Delving into the Latest Updates on Pirfenidone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pirfenidone (JAN/USAN/INN)

+ [18]

Target-

Mechanism-

Therapeutic Areas

Respiratory DiseasesOther DiseasesNeoplasms+ [5]

Active Indication

Idiopathic Pulmonary FibrosisInterstitial lung disease due to systemic diseasePneumoconiosis+ [9]

Inactive Indication

Acute myocardial infarctionAllograft RejectionAlveolitis, Extrinsic Allergic+ [15]

Originator Organization

InterMune, Inc.

Active Organization

Beijing Kangdini Pharmaceutical Co., Ltd.

Genentech, Inc.Viatris Ltd. (New Zealand)

+ [9]

Inactive Organization

Hoffmann-La Roche, Inc.Roche Pharma AG

GNI-EPS Pharmaceuticals, inc.

+ [4]

Drug Highest PhaseApproved

First Approval Date

JP (16 Oct 2008),

Idiopathic Pulmonary Fibrosis

RegulationSpecial Review Project (CN), Orphan Drug (JP), Fast Track (US), Breakthrough Therapy (US)

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Structure/Sequence

Molecular FormulaC12H11NO

InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N

CAS Registry53179-13-8

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another.
Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.
Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

Start Date24 Jan 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

KCT0009628

/ Not yet recruitingPhase 4IIT

A Multicenter, Double blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Pirfenidone vs Placebo in Patients with Progressive Pulmonary Fibrosis

Start Date31 Dec 2024

Sponsor / Collaborator

Asan Medical Center

IRCT20240804062647N2

/ RecruitingNot Applicable

Bioequivalence study of Pirfenidone 200 mg tablets produced by Actoverco pharmaceutical company with the reference drug Pirfenex 200 mg manufactured by CIPLA LTD company

Start Date21 Dec 2024

Sponsor / Collaborator-

100 Clinical Results associated with Pirfenidone

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100 Translational Medicine associated with Pirfenidone

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100 Patents (Medical) associated with Pirfenidone

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1,980

Literatures (Medical) associated with Pirfenidone

01 Mar 2025·Biomaterials Advances

The application and prospects of drug delivery systems in idiopathic pulmonary fibrosis

Review

Author: Li, Yunfei ; Zhang, Longju ; Wu, Manli ; Gong, Ling ; Zhang, Ling ; Tian, Jiahua ; Zhang, Xi ; Qin, Xiaofei

Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease primarily affecting elderly individuals aged >65 years and has a poor prognosis. No effective treatment is currently available for IPF. The two antipulmonary fibrosis drugs nintedanib and pirfenidone approved by the FDA in the United States have somewhat decelerated IPF progression. However, the side effects of these drugs can lead to poor patient tolerance and compliance with the medications. Researchers have recently developed various methods for IPF treatment, such as gene silencing and pathway inhibitors, which hold great promise in IPF treatment. Nevertheless, the nonselectivity and nonspecificity of drugs often affect their efficacies. Drug delivery systems (DDS) are crucial for delivering drugs to specific target tissues or cells, thereby minimizing potential side effects, enhancing drug bioavailability, and reducing lung deposition. This review comprehensively summarizes the current state of DDS and various delivery strategies for IPF treatment (e.g., nano-delivery, hydrogel delivery, and biological carrier delivery) to completely expound the delivery mechanisms of different drug delivery carriers. Subsequently, the advantages and disadvantages of different DDS are fully discussed. Finally, the challenges and difficulties associated with the use of different DDS are addressed so as to accelerate their rapid clinical translation.

