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)

This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.

开始日期2026-06-26

申办/合作机构

PureTech Health Plc

CTRI/2023/02/050138

/ Recruiting临床2期

A Randomized, Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).

开始日期2023-03-30

申办/合作机构

Puretech LYT, Inc.

NCT05321420

/ Active, not recruiting临床2期

A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

开始日期2022-07-22

申办/合作机构

PureTech Health Plc

100 项与 Deupirfenidone 相关的临床结果

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100 项与 Deupirfenidone 相关的转化医学

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100 项与 Deupirfenidone 相关的专利（医药）

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项与 Deupirfenidone 相关的文献（医药）

2026-08-01·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial

Article

Abstract:

Rationale:

Deupirfenidone is a strategically deuterated form of pirfenidone that retains pharmacodynamic activity but has a differentiated pharmacokinetic profile that may enable improved efficacy and favorable tolerability in patients with idiopathic pulmonary fibrosis (IPF).

Objectives:

To evaluate the efficacy and safety of deupirfenidone compared with placebo and pirfenidone in patients with IPF.

Methods:

Patients were randomized 1:1:1:1 to deupirfenidone 550 mg TID, deupirfenidone 825 mg TID, pirfenidone 801 mg TID, or placebo. The primary endpoint was the rate of change in forced vital capacity (FVC) for the combined arms of deupirfenidone versus placebo at 26 weeks. The primary and secondary analyses used Bayesian and frequentist approaches, respectively.

Measurements and Main Results:

A total of 257 patients with IPF were randomized, and the proportion on treatment at the end of the study was 80.0%, 68.3%, 64.6%, and 78.1% for the placebo, pirfenidone, deupirfenidone 550 mg, and deupirfenidone 825 mg arms, respectively. Posterior mean change in FVC for placebo was -110.71 mL (95% credible interval (CI), -148.75, -70.98), and for the combined deupirfenidone arms was -48.42 mL (95% CI, -87.66, -9.04) with a posterior mean difference of 62.29 mL (95% CI l, -6.13, 115.73; posterior probability, 0.985). Using a frequentist approach, the adjusted mean change in FVC for the placebo arm was -112.5 mL (95% CI, -167.2, -57.8), and for the deupirfenidone 825 mg arm was -21.5 mL (95% CI, -78.2, 35.1); the adjusted mean difference was 91.0 mL (95% CI, 12.2, 169.7; P = .02). The most common adverse events for each active treatment arm were gastrointestinal.

Conclusions:

In patients with IPF, treatment with deupirfenidone slowed lung disease progression over 26 weeks.

Trial Registration:

Clinicaltrials.gov number NCT05321420.

2026-03-01·ERJ Open Research

A phase 1 pharmacokinetics study of deupirfenidone (LYT-100) in healthy older adults

Article

作者: Camilla S. Graham ; Michael C. Chen ; Eric Elenko ; Chris C. Korth ; Toby M. Maher ; Mark D. Harnett ; Varun Garg

Background:

Deupirfenidone, a selectively deuterated form of pirfenidone, is being developed for idiopathic pulmonary fibrosis (IPF), where tolerability limits current antifibrotic use. Deupirfenidone retains the biological activity of pirfenidone, and the differentiated pharmacokinetic (PK) profile may be associated with improved tolerability.

Methods:

A phase 1, three-part, randomised, double-blind study was conducted to identify phase 2 doses. The safety, tolerability, steady-state PK and food effect profile of deupirfenidone were assessed in healthy older adults. Part 1 was a crossover study comparing deupirfenidone 850 mg twice daily to pirfenidone 801 mg three times daily. Part 2 was a crossover study comparing deupirfenidone 550 mg three times daily to pirfenidone 801 mg three times daily. Part 3 was a parallel study of deupirfenidone 550 mg three times daily titrated to deupirfenidone 824 mg three times daily versus placebo.

Results:

Deupirfenidone 850 mg twice daily met the equivalence criterion to pirfenidone 801 mg three times daily for area-under-the-curve (AUC); however, maximum measured concentration ( Cmax ) and treatment-emergent adverse events (TEAEs) were higher with deupirfenidone. Deupirfenidone 550 mg three times daily met equivalence criterion to pirfenidone 801 mg three times daily for AUC; however, Cmax was lower. Frequency of gastrointestinal (GI) and nervous system (NS) TEAEs for deupirfenidone in the fed state was 40% lower than for pirfenidone. When deupirfenidone was titrated from 550 mg three times daily to 824 mg three times daily, PK parameters increased without increases in GI or NS TEAEs.

