CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FGFRs antagonists(Fibroblast growth factor receptors antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesOther Diseases+ [6]

Active Indication

Locally Advanced Lung Non-Small Cell Carcinomametastatic non-small cell lung cancerRecurrent Non-Small Cell Lung Cancer+ [21]

Inactive Indication

Acute Erythroblastic LeukemiaAdenocarcinoma of large intestineAdvanced Colorectal Adenocarcinoma+ [66]

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization

Boehringer Ingelheim GmbH

Viatris, Inc.Accord Healthcare SL

+ [16]

Inactive Organization

Meilaipu (Beijing) Pharmaceutical Research Co., Ltd.

Boehringer Ingelheim Ltd.Boehringer Ingelheim España SA

License Organization

Grand Pharmaceutical (China) Co., Ltd.

Santen Pharmaceutical Co., Ltd.

Mount Sinai Medical Center of Florida, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (15 Oct 2014),

Idiopathic Pulmonary Fibrosis

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Special Review Project (China)

Structure/Sequence

Molecular FormulaC33H39N5O7S

InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N

CAS Registry656247-18-6

273

Clinical Trials associated with Nintedanib esylate

NCT07335562

/ SuspendedPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

Start Date03 Feb 2027

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

JPRN-jRCTs061260038

/ RecruitingPhase 2

Multicenter Prospective Study on the Safety of Amurubicin Plus Nintedanib Combination Therapy in Previously Treated Small-Cell Lung Cancer with Idiopathic Pulmonary Fibrosis (SANCTUARY study)

Start Date23 Jul 2026

Sponsor / Collaborator-

ChiCTR2600129329

/ SuspendedPhase 1IIT

A Phase Ib Clinical Trial of Neoadjuvant Nintedanib in Combination with Platinum-Based Doublet Chemotherapy and Adebrelimab in Patients with Resectable Non-Small Cell Lung Cancer

Start Date09 Jul 2026

Sponsor / Collaborator-

100 Clinical Results associated with Nintedanib esylate

100 Translational Medicine associated with Nintedanib esylate

100 Patents (Medical) associated with Nintedanib esylate

2,251

Literatures (Medical) associated with Nintedanib esylate

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

How extracellular vesicles contribute to pulmonary fibrosis: miRNA-mediated mechanisms, diagnostic potential, and emerging therapeutic strategies

Review

Author: Zhou, Jinhan ; Jiang, Lan ; Zhao, Zhenzhen ; Zhu, Lijuan ; Zhang, Wen ; Liu, Xinyi ; Wu, Xiaodan

Pulmonary fibrosis (PF) is a progressive interstitial lung disease driven by excessive fibroblast activation and extracellular matrix (ECM) deposition, for which pirfenidone and nintedanib slow but do not halt disease progression. Extracellular vesicles (EVs)-lipid bilayer-enclosed nanoparticles that shuttle microRNAs (miRNAs), proteins, and lipids between cells-are increasingly recognized as important mediators and potential modulators of fibrotic remodeling. On the pathogenic side, epithelial- and immune-cell-derived EVs can deliver pro-fibrotic miRNAs (e.g., miR-494-3p) that regulate transforming growth factor beta (TGF-β)/Smad and Wnt/β-catenin signaling, promoting fibroblast-to-myofibroblast transition and ECM accumulation. Conversely, selected mesenchymal stem cell-derived EV (MSC-EV) preparations have demonstrated anti-fibrotic effects in preclinical models through modulation of TGF-β/Smad signaling, M2 macrophage polarization, mitochondrial function, and epithelial-mesenchymal transition; a phase I clinical study has provided initial safety evidence for nebulized administration, although therapeutic efficacy in PF has not yet been established. Beyond MSC-EVs, plant-derived and milk-derived EVs have emerged as potential delivery platforms, although their applications remain largely preclinical. Meanwhile, EVs isolated from plasma, bronchoalveolar lavage fluid, sputum, and urine carry disease-associated molecular signatures that may serve as candidate biomarkers for PF detection or monitoring, but require further clinical validation. This review synthesizes recent evidence on the dual roles of EVs in PF pathogenesis and therapy, evaluates their potential diagnostic utility, and discusses translational hurdles-including cargo standardization, targeted delivery, and scalable manufacturing-that must be overcome for clinical adoption.

