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Last update 27 Apr 2026

Pirfenidone

Last update 27 Apr 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+ [7]

Active Indication

Idiopathic Pulmonary FibrosisInterstitial lung disease due to systemic diseasePneumoconiosis+ [21]

Inactive Indication

Allograft RejectionAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAsbestosis+ [16]

Originator Organization

InterMune, Inc.

Active Organization

Beijing Kangdini Pharmaceutical Co., Ltd.Viatris Ltd. (New Zealand)

Avalyn Pharma, Inc.

+ [9]

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

Structure/Sequence

Molecular FormulaC12H11NO

InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N

CAS Registry53179-13-8

220

Clinical Trials associated with Pirfenidone

NCT07388680

/ RecruitingPhase 2/3

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Trial on the Efficacy and Safety of Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune-related Pneumonia

Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II/III trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).

Start Date26 Mar 2026

Sponsor / Collaborator

Beijing Kangdini Pharmaceutical Co., Ltd.

[+1]

NCT06241560

/ 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 Date05 Mar 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07454291

/ Not yet recruitingPhase 1

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants

The purposes of this study are to:
1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and
2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).
This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.

Start Date01 Mar 2026

Sponsor / Collaborator

Endeavor BioMedicines, Inc

100 Clinical Results associated with Pirfenidone

100 Translational Medicine associated with Pirfenidone

100 Patents (Medical) associated with Pirfenidone

2,496

Literatures (Medical) associated with Pirfenidone

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

01 Jun 2026·ARCHIVES OF MEDICAL RESEARCH

Pirfenidone as a Pleiotropic Antifibrotic Agent in Metabolic Steatohepatitis: From Mechanisms to Clinical Evidence

Review

Author: Méndez-Sánchez, Nahum ; Ramírez-Mejía, Mariana M ; Poo, Jorge L ; Ponciano-Rodríguez, Guadalupe

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive phenotype of steatotic liver disease that can lead to advanced fibrosis, cirrhosis and liver-related complications. Pirfenidone is a small synthetic molecule that was originally approved for idiopathic pulmonary fibrosis. It has pleiotropic antifibrotic, anti-inflammatory, antioxidant, and immunomodulatory properties. In preclinical liver models, pirfenidone reduces hepatic stellate cell activation, collagen deposition, oxidative stress and proinflammatory cytokine expression, largely through the modulation of transforming growth factor β (TGF-β), platelet-derived growth factor (PDGF), mitogen-activated protein kinases, and the Nrf2 axis. Early clinical trials, including the large prospective cohort PROMETEO, the randomized controlled trial in compensated cirrhosis ODISEA, and the translational trial in post-sustained viral response fibrosis MINERVA, show improvements in noninvasive fibrosis markers, liver function tests, quality of life, and parallel epigenetic remodeling. These data suggest that pirfenidone acts on central fibrogenic biology and may contribute to histological regression in advanced disease. Larger and longer trials, as well as rational combinations with metabolic agents, are needed to define its therapeutic role in MASH.

01 May 2026·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Optimization and aerodynamic performance of nebulizable pirfenidone-loaded human serum albumin nanoparticles for targeted pulmonary delivery

Article

Author: Chen, Chih-Kuang ; Cheng, Meng-Hsuan ; Liu, Jia-Yu ; Lin, Zheng-Ian ; Chien, Chu-Chun ; Fang, Yi-Ping ; Chen, Shiou-Lan ; Chen, I-Ling

Idiopathic pulmonary fibrosis (IPF) is a severe fibrotic lung disease associated with poor survival and limited therapeutic efficacy. Oral pirfenidone (PFD), though clinically used, exhibits poor lung accumulation and systemic adverse effects. Human serum albumin (HSA) is a promising drug carrier due to its biocompatibility and ability to enhance solubility and lung targeting. This study developed nebulizable PFD-loaded HSA nanoparticles (PFD-HNPs) to improve pulmonary delivery and antifibrotic efficacy while minimizing systemic toxicity. Formulation parameters, including HSA concentration, pH, and drug loading, were optimized. The resulting PFD-HNPs (∼100 nm, PDI < 0.25, -50 mV) exhibited high entrapment efficiency (63-68%) and maintained physicochemical stability after nebulization. Next-Generation Impactor (NGI) analysis confirmed efficient aerosolization with preferential deposition in stages 5 and 6, indicating favorable lung retention. Cellular studies showed efficient PFD-HNP uptake by NR8383 macrophages and cytoplasmic retention, supporting localized drug reservoir formation. In MRC-5 cells, PFD-HNPs significantly inhibited TGF-β1-induced profibrotic marker expression, demonstrating anti-fibrotic efficacy comparable to that of free PFD. In vivo studies via nebulized inhalation showed no detectable toxicity in major organs. With their stability, efficient aerosol performance, potent antifibrotic effects, and favorable safety profile, PFD-HNPs represent a promising platform for inhaled PFD therapy and offer a potentially safer, more effective strategy for IPF treatment than conventional oral administration.

