Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate pirfenidone across diverse therapeutic indications, including idiopathic pulmonary fibrosis, connective tissue disease-associated interstitial lung disease, COVID-19 pneumonia, multiple sclerosis, and heart failure with preserved ejection fraction. Sponsored by academic medical centers, hospital trusts, government agencies such as the National Institute of Allergy and Infectious Diseases, and pharmaceutical companies including Boehringer Ingelheim, protocol statuses encompass actively recruiting, completed, active non-recruiting, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07082842 RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
Sunshine Lake Pharma Co., Ltd.
 2025-10-27 PHASE3
NCT07755813 NOT_YET_RECRUITING
Chronic Pancreatitis
Vikas Dudeja
 2026-08 PHASE2
NCT06912763 RECRUITING
Fibrosis Syndrome; Lymphedema; Head &Amp; Neck Cancer; Fibrosis
M.D. Anderson Cancer Center
 2025-08-08 PHASE2
NCT07284602 RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
PureTech
 2026-06-26 PHASE3
NCT07325357 NOT_YET_RECRUITING
Takayasu Arteritis
Shanghai Zhongshan Hospital
 2025-12-20 PHASE4
NCT07719023 NOT_YET_RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
Shanghai Ark Biopharmaceutical Co., Ltd.
 2026-08-31 PHASE3
NCT06253117 RECRUITING
Recurrent Acute Pancreatitis
University of Alabama at Birmingham
 2024-06-27 PHASE2
NCT07141810 NOT_YET_RECRUITING
Fibrotic Interstitial Lung Disease
Shanghai Pulmonary Hospital, Shanghai, China
 2025-10-01 PHASE4
NCT07654517 NOT_YET_RECRUITING
Idiopathic Subglottic Stenosis; Subglottic Stenosis (SGS)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2026-12-01 PHASE1
NCT06329401 ACTIVE_NOT_RECRUITING
Pulmonary Fibrosis; Progressive Pulmonary Fibrosis; Pulmonary Fibrosis Secondary to Systemic Sclerosis; Pulmonary Fibrosis, Interstitial Lung Disease; Interstitial Lung Disease; Interstitial Lung Disease Due to Connective Tissue Disease (Disorder); Interstitial Lung Disease in Patients With Rheumatoid Arthritis; Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere; Hypersensitivity Pneumonitis; Interstitial Lung Disease With Systemic Sclerosis
Avalyn Pharma Inc.
 2024-04-03 PHASE2
NCT07644286 RECRUITING
Colorectal Cancer (CRC)
Tao Zhang
 2025-12-01 PHASE2
NCT03109288 RECRUITING
Multiple Sclerosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-08-11 PHASE1; PHASE2
NCT04467723 RECRUITING
NSCLC Stage IV; NSCLC, Recurrent
University of Kansas Medical Center
 2022-05-18 PHASE1; PHASE2
NCT05842681 RECRUITING
Idiopathic Pulmonary Fibrosis
Assiut University
 2023-06-01
NCT07161791 NOT_YET_RECRUITING
Breast Cancer; Triple Negative Breast Cancer (TNBC)
Harbin Medical University
 2025-09-15 PHASE1; PHASE2
NCT07388680 RECRUITING
Radiation-induced Lung Injury; Immune-related Pneumonia
Beijing Continent Pharmaceutical Co, Ltd.
 2026-03-26 PHASE2; PHASE3
NCT07268677 NOT_YET_RECRUITING
Colorectal Cancer
Guoxiang Cai
 2025-12-01 PHASE2
NCT06928272 RECRUITING
Long COVID
Douglas D. Fraser
 2025-09-10 PHASE3
NCT07454291 RECRUITING
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2026-04-28 PHASE1
NCT05288179 RECRUITING
Pneumoconiosis
Beijing Continent Pharmaceutical Co, Ltd.