01 Dec 2026·Cells & Development

Macrophage-fibroblast communication driven by biomechanical stress in the pulmonary profibrotic niche: From signalling transduction to clinical translation

Review

Author: Ye, Liya ; Yang, Hong ; Tao, Xia ; Hou, Xingyun ; He, Yuqiong ; Chen, Wansheng

Pulmonary (interstitial) fibrosis, the terminal pathological stage of various interstitial lung diseases, remains a major therapeutic challenge. The three approved antifibrotic agents - pirfenidone, nintedanib, and nerandomilast - receive only moderate endorsements in current guidelines, as they decelerate rather than arrest or reverse fibrotic remodelling, and none directly engages the mechanical dysregulation of the extracellular matrix (ECM) that underlies fibrogenesis. Macrophages and fibroblasts, two highly plastic cell populations, are the principal orchestrators of the pulmonary profibrotic niche: fibroblasts undergo profibrotic activation to become the dominant extracellular matrix (ECM) producers, while macrophages acquire profibrotic states that sense and amplify microenvironmental signals. Because the lung is an inherently mechanosensitive organ, biomechanical stress within the fibrotic niche emerges as a critical - yet therapeutically underexploited - dimension of their interaction. This review consolidates recent progress in understanding how biomechanical stress drives macrophage-fibroblast communication during pulmonary fibrogenesis. We first delineate the profibrotic activation of each cell type and their biomechanical interplay within the stiffening niche; we then examine the core mechanosensitive signalling mechanisms operating in fibroblasts and macrophages individually, their shared cell-state changes, and the direct and indirect crosstalk - encompassing membrane mechanosensors, integrin-FAK and Piezo1-YAP/TAZ pathways, secreted factors and extracellular vesicles - that closes a self-reinforcing mechano-chemical loop. Finally, we discuss the clinical translation of mechanosignalling-targeted antifibrotic therapies, from the limited mechanosensing engagement of approved drugs to current pipeline advances and the preclinical and clinical hurdles ahead. By framing fibrosis as a druggable biomechanical circuit, this review aims to inform strategies that halt - and potentially reverse - pulmonary fibrosis.

01 Dec 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Mechanofusion-assisted magnesium stearate surface modification enhances dispersion and aerodynamic performance of carrier-based nintedanib inhalable dry powder formulations

Article

Author: Han, Chang-Soo ; Kim, Seungsu ; Jung, Woong-Young ; Choi, Yu-Rim ; Kang, Ji-Hyun ; Jeong, So-Jeong ; Park, Chun-Woong ; Jeong, Jin-Hyuk ; Kim, Dong-Wook

Oral administration of nintedanib, a multi-receptor tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, is associated with gastrointestinal side effects and limited lung targeting. Pulmonary delivery using dry powder inhalers (DPIs) offers a promising alternative, but the strong cohesiveness of drug microparticles hinders aerosolization and deep lung deposition. This study developed carrier-based DPI systems using mechanofusion with magnesium stearate (MgSt) at 0%, 1%, and 5% (w/w) and compared their physicochemical and aerodynamic performance with physical mixtures. Respirable nintedanib particles produced by jet milling were combined with lactose and MgSt to prepare six blends. Solid-state analyses by differential scanning calorimetry, powder X-ray diffraction, and Fourier transform infrared spectroscopy showed that mechanofusion enhanced drug-excipient interactions, with attenuated nintedanib peaks and modified thermal responses, while jet milling largely preserved the crystalline structure of nintedanib. Scanning electron microscopy, energy-dispersive X-ray spectroscopy, and Raman imaging confirmed more uniform adhesion and distribution of nintedanib and MgSt on the carrier surface. Bulk-density-derived flowability indices were numerically lower at higher MgSt contents. Aerodynamic evaluation using a next-generation impactor showed that mechanofusion, particularly with 5% MgSt, achieved higher fine and extra-fine particle fractions, confirming its synergistic role with MgSt in improving pulmonary delivery efficiency. These findings suggest that mechanofusion, particularly when combined with MgSt, is an effective strategy for improving the aerodynamic performance of carrier-based DPI formulations. By reducing particle cohesion and enhancing dispersion, this approach may facilitate more efficient pulmonary delivery of highly cohesive drugs such as nintedanib.

