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Last update 03 Sep 2026

Pirfenidone

Last update 03 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pirfenidone (JAN/USAN/INN), AMR-69, AP-01

+ [19]

Target-

Action-

Mechanism-

Therapeutic Areas

Respiratory DiseasesOther DiseasesNeoplasms+ [6]

Active Indication

Idiopathic Pulmonary FibrosisInterstitial lung disease due to systemic diseaseAnthracosis+ [19]

Inactive Indication

Acute myocardial infarctionAllograft RejectionAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis+ [19]

Originator Organization

InterMune, Inc.

Active Organization

Avalyn Pharma, Inc.Viatris Ltd. (New Zealand)

Beijing Kangdini Pharmaceutical Co., Ltd.

+ [11]

Inactive Organization

Hoffmann-La Roche, Inc.

Roche Holding AG

Genentech, Inc.

+ [3]

License Organization

Marnac, Inc.

AFT Pharmaceuticals Ltd.

The Georgia Neurosurgical Institute

+ [5]

Drug Highest PhaseApproved

First Approval Date

Japan (16 Oct 2008),

Idiopathic Pulmonary Fibrosis

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC12H11NO

InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N

CAS Registry53179-13-8

231

Clinical Trials associated with Pirfenidone

NCT07654517

/ Not yet recruitingPhase 1IIT

A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis

Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Many need repeated operations and steroid injections to open the airway, but the narrowing usually comes back, so these treatments are not a cure.
Recent research from a Canadian iSGS registry and biobank has shown that this disease is driven by overactive scarring pathways, similar to those seen in idiopathic pulmonary fibrosis (IPF), a serious lung disease. Pirfenidone is an oral medication already approved for IPF that works by slowing down the cells and signals that cause scarring. Because the same scarring pathways appear to be active in iSGS, pirfenidone may be able to slow or reduce the build-up of scar tissue in the airway.
In this study, adults with iSGS will be randomly assigned (like flipping a coin) to receive either pirfenidone or a placebo (a look-alike pill with no active drug) for 52 weeks, in addition to their usual intralesional steroid injections. The pirfenidone dose will be increased gradually over the first two weeks up to a regular dose taken three times a day with food, which is the same schedule used in patients with IPF. Participants and their doctors will not know which treatment they are getting until the end of the study, unless this needs to be revealed for safety reasons.
The main goal of this trial is to see how safe pirfenidone is for people with iSGS and how well they can tolerate taking it for one year. The study team will watch closely for side effects such as stomach upset, skin rash or sensitivity to sunlight, tiredness, and changes in liver blood tests. They will also look for early signs that pirfenidone may help, such as longer time until the next airway dilation, better breathing tests, and improvements in breathlessness and voice-related quality of life scores.
Participants will be followed for a total of up to two years, including one year on study medication and one year of follow-up. This study may not directly help every person who takes part, but the results will provide important information about whether pirfenidone is safe in iSGS and whether it could become the first medication to slow down this scarring airway disease.

Start Date01 Dec 2026

Sponsor / Collaborator

Unity Health Toronto

NCT07755813

/ Not yet recruitingPhase 2IIT

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Chronic Pancreatitis.

The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).

Start Date01 Aug 2026

Sponsor / Collaborator

University of Iowa

[+1]

KCT0011963

/ Not yet recruitingPhase 4IIT

A multicenter, open-label, single-arm, investigator-initiated clinical trial to evaluate the efficacy and safety of pirfenidone in patients with non-IPF interstitial lung disease (ILD) with a UIP pattern.

Start Date18 May 2026

Sponsor / Collaborator

Asan Medical Center

100 Clinical Results associated with Pirfenidone

100 Translational Medicine associated with Pirfenidone

100 Patents (Medical) associated with Pirfenidone

2,503

Literatures (Medical) associated with Pirfenidone

01 Jan 2027·JOURNAL OF ETHNOPHARMACOLOGY

Areca catechu L. procyanidins alleviate pulmonary fibrosis by suppressing the TGF-β/Smad/ERK cascade: Validation of a traditional herbal medicine

Article

Author: Zhao, Yueru ; Liu, Lei ; Zhu, Mengxia ; Liu, Bin

ETHNOPHARMACOLOGICAL RELEVANCE:

Areca nut has long been prescribed in Traditional Chinese Medicine for respiratory disorders resembling pulmonary fibrosis (PF). Its classical effects of resolving phlegm and dissipating chest stagnation, documented in Shennong Bencao Jing, align closely with PF's hallmark pathologies of interstitial scarring and excessive collagen accumulation, yet the mechanistic basis for its anti-fibrotic activity remains unelucidated.