 2022-06-07 PHASE3
NCT06241560 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2026-03-05 PHASE2
NCT06484153 RECRUITING
To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma; To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer; Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
 2024-07-22 PHASE2
NCT05075161 RECRUITING
Acute Respiratory Distress Syndrome (ARDS)
Università Vita-Salute San Raffaele
 2022-06-01 PHASE3
NCT07229716 RECRUITING
Pulmonary Fibrosis
Guangdong Hengrui Pharmaceutical Co., Ltd
 2026-04-04 PHASE1
NCT05195918 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
 2023-08-24 PHASE1
NCT05350371 RECRUITING
Pancreatitis, Acute
University of Alabama at Birmingham
 2023-08-01 PHASE1; PHASE2
NCT03939520 COMPLETED
Progressive Idiopathic Pulmonary Fibrosis
Hospices Civils de Lyon
 2020-06-11 PHASE4
NCT05704166 RECRUITING
Acute Lung Injury; Prevention
Fujian Medical University Union Hospital
 2023-03-16 PHASE2
NCT06871904 COMPLETED
Oral Submucous Fibrosis
Ziauddin University
 2025-04-07 PHASE1; PHASE2
NCT07015398 COMPLETED
Healthy Participants
Trevi Therapeutics
 2025-06-30 PHASE1
NCT05060822 ACTIVE_NOT_RECRUITING
Idiopathic Pulmonary Fibrosis
Sunshine Lake Pharma Co., Ltd.
 2021-06-30 PHASE2
NCT05505409 UNKNOWN
Pirfenidone; Connective Tissue Diseases; Interstitial Lung Disease
Qilu Hospital of Shandong University
 2022-06-22 PHASE4
NCT05801133 UNKNOWN
Lung Cancer
Hubei Cancer Hospital
 2023-03-31 PHASE2
NCT06224790 COMPLETED
Diabetic Nephropathies; Type 2 Diabetes
Sidrah Lodhi
 2024-03-10 PHASE4
NCT06717100 COMPLETED
Drug Interactions
PureTech
 2024-12-17 PHASE1
NCT05133453 UNKNOWN
Asbestosis
Cairo University
 2024-02
NCT06142318 UNKNOWN
Head and Neck Squamous Cell Carcinoma; Radiotherapy; Radiosensitizer; Pirfenidone
Nanfang Hospital, Southern Medical University
 2023-11-15 PHASE2
NCT05321420 ACTIVE_NOT_RECRUITING
Idiopathic Pulmonary Fibrosis
PureTech
 2022-07-22 PHASE2
NCT06569381 COMPLETED
Idiopathic Pulmonary Fibrosis
Overseas Pharmaceuticals, Ltd.
 2024-09-18 PHASE1
NCT04928586 UNKNOWN
Pirfenidone; Connective Tissue Diseases; Interstitial Lung Disease
Qilu Hospital of Shandong University
 2019-08-16 PHASE4
NCT05531955 UNKNOWN
Myocardial Fibrosis
Shanghai Zhongshan Hospital
 2022-08-05 PHASE2
NCT04258397 UNKNOWN
Chronic Kidney Disease
Veterans Medical Research Foundation
 2020-10-26 PHASE2
NCT06588517 COMPLETED
Idiopathic Pulmonary Fibrosis
Overseas Pharmaceuticals, Ltd.
 2024-04-08 PHASE1
NCT05373914 UNKNOWN
Idiopathic Pulmonary Fibrosis
Blade Therapeutics
 2022-05-31 PHASE2
NCT06070610 COMPLETED
Healthy
Boehringer Ingelheim
 2023-11-08 PHASE1
NCT03902509 COMPLETED
Radiation-induced Lung Injury
Beijing Continent Pharmaceutical Co, Ltd.
 2019-05-24 PHASE2
NCT05542615 UNKNOWN
Liver Cirrhosis; Hepatitis C, Chronic; Epigenetic Disorder
University of Guadalajara
 2019-08-01 PHASE2
NCT05676112 Withdrawn
Pulmonary Fibrosis
Boehringer Ingelheim|China-Japan Friendship Hospital
 2023-12-29 --
NCT06070610 Completed
Healthy
Boehringer Ingelheim
 2023-11-08 Phase 1
NCT05280873 UNKNOWN
Pneumonitis; Malignant Tumor
Zhou Chengzhi
 2021-10-10 PHASE1
NCT06589921 COMPLETED
Idiopathic Pulmonary Fibrosis
Overseas Pharmaceuticals, Ltd.