298

News (Medical) associated with Nintedanib esylate

23 Oct 2026

·www.biospace.com

Vicore’s Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results

Independent Data Monitoring Committee recommends ASPIRE continue without modification; no safety concerns identified Fully enrolled 378-patient trial advances toward 52-week readout STOCKHOLM, SE AND CAMBRIDGE, MA / ACCESS Newswire / October 22, 2026 / Vicore Pharma Holding AB (Nasdaq Stockholm:VICO)(Nasdaq US:VCRE), a biopharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists, today announced that the independent Data Monitoring Committee (iDMC) for the Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis (IPF) recommended that the trial continue without modification following a pre-planned futility analysis. In parallel, the iDMC conducted its regular safety and benefit-risk review of all available data and raised no concerns. ASPIRE continues as planned and remains on track to report 52-week topline results in mid-2027. "Passing this futility analysis is an important milestone that allows ASPIRE to continue as designed. With 378 patients enrolled and a 52-week FVC primary endpoint, ASPIRE was built to generate a high-quality dataset, and our focus remains on disciplined execution through database lock and expected topline results in mid-2027," said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. "Our cash runway into the second half of 2028 takes us beyond the readout and allows us to plan the next steps for the program and the company." "The futility analysis was designed to protect patients and allow us to preserve the integrity of the trial, and we thank the iDMC for its independent review," said Bernt van den Blink, MD, PhD, Chief Medical Officer of Vicore Pharma. "We look forward to the final assessment of the efficacy and safety of buloxibutid next year. We are grateful to the patients, investigators and site staff whose commitment makes this trial possible." The futility analysis assessed whether the trial should stop early for futility. The futility criteria were not met, and the iDMC recommended that the trial continue without modification. The analysis was conducted by an external statistician and reviewed by the iDMC, based on efficacy data from approximately the first 100 randomized patients who had completed 52 weeks of treatment or discontinued from the trial, representing around 27% of the enrolled patients. The analysis assessed the primary endpoint, the change from baseline in forced vital capacity (FVC) at Week 52, for the high dose of buloxibutid (100 mg twice daily) versus placebo. It used a conditional power approach, with a pre-specified threshold to consider stopping the trial for futility if conditional power was below 20%. Vicore remains blinded to the trial data. To preserve trial integrity, no quantitative results, such as treatment effect estimates or conditional power values, were disclosed to the company. For further information, please contact: Hans Jeppsson, Chief Financial Officer, +46 (0)70 553 14 65, hans.jeppsson@vicorepharma.com About Idiopathic Pulmonary Fibrosis (IPF) IPF is a progressive and lethal fibrotic lung disease impacting approximately 250,000 people across the United States and Europe. The average life expectancy following diagnosis is 3-5 years, and currently approved therapies only slow the decline of lung function. While there are three antifibrotic therapies available today, a large proportion of patients do not initiate treatment, and those who do often discontinue due to limited efficacy and significant tolerability issues. With a growing patient population, there is a clear need for new disease-modifying treatments. About the Phase 2b ASPIRE Trial ASPIRE is an ongoing global 52-week Phase 2b, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of buloxibutid in IPF patients who are either not currently on treatment or are receiving standard of care (nintedanib or nerandomilast). Participants are randomized to receive one of two doses of buloxibutid (50 mg or 100 mg taken orally twice daily) or placebo. The primary endpoint is change from baseline in forced vital capacity (FVC) at 52 weeks, the registrational endpoint for IPF. Secondary endpoints include safety, tolerability, and the proportion of patients with disease progression over the trial period. The trial completed enrollment in April 2026, with 378 patients randomized across over 100 sites in 14 countries, including the United States. Recruitment was completed ahead of schedule, positioning the company to report topline results in mid-2027. About Vicore Pharma Holding AB Vicore Pharma is a clinical-stage biopharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The company's lead program, buloxibutid, is an oral small-molecule angiotensin II type 2 receptor agonist, which received Orphan Drug and Fast Track designations from the United States Food and Drug Administration and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF. Vicore Pharma is publicly listed on Nasdaq Stockholm (VICO) and Nasdaq US (VCRE). Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the ongoing Phase 2b ASPIRE clinical trial; the potential clinical benefits, safety, and efficacy of buloxibutid; clinical development timelines, including expected timing of topline data from the ASPIRE trial and continued development plans for buloxibutid, strategic and business plans, financial position and the anticipated cash runway. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results and data from a small sample size may not be indicative of results that may be observed in a larger group), clinical trial execution risks, the occurrence of adverse safety events, and references to those risks identified in the section entitled "Risk Factors" in Vicore Pharma's filings with the U.S. Securities and Exchange Commission and discussed in Vicore Pharma's Swedish filings and its press releases. Vicore Pharma cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Vicore Pharma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Vicore Pharma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information is information that Vicore Pharma Holding is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-10-22 18:50 CEST. Attachments Vicore’s Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results SOURCE: Vicore Pharma Holding View the original press release on ACCESS Newswire