252

News (Medical) associated with Pirfenidone

27 Apr 2026

·www.biospace.com

Avalyn Strengthens Leadership Team to Support Long-Term Growth with Appointments of Industry Leaders Adam Golden and Frank Salisbury

BOSTON, April 27, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm for serious, rare respiratory diseases, today announced two appointments that further strengthen its leadership team as the company advances its clinical programs and prepares for future commercialization. Adam Golden, a seasoned legal and business adviser with over three decades of experience advising biopharma companies, was appointed General Counsel and Head of Business Development. Frank Salisbury, an established leader in launching multiple FDA-approved therapies, including ESBRIET ® (pirfenidone) for idiopathic pulmonary fibrosis (IPF), was appointed Senior Vice President, Commercial. “We are thrilled to welcome Adam and Frank to Avalyn at this important stage in our evolution,” said Lyn Baranowski, Chief Executive Officer of Avalyn. “Adam brings deep legal experience guiding life sciences companies through critical inflection points involving business development and legal strategy, all of which will be invaluable as we transition to life as a public company. Frank has a proven track record of building and leading commercial organizations for innovative respiratory treatments, including oral pirfenidone for IPF and sotatercept for PAH. Their expertise strengthens our ability to execute across corporate strategy, business operations, and commercial readiness as we advance our pipeline and position Avalyn for long-term success.” Adam Golden has over 30 years of experience advising biopharma companies, spanning legal, business development, and corporate strategy. Prior to joining Avalyn, Mr. Golden was a Partner and Global Head of Life Sciences at Freshfields LLP, where he founded and led the build-out of an internationally recognized life sciences practice. Previously, he served as Partner and Head of the New York Corporate Practice Group at Hogan Lovells, and spent over two decades at Kaye Scholer, where he held multiple roles, including Partner and Co-Chair, Corporate Department. Over the course of his career, Mr. Golden has advised on mergers and acquisitions, strategic collaborations, corporate governance, and SEC compliance. He currently serves on the Board of Advisors for Life Science Cares. Mr. Golden holds a J.D. from New York University School of Law and an A.B. in Chemistry from Princeton University. Frank Salisbury brings more than 24 years of commercial leadership experience across biotechnology and large pharmaceutical companies, with a focus on rare respiratory diseases. Over the course of his career, he has played a key role in the launch and commercialization of multiple therapies. At InterMune/Genentech, he led the U.S. launch and served as National Head of Sales for ESBRIET ® (pirfenidone) in IPF. He also held senior commercial roles at Acceleron Pharma, where he supported the launch of WINREVAIR ® for pulmonary arterial hypertension (PAH), as well as at Actelion, where he played a core role in the commercialization of OPSUMIT ® (macitentan) for PAH. He joins Avalyn from PureTech Health, where he was the Senior Vice President for Commercial and Product Strategy. Mr. Salisbury earned a B.A. in International Relations and an M.B.A. from Stanford University, and was a Fulbright Scholar in Germany, where he studied HIV prevention interventions. About Avalyn Pharma Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging tolerability and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone data. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver dual antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn. Investor Contact: Cassie Saitow, Avalyn Pharma Inc. Sr. Director, IR and Corporate Communications ir@avalynpharma.com Media Contact: Kat Lippincott, Deerfield Group kat.lippincott@deerfieldgroup.com media@avalynpharma.com

Phase 2Executive Change

24 Apr 2026

·www.fiercebiotech.com

Avalyn aims for $182M IPO to fund phase 3 trials of reformulated respiratory drugs