 2023-08-25 PHASE1
NCT05713292 COMPLETED
COVID-19 Pneumonia
Capital Medical University
 2022-12-01 PHASE3
NCT03692481 UNKNOWN
Idiopathic Pulmonary Fibrosis
Assistance Publique - Hôpitaux de Paris
 2020-02-04
NCT04653831 COMPLETED
Covid19; ARDS
Soroka University Medical Center
 2020-11-08
NCT04193592 UNKNOWN
Hermansky Pudlak Syndrome; Interstitial Lung Disease
Jesse Roman
 2019-12-01 PHASE2
NCT05713292 Active not recruiting
COVID-19 Pneumonia
Capital Medical University
 2022-12-30 Phase 3
NCT04856111 UNKNOWN
Novel Coronavirus-induced Lung Fibrosis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2021-03-17 PHASE4
NCT05118256 UNKNOWN
Silicosis; Progressive Massive Fibrosis; Complicated Silicosis
Instituto de investigación e innovación biomédica de Cádiz
 2021-11-15 PHASE2
NCT04461587 COMPLETED
Coal Workers' Pneumoconiosis (Complicated)
Pulmonary Research of Abingdon, LLC
 2020-08-31 PHASE2
NCT05428150 COMPLETED
Idiopathic Pulmonary Fibrosis
Excalibur Pharmaceuticals, Inc.
 2022-08-08 PHASE1
NCT04243837 TERMINATED
Breast Cancer Related Lymphoedema; Lymphoedema
PureTech
 2020-03-01 PHASE2
NCT04652518 TERMINATED
Covid19; Post-acute COVID-19 Respiratory Disease
PureTech
 2020-12-11 PHASE2
NCT05505409 Recruiting
Pirfenidone|Connective Tissue Diseases|Interstitial Lung Disease
Qilu Hospital of Shandong University
 2022-06-22 Phase 4
NCT04971746 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-07-19 PHASE1
NCT03221257 COMPLETED
Scleroderma, Systemic; Interstitial Lung Disease
Michael Roth
 2017-11-28 PHASE2
NCT03315741 COMPLETED
Bronchiolitis Obliterans; Graft Vs Host Disease
Stanford University
 2018-03-01 PHASE1
NCT04607928 UNKNOWN
Fibrotic Pulmonary Sequelae Post-COVID19 Infection
Institut d'Investigació Biomèdica de Bellvitge
 2020-08-01 PHASE2
NCT07456800 COMPLETED
Pharmacokinetic Analysis
PureTech
 2021-07-12 PHASE1
NCT06267794 COMPLETED
Liver Fibrosis; Cirrhosis, Liver; Chronic Liver Disease
Jorge L Poo
 2015-06-26 PHASE2
NCT04939467 COMPLETED
Drug Drug Interaction
Blade Therapeutics
 2021-10-15 PHASE1
NCT05383131 COMPLETED
Idiopathic Pulmonary Fibrosis
Sunshine Lake Pharma Co., Ltd.
 2021-06-23 PHASE1
NCT07588646 COMPLETED
Idiopathic Pulmonary Fibrosis
Sunshine Lake Pharma Co., Ltd.
 2021-06-29 PHASE1
NCT04126538 UNKNOWN
Renal Insufficiency
Beijing Continent Pharmaceutical Co, Ltd.
 2019-08-27 PHASE1
NCT03359863 COMPLETED
Restrictive Chronic Lung Allograft Dysfunction; Lung Transplant Rejection
University of California, San Francisco
 2018-03-07 PHASE2
NCT04888715 COMPLETED
Idiopathic Pulmonary Fibrosis
Daewoong Pharmaceutical Co. LTD.
