Drugs / Pirfenidone
Pirfenidone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ESBRIET | — | 2014-10-15 | fda.gov ↗ |
| Approved | EU (EMA) | Esbriet | — | 2011-02-28 | europa.eu ↗ |
Trials 93 · started per year
today
EU approved 2011
US approved 2014
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Also used as a comparator or background therapy in 31 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05195918 Background | Aug 2023 → Mar 2026 | idiopathic pulmonary fibrosis | Hal Chapman | Completed | No outcome recorded |
| Phase 1 | NCT07456800 Comparator | Jul 2021 → Jan 2022 | — | PureTech | Completed | No outcome recorded |
| Phase 1 | NCT03177291 Comparator | Sep 2017 → May 2021 | non-small cell lung carcinoma, squamous cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT05497284 Background | Nov 2022 → Aug 2024 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT05321420 Comparator | Jul 2022 → Oct 2024 overdue | idiopathic pulmonary fibrosis | PureTech | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05060822 Comparator | Jun 2021 → Jul 2025 overdue | idiopathic pulmonary fibrosis | Sunshine Lake Pharma Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04258397 Comparator | Oct 2020 → May 2024 | chronic kidney disease | Veterans Medical Research Foundation | Unknown | No outcome recorded |
| Phase 2 | NCT03287414 Background | Dec 2017 → Nov 2020 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02958917 Comparator | Jun 2017 → Mar 2021 | interstitial lung disease | Evans Fernandez Perez | Terminated | No outcome recorded |
| Phase 2 | NCT02932566 Comparator | Mar 2017 → Nov 2019 | heart failure | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT03530150 Comparator | Jan → Jun 2017 | — | Autonomous University of Nuevo León | Completed | No outcome recorded |
| Phase 2 | NCT02951429 Background | Dec 2016 → Sep 2019 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01872689 Background | Oct 2013 → Jul 2017 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02707640 Background | Aug 2013 → Feb 2015 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01890265 Comparator | Jul 2013 → Nov 2017 | idiopathic pulmonary fibrosis | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01417156 Background | Sep 2011 → Oct 2015 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00001596 Comparator | Sep 2005 → Sep 2009 | albinism, oculocutaneous albinism, platelet storage pool deficiency, pulmonary fibrosis | William Gahl, M.D. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06585319 Comparator | Feb 2020 → Jun 2021 | COVID-19 | Materno-Perinatal Hospital of the State of Mexico | Completed | No outcome recorded |
| Phase 2/3 | NCT02262299 Comparator | May 2015 → Dec 2019 | bronchiolitis obliterans syndrome, disease related to solid organ transplantation | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07284602 Comparator | Jun 2026 → Jun 2029 expected | idiopathic pulmonary fibrosis | PureTech | Recruiting | No outcome recorded |
| Phase 3 | NCT07299695 Comparator | Jan 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Argyrios Tzouvelekis | Recruiting | No outcome recorded |
| Phase 3 | NCT07082842 Comparator | Oct 2025 → Jan 2031 expected | idiopathic pulmonary fibrosis | Sunshine Lake Pharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06909812 Comparator | Jul 2015 → Jan 2016 | keloid | Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. | Completed | No outcome recorded |
| Phase 3 | NCT01366209 Comparator | Jun 2011 → Feb 2014 | idiopathic pulmonary fibrosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00287716 Comparator | Jul 2006 → Nov 2008 | idiopathic pulmonary fibrosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00287729 Comparator | Apr 2006 → Nov 2008 | idiopathic pulmonary fibrosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07141810 Comparator | Oct 2025 → Apr 2028 expected | interstitial lung disease | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04856111 Comparator | Mar 2021 → Nov 2022 | postinflammatory pulmonary fibrosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT03260556 Comparator | Sep 2017 → Dec 2019 | pulmonary sarcoidosis | University of Cincinnati | Unknown | No outcome recorded |