Avalyn has earmarked $150 million to take its lead drug AP01 through phase 2b topline data and into phase 3.\n Avalyn Pharma is hoping to rake in around $182 million from an IPO, which the biotech will use to take its inhaled versions of approved drugs for respiratory conditions into late-stage studies.The Boston-based biotech is planning to offer around 11.8 million shares priced between $16 and $18, according to an April 23 Securities and Exchange Commission filing. Assuming the final share price falls in the middle of this range, Avalyn expects the IPO to bring in net proceeds of $181.8 million.This figure could rise to $209.7 million if underwriters fully take up their option to buy an additional 1.7 million shares at the same price, according to the filing.Avalyn managed to secure a $100 million series D round in July 2025, backed by the likes of Novo Holdings. That raise followed a $175 million series C in 2023 and a $35.5 million series B back in 2020.The biotech still had $138.5 million at the start of the year, according to Thursday’s filing. Combined with IPO proceeds, Avalyn has earmarked $150 million to advance its lead drug, AP01, through phase 2b topline data and into phase 3 development. AP01 is an inhaled formulation of pirfenidone, which is sold under many names as a pill for idiopathic pulmonary fibrosis (IPF), such as Esbriet.The company also expects $90 million will be needed to take another asset, AP02, through an ongoing phase 2 trial and into phase 3. AP02 is an inhaled version of the IPF drug nintedanib, which is marketed as Ofev and Vargatef in its oral form.Another $10 million is needed to take a third med—an inhaled combination of pirfenidone and nintedanib called AP03—into the clinic, according to the filing. To date, pairing oral therapies hasn’t been possible due to additive side effects, but Avalyn is currently running preclinical studies for the asset. The biotech currently employs 51 full-time employees, of which 32 work in R&D, according to yesterday’s filing. The company is headed up by CEO Lyn Baranowski, whose previous roles included developing respiratory medicines at Pearl Therapeutics, which were later acquired by AstraZeneca and marketed as Breztri and Bevespi.Biotech IPO levels have fluctuated in the early months of 2026. The initial crop of offerings this year included other companies working on new formulations of approved drugs.SpyGlass Pharma, which secured a $150 million IPO in February, is developing long-acting versions of approved medicines for chronic eye conditions. Meanwhile, Veradermics, which made a splash with a $256.3 million debut on the New York Stock Exchange, is working on an oral version of the molecule behind hair loss treatment Rogaine.

IPOPhase 3Executive ChangePhase 2Acquisition

24 Apr 2026

·firstwordpharma.com

Biopharma bites: Avalyn eyes $200M IPO, Pfizer cuts manufacturing staff, and more from Sun Pharma, Novartis

Avalyn targets $200M in IPOPfizer axes over 100 staffers at Ireland facilitySun Pharma said to raise Organon bid to $13BEU panel recommends Novartis' SMA gene therapy reformulation Avalyn targets $200M in IPOAvalyn Pharma has set terms for a potential IPO, according to a Thursday securities filing. The biotech proposed to sell 11.8 million shares at a range of $16 to $18 per share; at the midpoint, it would raise $200.6 million and be valued at about $628 million. The company is developing inhaled products to treat idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Its lead candidate, AP01, is an inhaled formulation of pirfenidone being studied in the Phase IIb MIST trial for PPF. Avalyn also has AP02, an inhaled formulation of nintedanib, in the Phase II AURA study for IPF. Top-line data from MIST and AURA are both due in 2027.-Elizabeth EatonPfizer axes over 100 staffers at Ireland facilityPfizer is planning to cut 102 employees at its manufacturing site in Cork, Ireland, according to a report from the Irish Examiner. The move will reduce the pharma's roughly 800-person headcount at the facility by about 12%. The layoffs are expected to affect staffers in manufacturing operations positions and are slated to go into effect in the fourth quarter. A recent FirstWord analysis found that Pfizer has shrunk its headcount by 15% since 2023 (see – Vital Signs: Working smart (and hard) with pharma's most efficient employees). For a more in-depth look at job cuts across the industry, see Vital Signs: Largest layoffs of the first quarter.-Elizabeth EatonSun Pharma said to raise Organon bid to $13BSun Pharmaceutical is reportedly raising the stakes in its pursuit of women's health specialist Organon with a higher $13-billion binding offer, intensifying a competitive takeover battle that is said to include German drugmaker Grünenthal and private equity firm EQT as rival suitors.The news was first reported in The Economic Times, which cited unnamed sources with knowledge of the situation. Shares of Merck & Co. spinout Organon jumped about 29% on the news Friday.According to the report, Sun Pharma's Managing Director Dilip Shanghvi is moving ahead with the revised proposal, which is a step up from a recently rumoured $12-billion bid for Organon as the Indian drugmaker looks to transform itself from a generics heavyweight into a global player in branded and innovative medicines.-Anna BratulicEU panel recommends Novartis' SMA gene therapy reformulation The EMA's drug advisory panel has recommended approval of a fixed-dose, intrathecally delivered version of Novartis' spinal muscular atrophy (SMA) gene therapy onasemnogene abeparvovec-brve, five months after FDA approved the new formulation as Itvisma. The positive opinion for Itvisma covers children two years and older, teens and adults with SMA and a confirmed bi-allelic SMN1 mutation. The original intravenous infusion, marketed as Zolgensma, had a more narrow approval in babies and children weighing up to 21 kg. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on data from the Phase III STEER study, which enrolled 126 treatment-naïve patients with SMA type 2 between the ages of 2 and 17 who were able to sit, but had never walked on their own. STEER met its primary endpoint with Itvisma achieving a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale – Expanded compared to 0.51 points in the sham control arm.-Elizabeth Eaton