Conclusions:

Results suggest evaluating a dose for deupirfenidone in healthy older adults of between 550 mg three times daily and 825 mg three times daily. Both doses are being evaluated in a 26-week, phase 2b study in patients with IPF.

2025-07-01·ERJ Open Research

Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications

Article

作者: Harnett, Mark ; Santiaguel, Joel ; Krop, Julie ; Kulkarni, Tejaswini ; Aul, Raminder ; Chen, Michael C ; Maher, Toby M ; Graham, Camilla S

Introduction:

The pathophysiology of respiratory complications in post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is poorly understood, but a high incidence of progressive pulmonary fibrosis was anticipated. Deupirfenidone (LYT-100) is a selectively deuterated form of pirfenidone that retains antifibrotic and anti-inflammatory activity but with improved tolerability. This study evaluated the safety and efficacy of deupirfenidone in PASC patients with respiratory complications.

Methods:

Global, double-blind, randomised placebo-controlled trial evaluating 750 mg deupirfenidone twice daily versus placebo for 3 months in PASC patients with respiratory complications following hospitalisation for acute COVID-19 infection severe enough to necessitate supplemental oxygen (NCT04652518).

Results:

185 patients were randomised and treated (95 with deupirfenidone, 90 with placebo), with 177 included in the modified intention-to-treat population. The mean age was 54.5 years, 62.7% were male and 10.7% had prior mechanical ventilation. The 6-min walk distance improved across both arms between baseline and day 91 (deupirfenidone 44.3 m (95% CI 24.8–63.8 m) versus placebo 48.8 m (95% CI 29.2–68.4 m); p=0.70). The most common treatment-emergent adverse events (TEAEs) for deupirfenidone versus placebo were nausea (9.5% versus 1.1%), upper abdominal discomfort (5.3% versus 2.2%) and dyspepsia (6.3% versus 1.1%). TEAEs leading to trial drug discontinuation were 11.6% for deupirfenidone and 4.4% for placebo. The proportion of discontinuations considered at least possibly related to treatment was 8.6% for deupirfenidone and 2.4% for placebo.

Discussion:

Most patients with PASC and respiratory complications showed significant improvement over 91 days irrespective of treatment assignment. Deupirfenidone was well tolerated, with low rates of TEAEs, which supports further investigation in patients with idiopathic pulmonary fibrosis.

项与 Deupirfenidone 相关的新闻（医药）

2026-10-29

·BioSpace

PureTech Founded Entity Celea Therapeutics Appoints Paul Audhya, MD, MBA, as Chief Medical Officer

