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+ [4]

Active Indication

Locally Advanced Lung Non-Small Cell Carcinomametastatic non-small cell lung cancerRecurrent Non-Small Cell Lung Cancer+ [22]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Colorectal AdenocarcinomaAdvanced Hepatocellular Carcinoma+ [48]

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization

Accord Healthcare SLU

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbH

+ [14]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 Oct 2014),

Idiopathic Pulmonary Fibrosis

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

Structure/Sequence

Molecular FormulaC33H39N5O7S

InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N

CAS Registry656247-18-6

255

Clinical Trials associated with Nintedanib esylate

NCT06297096

/ Not yet recruitingPhase 3IIT

Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.

Start Date01 Jan 2025

Sponsor / Collaborator

Medical Research Agency

NCT06717100

/ Not yet recruitingPhase 1

A Phase 1 Study in Healthy Volunteers to Determine the Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) with Nintedanib

This is a trial of up to 60-day duration for safety, tolerability, and pharmacokinetics in healthy volunteers administered deupirfenidone (LYT-100) alone or in combination with nintedanib .

Start Date01 Dec 2024

Sponsor / Collaborator

PureTech Health Plc

[+1]

NCT06643091

/ Not yet recruitingPhase 2IIT

Nintedanib Treatment in Unicentric Castleman Disease

Unicentric Castleman Disease (UCD) is a rare non-malignant localised disease involving one or more lymph nodes, associating germinal centre atrophy, mantle zone thickening and intense vascular proliferation penetrating the germinal centres. Patients usually seek medical attention because of a localised, sometimes compressive, lymph node or the development of life-threatening autoimmune complications (paraneoplastic pemphigus or PNP or myasthenia gravis or MG). The best treatment option is complete surgical excision, but it has been recently demonstrated that up to half of the patients cannot undergo surgery. In these patients, an efficient medical approach needs be defined, as no current medical treatment has demonstrated to lower morbidity and mortality. The cause of UCD is currently unknown and current data favour a scenario of stromal impairment leading to the loss of lymph node architecture rather than one of a primary hematopoietic disease. UCD lesions are often associated with synchronous follicular dendritic cell (FDC) proliferation and can sometimes evolve towards a true FDC sarcoma (FDCS), indicating a possible role for FDC, a germinal centre stromal cell component, in UCD pathogenesis. A recurrent somatic activating mutation in PDGFRB (p.N666S) has been recently described in the CD45 negative (non-hematopoietic) compartment of up to 17% UCD specimens. Moreover, activation of the VEGFR pathway is thought to play a role in the development of the disease, especially in the increased vascularity characteristic of the UCD lesion.
Nintedanib is a commercially available tyrosine-kinase inhibitor targeting PDGF, VEGF and FGF receptors. The drug has obtained European Market Authorization in 2015 for the treatment of Non-Small Cell Lung Cancer and Idiopathic Pulmonary Fibrosis with a satisfactory safety profile. The hypothesis is that nintedanib could benefit patients with unresectable or partially resectable UCD.

Start Date01 Nov 2024

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

100 Clinical Results associated with Nintedanib esylate

100 Translational Medicine associated with Nintedanib esylate

100 Patents (Medical) associated with Nintedanib esylate

2,475

Literatures (Medical) associated with Nintedanib esylate

31 Dec 2025·Pulmonology

The clinical meaning of the UIP pattern in fibrotic hypersensitivity pneumonitis on cryobiopsy: A multicentre retrospective study

Article

Author: Poletti, Venerino ; Madsen, Line Bille ; Kronborg White, Sissel ; Fabbri, Elisabetta ; Petrarulo, Simone ; Dubini, Alessandra ; Piciucchi, Sara ; Spagnolo, Paolo ; Bendstrup, Elisabeth ; Lex, Frederik ; Ravaglia, Claudia

Fibrotic hypersensitivity pneumonitis (f-HP) is an interstitial lung disease in which various antigens in susceptible individuals may play a pathogenetic role. This study evaluates the role of transbronchial lung cryobiopsy (TBLC) and bronchoalveolar lavage (BAL) in identifying a UIP-like pattern and its association with fibrosis progression. We conducted a multicentre retrospective cohort study of patients diagnosed with f-HP who underwent BAL and TBLC between 2011 and 2023. A UIP-like pattern was defined by the presence of (A) patchy fibrosis and fibroblastic foci or (B) honeycombing ± (A). We investigated BAL's role in predicting UIP-like patterns within a clinical-radiological-serological framework, examining disease progression in these patients using spirometry and mortality data. A total of 195 patients were enrolled, 59 (30%) of whom exhibited a UIP-like pattern. These patients showed greater lung function decline, lower BAL lymphocytosis (14.4% vs. 37.4%, p < 0.001), higher nintedanib prescription (35% vs. 14%, p < 0.001), and higher 10-year mortality (HR 2.8, 95% CI 1.3-5.8, p = 0.004). f-HP patients with a UIP-like pattern exhibit worse clinical outcomes and higher mortality. In cases of low BAL lymphocytosis with a high pre-test clinical suspicion of f-HP, lung biopsy may not be necessary as it increases the likelihood of identifying a UIP-like pattern.

