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 94 · started per year
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-04-13 | Avalyn Pharma Inc. | Results Avalyn Showcases Clinical Data Across Multiple Pulmonary Fibrosis Programs at ATS 2025 avalynpharma.com ↗
AP01 (inhaled pirfenidone) treatment demonstrated long-term antifibrotic effects and continued favorable safety out to over 4.5 years |
| 2024-12-16 | PureTech | Results PureTech’s Deupirfenidone (LYT-100) Slowed Lung Function Decline in People with Idiopathic Pulmonary Fibrosis (IPF) as Measured by Forced Vital Capacity (FVC), Achieving the Primary and Key Secondary Endpoints in the ELEVATE IPF Phase 2b Trial puretechhealth.com ↗ |
| 2023-08-29 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Pirfenidone Capsules lupin.com ↗ |
| 2023-08-25 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Pirfenidone Tablets lupin.com ↗ |
| 2023-01-17 | Kinarus AG | Results Kinarus Therapeutics Reports Preclinical Data in Lung Fibrosis and Discloses Clinical Development Plan kinarus.com ↗
KIN001 was more effective in direct comparison to pirfenidone, a marketed IPF therapy. |
| 2022-09-05 | PureTech | Results PureTech Presents Data for LYT-100 (Deupirfenidone) Supporting Design of Dose-Ranging Trial in Idiopathic Pulmonary Fibrosis (IPF) at European Respiratory Society International Congress 2022 puretechhealth.com ↗
The data from the Phase 1 trial demonstrated that LYT-100 showed a lower incidence of adverse events (AEs) compared to pirfenidone at comparable exposure levels. |
| 2022-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 24th May, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it .has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. |
| 2021-01-20 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). |
| 2020-03-02 | Genentech, Inc. | Regulatory FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease gene.com ↗
South San Francisco, CA -- March 2, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Esbriet® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). |
| 2017-09-13 | Hoffmann-La Roche | Results Results of a six-month study combining Roche’s Esbriet with nintedanib in patients with IPF presented at ERS roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results of a six month study combining Esbriet (pirfenidone) and nintedanib treatment, showing a similar safety profile for the combination treatment to that expected for each treatment alone. |
| 2017-09-11 | Boehringer Ingelheim | Results Results from the INJOURNEY™ trial investigating Ofev® with add-on pirfenidone provide new insights into this combination treatment for IPF prnewswire.com ↗
The data show that the safety and tolerability profile of nintedanib with add-on pirfenidone is consistent with the known profiles of the individual drugs in patients with IPF. |
| 2017-06-27 | Hoffmann-La Roche | Regulatory 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 ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved a new tablet formulation of Esbriet® (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a fatal condition that causes irreversible, progressive scarring of the lungs. |
| 2017-05-24 | Hoffmann-La Roche | Results New data at ATS add to the body of evidence for Roche’s Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF) roche.com ↗
In new post hoc analyses of phase III data, Esbriet reduced the risk of death in patients with more advanced lung function impairment and the risk of respiratory-related hospitalisations as a first progressive event |
All press releases naming this drug 22 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 127 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 ↗124“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)” NCT06871904 ↗ “Pirfenidone (PFD)” NCT07456800 ↗ “Pirfenidone (PFD)” NCT03221257 ↗ |
| 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 ↗ |