Phase 2Orphan DrugFast Track

13 Oct 2026

·www.biospace.com

aTyr Pharma Announces Publication Demonstrating Anti-Fibrotic Effects of ATYR0101 in the Journal of Biological Chemistry

Findings highlight ATYR0101’s potential as a transformative therapy for disrupting the process of chronic tissue fibrosis. ATYR0101 is currently undergoing IND-enabling studies and expects to be advanced into the clinic in 2027. SAN DIEGO, Oct. 13, 2026 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced a publication demonstrating the anti-fibrotic effects of ATYR0101 in the Journal of Biological Chemistry . The publication, entitled, “Natural Asp-tRNA Synthetase Fragment Targets Myofibroblasts to Abrogate Tissue Fibrosis,” is available on the journal’s website and at: (26)02458-0/fulltext . ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce myofibroblast apoptosis. “Fibrosis remains a major global health challenge across multiple organ and tissue systems with limited therapies that only slow disease progression,” said Leslie A. Nangle, Ph.D., Vice President, Research at aTyr Pharma. “This publication highlights the novel mechanism by which ATYR0101 disrupts fibrosis through a unique molecular program that facilitates a transition towards a restorative phenotype thus fundamentally altering the underlying fibrotic cellular landscape. These findings suggest that ATYR0101 does not merely stop disease progression but may also facilitate a reversal of fibrotic pathology, providing a differentiated approach to current anti-fibrotic therapies in conditions such as idiopathic pulmonary fibrosis, where more effective treatment options are greatly needed.” The publication describes the mechanism by which ATYR0101 selectively triggers apoptosis in myofibroblasts by targeting LTBP-1 on the extracellular matrix, with ATY0101 induced myofibroblast apoptosis shown to be dependent on active transforming growth factor beta (TGF-β), a central player in the pathogenesis of fibrotic diseases. Furthermore, the pharmacologic activity of ATYR0101 was demonstrated in an in vivo bleomycin lung model of fibrosis, where ATYR0101 showed a significant reduction in both collagen content and Ashcroft score leading to a marked decline in pulmonary fibrosis compared to the use of nintedanib, a known anti-fibrotic, as a control. About ATYR0101 ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce myofibroblast apoptosis. ATYR0101 interacts with LTBP-1 through a unique way that presents a differentiated approach to targeting fibrosis. ATYR0101 has demonstrated anti-fibrotic effects in models of lung and kidney fibrosis suggesting it may have broad therapeutic potential in multiple fibrotic diseases. ATYR0101 is currently undergoing IND-enabling studies. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as "anticipate," “believes,” “can,” “could,” “designed,” “expects,” “intends,” “may,” “plans,” “potential,” “upcoming,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding the potential therapeutic benefits and applications of ATYR0101, including the potential for ATYR0101 to provide a differentiated approach to current anti-fibrotic therapies in conditions such as idiopathic pulmonary fibrosis; timelines, plans and expected results with respect to certain research and development activities and development goals, including IND-enabling studies and our expectation that ATYR0101 will be advanced into the clinic in 2027. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of our product candidates, the risks inherent in studies of potential medical therapies, the risk that we or future partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that future collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contact: Ashlee Dunston Investor Relations and Public Affairs adunston@atyrpharma.com