| Phase 4 | NCT02530359 Comparator | Oct 2015 → Mar 2016 | acute kidney injury, infectious disease with sepsis | Hospital Civil de Guadalajara | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05133453 Comparator | Feb 2024 → Feb 2025 | asbestosis | Cairo University | Unknown | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-09-13 | Roche Global Development | Results of a six-month study combining Roche’s Esbriet with nintedanib in patients with IPF presented at ERS roche.com ↗ |
| 2017-06-27 | Roche Global Development | Fewer pills, more flexibility in dosing: Roche’s new Esbriet tablet formulation approved in Europe for mild to moderate idiopathic pulmonary fibrosis (IPF) roche.com ↗ |
| 2017-05-24 | Roche Global Development | New data at ATS add to the body of evidence for Roche’s Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF) roche.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 126 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pirfenidone | “On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum antifibrotic drug that modulates diverse cytokines action” NCT03076320 ↗123“Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated.” NCT07299695 ↗ “Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers” NCT05428150 ↗ “100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System.” NCT06951217 ↗ “Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy” NCT03287414 ↗ “Pirfenidone (Esbriet) orally (PO) with food according to this schedule:” NCT04467723 ↗ “Efficacy and Safety of Pirfenidone in CTD-ILD” NCT05505409 ↗ “nintedanib, pirfenidone, or neither” NCT05497284 ↗ |
| Known as | AP01 | “100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System.” NCT06951217 ↗ |
| Known as | Deskar | “This study will examine the effectiveness of the drug pirfenidone (Deskar) in improving heart function in patients with hypertrophic cardiomyopathy (HCM).” NCT00011076 ↗ |
| Known as | Esbriet | “Pirfenidone (Esbriet) orally (PO) with food according to this schedule:” NCT04467723 ↗4“Pirfenidone (Esbriet) orally (PO) with food according to this schedule:” NCT06484153 ↗ “Pirfenidone Name: Esbriet 267 mg hard capsules” NCT04607928 ↗ “Pirfenidone 267 MG [Esbriet]” NCT03315741 ↗ “Pirfenidone 267 MG [Esbriet]” NCT07654517 ↗ |
| Known as | KitosCell LP | “Since 2000, the Mexican company Grupo Medifarma has manufactured the molecule 1-phenyl-5-methyl-2- (1H)-pyridone (PFD), hereinafter KitosCell ® LP in its plant located in...” NCT06267794 ↗2“Pilot Study of Kitoscell LP (pirfenidone LP) Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19” NCT06585319 ↗ “1200 mg / day of Pirfenidone (KitosCell® LP)” NCT05542615 ↗ |
| Known as | “The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment” NCT02530359 ↗ | |
| Known as | PFD | “On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum antifibrotic drug that modulates diverse cytokines action” NCT03076320 ↗7“Pirfenidone (5-methyl-1-phenyl-2-\[1H\]-pyridone, here and after PFD), a drug initially known for its analgesic and anti-inflammatory capabilities.” NCT06267794 ↗ “Pirfenidone (PFD), an oral antifibrotic drug” NCT04099407 ↗ “Pirfenidone (PFD) is TGF- β The inhibitor” NCT05531955 ↗ “Drug: Pirfenidone (PFD)” NCT07284602 ↗ “Pirfenidone (PFD)” NCT03221257 ↗ “Pirfenidone (PFD)” NCT06871904 ↗ “Pirfenidone (PFD)” NCT07456800 ↗ |
| Known as | Pirespa | “Pirfenidone Tablets (trade name: Pirespa®, strength: 200 mg/tablet) produced by Shionogi \& Co., Ltd. as the reference product.” NCT06589921 ↗1“Pirfenidone Tablets (trade name: Pirespa®, strength: 200 mg/tablet)” NCT06588517 ↗ |
| Known as | pirfenidone LP | “Pilot Study of Kitoscell LP (pirfenidone LP) Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19” NCT06585319 ↗ |
| Known as | Pirfenidone Modified-Release Tablets | “Pirfenidone Modified-Release Tablets (strength: 600 mg/tablet)” NCT06588517 ↗ |
| Known as | Pirfenidone Tablets | “Pirfenidone Tablets (trade name: Pirespa®, strength: 200 mg/tablet)” NCT06588517 ↗ |
| Known as | PR-PFD | “The anti-inflammatory activity of prolonged-release pirfenidone (PR-PFD) could be beneficial in this clinical setting.” PMID 33520317 ↗ Jan 20211“patients with remaining fibrosis who were treated with prolonged-release pirfenidone (PR-PFD).” PMID 41044745 ↗ Oct 2025 |
| Action | Inhibit | “Pirfenidone is a novel antifibrotic agent that inhibits these and other growth factors.” NCT00076102 ↗ |
| Modality | Small molecule | “Pirfenidone is a synthetic molecule” NCT02222376 ↗ |
| Route | Oral | “Oral Pirfenidone” NCT00001596 ↗ |