roche logo

Roche·Phase 2·NCT02951429·177 enrolled

A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03958071·13,264 enrolled

Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)

Not yet recruiting·PPureTech·Phase 3·NCT07284602·1,100 enrolled

Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 3·NCT00662038·1,058 enrolled

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

Completed· Roche logo

Roche·Phase 1·NCT02648048·21 enrolled

A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche·Phase 2·NCT02707640·123 enrolled

Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Completed· Roche logo

Roche·Phase 3·NCT00287716·435 enrolled

Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

Completed· Roche logo

Roche·Phase 2·NCT00080223·83 enrolled

Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)

Unknown status·BBeijing Kawin Technology Share-Holding Co., Ltd.·Phase 2·NCT01504334·80 enrolled

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Active, not recruiting·PPureTech·Phase 2·NCT05321420·240 enrolled

Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

Completed· Roche logo

Roche··NCT02622477·12 enrolled

Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed· Roche logo

Roche··NCT02699879·1,009 enrolled

Fibrosis5 trials

Effect of Pirfenidone on TA Fibrosis

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT07325357·92 enrolled

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

Completed·NNational Cancer Institute (NCI)·N/A·NCT00020631

Pirfenidone to Prevent Fibrosis in Ards.

Recruiting·UUniversità Vita-Salute San Raffaele·Phase 3·NCT05075161·130 enrolled

Show 2 more trials

Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).

Unknown status·UUniversity of Guadalajara·Phase 2·NCT05542615·60 enrolled

Pirfenidone and Advanced Liver Fibrosis.

Completed·GGrupo Mexicano para el Estudios de las Enfermedades Hepaticas·Phase 2·NCT04099407·122 enrolled

Interstitial Lung Disease5 trials

A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease

Completed· Roche logo

Roche·Phase 2·NCT03099187·253 enrolled

Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Completed· Roche logo

Roche·Phase 2·NCT01933334·63 enrolled

Efficacy and Safety of Pirfenidone in Patient With Dermatomyositis Interstitial Lung Disease (Dm-ILD)

Unknown status·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT03857854·152 enrolled

Show 2 more trials

Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis

Unknown status·RRenJi Hospital·Phase 4·NCT02821689·57 enrolled

Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease

Unknown status·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT03856853·144 enrolled

Interaction4 trials

Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects

Completed·GGalapagos NV·Phase 1·NCT04971746·58 enrolled

A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants

Completed·TTrevi Therapeutics·Phase 1·NCT07015398·132 enrolled

Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers

Completed·BBlade Therapeutics·Phase 1·NCT04939467·86 enrolled

Show 1 more trial

A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03981094·22 enrolled

IPF4 trials

Phase ll Study of HEC585 in Patients With IPF

Unknown status· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 2·NCT05060822·270 enrolled

Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03242759·101 enrolled

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02579603·105 enrolled

Show 1 more trial

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

Not yet recruiting· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 3·NCT07082842·472 enrolled

53 more indications

Drug Interactions4 trials

To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT04888715·48 enrolled

To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

Completed· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1·NCT05383131·33 enrolled

Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects

Not yet recruiting· Guangdong Hengrui Pharmaceutical Co., Ltd logo

Guangdong Hengrui Pharmaceutical Co., Ltd·Phase 1·NCT07229716·20 enrolled

Show 1 more trial

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants

Not yet recruiting·EEndeavor Biomedicines, Inc.·Phase 1·NCT07454291·57 enrolled

COVID-193 trials

Treatment With Pirfenidone for COVID-19 Related Severe ARDS

Completed·SSoroka University Medical Center·N/A·NCT04653831·26 enrolled

Pirfenidone in Adult Hospitalized Patients With COVID-19

Completed·—·Phase 3·NCT05713292·168 enrolled

Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19

Completed·MMaterno-Perinatal Hospital of the State of Mexico·Phase 2/3·NCT06585319·36 enrolled

Chronic Kidney Disease3 trials

Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease

Completed·UUniversity of Guadalajara·Phase 1/2·NCT02408744·30 enrolled

Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease

Unknown status·VVeterans Medical Research Foundation·Phase 2·NCT04258397·200 enrolled

Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics

Unknown status·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT04126538·24 enrolled

Injury3 trials

Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors

Recruiting·UUnknown Sponsor·Phase 2·NCT05801133·41 enrolled

A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT03902509·126 enrolled

Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Unknown status·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 2·NCT02296281·48 enrolled

Fed3 trials

Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions

Completed·OOverseas Pharmaceuticals, Ltd.·Phase 1·NCT06589921·24 enrolled

Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions

Completed·OOverseas Pharmaceuticals, Ltd.·Phase 1·NCT06569381·18 enrolled

Comparative Pharmacokinetic(PK) Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions

Completed·OOverseas Pharmaceuticals, Ltd.·Phase 1·NCT06588517·12 enrolled

Hypersensitivity Pneumonitis3 trials

Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Completed·ZZagazig University·Phase 2·NCT04675619·40 enrolled

Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis

Terminated·EEvans Fernandez Perez·Phase 2·NCT02958917·40 enrolled

Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

Unknown status·GGrupo Medifarma, S. A. de C. V.·Phase 2/3·NCT02496182·60 enrolled

TED3 trials

A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02606877·37 enrolled

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06070610·14 enrolled

Safety of Nintedanib in Real World in China

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05676112

Pulmonary Fibrosis3 trials

Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03385668·7 enrolled

Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19

Unknown status·IInstitut d'Investigació Biomèdica de Bellvitge·Phase 2·NCT04607928·148 enrolled

Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis

Completed·PPulmonary Research of Abingdon, LLC·Phase 2·NCT04461587·50 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Pirfenidone in CTD-ILD

Unknown status·QQilu Hospital of Shandong University·Phase 4·NCT05505409·120 enrolled

Efficacy and Safety of Pirfenidone Treatment in HPS-ILD

Unknown status·JJesse Roman·Phase 2·NCT04193592·50 enrolled

Treatment2 trials

Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)

Terminated·UUniversity of Michigan·Phase 2·NCT03473340·24 enrolled

Real-life-persistence to Antifibrotic Treatments

Active, not recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT06485635·10,646 enrolled

Acute Pancreatitis2 trials

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Recruiting·UUniversity of Alabama at Birmingham·Phase 1/2·NCT05350371·60 enrolled

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.

Recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT06253117·60 enrolled

Heart Failure1 trial

The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Completed·MManchester University NHS Foundation Trust·Phase 2·NCT02932566·129 enrolled

Medication1 trial

Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05779007·2,778 enrolled

Adult1 trial

A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants

Completed· Roche logo

Roche·Phase 1·NCT02525484·44 enrolled

Systemic Sclerosis1 trial

Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

Unknown status·RRenJi Hospital·Phase 2/3·NCT03068234·72 enrolled

Long COVID1 trial

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Recruiting·—·Phase 3·NCT06928272·348 enrolled

Trial1 trial

European Trial of Pirfenidone in BOS, A European Multi-center Study

Completed·RRigshospitalet, Denmark·Phase 2/3·NCT02262299·90 enrolled

Neurofibromatosis1 trial

Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1

Completed·MMayo Clinic·Phase 2·NCT00754780·24 enrolled

Unknown status·CCentro Dermatológico Dr. Ladislao de la Pascua·Phase 3·NCT02823236·102 enrolled

Wound Healing1 trial

Pirfenidone and Its Role in Burn Wound Healing

Completed·UUniversidad Autonoma de Nuevo Leon·Phase 2·NCT03530150·8 enrolled

Cirrhosis1 trial

Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.

Completed·JJorge L Poo·Phase 2·NCT06267794·180 enrolled

Scleroderma1 trial

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Completed·MMichael Roth·Phase 2·NCT03221257·51 enrolled

Acute Kidney Injury1 trial

Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury

Unknown status·HHospital Civil de Guadalajara·Phase 4·NCT02530359·90 enrolled

BOS1 trial

The Safety and Tolerability of Pirfenidone for BOS After HCT

Completed·SStanford University·Phase 1·NCT03315741·30 enrolled

Silicosis1 trial

Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis

Unknown status·IInstituto de investigación e innovación biomédica de Cádiz·Phase 2·NCT05118256·18 enrolled

Pneumoconiosis1 trial

Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

Recruiting·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 3·NCT05288179·272 enrolled

Acute Myocardial Infarction1 trial

Pirfenidone Treat Myocardial Fibrosis After Acute Myocardial Infarction

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT05531955·100 enrolled

Oral Submucous Fibrosis1 trial

Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis

Completed·ZZiauddin University·Phase 1/2·NCT06871904·45 enrolled

Kidney Disease1 trial

Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes

Completed·—·Phase 1/2·NCT00063583·77 enrolled

CTD-ILD1 trial

Immunosuppressant Combined With Pirfenidone in CTD-ILD

Unknown status·QQilu Hospital of Shandong University·Phase 4·NCT04928586·200 enrolled

Diabetic Nephropathy1 trial

Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT02689778·62 enrolled

Cardiovascular Disease1 trial

Biomarkers in HF: Circulating Biomarkers of Fibrosis and Cardiovascular Disease

Completed·MManchester University NHS Foundation Trust··NCT05826821·107 enrolled

Focal Segmental Glomerulosclerosis1 trial

Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00001959·21 enrolled

Hypertrophic Cardiomyopathy1 trial

Pirfenidone to Treat Hypertrophic Cardiomyopathy

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00011076·50 enrolled

Corona Virus Infection1 trial

A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection

Unknown status·HHuilan Zhang·Phase 3·NCT04282902·294 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2·NCT06142318·66 enrolled