01 Mar 2025·The International Journal of Biochemistry & Cell Biology

The role of TRP channels in lung fibrosis: Mechanisms and therapeutic potential

Article

Author: Ratnasingham, M ; Roach, K M ; Bradding, P

Idiopathic pulmonary fibrosis (IPF) is a severe lung disease affecting around 5 million people globally, with a median survival of 3-4 years. Characterized by excessive scarring of lung tissue, IPF results from the accumulation of myofibroblasts that deposit extracellular matrix (ECM), causing fibrosis. Current treatments, pirfenidone and nintedanib, slow the disease but do not stop its progression. IPF pathogenesis involves repeated alveolar injury, leading to pro-fibrotic mediators like TGFβ1, which trigger fibroblast-to-myofibroblast transitions and ECM deposition. Recent research suggests that transient receptor potential (TRP) channels, such as TRPV4, TRPC6, and TRPA1, play a key role in regulating calcium signalling and mechanical stress, crucial in myofibroblast activation. Targeting TRP channels may disrupt fibrosis and offer new therapeutic strategies. Preclinical studies indicate that inhibiting TRP channels could reduce fibrosis, warranting further trials to explore their efficacy and safety in treating IPF and related fibrotic conditions.

01 Feb 2025·Microbial Pathogenesis

Recent advances in TGF-β signaling pathway in COVID-19 pathogenesis: A review

Review

Author: Azizi, Seyed Ghader ; Davodabadi, Fatemeh ; Abdollahi, Zahra ; Shahriari, Hossein ; Sargazi, Saman ; Sabeti Akbar-Abad, Mahboobeh ; Majidpour, Mahdi

The coronavirus disease 2019 (COVID-19) has resulted in approximately 7.0 million fatalities between 2019 and 2022, underscoring a pressing need for comprehensive research into its underlying mechanisms and therapeutic avenues. A distinctive feature of severe COVID-19 is the dysregulated immune response characterized by excessive activation of immune cells and the consequent cytokine storms. Recent advancements in our understanding of cellular signaling pathways have illuminated the role of Transforming Growth Factor Beta (TGF-β) as a pivotal signaling molecule with significant implications for the pathogenesis of infectious diseases, including COVID-19. Emerging evidence reveals that TGF-β signaling, when activated by viral components or secondary pathways, adversely affects diverse cell types, particularly immune cells, and lung tissue, leading to complications such as pulmonary fibrosis. In our review article, we critically evaluate recent literature on the involvement of TGF-β signaling in the progression of COVID-19. We discuss a range of pharmacological interventions, including nintedanib, pirfenidone, corticosteroids, proton pump inhibitors, and histone deacetylase inhibitors, and their potential to modulate the TGF-β pathway in the context of COVID-19 treatment. Additionally, we explore ongoing clinical trials involving mesenchymal stem cells, low-dose radiation therapy, and artemisinin derivatives to assess their impact on TGF-β levels and subsequent clinical outcomes in COVID-19 patients. This review is particularly relevant at this juncture as the global health community continues to grapple with the ramifications of the COVID-19 pandemic, highlighting the urgent need for targeted therapeutic strategies aimed at TGF-β modulation to mitigate disease severity and improve patient outcomes.

137

News (Medical) associated with Pirfenidone

06 Jan 2025

·www.globenewswire.com

Gyre Therapeutics Announces the Appointment of Ping Zhang to Board of Directors

SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced the appointment of Ping Zhang to its Board of Directors (the “Board”) as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee of the Board. In addition, Ying Luo, Ph.D. resigned as Chairman and a member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People’s Republic of China (“PRC”), to focus on other responsibilities at GNI Group Ltd. Songjiang Ma has been appointed Chairman of the Board of Directors of Gyre Pharmaceuticals. Mr. Zhang has served as a Managing Partner of String Capital Management Co., Limited since 2018. Previously he was the Head of Private Equity Investment and Fund of Funds Business at AEON Life Insurance Company, Ltd. From 2011 to 2015, he served as a Managing Partner of Japan Asia Investment Co., Ltd. Prior to joining Japan Asia Investment Co., Mr. Zhang served as a Managing Director at AEA Investors LP and as a Managing Director of Mitsubishi UFJ Securities Co., Ltd. Mr. Zhang currently serves on the board of directors of GNI and Asian Star Co (TSE: 8946). He received his B.S. in Polymer Science from Fudan University and his M.B.A. in Finance from the University of Chicago Booth School of Business. “As we enter a potentially transformative year for the company, we are excited to welcome Mr. Zhang to our Board, where his deep financial background will prove to be invaluable, and I look forward to leveraging his insights,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “I would also like to thank Dr. Luo for his leadership and contributions as Chairman of the Board. We wish him all the best in his future endeavors.” About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. About Gyre Pharmaceuticals Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2023 net sales of $112.1 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by early 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.). For Investors:Stephen Jasperstephen@gilmartinir.com

