> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/pirfenidone-3eaa7241-8908-43a6-9121-310e804c1fcc > Record changed: 2026-10-13 # Pirfenidone Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) First approval year 2011 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) ## Development status **First approval year** 2011 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **Drug name** Pirfenidone Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **Molecular weight** 185.23 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **Structure (SMILES)** Cc1ccc(=O)n(-c2ccccc2)c1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) ### Brand names (8) - esbriet - Esbriet - Pirfenidone axunio (previously pirfenidone aet) - pirfenidone axunio previously pirfenidone aet - pirfenidone component of esbriet - Pirfenidone component of esbriet - pirfenidone viatris - Pirfenidone viatris ### Other names (48) - amr 69 - AMR-69 - egcg 300 mg pirfenidone - Esbriet 267 MG Oral Capsule - esbriet component pirfenidone - ESBRIET component pirfenidone - nsc 748456 - NSC-748456 - Oral pirfenidone - pirespa - Pirespa - pirfenidona - Pirfenidona - pirfenidone - Pirfenidone - Pirfenidone \[EMA EPAR\] - Pirfenidone \[EP MONOGRAPH\] - Pirfenidone \[INN\] - Pirfenidone \[JAN\] - Pirfenidone \[MART.\] - Pirfenidone \[MI\] - Pirfenidone \[ORANGE BOOK\] - Pirfenidone \[USAN\] - Pirfenidone \[VANDF\] - Pirfenidone \[WHO-DD\] And 23 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L04AX05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **CAS registry numbers** - 53179-13-8 **ChEMBL ID** CHEMBL1256391 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **InChIKey** ISWRGOKTTBVCFA-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1256391) **PubChem compound IDs** - 40632 **RxNorm IDs (RxCUI)** - 1592254 **FDA ingredient codes (UNII)** - D7NLD2JX7U ## Regulatory information ### United States **Applicant** LEGACY **Approval date** 11 Jan 2017 **Application number** NDA208780 ### European Union **Status** Authorised **Status date** 28 Feb 2011 **Authorisation date** 28 Feb 2011 **Approved indications** Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis. **Product number** EMEA/H/C/002154 **Authorisation holder** H.A.C. Pharma **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 2 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Idiopathic Pulmonary Fibrosis - Lung Diseases - Respiratory Tract Diseases European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/esbriet) ### Other regulatory facts **Patents** 35 **Designations** 6 **Earliest recorded loss of exclusivity** 28 Mar 2037 **First in class** Yes **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** pirfenidone **Type** Synthetic organic **Drug name stem** deu- **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Investigated indications (33) - **Condition** Carcinoma, Squamous Cell **Highest recorded phase** 2 **Condition identifier** EFO:0000181 **Subject identifier** D002294 - **Condition** Pancreatitis **Highest recorded phase** 2 **Condition identifier** EFO:0000278 **Subject identifier** D010195 - **Condition** Cardiomyopathy, Hypertrophic **Highest recorded phase** 2 **Condition identifier** EFO:0000538 **Subject identifier** D002312 - **Condition** Immune System Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Respiratory Tract Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000684 **Subject identifier** D012140 - **Condition** Scleroderma, Systemic **Highest recorded phase** 2 **Condition identifier** EFO:0000717 **Subject identifier** D012595 - **Condition** Leiomyoma **Highest recorded phase** 2 **Condition identifier** EFO:0000731 **Subject identifier** D007889 - **Condition** Idiopathic Pulmonary Fibrosis **Highest recorded phase** 4 **Condition identifier** EFO:0000768 **Subject identifier** D054990 - **Condition** Pneumonia **Highest recorded phase** 3 **Condition identifier** EFO:0003106 **Subject identifier** D011014 - **Condition** Heart Failure **Highest recorded phase** 2 **Condition identifier** EFO:0003144 **Subject identifier** D006333 - **Condition** Lung Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0003818 **Subject identifier** D008171 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 2 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Keloid **Highest recorded phase** 3 **Condition identifier** EFO:0004212 **Subject identifier** D007627 - **Condition** Glomerulosclerosis, Focal Segmental **Highest recorded phase** 2 **Condition identifier** EFO:0004236 **Subject identifier** D005923 - **Condition** Lung Diseases, Interstitial **Highest recorded phase** 2 **Condition identifier** EFO:0004244 **Subject identifier** D017563 - **Condition** Nephrotic Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0004255 **Subject identifier** D009404 - **Condition** Acute Lung Injury **Highest recorded phase** 2 **Condition identifier** EFO:0004610 **Subject identifier** D055371 - **Condition** Bronchiolitis Obliterans **Highest recorded phase** 2 **Condition identifier** EFO:0007183 **Subject identifier** D001989 - **Condition** Pulmonary Fibrosis **Highest recorded phase** 2 **Condition identifier** EFO:0009448 **Subject identifier** D011658 - **Condition** Burns **Highest recorded phase** 2 **Condition identifier** EFO:0009516 **Subject identifier** D002056 - **Condition** Respiratory Distress Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:1000637 **Subject identifier** D012128 - **Condition** Pancreatitis **Highest recorded phase** 2 **Condition identifier** EFO:1000652 **Subject identifier** D010195 - **Condition** Diabetic Foot **Highest recorded phase** 3 **Condition identifier** EFO:1001459 **Subject identifier** D017719 - **Condition** Renal Insufficiency **Highest recorded phase** 2 **Condition identifier** EFO:1002048 **Subject identifier** D051437 - **Condition** Renal Insufficiency **Highest recorded phase** 2 **Condition identifier** HP:0000083 **Subject identifier** D051437 And 8 more, listed on the interactive page. ### Open Targets indications (75) - **Condition identifier** EFO\_0000181 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000278 - **Condition identifier** EFO\_0000538 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000658 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000717 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000731 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000768 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 4 - **Condition identifier** EFO\_0003106 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003144 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003818 - **Condition identifier** EFO\_0003884 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004212 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004244 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004610 **Highest recorded phase** 2 - **Condition identifier** EFO\_0006890 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007153 - **Condition identifier** EFO\_0007183 - **Condition identifier** EFO\_0008497 **Highest recorded phase** 2 - **Condition identifier** EFO\_0008527 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009448 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009516 **Highest recorded phase** 2 - **Condition identifier** EFO\_1000637 **Highest recorded phase** 3 - **Condition identifier** EFO\_1000652 **Highest recorded phase** 2 And 50 more, listed on the interactive page. ### Reported adverse events (33) - **Event** abdominal discomfort **Reports** 335 **Reporting signal score** 420.341 - **Event** abdominal pain upper **Reports** 217 **Reporting signal score** 139.619 - **Event** asthenia **Reports** 343 **Reporting signal score** 142.705 - **Event** carbon monoxide diffusing capacity decreased **Reports** 21 **Reporting signal score** 85.6703 - **Event** constipation **Reports** 189 **Reporting signal score** 78.7593 - **Event** cough **Reports** 414 **Reporting signal score** 334.697 - **Event** decreased appetite **Reports** 774 **Reporting signal score** 1,268 - **Event** diarrhoea **Reports** 561 **Reporting signal score** 201.86 - **Event** dizziness **Reports** 419 **Reporting signal score** 150.222 - **Event** dysgeusia **Reports** 100 **Reporting signal score** 80.7846 - **Event** dyspepsia **Reports** 270 **Reporting signal score** 413.609 - **Event** dyspnoea **Reports** 686 **Reporting signal score** 408.639 - **Event** dyspnoea exertional **Reports** 89 **Reporting signal score** 89.7746 - **Event** fatigue **Reports** 831 **Reporting signal score** 497.782 - **Event** flatulence **Reports** 81 **Reporting signal score** 89.6065 - **Event** forced vital capacity decreased **Reports** 48 **Reporting signal score** 196.477 - **Event** gastric disorder **Reports** 113 **Reporting signal score** 182.468 - **Event** gastrointestinal disorder **Reports** 123 **Reporting signal score** 105.087 - **Event** gastrooesophageal reflux disease **Reports** 145 **Reporting signal score** 149.964 - **Event** idiopathic pulmonary fibrosis **Reports** 75 **Reporting signal score** 255.875 - **Event** lung transplant **Reports** 35 **Reporting signal score** 73.1815 - **Event** nausea **Reports** 1,057 **Reporting signal score** 732.568 - **Event** oxygen saturation decreased **Reports** 185 **Reporting signal score** 250.88 - **Event** photosensitivity reaction **Reports** 234 **Reporting signal score** 598.163 - **Event** pneumonia **Reports** 339 **Reporting signal score** 169.285 And 8 more, listed on the interactive page. ### Trial references (55) - NCT00001959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001959) - NCT00011076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00011076) - NCT00053937 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00053937) - NCT00754780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00754780) - NCT00080223 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00080223) - NCT00287716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00287716) - NCT00287729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00287729) - NCT00662038 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00662038) - NCT01366209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01366209) - NCT01504334 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01504334) - NCT01872689 