Immunotherapy

12 Oct 2026

·www.biopharmadive.com

Bristol Myers dips on ‘confounding’ lung drug results

Dive Brief:Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants breathing capacity when compared to a placebo over the course of a year.However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didnt meet the threshold for statistical significance, the company said.The failure of the high-dose arm is confounding and requires further explanation, RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug demonstrated a well-tolerated safety profile and treatment-related study discontinuations were similar between study groups.Dive Insight:Admilparant is the furthest along among a class of idiopathic pulmonary fibrosis, or IPF, drugs called LPA1 receptor antagonists. These treatments work by blocking a signaling molecule that plays an important role in lung scarring. They could emerge as alternatives to marketed drugs like Esbriet, Ofev and Jascayd, each of which has limitations.These admilparant results represent an important advancement as there remains a need for therapies that are both effective and tolerable for patients living with IPF, Fernando Martinez, the trial steering committee chair and a medical professor at the University of Massachusetts, in a statement from Bristol Myers.Earlier LPA1 drugs struggled in clinical testing. Bristol Myers scrapped one because of liver toxicity and Amgen canceled work on another after it fell short in a Phase 2 trial. News last month that Bristol Myers changed safety monitoring protocols in Europe for admilparants trial fueled additional consternation among Wall Street analysts and investors and heightened anticipation for the coming study readout.The announcement Monday that a 60 mg dose helped meaningfully improve forced vital capacity, or the amount of air people can exhale from their lungs at once, when compared to a placebo would ordinarily be taken as positive. However, physicians and drug reviewers frequently look to see whether higher doses perform better than lower ones. The lack of this kind of dose response sparked debate about admilparants prospects.The results could be sufficient to support admilparant regulatory approval, but the lack of dose response raises questions about [admilparants] profile, Leerink Partners analyst David Risinger wrote in a Monday client note. We await detailed results to better understand the drugs efficacy.Others were more positive. While there will be some lingering questions on dose response and the magnitude of benefit for admilparant, the success of the lower dose is likely to open a blockbuster opportunity, William Blair analyst Matt Phipps wrote in a separate note.Bristol Myers shares initially climbed more than 6% in pre-market trading before reversing course and settling into a roughly 4% loss. The data were also taken as bad news by investors of Contineum Therapeutics, which has a different LPA1 drug in Phase 2 testing. Contineums stock price fell about 30% in Monday morning trading.Bristol Myers separately claimed success in a different late-stage study testing a radiopharmaceutical called RYZ-101 against certain neuroendocrine tumors. The drugmaker gained control of RYZ-101 in a $4.1 billion buyout of RayzeBio. '