Executive ChangeDrug ApprovalPhase 3Breakthrough Therapy

17 Dec 2024

·www.globenewswire.com

Avalyn to Present at the 43rd Annual J.P. Morgan Healthcare Conference

CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 3:00 p.m. PT in San Francisco. Ms. Baranowski, CEO; Douglas Carlson, CFO, CBO; Howard Lazarus, M.D., FCCP, CMO; and Melissa Rhodes, Ph.D., COO, will also participate in 1x1 meetings with investors. About Avalyn PharmaAvalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex StrausTHRUST Strategic Communicationsalex@thrustsc.comir@avalynpharma.com Media Contact:Marites CoulterDeerfield Groupmarites.coulter@deerfieldgroup.commedia@avalynpharma.com

Phase 2Phase 1

16 Dec 2024

·endpts.com

PureTech declares mid-stage trial win for pulmonary fibrosis drug

PureTech Health unveiled positive Phase 2b data on Monday for its idiopathic pulmonary fibrosis drug, which showed it can reduce lung function decline in patients. The drug hit the trial’s primary and secondary endpoints, with deupirfenidone showing superiority to placebo in slowing the rate of lung function decline in people with IPF as measured by forced vital capacity — defined as the amount of air a person can exhale after taking a breath in — at 26 weeks. Patients taking the investigational drug at 825 mg three times a day saw an 80.9% treatment effect. In contrast, patients taking 801 mg of pirfenidone, a standard-of-care for IPF, saw a 54.1% effect. In a secondary endpoint, there was a 99.6% probability that the pooled deupirfenidone arms of the trial were superior to placebo in slowing the rate of lung function decline when using a Bayesian analysis. Executives on a Monday investor call said that the results supported moving into a Phase 3 trial. CEO Bharatt Chowrira added on the call that based on the data, only one more trial may be necessary before the company seeks approval. PureTech’s stock $PRTC on the Nasdaq was up nearly 10% on Monday. Deupirfenidone, a deuterated form of pirfenidone, is an oral treatment that works by inhibiting IL-6, TNF-α and transforming growth factor beta, according to the National Cancer Institute. As for safety, the most common adverse events included gastrointestinal issues like nausea and dyspepsia, and the only “key” gastrointestinal adverse event seen was abdominal pain, with 14.1% of patients on the drug experiencing the issue. “We’ve looked into it,” PureTech’s VP of medical affairs Camilla Graham told investors. “There’s no signal, no cause for any concern, and we’re continuing to dig into all of these numbers.” There were discontinuations, with 187 out of 257 patients completing the trial: 42 out of 65 patients in the deupirfenidone 550 mg arm and 50 out of 64 patients in the 825 mg arm. Of the patients who completed the trial, 170 enrolled in the open-label extension portion of the trial. In response to a question about discontinuations from Endpoints News , a representative for the company said they “have just received these data and our primary focus has been assessing efficacy and the key GI adverse events,” adding that “there is nothing in the data to give us cause for concern.”

