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

198

Clinical Trials associated with Pirfenidone

NCT06912763

/ Not yet recruitingPhase 2IIT

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.

Start Date18 Sep 2025

Sponsor / Collaborator-

NCT06241560

/ Not yet recruitingPhase 2

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

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 Date04 Aug 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07015398

/ RecruitingPhase 1

A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects

The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.

Start Date30 Jun 2025

Sponsor / Collaborator

Trevi Therapeutics, Inc.

100 Clinical Results associated with Pirfenidone

100 Translational Medicine associated with Pirfenidone

100 Patents (Medical) associated with Pirfenidone

2,718

Literatures (Medical) associated with Pirfenidone

01 Dec 2025·Annals of Diagnostic Pathology

Relationship between fibroblastic foci and respiratory function: Does the abundance of fibroblastic foci reflect a recent decline in respiratory function?

Article

Author: Sakamoto, Ryo ; Nakajima, Daisuke ; Tanaka, Satona ; Handa, Tomohiro ; Date, Hiroshi ; Hamaji, Masatsugu ; Katsuragawa, Hiroyuki ; Haga, Hironori ; Ito, Hiroaki ; Yoshizawa, Akihiko

AIMS:

Fibroblastic foci (FF) are main findings in idiopathic pulmonary fibrosis (IPF) but are not specific to IPF. Pirfenidone and nintedanib are standard antifibrotic treatments for IPF and affect factors associated with fibroblasts. A proportion of interstitial lung diseases (ILDs) are progressive fibrosing ILDs (PF-ILDs). This progressive fibrosing phenotype includes various ILDs, including fibrotic hypersensitivity pneumonitis (FHP) and connective tissue disease-related ILD (CTD-ILD). We examined the relationship between FF and a relative decline in respiratory function.

METHODS AND RESULTS:

Among patients with lung transplantation (LT), those diagnosed with IPF, nonspecific interstitial pneumonia (NSIP), CTD-ILD, and FHP for whom respiratory function test results within 24 months before LT were retrospectively available were included (n = 67). Patients were classified as PF-ILD+ or PF-ILD- based on the criteria for the progression of a relative decline in the predicted value of forced vital capacity (FVC) within 24 months before LT. We classified FF into peripheral (pFF), alveolar (aFF), centrilobular (cFF), and distorted or dense fibrotic lesions (dFF). The number of FF/cm² at each location was counted, and its percentage was calculated. Spearman's rank correlation coefficient between a relative decline in %FVC and total FF/cm² in NSIP was 0.721. The dFF/cm² and dFF/total FF ratios were higher and the aFF/total FF ratio was lower in the PF-ILD+ group than in the PF-ILD- group.

CONCLUSION:

Total FF correlated with relative declines in %FVC in NSIP. Higher dFF/total FF ratios were associated with progressive status, and higher aFF/total FF ratios were associated with less progressive status.

01 Oct 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Focal adhesion kinase inhibitors in fibrotic diseases therapy: Development and therapeutic potential

Review

Author: Wei, Wei ; Yu, Yan ; Su, Xingping ; Xie, Yuting ; Yue, Lin ; Liu, Zhihao ; Xue, Taixiong ; Ye, Tinghong ; Gan, Cailing

Organ fibrosis, characterized by dysregulated extracellular matrix deposition due to abnormal tissue repair, remains a significant challenge in medical research. Although nintedanib and pirfenidone have been approved for pulmonary fibrosis, effective treatments for hepatic, cardiac, and renal fibrosis remain markedly limited. The focal adhesion kinase (FAK) has been extensively implicated in the pathogenesis of organ fibrosis, with FAK kinase inhibition emerging as a pivotal therapeutic strategy for fibrosis modulation. In this review, we present a comprehensive analysis of FAK's biological functions in fibrotic progression and review preclinical advancements in FAK inhibitor development. We focus on the classification of FAK inhibitors, emphasizing their binding patterns, pharmacodynamic efficacy, and selectivity profiles from the perspective of pharmaceutical chemists. Additionally, we propose strategic frameworks for development of novel drugs targeting FAK for the treatment of fibrosis. The findings discussed in this review can guide the development of FAK inhibitors for treating organ fibrosis and underscore potential challenges in the drug development process.