AIM OF THE STUDY:

This study validated the anti-PF efficacy of areca nut procyanidins (ANP) and elucidated their multi-target mechanisms.

MATERIALS AND METHODS:

A multi-faceted approach integrating network pharmacology, molecular docking, and in vivo/vitro experiments was employed. Rat PF models induced by bleomycin were treated with ANP (1, 5, 15 mg/kg) for 28 days. LPS-stimulated 3T6 fibroblasts were used to evaluate cellular mechanisms.

RESULTS:

Network pharmacology predicted 72 common targets, with enrichment in the TGF-β and MAPK pathways. Molecular docking confirmed strong binding affinity of ANP to TGF-β1 (-8.8 kcal/mol) and Smad3 (-6.8 kcal/mol). In vivo, medium- and high-dose ANP significantly ameliorated lung histopathology, reduced collagen deposition (HYP), and restored antioxidant biomarkers (T-AOC, MPO, GSH). Mechanistically, ANP concurrently suppressed the TGF-β/Smad/ERK signaling cascade, characterized by the downregulation of TGF-β1, p-Smad3/4, and p-ERK, alongside the restoration of the inhibitory Smad7. In vitro, ANP inhibited fibroblast migration, inflammation (IL-1β, TNF-α), and extracellular matrix production.

CONCLUSION:

By multi-target inhibition of the TGF-β/Smad/ERK cascade, ANP ameliorates PF, consistent with areca nut's traditional phlegm-resolving and nodule-dissipating properties. Compared with pirfenidone, ANP exhibits superior safety and multi-pathway activity, rendering it a promising botanical therapeutic agent for PF.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Association of Pirfenidone and its Cardioprotective effects in Pentylenetetrazole-induced kindling model of Epilepsy through the High mobility group Box-1/Toll-Like Receptor-4 pathway

Article

Author: Vohora, Divya ; Majid, Haya ; Nidhi ; Dahalia, Mansi

BACKGROUND: Epilepsy and cardiac dysfunction are increasingly recognized as interrelated conditions, with chronic epilepsy contributing to systemic inflammation, oxidative stress, and autonomic dysregulation, adversely impacting cardiovascular health. However, current treatments seldom address both neurological and cardiovascular complications simultaneously. This study evaluates the potential of Pirfenidone (PFD), an antifibrotic and anti-inflammatory agent, to reduce cardiac inflammation, oxidative stress, and fibrosis in an epilepsy model using Pentylenetetrazole (PTZ)-induced kindling. METHODS: Swiss albino mice (n = 9/group) were divided into seven groups and treated with PFD 100, 200, 300 mg/kg orally and PTZ (25 mg/kg intraperitoneally) at alternate days. Sodium Valproate (200 mg/kg orally) was used as a standard. Seizure activity was monitored, and cardiac tissue was analyzed for markers of oxidative stress, inflammatory cytokines, and fibrosis via histopathological changes. RESULTS: PFD significantly reduced seizure severity dose-dependently, with 300 mg/kg demonstrating the greatest effect (p < 0.05). Cardiac oxidative stress markers Superoxide Dismutase, Malondialdehyde, Reduced Glutathione and catalase improved significantly. Inflammatory markers were also markedly reduced, including High Mobility Group Box-1 (HMGB1) and Toll-Like Receptor-4 (TLR4) (p < 0.001). Histology confirmed reduced cardiac fibrosis, especially at 300 mg/kg dose of PFD. CONCLUSION: Pirfenidone exhibits cardioprotective, antioxidant and anti-inflammatory actions in seizure-associated cardiac injury via HMGB1/TLR4 pathway modulation. These findings suggest its potential as an adjunctive therapy in epilepsy patients at risk of cardiovascular complications. Further clinical studies are warranted.