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, notes that its Founded Entity, Celea Therapeutics, Inc. (“Celea”), today announced the appointment of Paul Audhya, MD, MBA, as Chief Medical Officer. Dr. Audhya joins an experienced leadership team that includes Sven Dethlefs, PhD, Chief Executive Officer; Vishwas (Vish) Setia, MBA, Chief Financial Officer; Ronen Tamir, MBA, Chief Operating Officer; and David M. Stark, JD, General Counsel, Secretary and Chief Compliance Officer. Collectively, Celea’s leadership team brings experience across clinical development, regulatory strategy, commercial launches, strategic transactions, financing, and organizational growth. The full text of the announcement from Celea is as follows: Celea Therapeutics Appoints Paul Audhya, MD, MBA, as Chief Medical Officer Appointment strengthens Celea’s leadership team as the company advances deupirfenidone through Phase 3 development in idiopathic pulmonary fibrosis (IPF) BOSTON -- October 29, 2026 – Celea Therapeutics, Inc. (“Celea” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need, today announced the appointment of Paul Audhya, MD, MBA, as Chief Medical Officer. Dr. Audhya brings nearly three decades of experience in leading clinical development and global medical affairs organizations. He joins Celea’s experienced leadership team and will oversee Celea’s clinical development and medical strategy, including the ongoing Phase 3 SURPASS-IPF trial. “Paul brings deep clinical development and medical affairs expertise, as well as a proven record of guiding programs from development through commercialization,” said Sven Dethlefs, PhD, Chief Executive Officer of Celea. “His appointment marks an important step in building out the leadership team required for Celea’s next phase of growth. Following the closing of our $180 million financing in July and Celea’s spin-off from PureTech Health, we have assembled an accomplished team with deep experience in company building, clinical development, commercialization, strategic finance, and global operations. Together, we are focused on advancing deupirfenidone with the ongoing Phase 3 SURPASS-IPF trial, and building Celea into a leading respiratory disease company.” “For too long, people living with IPF have faced a difficult balance between treatment efficacy and tolerability. With deupirfenidone, we aim to move beyond that trade-off and raise the bar for efficacy in IPF,” said Dr. Audhya. “Initiating the landmark Phase 3 SURPASS-IPF trial is a transformative milestone for our program. I am thrilled to join the exceptional team at Celea and eager to collaborate with our investigators, advisors, and the patient community to unlock the full potential of deupirfenidone.” Dr. Audhya most recently served as Chief Medical Officer of KalVista Pharmaceuticals, Inc., where he led global clinical development strategy and regulatory authority submissions across major international markets. He previously held senior leadership roles at Arena Pharmaceuticals, Inc., Vertex Pharmaceuticals Incorporated, Hospira, Inc., and Reata Pharmaceuticals, Inc., and had roles of increasing responsibility at Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb Company, and Janssen Pharmaceuticals, Inc., and has guided programs from development through commercialization across multiple therapeutic areas, including for rare diseases. Building Celea’s Leadership Team for its Next Phase Dr. Audhya joins an experienced leadership team led by Chief Executive Officer Sven Dethlefs, PhD, and further strengthens the Company’s executive leadership team following its spin-off from PureTech Health and the closing of the Company’s $180 million financing in July 2026. The team also includes: Vishwas (Vish) Setia, MBA, Chief Financial Officer, who previously served as Chief Financial Officer of MapLight Therapeutics, Inc., where he led the company’s Series D financing and initial public offering, and previously spent a decade in healthcare investment banking at BofA Securities, Inc. Ronen Tamir, MBA, Chief Operating Officer, who has built and scaled global organizations through leadership roles at Pfizer Inc., Teva Pharmaceutical Industries Limited, GE Healthcare, Rosetta Genomics Ltd., Novartis AG and EMD Serono Inc. David M. Stark, JD, General Counsel, Secretary and Chief Compliance Officer, who previously served as Chief Legal Officer of Teva Pharmaceutical Industries Limited, where he led the global legal organization for nearly a decade. Collectively, Celea’s leadership team brings experience across clinical development, regulatory strategy, commercial launches, strategic transactions, financing, and organizational growth. Their experience, spanning global pharmaceutical leadership and emerging biotechnology company building, positions Celea to execute its mission with speed, discipline, and a strong focus on creating value for patients and stakeholders. About Celea Therapeutics Celea Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need. The Company’s therapeutic candidate, deupirfenidone, is an investigational next-generation oral antifibrotic therapy being evaluated in a Phase 3 clinical program for IPF, a progressive and fatal lung disease. Building on the established antifibrotic foundation of pirfenidone, deupirfenidone is being developed with the goal of improving outcomes for patients with IPF and potentially other progressive fibrotic interstitial lung diseases. Through its focus on enhancing the therapeutic benefits of antifibrotic treatment, Celea aims to advance the standard of care in fibrotic lung disease. 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 X (formerly Twitter) @puretechh. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com