 2021-07-23 PHASE1
NCT03473340 TERMINATED
Disorder Related to Lung Transplantation; Chronic Lung Allograft Dysfunction
University of Michigan
 2018-04-27 PHASE2
NCT06585319 COMPLETED
COVID 19
Materno-Perinatal Hospital of the State of Mexico
 2020-02-01 PHASE2; PHASE3
NCT03177291 COMPLETED
Lung Cancer; Non Small Cell Lung Cancer; Advanced Cancer; Metastatic Lung Cancer; Squamous Cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung
H. Lee Moffitt Cancer Center and Research Institute
 2017-09-26 PHASE1
NCT02808871 COMPLETED
Rheumatoid Arthritis Interstitial Lung Disease
Brigham and Women's Hospital
 2017-04-07 PHASE2
NCT02958917 TERMINATED
Interstitial Lung Disease
Evans Fernandez Perez
 2017-06-05 PHASE2
NCT03856853 UNKNOWN
Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)
Beijing Continent Pharmaceutical Co, Ltd.
 2018-06-15 PHASE3
NCT03857854 UNKNOWN
Dermatomyositis Interstitial Lung Disease (Dm-ILD)
Beijing Continent Pharmaceutical Co, Ltd.
 2018-06-05 PHASE3
NCT04099407 COMPLETED
Liver Fibrosis; Chronic Liver Disease
Grupo Mexicano para el Estudios de las Enfermedades Hepaticas
 2019-08-01 PHASE2
NCT03385668 COMPLETED
Pulmonary Fibrosis
Assistance Publique - Hôpitaux de Paris
 2018-01-31 PHASE2
NCT04675619 COMPLETED
Hypersensitivity Pneumonitis
Zagazig University
 2019-12-01 PHASE2
NCT04282902 UNKNOWN
Novel Coronavirus Pneumonia; Pneumonia; Pirfenidone
Huilan Zhang
 2020-02-04 PHASE3
NCT03539289 COMPLETED
Pulmonary Disease
Consorcio Centro de Investigación Biomédica en Red (CIBER)
 2017-12-28
NCT03260556 UNKNOWN
Sarcoidosis, Pulmonary
University of Cincinnati
 2017-09-27 PHASE4
NCT02823236 UNKNOWN
Keloid
Centro Dermatológico Dr. Ladislao de la Pascua
 2016-10-24 PHASE3
NCT02262299 COMPLETED
Disorder Related to Lung Transplantation; CLAD, Bronchiolitis Obliterans
Rigshospitalet, Denmark
 2015-05 PHASE2; PHASE3
NCT02689778 COMPLETED
Diabetic Nephropathy; Albuminuria
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-03 PHASE3
NCT02932566 COMPLETED
Cardiac Failure
Manchester University NHS Foundation Trust
 2017-03-02 PHASE2
NCT03208933 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2017-10-23 PHASE3
NCT02951429 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2016-12-31 PHASE2
NCT03981094 COMPLETED
Idiopathic Pulmonary Fibrosis (IPF)
Bristol-Myers Squibb
 2019-05-10 PHASE1
NCT03068234 UNKNOWN
Systemic Sclerosis
RenJi Hospital
 2017-05 PHASE2; PHASE3
NCT03099187 COMPLETED
Lung Diseases, Interstitial
Hoffmann-La Roche
 2017-05-15 PHASE2
NCT01890265 COMPLETED
Idiopathic Pulmonary Fibrosis
Kyntra Bio
 2013-07-30 PHASE2
NCT01872689 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2013-10-13 PHASE2
NCT03530150 COMPLETED
Second-degree Burn
Universidad Autonoma de Nuevo Leon
 2017-01-01 PHASE2
NCT02821689 UNKNOWN
Dermatopolymyositis; Interstitial Lung Disease
RenJi Hospital
 2016-07 PHASE4
NCT02598193 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2016-01-14 PHASE4
NCT02606877 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2016-04-19 PHASE4
NCT02579603 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2015-10-16 PHASE4
NCT02648048 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2016-01-15 PHASE1
NCT02296281 UNKNOWN
Radiation Pneumonitis
Beijing Continent Pharmaceutical Co, Ltd.
 2015-01 PHASE2
NCT02530359 UNKNOWN
Acute Kidney Injury; Sepsis
Hospital Civil de Guadalajara
 2015-10 PHASE4
NCT00662038 COMPLETED
Idiopathic Pulmonary Fibrosis
Genentech, Inc.