01 Sep 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Naltrexone reduces bleomycin-induced lung fibrosis in rats by attenuating fibrosis, inflammation, oxidative stress, and extracellular matrix remodeling

Article

Author: Kazemzadeh, Houman ; Shafaroodi, Hamed ; Tavangar, Seyed Mohammad ; Teymoori Masuleh, Mohammad ; Dehpour, Ahmad Reza ; Manavi, Mohammad Amin ; Mohammadi Hamaneh, Amirabbas ; Nejati, Fatemeh

Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal lung disease characterized by excessive extracellular matrix (ECM) accumulation, fibroblast activation, and chronic inflammation. This study examined the antifibrotic effects of naltrexone (NTX), an opioid receptor antagonist, in a bleomycin (BLM)-induced pulmonary fibrosis model in Wistar rats. Daily administration of NTX significantly reduced alveolar wall thickening, collagen deposition, and histopathological injury scores. At higher doses, NTX markedly decreased levels of pro-inflammatory cytokines (TNF-α, IL-6, TGF-β), oxidative stress markers (MPO, NO), and key fibrotic markers including α-SMA and delta opioid receptor (DOR). Additionally, NTX restored antioxidant defenses (GSH, TAC) and enhanced GSK-3β phosphorylation, thereby modulating the Wnt/β-catenin and NF-κB signaling pathways. To further investigate the cellular mechanisms underlying NTX's antifibrotic activity, in vitro experiments were conducted using BLM-stimulated NIH-3 T3 fibroblasts. NTX inhibited the production of collagen type I and III, tissue inhibitors of metalloproteinases (TIMP-1 and TIMP-2), and matrix metalloproteinases (MMP-2 and MMP-9) in a dose- and time-dependent manner. This dual regulation of ECM synthesis and degradation suggests a more balanced therapeutic strategy compared to merely inhibiting collagen accumulation. Molecular docking analyses revealed strong interactions between NTX and key proteins involved in inflammatory and fibrotic signaling cascades. Notably, NTX at a dose of 20 mg/kg demonstrated antifibrotic efficacy comparable to that of pirfenidone. Collectively, these findings suggest that NTX exerts protective effects in pulmonary fibrosis by simultaneously targeting inflammation, oxidative stress, and ECM remodeling. Given its favorable tolerability and potential cost-effectiveness, NTX emerges as a promising candidate for IPF therapy. Further clinical investigations are warranted to evaluate its translational potential.

197

News (Medical) associated with Pirfenidone

22 Jul 2025

·www.fiercepharma.com

Avalyn raises $100M to advance inhaled versions of approved lung disease meds

Avalyn Pharma hopes its inhaled formulations of approved medicines will reduce systemic exposure and deliver medication directly to the site of disease. Avalyn Pharma has added on $100 million to accelerate novel inhaled versions of approved drugs for lung conditions.The company’s series D fundraise was led by Suvretta Capital Management and SR One and included 16 other investors, such as Novo Holdings, the investor fund best known as the controlling shareholder of Novo Nordisk.The new cash will go toward Avalyn’s clinical programs for pulmonary fibrosis, a lung-scarring condition that makes it harder to breathe. The Cambridge, Massachusetts-based business touts an inhaled formulation of pirfenidone—sold under many names as a pill for idiopathic pulmonary fibrosis (IPF), such as Pirespa—as one of its two lead programs.Dubbed AP01, Avalyn is currently assessing the candidate in a global phase 2b study, coded Mist, for patients with progressive pulmonary fibrosis. The trial is expected to enroll 300 participants and has a primary readout slated for April of next year, according to ClinicalTrials.gov.In an ongoing open-label extension of a phase 1b trial, the inhaled asset demonstrated safety and efficacy for more than four years, according to Avalyn.The company’s other lead program is another reformulation of an oral medication for IPF called nintedanib, which is marketed as Ofev and Vargatef. Avalyn’s inhaled version is known as AP02 and is expected to enter phase 2 testing for IPF.“Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis,” Avalyn CEO Lyn Baranowski said in a July 22 release. The series D money raise follows a $175 million series C in 2023 and a $35.5 million series B in 2020.The company hopes its inhaled formulations of approved medicines will be able to reduce systemic exposure and deliver medication directly to the site of disease for pulmonary fibrosis patients. Avalyn is also advancing AP03, a next-gen inhaled fixed-dose combination of AP01 and AP02. To date, pairing the oral therapies hasn’t been possible because of the additive side effects. Avalyn is currently running preclinical studies for the asset.