Phase 2Phase 3Drug ApprovalClinical ResultGene Therapy

100 Deals associated with Pirfenidone

External Link

KEGG	Wiki	ATC	Drug Bank
D01583	Pirfenidone	L04AX05	DB04951

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

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
Interstitial lung disease due to systemic disease	Phase 3	China	GNI Group Ltd.	29 May 2023
Pneumoconiosis	Phase 3	China	GNI Group Ltd.	29 May 2023
Anthracosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	07 Jun 2022
Silicosis	Phase 3	China	Beijing Kangdini Pharmaceutical Co., Ltd.	09 May 2022
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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06484153 (ASCO_GI2026)	Phase 1/2	Metastatic Colorectal Carcinoma pMMR \| MSS	24	Fruquintinib+pirfenidone+anti-PD-1 antibody	yzodplzgvm(pyijtconzz) = qpugtnyqav avnhpohpmj (butnbhlxhh ) 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	llelwbdobn(nxxtvuuwqq) = alnbuytwww nlplrmhmjl (drfexupyrk )	Positive	01 Dec 2025
				Placebo two times per day	puipwlgutg(mpsadsgtyv) = snvhmbfdnl iqnplcrrlr (kwjtwzswze )
NCT03902509 (Pubmed \| Lancet Oncol)	Phase 2	-	134	Pirfenidone plus glucocorticoids	iktpaaequk(gcffgsyfyp) = 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). nzwodrintx (owmdqqgobs )	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)	zxabquumbt(xghagtcgjq) = iuhhybjauf hallsmzwis (xjigcpbgua ) View more	Positive	24 Oct 2025
				pirfenidone (RA-ILD + SSc-ILD + SADs-ILD)	zxabquumbt(xghagtcgjq) = nsonumleoe hallsmzwis (xjigcpbgua ) View more
ACR2025	Not Applicable	Primary Sjögren's syndrome anti-SSA/Ro \| anti-SSB/La	45	Glucocorticoids	xhdxzxirjk(jundssophg) = ylyfjujsge vrrgiodefb (xrgslzcidn, 114.0) View more	Positive	24 Oct 2025
ChiCTR2400081900 (ESMO2025)	Phase 2	radiation oral mucositis	87	Pirfenidone	bxiboitgii(dgqndfwarl) = qldnspmqzz lhihmpqwzy (pxuzjjssit )	Positive	17 Oct 2025
				Pirfenidone (Historical controls)	bxiboitgii(dgqndfwarl) = sfwmiwxaut lhihmpqwzy (pxuzjjssit )
ASCO2025	Not Applicable	Idiopathic Pulmonary Fibrosis	4,529	Pirfenidone	yazqgfwznz(sxkinqypwm) = crniemcnza opwaaaoihu (wkxjscujls )	Positive	30 May 2025
				Non-Pirfenidone	yazqgfwznz(sxkinqypwm) = jmoucftbtj opwaaaoihu (wkxjscujls )
ATLAS Phase 1b Trial (ATS2025)	Phase 1	-	28	AP01 50mg QD	divvrjvgdx(novgxqvbpn) = vonfhwtuzf adopztorlz (vrwswwfdsb, 5.61)	Positive	16 May 2025
				AP01 100mg BID	divvrjvgdx(novgxqvbpn) = oemgboyfog adopztorlz (vrwswwfdsb, 7.87)
ATLAS Phase 1b Trial (ATS2025)	Phase 1	Idiopathic Pulmonary Fibrosis	64	Nebulised AP01 50mg QD	aezfntrujk(tgltyudnut) = mftopphwsz kgbfuwgfpi (exvnkzcpjf ) View more	Positive	16 May 2025
				Nebulised AP01 100mg BID	aezfntrujk(tgltyudnut) = wzeedkpyxp kgbfuwgfpi (exvnkzcpjf ) View more
AP01-002 (ATLAS) (ATS2025)	Not Applicable	-	91	50 mg AP01 once daily	riynvvgqvv(sqzvtqbdkz) = vdpgwaytca dvzskthmzt (uyktpwefpu )	Positive	16 May 2025
				100 mg AP01 twice daily	riynvvgqvv(sqzvtqbdkz) = cweyhjuynx dvzskthmzt (uyktpwefpu ) View more

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