2026-10-29

·BioSpace

Celea Therapeutics Appoints Paul Audhya, MD, MBA, as Chief Medical Officer

Appointment strengthens Celea’s leadership team as the company advances deupirfenidone through Phase 3 development in idiopathic pulmonary fibrosis (IPF) BOSTON--(BUSINESS WIRE)--Celea Therapeutics, Inc. (“Celea” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need, today announced the appointment of Paul Audhya, MD, MBA, as Chief Medical Officer. Dr. Audhya brings nearly three decades of experience in leading clinical development and global medical affairs organizations. He joins Celea’s experienced leadership team and will oversee Celea’s clinical development and medical strategy, including the ongoing Phase 3 SURPASS-IPF trial. “Paul brings deep clinical development and medical affairs expertise, as well as a proven record of guiding programs from development through commercialization,” said Sven Dethlefs, PhD, Chief Executive Officer of Celea. “His appointment marks an important step in building out the leadership team required for Celea’s next phase of growth. Following the closing of our $180 million financing in July and Celea’s spin-off from PureTech Health, we have assembled an accomplished team with deep experience in company building, clinical development, commercialization, strategic finance, and global operations. Together, we are focused on advancing deupirfenidone with the ongoing Phase 3 SURPASS-IPF trial, and building Celea into a leading respiratory disease company.” “For too long, people living with IPF have faced a difficult balance between treatment efficacy and tolerability. With deupirfenidone, we aim to move beyond that trade-off and raise the bar for efficacy in IPF,” said Dr. Audhya. “Initiating the landmark Phase 3 SURPASS-IPF trial is a transformative milestone for our program. I am thrilled to join the exceptional team at Celea and eager to collaborate with our investigators, advisors, and the patient community to unlock the full potential of deupirfenidone.” Dr. Audhya most recently served as Chief Medical Officer of KalVista Pharmaceuticals, Inc., where he led global clinical development strategy and regulatory authority submissions across major international markets. He previously held senior leadership roles at Arena Pharmaceuticals, Inc., Vertex Pharmaceuticals Incorporated, Hospira, Inc., and Reata Pharmaceuticals, Inc., and had roles of increasing responsibility at Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb Company, and Janssen Pharmaceuticals, Inc., and has guided programs from development through commercialization across multiple therapeutic areas, including for rare diseases. Building Celea’s Leadership Team for its Next Phase Dr. Audhya joins an experienced leadership team led by Chief Executive Officer Sven Dethlefs, PhD, and further strengthens the Company’s executive leadership team following its spin-off from PureTech Health and the closing of the Company’s $180 million financing in July 2026. The team also includes: Vishwas (Vish) Setia, MBA, Chief Financial Officer, who previously served as Chief Financial Officer of MapLight Therapeutics, Inc., where he led the company’s Series D financing and initial public offering, and previously spent a decade in healthcare investment banking at BofA Securities, Inc. Ronen Tamir, MBA, Chief Operating Officer, who has built and scaled global organizations through leadership roles at Pfizer Inc., Teva Pharmaceutical Industries Limited, GE Healthcare, Rosetta Genomics Ltd., Novartis AG and EMD Serono Inc. David M. Stark, JD, General Counsel, Secretary and Chief Compliance Officer, who previously served as Chief Legal Officer of Teva Pharmaceutical Industries Limited, where he led the global legal organization for nearly a decade. Collectively, Celea’s leadership team brings experience across clinical development, regulatory strategy, commercial launches, strategic transactions, financing, and organizational growth. Their experience, spanning global pharmaceutical leadership and emerging biotechnology company building, positions Celea to execute its mission with speed, discipline, and a strong focus on creating value for patients and stakeholders. About Celea Therapeutics Celea Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need. The Company’s therapeutic candidate, deupirfenidone, is an investigational next-generation oral antifibrotic therapy being evaluated in a Phase 3 clinical program for IPF, a progressive and fatal lung disease. Building on the established antifibrotic foundation of pirfenidone, deupirfenidone is being developed with the goal of improving outcomes for patients with IPF and potentially other progressive fibrotic interstitial lung diseases. Through its focus on enhancing the therapeutic benefits of antifibrotic treatment, Celea aims to advance the standard of care in fibrotic lung disease. Contacts For additional information: Info@celeatx.com US Media Justin Chen TBCCelea@tenbridgecommunications.com

高管变更临床3期

2026-09-30

·BioSpace

Celea Therapeutics Presents SURPASS-IPF Phase 3 Trial Design and Statistical Considerations for Evaluating Clinical Trials in Idiopathic Pulmonary Fibrosis at the IPF Summit 2026

SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial comparing an investigational drug to an approved antifibrotic in patients with idiopathic pulmonary fibrosis (IPF) Considerations of statistical methods illustrate how analytical choices affect perceptions of efficacy, highlighting differences in parametric and non-parametric approaches BOSTON--(BUSINESS WIRE)--Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need, today announced that the Company will deliver two poster presentations showcasing its deupirfenidone (LYT-100) program at the IPF Summit, taking place in Boston, MA, from September 29 to October 1, 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 IPF. The first poster 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 is the first industry-sponsored Phase 3 head-to-head trial comparing an investigational drug to an approved antifibrotic in patients with IPF. The second poster will examine statistical considerations for evaluating forced vital capacity (FVC), a widely used measure of disease progression and primary endpoint in many IPF clinical trials, including SURPASS-IPF, with a focus on how analytical choices may affect perceptions of efficacy. “Building on positive Phase 2b results, SURPASS-IPF takes an important next step by directly comparing deupirfenidone to pirfenidone in IPF,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “We are applying carefully considered statistical methods to rigorously evaluate whether deupirfenidone is superior to a current standard of care, with the goal of generating clear, robust evidence that can help advance treatment for people living with IPF.” Details of the presentations are as follows: Title: SURPASS-IPF: Study Design of a Phase 3, Head-to-Head Trial of Deupirfenidone Versus Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Presenter: Toby Maher, M.D., Ph.D., Director of Interstitial Lung Disease, Keck School of Medicine of the University of Southern California Session: Afternoon Break & Poster Session Date and Time: September 30, 2026, 4:00 PM EDT Title: Statistical Consideration of the Phase 3 Deupirfenidone vs Pirfenidone Trial: SURPASS-IPF Presenter: Toby Maher, M.D., Ph.D., Director of Interstitial Lung Disease, Keck School of Medicine of the University of Southern California Session: Afternoon Break & Poster Session Date and Time: September 30, 2026, 4:00 PM EDT 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 TID over pirfenidone 801 mg TID in approximately 1,100 adults living with IPF who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute 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 IPF and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) 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 trial 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) 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 a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need. Celea’s therapeutic candidate, deupirfenidone, is an investigational next-generation oral antifibrotic therapy being evaluated in a Phase 3 clinical program for IPF, a progressive and fatal lung disease. Building on the established antifibrotic foundation of pirfenidone, deupirfenidone is being developed with the goal of improving outcomes for people living with IPF and potentially other progressive fibrotic interstitial lung diseases. ____________________ [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 Information info@celeatx.com US Media Justin Chen TBCCelea@tenbridgecommunications.com