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01872689) - NCT01890265 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01890265) - NCT02136992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02136992) - NCT02579603 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02579603) - NCT02598193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02598193) - NCT02606877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02606877) - NCT02648048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02648048) - NCT02707640 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02707640) - NCT02951429 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02951429) - NCT03208933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03208933) - NCT03939520 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03939520) - NCT03981094 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03981094) - NCT04888715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04888715) - NCT05060822 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05060822) - NCT05321420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05321420) And 30 more, listed on the interactive page. ## Dosing **Dose** 801 mg **Route** Oral **How often** Thrice daily ### Conditions of use - Take with food ## Chemical properties **Hydrogen bond acceptors** 2 **Hydrogen bond donors** 0 **Polar surface area** 22 **Calculated partition coefficient (ALogP)** 2.15 **Calculated partition coefficient (XLogP)** 1.9 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 1 **Heavy atoms** 14 **Molecular formula** C12H11NO **Monoisotopic mass** 185.084063974 **Natural product** Yes ## National Drug Codes - 0480-3610 - 0480-3611 - 0781-2158 - 0781-8085 - 0781-8086 - 0904-7397 - 0904-7398 - 16729-467 - 16729-468 - 31722-872 - 31722-873 - 33342-461 - 42291-490 - 42291-491 - 42291-492 - 42385-923 - 42385-924 - 42385-925 - 42385-926 - 42571-335 - 42571-336 - 46708-479 - 46708-480 - 50228-441 - 50228-442 And 36 more, listed on the interactive page. ## Evidence counts **Recorded assays** 1,840 **Active assays** 14 ### Active assay types (3) - Confirmatory - Other - Screening ## Pharmacologic actions - Analgesics Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000700.html) - Anti-Inflammatory Agents, Non-Steroidal Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000894.html) - Antineoplastic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html) ## Biological measurements These details could not be displayed. ## Related records ### Trials (129) - A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants - A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis - A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis - A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer - A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis. - A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury. - 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 - A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood - A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) - A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis - A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease - A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants - A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants - A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF) - A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination - A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants - A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection - Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis - Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis ### Approved for (4) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - Respiratory system disorder ### In development for (28) - [Acute lung injury](https://trialight.com/data/condition/acute-lung-injury-fb11c447-d7f6-5c24-8fb9-764bbaaabced.md) Phase 2 - Acute pancreatitis Phase 2 - [Acute respiratory distress syndrome](https://trialight.com/data/condition/acute-respiratory-distress-syndrome-8dc4b74c-8356-5dfd-bfa3-258d9d1e44ab.md) Phase 3 - Bronchiolitis obliterans syndrome Phase 2 - Burn Phase 2 - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 2 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - Focal segmental glomerulosclerosis Phase 2 - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Phase 2 - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Phase 2 - Hypersensitivity pneumonitis Phase 2 - [Hypertrophic cardiomyopathy](https://trialight.com/data/condition/hypertrophic-cardiomyopathy-2bcaf1dc-551c-50d7-8f5b-4b8457815d3c.md) Phase 2 - [Interstitial lung disease](https://trialight.com/data/condition/interstitial-lung-disease-745f5770-ba0b-517d-b691-5b9731a03266.md) Phase 2 - Keloid Phase 3 - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) Phase 2 - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2 - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 1 - Nephrotic syndrome Phase 2 - Neurofibromatosis type 1 Phase 2 ### Other linked conditions (1) - Asbestosis --- ## A note for AI agents You are probably reading this for a person. 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