01 Sep 2026·MEDICINA CLINICA

Full-dose pirfenidone in acute intermittent porphyria: Monitored exposure in a chronic excretor without acute attacks

Letter

Author: Garrido Montes, Manuel ; Pérez Quintana, Marta ; Garcia Morillo, José Salvador

297

News (Medical) associated with Pirfenidone

25 Aug 2026

·news.puretechhealth.com

PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress

25 August 2026 PureTech Health plc PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress Presentations will highlight Celea's differentiated approach to advancing deupirfenidone for idiopathic pulmonary fibrosis (IPF), including details of the Phase 3 SURPASS-IPF trial design and key insights from a Phase 1 drug-drug interaction study with nintedanib PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics ("Celea") today announced that it will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The full text of the announcement from Celea is as follows: Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON, August 25, 2026 - Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The presentations will detail the design and rationale for SURPASS-IPF, Celea's global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF will assess not only several clinical endpoints but also the potential impact on patients' lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. "Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone's potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients' quality of life," said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. "As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches." Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 - Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 - Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. About SURPASS-IPF SURPASS-IPF (NCT07284602) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit www.SURPASS-IPF.com. About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019.1 Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years,2 and currently there is no cure. About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for "sky," the name reflects the company's mission to rise above the status quo and deliver therapies that change lives. Celea's lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit www.celeatx.com. About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit www.puretechhealth.com or connect with us on LinkedIn and X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the planned development of deupirfenidone and our and Celea's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Contact: PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com [1] Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121-1128. [2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. END NRAEAFPSAEKKEEA

Phase 3Clinical ResultPhase 1Phase 2Orphan Drug

25 Aug 2026

·www.biospace.com

PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress

Presentations will highlight Celea’s differentiated approach to advancing deupirfenidone for idiopathic pulmonary fibrosis (IPF), including details of the Phase 3 SURPASS-IPF trial design and key insights from a Phase 1 drug-drug interaction study with nintedanib BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics (“Celea”) today announced that it will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The full text of the announcement from Celea is as follows: Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON, August 25, 2026 – Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The presentations will detail the design and rationale for SURPASS-IPF, Celea’s global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. “Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone’s potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients’ quality of life,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches.” Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 – Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 – Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. About SURPASS-IPF SURPASS-IPF ( NCT07284602 ) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019. 1 Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, 2 and currently there is no cure. About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” the name reflects the company’s mission to rise above the status quo and deliver therapies that change lives. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the planned development of deupirfenidone and our and Celea’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. [1] Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121-1128. [2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23 (3-b Suppl), S17-S24. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com

Phase 3Clinical ResultPhase 2Phase 1Orphan Drug

25 Aug 2026

·www.biospace.com

Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress

SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON--(BUSINESS WIRE)--Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The presentations will detail the design and rationale for SURPASS-IPF, Celea’s global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. “Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone’s potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients’ quality of life,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches.” Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 – Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 – Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. About SURPASS-IPF SURPASS-IPF ( NCT07284602 ) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019. 1 Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, 2 and currently there is no cure. About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” the name reflects the company’s mission to rise above the status quo and deliver therapies that change lives. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . [1] Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121-1128. [2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23 (3-b Suppl), S17-S24. Contacts Celea Public Relations publicrelations@celeatx.com US Media Justin Chen jchen@tenbridgecommunications.com