Phase 2

22 Jul 2025

·www.globenewswire.com

Avalyn Completes Oversubscribed $100 Million Series D Financing to Further Advance Clinical Development of Novel Inhaled Therapies for Pulmonary Fibrosis

Financing led by Suvretta Capital Management and SR One with participation from 16 additional healthcare investors Proceeds will support key clinical milestones across all of Avalyn’s pipeline programs CAMBRIDGE, Mass., July 22, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced the closing of an oversubscribed $100 million Series D financing. The raise was co-led by Suvretta Capital Management and SR One, with participation from Novo Holdings A/S, F-Prime, Perceptive Xontogeny Venture Funds, Norwest, Eventide Asset Management, Wellington Management, Vida Ventures, Catalio Capital Management, RiverVest Venture Partners, Pivotal bioVenture Partners, TPG Biotech, Hamilton Square Partners Management, LP (HSq), Rock Springs Capital, Surveyor Capital (a Citadel company), funds and accounts advised by T. Rowe Price Associates, Inc., and Piper Heartland. In conjunction with the financing, David Friedman, M.D., Managing Director of Suvretta Capital Management, joined Avalyn’s Board of Directors and Diamantis Xylas, M.D., Partner and Head of Research of Catalio Capital Management, joined as a Board Observer. “Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis,” said Lyn Baranowski, CEO of Avalyn. “We’ve made tremendous progress across our entire portfolio, completing Phase 1 clinical trials of AP02 and initiating a global Phase 2b clinical trial of AP01. With the support from an esteemed group of investors, we will continue the expeditious advancement of our clinical programs, while also bringing our third program into the clinic, all of which positions Avalyn for an exciting future of growth.” Proceeds will support key clinical milestones across Avalyn’s pipeline programs in pulmonary fibrosis, including the late-stage development of Avalyn’s lead programs: optimized inhaled formulations of pirfenidone (AP01) and nintedanib (AP02), as well as the advancement of the pirfenidone/nintedanib fixed dose combination (AP03) into Phase 1 clinical trials. AP01 is currently being evaluated in a global Phase 2b MIST trial in patients with progressive pulmonary fibrosis (PPF). In the completed Phase 1b ATLAS trial in patients with idiopathic pulmonary fibrosis (IPF), AP01 reduced lung function decline in a dose-responsive manner and demonstrated potential disease-modifying effects on fibrosis as observed by analyses of high-resolution computed tomography (HRCT) scans. In an ongoing open-label extension trial of patients with different forms of pulmonary fibrosis, AP01 has shown long-term safety and efficacy for more than 4.5 years. In addition, Avalyn recently completed Phase 1 trials of AP02, which demonstrated safety and tolerability at all dose levels and a favorable pharmacokinetic profile. The company plans to initiate a Phase 2 clinical trial for AP02 in patients with IPF. “Avalyn is at an exciting point in its evolution with multiple transformative product opportunities in clinical development, each with significant commercial potential,” said David Friedman, M.D., Managing Director of Suvretta Capital Management. “The clinical data generated to date for AP01 and AP02 are clinically compelling on their own, but when compared to the data for the currently approved oral treatments, they support the potential for Avalyn to achieve disease modification for patients with pulmonary fibrosis. We are thrilled to back such an exceptional team translating breakthrough science into real clinical impact, and what we believe will be a category-changing company in respiratory medicine.” “Lyn and team are executing a clear growth strategy for Avalyn rooted in both clinical insight and operational excellence,” said Jill Carroll, Partner at SR One and an Avalyn Board Director. “On behalf of the entire Board, we’re proud of their patient-focused approach and commitment to innovation and scientific rigor, which positions this company to redefine the future of what’s possible for patients suffering from pulmonary fibrosis.” Avalyn’s earlier-stage pipeline includes AP03, a next-generation inhaled fixed-dose combination of AP01 and AP02. Clinical data indicate that the combination of pirfenidone and nintedanib may offer additive, or even synergistic, efficacy advantages over either product alone. Combining these oral therapies has not been feasible due to the additive side effects when taken together. Inhaled delivery has the potential to solve the tolerability challenges of the oral antifibrotics, enabling Avalyn to combine these medicines effectively for the first time. Avalyn is advancing IND-enabling studies for AP03 and is planning a Phase 1 clinical trial. About Avalyn PharmaAvalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and 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’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s 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. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex Straus, THRUST alex@thrustsc.comir@avalynpharma.com Media Contact:Kat Lippincott, Deerfield Groupkat.lippincott@deerfieldgroup.commedia@avalynpharma.com

