78 completed, 22 unknown, 15 recruiting, 8 not yet recruiting. 60 Phase 2, 32 Phase 1, 23 Phase 3, 12 Phase 4, 4 Not applicable.
Follow pirfenidone: new trials by email Literature Review of pirfenidone trials Research Report on pirfenidone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis Pirfenidone 267 MG [Esbriet], Placebo - Idiopathic Subglottic Stenosis, Subglottic Stenosis (SGS) | Phase 1 | Not yet recruiting | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 40 | 2026-12-01 | 2026-06-17 |
| Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer Paricalcitol, pirfenidone - Peritoneal (Metastatic) Cancer, Peritoneal Carcinoma | Phase 2 | Not yet recruiting | Patrick Wagner, MD, FACS | 74 | 2026-09-01 | 2026-10-05 |
| A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis AK3280, Placebo, Pirfenidone - Idiopathic Pulmonary Fibrosis (IPF) | Phase 3 | Not yet recruiting | Shanghai Ark Biopharmaceutical Co., Ltd. | 263 | 2026-08-31 | 2026-07-22 |
| Pirfenidone as Treatment of Chronic Pancreatitis Pirfenidone 267 mg Oral Tablet, Placebo, PROMIS-Global Health - Chronic Pancreatitis | Phase 2 | Not yet recruiting | Vikas Dudeja | 60 | 2026-08-01 | 2026-08-10 |
| Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) Deupirfenidone, Pirfenidone (PFD) - Idiopathic Pulmonary Fibrosis (IPF) | Phase 3 | Recruiting | PureTech | 1100 | 2026-06-26 | 2026-10-23 |
| A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants taladegib, nintedanib, pirfenidone - Idiopathic Pulmonary Fibrosis | Phase 1 | Recruiting | Endeavor Biomedicines, Inc. | 57 | 2026-04-28 | 2026-05-15 |
| Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects HRS-9813 Capsule, Nintedanib Soft Capsules, Pirfenidone Tablets - Pulmonary Fibrosis | Phase 1 | Completed | Guangdong Hengrui Pharmaceutical Co., Ltd | 20 | 2026-04-04 | 2026-09-21 |
| Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg）, Pirfenidone Capsules（0mg） - Radiation-induced Lung Injury, Immune-related Pneumonia | Phase 2 / Phase 3 | Recruiting | Beijing Continent Pharmaceutical Co, Ltd. | 298 | 2026-03-26 | 2026-04-22 |
| A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood BI 1015550, Pirfenidone - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | Boehringer Ingelheim | 20 | 2026-03-05 | 2026-08-21 |
| Effect of Pirfenidone on TA Fibrosis Pirfenidone Capsules, Placebo - Takayasu Arteritis | Phase 4 | Not yet recruiting | Shanghai Zhongshan Hospital | 92 | 2025-12-20 | 2026-01-08 |
| A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer Pirfenidone in combination with a PD-1 inhibitor, hypofractionated radiotherapy - Colorectal Cancer (CRC) | Phase 2 | Recruiting | Tao Zhang | 48 | 2025-12-01 | 2026-06-12 |
| A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis. pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy - Colorectal Cancer | Phase 2 | Not yet recruiting | Guoxiang Cai | 30 | 2025-12-01 | 2025-12-08 |
| Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF HEC585, Placebo, Pirfenidone - Idiopathic Pulmonary Fibrosis (IPF) | Phase 3 | Recruiting | Sunshine Lake Pharma Co., Ltd. | 472 | 2025-10-27 | 2026-04-21 |
| Efficacy and Safety of Early Antifibrotic Therapy for Non-progressive Fibrotic Interstitial Lung Disease Antifibrotic drugs (nidanib or pirfenidone) - Fibrotic Interstitial Lung Disease | Phase 4 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | 104 | 2025-10-01 | 2025-08-26 |
| Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer Camrelizumab Combined With Pirfenidone and Chemotherapy - Breast Cancer, Triple Negative Breast Cancer (TNBC) | Phase 1 / Phase 2 | Not yet recruiting | Harbin Medical University | 12 | 2025-09-15 | 2025-09-09 |
| Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study Pirfenidone, Placebo for pirfenidone, Upadacitinib - Long COVID | Phase 3 | Recruiting | Douglas D. Fraser | 348 | 2025-09-10 | 2026-10-06 |
| A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants NAL ER, Pirfenidone, Nintedanib - Healthy Participants | Phase 1 | Completed | Trevi Therapeutics | 132 | 2025-06-30 | 2025-10-10 |
| Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD Antifibrotic drugs (nidanib or pirfenidone), MMF Immunosuppression - SSc-Systemic Sclerosis | Recruiting | University of Patras | 35 | 2025-06-01 | 2026-03-24 | |
| Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis Metformin Hydrochloride 500Mg Tablet, Pirfenidone (PFD), Beclomaethasone and Vitamin E - Oral Submucous Fibrosis | Phase 1 / Phase 2 | Completed | Ziauddin University | 45 | 2025-04-07 | 2026-02-03 |
| Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib Nintedanib 150 MG [Ofev] - Drug Interactions | Phase 1 | Completed | PureTech | 24 | 2024-12-17 | 2026-08-13 |
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Idiopathic Pulmonary Fibrosis (41) · Pulmonary Fibrosis (15) · Lung Diseases, Interstitial (10) · Fibrosis (9) · Scleroderma, Systemic (5) · COVID-19 (4) · Cicatrix (4) · Diabetic Nephropathies (3) · Neurofibroma, Plexiform (3) · Pancreatitis (3) · Post-Acute COVID-19 Syndrome (3) · Alveolitis, Extrinsic Allergic (2) · Arthritis, Rheumatoid (2) · Breast Neoplasms (2) · Bronchiolitis Obliterans (2)
Hoffmann-La Roche (11) · Boehringer Ingelheim (10) · Beijing Continent Pharmaceutical Co, Ltd. (7) · Genentech, Inc. (7) · PureTech (6) · Sunshine Lake Pharma Co., Ltd. (4) · National Cancer Institute (NCI) (3) · University of Guadalajara (3) · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (2) · Manchester University NHS Foundation Trust (2) · Overseas Pharmaceuticals, Ltd. (2) · Qilu Hospital of Shandong University (2) · RenJi Hospital (2) · Shanghai Pulmonary Hospital, Shanghai, China (2) · Shanghai Zhongshan Hospital (2)
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PMID 37391667, PMID 26835133, PMID 35688625, PMID 26968970, PMID 27708114, PMID 28388260, PMID 30072107, PMID 30116539, PMID 30472023, PMID 31047956, PMID 31153107, PMID 31401786, PMID 33434107, PMID 21571362, PMID 42548365, PMID 24753394, PMID 24836312, PMID 25064094, PMID 25856121, PMID 26173796, PMID 26496265, PMID 27370878, PMID 28889759, PMID 28898890, PMID 29532550, PMID 29946005, PMID 30219058, PMID 30233802, PMID 30695649, PMID 30950636, PMID 30975118, PMID 31069575, PMID 31515704, PMID 31578169, PMID 31762329, PMID 31784348, PMID 32026243, PMID 32026347, PMID 32026407, PMID 32160670, PMID 32813194, PMID 32822614, PMID 33287583, PMID 33472968, PMID 33798455, PMID 34109243, PMID 34385704, PMID 34779583, PMID 34936057, PMID 35138474
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