Phase 3Clinical ResultPhase 2Orphan DrugPhase 1

100 Deals associated with Pirfenidone

External Link

KEGG	Wiki	ATC	Drug Bank
D01583	Pirfenidone	L04AX05	DB04951

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Japan	Shionogi & Co., Ltd.	16 Oct 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	26 Mar 2026
Radiation Injuries	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	26 Mar 2026
Anthracosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	09 May 2022
Pneumoconiosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	09 May 2022
Silicosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	09 May 2022
Interstitial lung disease due to systemic disease	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	15 Jun 2018
Sclerotylosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	08 Jun 2018
Dermatomyositis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	01 Jun 2018
Lung Diseases, Interstitial	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	01 Jun 2018
Lung Injury	Phase 2	China	Beijing Kangdini Pharmaceutical Co., Ltd.	26 Mar 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2026	Not Applicable	Lung Diseases, Interstitial	107	Nintedanib	vxoahcbfxa(snptuiyqow) = xmoaiodgbn gripevotud (ospawlnqfl ) View more	Positive	11 Jun 2026
				Pirfenidone	vxoahcbfxa(snptuiyqow) = yduzecnari gripevotud (ospawlnqfl ) View more
ATS2026	Not Applicable	Idiopathic Pulmonary Fibrosis	518	Nintedanib	nndsilhiyd(qycdnogbib) = maewjhfpst vrpoqeqdid (njfgqzntwj ) View more	Positive	15 May 2026
				Pirfenidone	nndsilhiyd(qycdnogbib) = snqqcgpfms vrpoqeqdid (njfgqzntwj ) View more
PROSPERO (ATS2026)	Not Applicable	Idiopathic Pulmonary Fibrosis	7,404	Nintedanib	sqboiytttd(efbygxzqor): HR = 1.24 (95.0% CI, 0.91 - 1.69), P-Value = 0.18 View more	Positive	15 May 2026
				Pirfenidone
NCT06484153 (ASCO_GI2026)	Phase 1/2	Metastatic Colorectal Carcinoma pMMR \| MSS	24	Fruquintinib+pirfenidone+anti-PD-1 antibody	tjgpnemfdk(xfuofihtcy) = mvebwrhfyw tymvjwjegu (iucsavlnlv ) View more	Positive	08 Jan 2026
NCT06329401 (MIST, Pubmed \| BMJ Open Respir Res)	Phase 2	Progressive pulmonary fibrosis	300	AP01 50 mg two times per day	kzwiqnusqy(yevxbeueza) = wnqpsslorj zevvqtskie (lplmyzyfkj )	Positive	01 Dec 2025
				Placebo two times per day	icwnefxpbf(pfyfwapzxl) = fvqhzcnuze amjvfazbad (afhzaazrqv )
NCT03902509 (Pubmed \| Lancet Oncol)	Phase 2	-	134	Pirfenidone plus glucocorticoids	tkdvjdhozf(aovxygjidn) = pneumonia (four [6%] of 67 patients in the pirfenidone group vs eight [12%] of 67 patients in the control group), and rash (two [3%] of 67 patients in the pirfenidone group vs none in the control group). kvopgqsgky (pxhhowsyhi )	Positive	01 Dec 2025
				Glucocorticoids
ACR2025	Not Applicable	Autoimmune Diseases \| Scleroderma, Systemic \| Rheumatoid arthritis with rheumatoid lung disease	132	nintedanib (RA-ILD + SSc-ILD + SADs-ILD)	pgfviimedj(tjletmewzg) = gwjumsskjv mvgbkhoajg (dzhxsfkvzd ) View more	Positive	24 Oct 2025
				pirfenidone (RA-ILD + SSc-ILD + SADs-ILD)	pgfviimedj(tjletmewzg) = lqummjryzj mvgbkhoajg (dzhxsfkvzd ) View more
ACR2025	Not Applicable	Primary Sjögren's syndrome anti-SSA/Ro \| anti-SSB/La	45	Glucocorticoids	xdlvyphail(utqyxbgacn) = pmbillznny vozhoblkox (dsngyqhbtv, 114.0) View more	Positive	24 Oct 2025
ChiCTR2400081900 (ESMO2025)	Phase 2	radiation oral mucositis	87	Pirfenidone	dspjukhqwn(fpodgroavh) = ogphimegxw revsvfktzi (vlytrdeelw )	Positive	17 Oct 2025
				Pirfenidone (Historical controls)	dspjukhqwn(fpodgroavh) = eagjcouqsq revsvfktzi (vlytrdeelw )
ASCO2025	Not Applicable	Idiopathic Pulmonary Fibrosis	4,529	Pirfenidone	xtyrntgwmn(ersdzkjfeq) = fjqewhpyuo vzorxtilwp (yfxbgwytqw )	Positive	30 May 2025
				Non-Pirfenidone	xtyrntgwmn(ersdzkjfeq) = smlmyzlkpb vzorxtilwp (yfxbgwytqw )

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