Phase 1Phase 2Clinical Result

22 Jul 2025

·firstwordpharma.com

Avalyn pulls in $100M to challenge oral lung fibrosis drugs with inhaled rivals

Avalyn Pharma closed an oversubscribed $100 million series D financing round to advance its pipeline of inhaled therapies for pulmonary fibrosis, the company announced Tuesday. The round was co-led by Suvretta Capital Management and SR One, with participation from a slate of additional healthcare investors including Novo Holdings and F-Prime.The financing comes as Avalyn is looking to challenge the current standard of care — oral medications such as Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone) — with targeted inhaled versions that could be both safer and more effective.While existing drugs can slow lung scarring, their side effects, mainly due to the high doses needed to compensate for inefficient gut absorption, can limit their use. By delivering drugs directly to the lungs in smaller doses, Avalyn believes it can sidestep the side effects that hinder current therapies without compromising on efficacy."Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach," said CEO Lyn Baranowski in a company release.Breathing new life into old drugsAvalyn's lead programme, AP01, is an inhaled formulation of pirfenidone that is currently being evaluated in the Phase IIb MIST trial for progressive pulmonary fibrosis. Earlier this year, it teamed up with image analytics firm Qureight to help measure efficacy in the trial.In the previous Phase Ib ATLAS study, AP01 showed dose-dependent slowing of lung function decline in patients with idiopathic pulmonary fibrosis (IPF). Further, AP01 has also demonstrated sustained safety and antifibrotic benefits in an open-label extension, with some patients on treatment for over 4.5 years.Its second programme, AP02, is an inhaled version of nintedanib that recently completed Phase I trials showing safety and favourable pharmacokinetics. The company plans to initiate a Phase II study for AP02 in patients with IPF.Combined punchMeanwhile, Avalyn's third programme, AP03, is a preclinical fixed-dose combination of its two lead compounds that could potentially offer synergistic benefits. "Combining these oral therapies has not been feasible due to the additive side effects when taken together," the company said. It plans to move AP03 into the clinic following IND-enabling studies."Avalyn is at an exciting point in its evolution with multiple transformative product opportunities in clinical development, each with significant commercial potential," said David Friedman, managing director of Suvretta, who joined Avalyn's board in conjunction with the financing. Data for AP01 and AP02 are "clinically compelling on their own, but when compared to the data for the currently approved oral treatments, they support the potential for Avalyn to achieve disease modification for patients with pulmonary fibrosis."Avalyn raised $175 million in 2023 to advance AP01 and AP02.