临床3期临床2期临床结果孤儿药

100 项与 Deupirfenidone 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床3期	美国	Celea Therapeutics, Inc. (United States)	2026-06-26
特发性肺纤维化	临床3期	美国	PureTech Health Plc	2026-06-26
特发性肺纤维化	临床3期	加拿大	PureTech Health Plc	2026-06-26
新冠肺炎后遗症	临床2期	美国	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	阿根廷	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	巴西	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	摩尔多瓦	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	菲律宾	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	罗马尼亚	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	乌克兰	PureTech Health Plc	2020-12-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05321420 (ELEVATE-IPF, Pubmed \| Am J Respir Crit Care Med)	临床2期	特发性肺纤维化	257	Deupirfenidone 550 mg	願窪網積築齋壓夢構獵(衊蓋衊簾憲醖網廠襯選) = 膚膚壓餘齋製選鹽襯築範鑰簾構膚壓憲夢鬱簾 (鏇鏇範鏇鑰夢選觸觸憲, -87.66 ~ -9.04)	积极	2026-08-01
				Deupirfenidone 825 mg	願窪網積築齋壓夢構獵(衊蓋衊簾憲醖網廠襯選) = 衊顧餘顧鏇糧齋鹽艱顧範鑰簾構膚壓憲夢鬱簾 (鏇鏇範鏇鑰夢選觸觸憲, -148.75 ~ -70.98)
NCT04652518 (CTgov)	临床2期	新冠肺炎后遗症	185	Placebo (Placebo)	觸構壓築簾遞獵築選範(範簾鹽願製繭積顧膚醖) = 艱鹽鬱網壓糧簾憲觸鏇糧壓積餘廠窪觸鏇築鑰 (襯鏇遞餘鬱鹽衊鑰簾蓋, 9.997) 更多	-	2026-06-23
				LYT-100 (LYT-100)	觸構壓築簾遞獵築選範(範簾鹽願製繭積顧膚醖) = 膚齋夢選餘範廠選積廠糧壓積餘廠窪觸鏇築鑰 (襯鏇遞餘鬱鹽衊鑰簾蓋, 9.948) 更多
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	257	Deupirfenidone 825 mg TID (≥75 y)	積鏇鑰製遞窪鬱範衊願(鑰選鬱壓淵鬱憲襯窪構) = TEAEs, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. 窪積鹹廠觸艱築鬱範糧 (願膚襯艱遞積淵壓鑰襯 ) 更多	积极	2025-10-22
				Deupirfenidone 825 mg TID (<75 y)
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	170	Deupirfenidone 550 mg TID	膚艱襯憲餘鑰範廠衊鏇(鹹觸製網醖遞糧顧繭遞) = The most common TEAEs were nausea (8.4% vs. 11.5%), dyspepsia (14.5% vs. 12.6%), upper respiratory infections (16.9% vs. 17.2%), and cough (10.8% vs. 4.6%) for deupirfenidone 550 mg TID and deupirfenidone 825 mg TID, respectively. 願衊網網夢製齋範鹹鏇 (構顧衊夢鑰夢顧餘製鏇 ) 更多	积极	2025-09-29
				Deupirfenidone 825 mg TID
NCT04652518 (Pubmed \| ERJ Open Res)	临床2期	新冠肺炎后遗症	177	Deupirfenidone (LYT-100) 750 mg	築遞鬱鑰憲齋鏇遞觸鹽(築衊膚壓醖醖鬱鹹鏇衊) = 顧齋遞廠齋壓顧繭鹽鑰鹹蓋鬱製簾襯鏇鑰夢壓 (鏇選糧遞簾襯積願簾餘, 24.8 ~ 63.8) 更多	积极	2025-07-01
				Placebo	築遞鬱鑰憲齋鏇遞觸鹽(築衊膚壓醖醖鬱鹹鏇衊) = 構襯憲遞壓醖膚餘觸鹽鹹蓋鬱製簾襯鏇鑰夢壓 (鏇選糧遞簾襯積願簾餘, 29.2 ~ 68.4) 更多
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	-	Deupirfenidone 550 mg TID	壓衊糧餘築淵襯淵鏇壓(網憲築餘憲淵鹹顧衊範) = 獵糧網蓋壓餘範遞憲鑰製壓遞積簾製衊醖襯選 (蓋獵鏇範餘膚廠製鬱觸 )	积极	2025-05-20
				Deupirfenidone 825 mg TID	獵遞鹽顧壓糧鏇壓製築(襯製襯膚鹹製糧製獵積) = 簾鑰蓋鹽鬱餘網廠壓壓鏇憲網構壓醖顧範製顧 (顧憲窪構艱簾網艱齋選 ) 更多
NCT05321420 (ELEVATE IPF, BusinessWire) 人工标引	临床2期	特发性肺纤维化	-	Placebo TID	遞築夢衊鑰壓憲繭網遞(範顧網襯構夢艱壓鹹選) = 構鬱廠顧範觸鏇窪觸窪齋齋艱願鹽膚積襯窪鹹 (糧壓鑰膚鹹餘鑰憲艱窪, 27.84) 达到更多	积极	2024-12-16
				Pirfenidone 801 mg TID	遞築夢衊鑰壓憲繭網遞(範顧網襯構夢艱壓鹹選) = 鹽繭艱衊壓糧膚獵鬱廠齋齋艱願鹽膚積襯窪鹹 (糧壓鑰膚鹹餘鑰憲艱窪, 29.13) 达到更多
Biospace 人工标引	N/A	特发性肺纤维化	-	LYT-100	廠積製廠鑰選選遞夢鏇(築選遞願鏇顧築糧獵窪) = LYT-100 also demonstrated a 24% lower than pirfenidone 襯鏇壓窪選鹹蓋範築襯 (願網窪製獵壓襯醖網遞 ) 更多	积极	2023-10-11
				pirfenidone
ATS2023	N/A	新冠肺炎后遗症	-	LYT-100 750mg BID	淵鹹築觸鬱製觸膚觸獵(簾鹹遞鹽鹹繭選醖膚積) = 衊選觸齋鑰醖觸鹽餘衊艱齋蓋範鏇蓋選範築積 (構範膚膚齋襯壓鏇獵築, 24.8 ~ 63.8)	-	2023-05-21
				Placebo	淵鹹築觸鬱製觸膚觸獵(簾鹹遞鹽鹹繭選醖膚積) = 製積積鏇艱積齋獵餘糧艱齋蓋範鏇蓋選範築積 (構範膚膚齋襯壓鏇獵築, 29.2 ~ 68.4)
NCT04652518 (Corporate Publications) 人工标引	临床2期	新冠肺炎后遗症	177	deupirfenidone	齋醖壓繭選願願淵觸網(夢淵窪膚觸淵壓膚艱夢) = Individuals in both the treatment and placebo arms meaningfully improved walking distance on the 6MWT as compared to baseline, and no statistically significant differences between treatment groups were observed. 艱餘觸淵鏇衊醖餘衊艱 (鹹窪願憲醖鹹夢膚襯選 ) 更多	不佳	2022-06-14
				Placebo