Pirfenidone clinical trials
Pirfenidone is named as an intervention in 15 current clinical trials in our China, Canada, Japan, USA, Italy, Australia, UK, Germany, France, Spain, Netherlands, Belgium, Poland, Turkey, Israel, India, Mexico, South Korea, Brazil and Egypt registers. 10 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is PureTech (2). The most-studied condition is Idiopathic Pulmonary Fibrosis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Pirfenidone is approved
All regulators →Of the three regulators tracked here, the first to approve Pirfenidone was the EU, on 28 Feb 2011. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of idiopathic pulmonary fibrosis (24 Jun 2022, positive)
- 1 EU safety letter (DHPC), latest: type ii variation for Esbriet, 29 Oct 2020
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Pirfenidone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Pirfenidone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 17 listed patents; the last listed expires 28 Mar 2037 (US 10188637).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Pirfenidone
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Pirfenidone works
All drug targets →- Cognitive impairmentPhase 3
- DyspneaPhase 3
- FatiguePhase 3
- Respiratory distressPhase 3
- Acute respiratory distress syndromePhase 3
- Diabetic footPhase 3
- Diabetic kidney diseasePhase 3
- Interstitial lung diseasePhase 3
- PneumoconiosisPhase 3
- Pulmonary fibrosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1256391, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7532, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Pirfenidone
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Pirfenidone. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Pirfenidone for treating idiopathic pulmonary fibrosis NICE TA504 | Optimised | 6 Feb 2018 | Current |
| Pirfenidone for treating idiopathic pulmonary fibrosis NICE TA282 | Optimised | 24 Apr 2013 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Pirfenidone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 26 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Esbriet, Pirfenidone Viatris (generic), Pirfenidone axunio (previously Pirfenidone AET) (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Pirfenidone
- ATC code
- L04AX05
- ChEMBL
- CHEMBL1256391
- DrugBank
- DB04951
- PubChem CID
- 40632
- CAS number
- 53179-13-8
- FDA UNII
- D7NLD2JX7U
- Wikidata
- Q2060696
- Wikipedia
- Pirfenidone
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Pirfenidone
15 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Pirfenidone in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pirfenidone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults with Idiopathic Pulmonary Fibrosis (SURPASS-IPF)
2025-524493-42-00 · Respiratory Tract Diseases
|
Phase 3 | Authorised | Puretech Lyt 100 Inc | Greece, Italy, Czechia + 9 more |
Pirfenidone across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
26 single-substance products containing Pirfenidone on the HPRA medicines list.
- Pirfenidone Accord 801 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/270/002 · Marketed
- Pirfenidone Clonmel 267 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/350/001 · Marketed
- Pirfenidone Clonmel 801 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/350/002 · Marketed
- Pirfenidone Teva 267 mg Film-coated TabletsNorton Waterford · PA0436/048/001 · Marketed
- Pirfenidone Teva 801 mg Film-coated TabletsNorton Waterford · PA0436/048/002 · Marketed
Supply shortages
No entry for Pirfenidone in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Pirfenidone
17 conditionsAll 17 conditions
| Condition (as registered) | Trials |
|---|---|
| Idiopathic Pulmonary Fibrosis | 4 |
| Idiopathic Pulmonary Fibrosis (IPF) | 3 |
| Pulmonary Fibrosis | 1 |
| Progressive Pulmonary Fibrosis | 1 |
| Pulmonary Fibrosis Secondary to Systemic Sclerosis | 1 |
| Pulmonary Fibrosis, Interstitial Lung Disease | 1 |
| To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma | 1 |
| To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer | 1 |
| Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer | 1 |
| Radiation-induced Lung Injury | 1 |
| Immune-related Pneumonia | 1 |
| Colorectal Cancer (CRC) | 1 |
| Pneumoconiosis | 1 |
| Acute Respiratory Distress Syndrome (ARDS) | 1 |
| Long COVID | 1 |
| Idiopathic Subglottic Stenosis | 1 |
| Subglottic Stenosis (SGS) | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Pirfenidone trials
How many clinical trials are testing Pirfenidone?
15 current trials in our China, Canada, Japan, USA, Italy, Australia, UK, Germany, France, Spain, Netherlands, Belgium, Poland, Turkey, Israel, India, Mexico, South Korea, Brazil and Egypt registers name Pirfenidone (also registered as AP01) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Pirfenidone trials recruiting patients?
Yes. 10 of the 15 trials are recruiting: 5 with sites in China, 2 with sites in Canada, 2 with sites in Japan, 1 with sites in USA, 2 with sites in Italy, 1 with sites in Australia, 1 with sites in Brazil and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pirfenidone clinical trials?
PureTech (2), Sunshine Lake Pharma Co., Ltd (2), Beijing Continent Pharmaceutical Co, Ltd (2) and Avalyn Pharma Inc (1), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Pirfenidone licensed in Ireland?
Yes. The HPRA medicines list includes 26 single-substance products containing Pirfenidone, for example Pirfenidone Accord 801 mg film-coated tablets (Accord Healthcare Ireland Ltd.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Pirfenidone shortage?
Not in the lists we track: Pirfenidone has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pirfenidone works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pirfenidone works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pirfenidone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.