Clinical ResultPhase 3Phase 2

100 Deals associated with Pirfenidone

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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	JP	Shionogi & Co., Ltd.	16 Oct 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Interstitial lung disease due to systemic disease	Phase 3	CN	GNI Group Ltd.	29 May 2023
Pneumoconiosis	Phase 3	-	Beijing Kangdini Pharmaceutical Co., Ltd.	15 Apr 2022
Dermatomyositis	Phase 3	CN	Beijing Kangdini Pharmaceutical Co., Ltd.	01 Jun 2018
Lung Diseases, Interstitial	Phase 3	CN	Beijing Kangdini Pharmaceutical Co., Ltd.	31 Oct 2017
Sclerotylosis	Phase 3	CN	Beijing Kangdini Pharmaceutical Co., Ltd.	31 Oct 2017
Idiopathic Pulmonary Fibrosis	Phase 3	CN	Shandong Bestcomm Pharmaceutical Co., Ltd.	22 Nov 2013
Multiple Sclerosis	Phase 1	US	Marnac, Inc.	01 Mar 2002
Multiple Sclerosis	Phase 1	US	Marnac, Inc.	01 Mar 2002
Multiple Sclerosis	Preclinical	US	Bayer Schering Pharma AG	01 Mar 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASTRO2024	Phase 2	Radiation Injuries	134	Pirfenidone plus standard therapy	xjvrxblxjn(xlwlzmskga) = ypmdfdfghq avzvnuflun (moumzkhvbd ) View more	Positive	01 Oct 2024
WCLC2024	Phase 2	Lung Injury PD-1 inhibitors	14	Pirfenidone	jcarsvkbgc(dyzeqymcrm) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction nbixxmvqee (lajrxckolk )	Positive	07 Sep 2024
				Immune Checkpoint Inhibitors
ATS2024	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Ezetimibe users	qkamxugovr(wxfsgdvgpf) = lnsiebxggy feqtlzkqkl (ijzyhjzogw )	Positive	19 May 2024
				Non-users	qkamxugovr(wxfsgdvgpf) = jrczdbnrow feqtlzkqkl (ijzyhjzogw )
ESC2024	Not Applicable	Vascular Diseases	-	Pirfenidone diet	pnwxqljxqv(hpuulawzbc) = anqomlanuo mhqlomsqrg (wxbmqtkjgf, 13.02)	-	12 Apr 2024
				Pirfenidone (Conventional diet)	pnwxqljxqv(hpuulawzbc) = uapnkfvppf mhqlomsqrg (wxbmqtkjgf, 19.81)
NCT02622477 (AERplus, Pubmed \| Pneumologie) Manual	Not Applicable	Idiopathic Pulmonary Fibrosis	34	Pirfenidone	(plppqcfvqc) = hgbbwxnwbd fnqnzukfbv (cfgrafrqjr ) View more	Positive	01 Apr 2024
NCT03221257 (SLSIII, CTgov)	Phase 2	Scleroderma, Systemic \| Lung Diseases, Interstitial	51	Placebo (Plac)+Mycophenolate Mofetil (MMF) (Placebo (Plac) + Mycophenolate (MMF))	vsbsfrtsjx(mvsjlowqof) = jiwhomuzja exxsnplmlx (wdmesntkdr, haxabhtngg - zxuylzqbvg) View more	-	15 Dec 2023
				Pirfenidone (PFD)+Mycophenolate Mofetil (MMF) (Pirfenidone (PFD) + Mycophenolate (MMF))	vsbsfrtsjx(mvsjlowqof) = fvbhtuejxs exxsnplmlx (wdmesntkdr, ladpcfuubv - rajumqbkud) View more
AP01-005 (NEWS) Manual	Not Applicable	Idiopathic Pulmonary Fibrosis \| Lung Diseases, Interstitial	100	pirfenidone	(sljixlcmdd) = rokeosoeeg nnhxcxdizm (kiankveeeu )	Positive	09 Nov 2023
AP01-002 (NEWS) Manual	Phase 1	Idiopathic Pulmonary Fibrosis	69	pirfenidone	(bvnqjjhsow) = igxqqieogl pgmydbymly (jwbemtffys, 185.28) View more	Positive	09 Nov 2023
				pirfenidone	(bvnqjjhsow) = yzsrbtuuux pgmydbymly (jwbemtffys, 271.17) View more
SITC2023	Not Applicable	Pneumonia \| Non-Small Cell Lung Cancer	48	Pirfenidone	iknbqqnqex(pgfhcwrymz) = ucsazeubtn ocadgfeesd (dnqjeymgct )	Positive	02 Nov 2023
ATS2023	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Pirfenidone	(ukvpcxbwxo) = lozkpumpjo vncpfxjhka (loenbszqbs )	-	21 May 2023
				Nintedanib	(ukvpcxbwxo) = zsjmcdyrnu vncpfxjhka (loenbszqbs )