 2008-08 PHASE3
NCT06909812 COMPLETED
Scars; Keloids; Hypertrophic Scar
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
 2015-07-14 PHASE3
NCT02496182 UNKNOWN
Alveolitis Extrinsic Allergic; Pulmonary Fibrosis
Grupo Medifarma, S. A. de C. V.
 2015-07 PHASE2; PHASE3
NCT02632877 COMPLETED
Diabetic Foot Ulcer
University of Guadalajara
 2014-01 PHASE1; PHASE2
NCT01417156 COMPLETED
Pulmonary Fibrosis
Boehringer Ingelheim
 2011-09 PHASE2
NCT02525484 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2015-08 PHASE1
NCT00080223 COMPLETED
Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
Genentech, Inc.
 2003-08-31 PHASE2
NCT02222376 COMPLETED
Diabetic Foot Ulcers
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2013-10 PHASE3
NCT02707640 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2013-08 PHASE2
NCT01933334 COMPLETED
Systemic Sclerosis
Genentech, Inc.
 2013-10 PHASE2
NCT01366209 COMPLETED
Idiopathic Pulmonary Fibrosis
Genentech, Inc.
 2011-06 PHASE3
NCT02136992 COMPLETED
Idiopathic Pulmonary Fibrosis
Shanghai Pulmonary Hospital, Shanghai, China
 2011-12 PHASE2
NCT01504334 UNKNOWN
Idiopathic Pulmonary Fibrosis
Beijing Kawin Technology Share-Holding Co., Ltd.
 2012-01 PHASE2
NCT01136174 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2010-05 PHASE2
NCT02408744 COMPLETED
Fibrosis; Chronic Kidney Disease
University of Guadalajara
 2009-09 PHASE1; PHASE2
NCT00076102 COMPLETED
Neurofibromatosis 1; Neurofibroma, Plexiform
National Cancer Institute (NCI)
 2004-07-21 PHASE2
NCT00001596 COMPLETED
Albinism; Inborn Errors of Metabolism; Oculocutaneous Albinism; Platelet Storage Pool Deficiency; Pulmonary Fibrosis
William Gahl, M.D.
 2005-09 PHASE2
NCT00287716 COMPLETED
Idiopathic Pulmonary Fibrosis
Genentech, Inc.
 2006-07-14 PHASE3
NCT00287729 COMPLETED
Idiopathic Pulmonary Fibrosis
Genentech, Inc.
 2006-04 PHASE3
NCT00001959 COMPLETED
Fibrosis; Focal Glomerulosclerosis; Kidney Failure; Nephrotic Syndrome; Proteinuria
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1999-12 PHASE2
NCT00063583 COMPLETED
Diabetes Mellitus; Diabetic Nephropathy
Sharma, Kumar, M.D.
 2003-06 PHASE1; PHASE2
NCT02161952 COMPLETED
Fibrosis; Hepatitis C Chronic
University of Guadalajara
 2005-05 PHASE2
NCT00754780 COMPLETED
Neurofibromatosis
Mayo Clinic
 2000-09 PHASE2
NCT00020631 COMPLETED
Radiation Fibrosis
National Cancer Institute (NCI)
 2001-10
NCT00332033 COMPLETED
Uterine Leiomyoma; Fibroids
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2006-05-25 PHASE2
NCT00011076 COMPLETED
Hypertrophic Cardiomyopathy
National Heart, Lung, and Blood Institute (NHLBI)
 2001-02 PHASE2
NCT00053937 COMPLETED
Neurofibromatosis Type 1; Precancerous Condition
National Cancer Institute (NCI)
 2002-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Pirfenidone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pirfenidone suppresses transforming growth factor-beta (TGF-β) production and TGF-β-stimulated collagen synthesis while downregulating pro-inflammatory cytokines and chemokines, including TNF-α, IL-1β, CCL2, and CCL12. By inhibiting cytokine release and extracellular matrix accumulation, pirfenidone attenuates tissue fibrogenesis and inflammatory cascades, directly contributing to its clinical efficacy in managing idiopathic pulmonary fibrosis and connective tissue disease-associated interstitial lung diseases.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.