Phase 2AcquisitionPhase 3Clinical ResultClinical Trial Failure

100 Deals associated with Nintedanib esylate

External Link

KEGG	Wiki	ATC	Drug Bank
D10396 D10481	Nintedanib esylate	L01EX09	DB09079

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Boehringer Ingelheim Pty Ltd.	01 Sep 2015
metastatic non-small cell lung cancer	Australia	Boehringer Ingelheim Pty Ltd.	01 Sep 2015
Recurrent Non-Small Cell Lung Cancer	Australia	Boehringer Ingelheim Pty Ltd.	01 Sep 2015
Interstitial lung disease due to systemic disease	European Union	Boehringer Ingelheim International GmbH	14 Jan 2015
Interstitial lung disease due to systemic disease	Iceland	Boehringer Ingelheim International GmbH	14 Jan 2015
Interstitial lung disease due to systemic disease	Liechtenstein	Boehringer Ingelheim International GmbH	14 Jan 2015
Interstitial lung disease due to systemic disease	Norway	Boehringer Ingelheim International GmbH	14 Jan 2015
Progressive fibrotic interstitial lung disease	European Union	Boehringer Ingelheim International GmbH	14 Jan 2015
Progressive fibrotic interstitial lung disease	Iceland	Boehringer Ingelheim International GmbH	14 Jan 2015
Progressive fibrotic interstitial lung disease	Liechtenstein	Boehringer Ingelheim International GmbH	14 Jan 2015
Progressive fibrotic interstitial lung disease	Norway	Boehringer Ingelheim International GmbH	14 Jan 2015
Adenocarcinoma of Lung	European Union	Boehringer Ingelheim International GmbH	21 Nov 2014
Adenocarcinoma of Lung	Iceland	Boehringer Ingelheim International GmbH	21 Nov 2014
Adenocarcinoma of Lung	Liechtenstein	Boehringer Ingelheim International GmbH	21 Nov 2014
Adenocarcinoma of Lung	Norway	Boehringer Ingelheim International GmbH	21 Nov 2014
Adenocarcinoma of Lung	United Kingdom	Boehringer Ingelheim GmbH	21 Nov 2014
Idiopathic Pulmonary Fibrosis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	15 Oct 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic interstitial lung disease	NDA/BLA	European Union	Accord Healthcare SL	22 Feb 2024
Lung Diseases, Interstitial	NDA/BLA	United States	Boehringer Ingelheim GmbH	25 Jul 2023
Pterygium	Phase 3	United States	Cloudbreak Therapeutics LLC	30 Jun 2022
Pterygium	Phase 3	China	Cloudbreak Therapeutics LLC	30 Jun 2022
Pterygium	Phase 3	Australia	Cloudbreak Therapeutics LLC	30 Jun 2022
Pterygium	Phase 3	India	Cloudbreak Therapeutics LLC	30 Jun 2022
Pterygium	Phase 3	New Zealand	Cloudbreak Therapeutics LLC	30 Jun 2022
Scleroderma	Phase 3	United States	Boehringer Ingelheim International GmbH	05 Dec 2017
Scleroderma	Phase 3	Japan	Boehringer Ingelheim International GmbH	05 Dec 2017
Scleroderma	Phase 3	Argentina	Boehringer Ingelheim International GmbH	05 Dec 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2026	Not Applicable	Interstitial lung disease due to systemic disease	1,530	Tocilizumab	jrfddsewha(vovauaomvx) = fdksusqhkv obxesfxska (ndprljqgwu ) View more	Positive	06 Nov 2026
ACR2026	Not Applicable	Interstitial lung disease due to systemic disease	1,530	Nintedanib	jrfddsewha(vovauaomvx) = uwhqdtpmrw obxesfxska (ndprljqgwu ) View more	Positive	06 Nov 2026
ACR2026	Not Applicable	Interstitial lung disease due to systemic disease	36	Nintedanib with background immunosuppression	csybeeoaig(badtjoegjp) = diarrhea in 18 (50.0%), dose reduction in 23 (63.9%), and permanent discontinuation in only 2 (5.6%). umolwvqnjr (rnvukouwfn )	Positive	06 Nov 2026
NCT05799755 (MINT, ACR2026)	Phase 2	Lung Diseases, Interstitial	49	Nintedanib	sdlajmsosd(svtsjqcxnc) = every component achieved ≥88.9% top-2-box satisfaction, and most components reached ≥93% gytwzxinyq (hkwslkgkrf )	Positive	06 Nov 2026
ACR2026	Not Applicable	Interstitial lung disease due to systemic disease	20	Nintedanib or pirfenidone	daderteajn(swlryolpxz) = imholmucpc dnjhbzdhxm (bwrjizutft ) View more	Positive	06 Nov 2026
ESMO2026	Not Applicable	Non-Small Cell Lung Cancer CTNNB1 mutations	228	ChT+ICI (EGFR-wt tumors)	dkrqkrukuw(snablebail) = yyflwiknrl tzbotbosul (sysprvbyyu ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Non-Small Cell Lung Cancer CTNNB1 mutations	228	iVEGF (bevacizumab/ramucirumab/nintedanib)	dkrqkrukuw(snablebail) = ckcrctfitw tzbotbosul (sysprvbyyu ) View more	Positive	23 Oct 2026
EULAR2026	Not Applicable	Interstitial lung disease due to systemic disease	19	Nintedanib	dbkfeiosml(zyqbqckdgy) = No statistically significant difference was detected between baseline and 12-month follow-up CT findings (p = 0.07). Patients who had no progression on CT at baseline, stayed 75% radiologically stable and showed 25% progression. Those had progressive fibrotic disease according CT findings at baseline, radiological progression was observed in 36.4% at the end of 12 months. fjpnvwjkax (rtmoxkjthk )	Positive	11 Jun 2026
EULAR2026	Not Applicable	Rheumatoid arthritis with rheumatoid lung disease	526	Abatacept ± other drugs (Non-progressive ILD)	xjjbwcrvmb(tyhtfcnrdk) = eqbsravsid jzrkanfhpk (txnjbdtskm )	Positive	11 Jun 2026
EULAR2026	Not Applicable	Lung Diseases, Interstitial	64	Nintedanib + Mycophenolate mofetil + Rituximab	oyysmcfzqx(ebmbjejctk) = whqftvkyvy bqfiuqieds (exrydjgjbl ) View more	Positive	11 Jun 2026
EULAR2026	Not Applicable	Lung Diseases, Interstitial	64	Nintedanib + Mycophenolate mofetil + Rituximab	-	Positive	11 Jun 2026
EULAR2026	Not Applicable	Lung Diseases, Interstitial	1,037	biologic-treated RA	tzyifwsotg(qytshmetal) = When available, baseline PFTs showed a median FVC of 99% (60-157) predicted, FEV1 90% (41-145), DLCO 71% (40-98), and values declined at first follow-up to FVC 86% (52-193), FEV1 88% (53-182), DLCO 65% (44-94). kgbnmuwkso (bfkatgqnfd ) View more	Positive	11 Jun 2026
EULAR2026	Not Applicable	Rheumatic Diseases	135	Nintedanib + Nintedanibressants	stcemfaahw(hessfwlbkf) = bztpukawew xsgqehbnyy (epilpuqmzy ) View more	Positive	11 Jun 2026

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