Phase 2Phase 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
Interstitial lung disease due to systemic disease	Phase 3	China	GNI Group Ltd.	29 May 2023
Anthracosis	Phase 3	-	Beijing Kangdini Pharmaceutical Co., Ltd.	15 Apr 2022
Pneumoconiosis	Phase 3	-	Beijing Kangdini Pharmaceutical Co., Ltd.	15 Apr 2022
Silicosis	Phase 3	-	Beijing Kangdini Pharmaceutical Co., Ltd.	15 Apr 2022
Dermatomyositis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	01 Jun 2018
Lung Diseases, Interstitial	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	31 Oct 2017
Sclerotylosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	31 Oct 2017
Progressive pulmonary fibrosis	Phase 2	United States	Avalyn Pharma, Inc.	03 Apr 2024
Progressive pulmonary fibrosis	Phase 2	Argentina	Avalyn Pharma, Inc.	03 Apr 2024
Progressive pulmonary fibrosis	Phase 2	Australia	Avalyn Pharma, Inc.	03 Apr 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Idiopathic Pulmonary Fibrosis	4,529	Pirfenidone	wpccjwxzsf(vcvmoclnol) = xkybruxpor taczbtpein (awytmnkzvt )	Positive	30 May 2025
				Non-Pirfenidone	wpccjwxzsf(vcvmoclnol) = mfjhovghuj taczbtpein (awytmnkzvt )
ATLAS Phase 1b Trial (ATS2025)	Phase 1	Idiopathic Pulmonary Fibrosis	64	Nebulised AP01 50mg QD	ojtjkbvxzr(qlpknjomnb) = ewciunxzjc adtvqdhpqj (tfgxnqjrty ) View more	Positive	16 May 2025
				Nebulised AP01 100mg BID	ojtjkbvxzr(qlpknjomnb) = qhvmbtouwv adtvqdhpqj (tfgxnqjrty ) View more
AP01-002 (ATLAS) (ATS2025)	Not Applicable	-	91	50 mg AP01 once daily	ovkedrfooj(jimedecvne) = xknmnuwivs grcrexfrmw (edlgatrxkn )	Positive	16 May 2025
				100 mg AP01 twice daily	ovkedrfooj(jimedecvne) = lamhfarkeq grcrexfrmw (edlgatrxkn ) View more
ATS2025	Not Applicable	Progressive pulmonary fibrosis	33	Pirfenidone	pxdbcrcvwo(muvpdjepsa) = 21.2% zeasknlmzo (lnjzobahvz ) View more	Positive	16 May 2025
ATS2025	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Full dose antifibrotic therapy	yaglsjaqlq(njslylbnhz) = sbpcxtmrhi rdxlvipiau (vdfoqrpxmg )	Positive	16 May 2025
				Reduced dose antifibrotic therapy	yaglsjaqlq(njslylbnhz) = jbnkybkoge rdxlvipiau (vdfoqrpxmg )
ASTRO2024	Phase 2	Radiation Injuries	134	Pirfenidone plus standard therapy	eswkwkmlya(solunyqmij) = rohjvqnzyu htcsyxwxla (jpgszkicku ) View more	Positive	01 Oct 2024
WCLC2024	Phase 2	Lung Injury PD-1 inhibitors	14	Pirfenidone	orsfpmtkkv(ahujqxsezq) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction rhyjfebqsv (tpxkuaprru )	Positive	07 Sep 2024
				Immune Checkpoint Inhibitors
ATS2024	Not Applicable	-	-	50mg AP01 once daily	qfmtcnihsr(iriezedvrh) = AE were present in 93.3% of patients overall, with AE frequencies similar across cohorts ngracogwmm (rxqctogdoi )	-	19 May 2024
				100mg AP01 twice daily
ATS2024	Not Applicable	Disease Progression	-	AP01 100 mg BID	sgadlfnkyt(vafjsqgfvn) = jnzmyewjyw sihppcfcvj (qceqdgneml )	-	19 May 2024
				AP01 50 mg QD	sgadlfnkyt(vafjsqgfvn) = jdicfhmhhw sihppcfcvj (qceqdgneml )
ATS2024	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Fybro® 400 mg	juyenfhxrp(uubckfpeka) = 16.5% jwjciahicp (pawyekvono ) View more	-	19 May 2024

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