Sarcoidosis1 trial

Pirfenidone for Progressive Fibrotic Sarcoidosis

Unknown status·UUniversity of Cincinnati·Phase 4·NCT03260556·60 enrolled

Hermansky-Pudlak syndrome1 trial

Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome

Completed·—·Phase 2·NCT00001596·35 enrolled

Asbestosis1 trial

Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Unknown status·—·N/A·NCT05133453·40 enrolled

Plexiform Neurofibroma1 trial

Pirfenidone in Children and Young Adults With Neurofibromatosis Type I and Progressive Plexiform Neurofibromas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00076102·36 enrolled

Drug1 trial

Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Completed·UUniversity of Guadalajara·Phase 2·NCT02161952·150 enrolled

Uterine leiomyoma1 trial

Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00332033·32 enrolled

Lung Disease1 trial

Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT04856111·48 enrolled

Allograft1 trial

Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction

Completed·UUniversity of California, San Francisco·Phase 2·NCT03359863·10 enrolled

ILD1 trial

Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)

Completed·—·Phase 2·NCT02808871·123 enrolled

Diabetic Neuropathy1 trial

Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

Completed·SSidrah Lodhi·Phase 4·NCT06224790·60 enrolled

Chemotherapy1 trial

Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03177291·48 enrolled

Quality of Life1 trial

Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

Completed· Roche logo

Roche··NCT03115619·102 enrolled

Neurofibromatosis Type 11 trial

Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00053937

Multiple Sclerosis1 trial

Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT03109288·250 enrolled

Unspecified1 trial

PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

Completed·PPureTech·Phase 1·NCT07456800·116 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 15, 2014

ESBRIET

NDA NDA022535

Jan 11, 2017

ESBRIET

NDA NDA208780

Sources

References

[1]
ClinicalTrials.gov — 112 trial records for Pirfenidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Esbriet drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pirfenidone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pirfenidone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208780). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Esbriet. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Legacy Health System company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: LLegacy Health System

Patent Landscape[6]

Patent Cliff

Sep 22, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7988994Sep 22, 2026

8753679Sep 22, 2026

7767225Sep 22, 2026

8420674Dec 18, 2027

7767700Dec 18, 2027

15 more patents

7696236Dec 18, 2027

8383150May 10, 2028

7635707Apr 22, 2029

8592462Apr 22, 2029

7566729Apr 22, 2029

8609701Apr 22, 2029

7910610Jan 8, 2030

8084475Jan 8, 2030

8318780Jan 8, 2030

8754109Jan 8, 2030

8013002Jan 8, 2030

7816383Jan 8, 2030

8648098Jan 8, 2030

8778947Aug 30, 2033

10188637Mar 28, 2037

Esbriet

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

Idiopathic Pulmonary Fibrosis21 trials

Fibrosis5 trials

Interstitial Lung Disease5 trials

Interaction4 trials

IPF4 trials

Drug Interactions4 trials

COVID-193 trials

Chronic Kidney Disease3 trials

Injury3 trials

Fed3 trials

Hypersensitivity Pneumonitis3 trials

TED3 trials

Pulmonary Fibrosis3 trials

Efficacy and Safety2 trials

Treatment2 trials

Acute Pancreatitis2 trials

Heart Failure1 trial

Medication1 trial

Adult1 trial

Systemic Sclerosis1 trial

Long COVID1 trial

Trial1 trial

Neurofibromatosis1 trial

Diabetic Ulcer1 trial

Colorectal Carcinoma1 trial

Keloid1 trial

Wound Healing1 trial

Cirrhosis1 trial

Scleroderma1 trial

Acute Kidney Injury1 trial

BOS1 trial

Silicosis1 trial

Pneumoconiosis1 trial

Acute Myocardial Infarction1 trial

Oral Submucous Fibrosis1 trial

Kidney Disease1 trial

CTD-ILD1 trial

Diabetic Nephropathy1 trial

Cardiovascular Disease1 trial

Focal Segmental Glomerulosclerosis1 trial

Hypertrophic Cardiomyopathy1 trial

Corona Virus Infection1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Sarcoidosis1 trial

Hermansky-Pudlak syndrome1 trial

Asbestosis1 trial

Plexiform Neurofibroma1 trial

Drug1 trial

Uterine leiomyoma1 trial

Lung Disease1 trial

Allograft1 trial

ILD1 trial

Diabetic Neuropathy1 trial

Chemotherapy1 trial

Quality of Life1 trial

Neurofibromatosis Type 11 trial

Multiple Sclerosis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News