01 Dec 2025·LUNG

Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON

Article

Author: Dumistracel, Mihaela ; Chaudhuri, Nazia ; Varone, Francesco ; Antin-Ozerkis, Danielle ; Cottin, Vincent ; Wuyts, Wim A ; Song, Jin Woo ; Coeck, Carl ; Miede, Corinna ; Bonella, Francesco

PURPOSE:

In the INBUILD trial in patients with progressive pulmonary fibrosis (PPF), nintedanib slowed the decline in forced vital capacity (FVC) versus placebo, with a safety profile characterised mainly by gastrointestinal events. INBUILD-ON, the open-label extension of INBUILD, assessed the safety of nintedanib during longer-term treatment. Data on FVC were collected.

STUDY DESIGN AND METHODS:

Adverse events and changes in FVC in INBUILD-ON were assessed descriptively in all patients and in two subgroups: patients who received nintedanib in INBUILD and continued nintedanib in INBUILD-ON ("continued nintedanib" group) (n = 212) and patients who received placebo in INBUILD and initiated nintedanib in INBUILD-ON ("initiated nintedanib" group) (n = 222). Changes in FVC were based on observed values.

RESULTS:

Median exposure to nintedanib in INBUILD-ON was 22.0 months. Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity. Adverse events led to discontinuation of nintedanib at a rate of 16.7 per 100 patient-years. Serious and fatal adverse events were reported at rates of 37.2 and 9.5 per 100 patient-years. Mean (SE) changes in FVC from baseline to week 48 were - 71.6 (16.1) mL [- 128.5 (25.5) mL in continued nintedanib group (n = 106), - 14.8 (18.2) mL in initiated nintedanib group (n = 106)].

CONCLUSION:

The safety profile of nintedanib in INBUILD-ON was consistent with that in INBUILD. Change in FVC in INBUILD-ON was consistent with decline in FVC in the nintedanib group of INBUILD. These results support the use of nintedanib in the long-term treatment of PPF.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov; NCT03820726; registered January 29, 2019.

01 Jul 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Surface-modified nintedanib-loaded solid lipid nanoparticles for effective targeting of non-small cell lung cancer

Article

Author: Nasir, Nazim ; Deshmukh, Vishambhar ; Nalawade, Shubhangi ; Gajbhiye, Kavita R ; Wahab, Shadma ; Kesharwani, Prashant ; Narwade, Mahavir

Lung cancer remains a significant global health burden as the second most common and fatal malignancy, with treatment complexities heightened by limited knowledge of inhaler techniques and respiratory challenges, particularly in elderly and pediatric patients. Despite the availability of oral chemotherapeutics like Nintedanib, its clinical efficacy is undermined by suboptimal pharmacokinetics, high systemic toxicity, and low bioavailability. To overcome these limitations, we developed folic acid-conjugated Nintedanib-loaded solid lipid nanoparticles (FA-NIN-SLNPs), which offer targeted therapy with enhanced delivery and reduced adverse effects, potentially improving patient adherence. Prepared through a refined nanoprecipitation and self-assembly method, FA-NIN-SLNPs exhibited a particle size of 220.5 ± 6.08 nm, a zeta potential of 32.1 ± 3.05 mV, and an entrapment efficiency of 98.3 ± 0.80 %. In vitro release studies indicated accelerated drug release at acidic tumor pH, with FA-NIN-SLNPs showing significantly enhanced apoptosis (86.65 %) in A549 lung cancer cells versus NIN-SLNPs (67.65 %) and free drug (23.53 %). Cellular uptake assays highlighted its targeted capabilities, while histopathological and hemolysis assessments confirmed its safety profile. In vivo pharmacokinetic and biodistribution studies further demonstrated superior lung-specific accumulation, positioning this nanoformulation as a promising, safer, and more efficacious approach for targeted lung cancer therapy.

139

News (Medical) associated with Nintedanib esylate

26 Feb 2025

·investors.mannkindcorp.com

MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

2024 revenues of $286M , +43% v. 2023; 4Q 2024 revenues of $77M , +31% v. 4Q 2023 2024 net income of $28M ; Non-GAAP net income of $68M 4Q 2024 net income of $7M ; Non-GAAP net income of $23M Reduced debt principal by $236M ; remaining convertible debt of $36M Year-end 2024 cash, cash equivalents and investments of $203M Advanced pipeline: Reported primary endpoint of INHALE-1 for Afrezza in pediatrics Progressed MNKD-101 to Global Phase 3 Completed Phase 1 of MNKD-201 Reported primary endpoint of INHALE-1 for Afrezza in pediatrics Progressed MNKD-101 to Global Phase 3 Completed Phase 1 of MNKD-201 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. , Feb. 26, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter and year ended December 31, 2024 , and provided a business update. “Throughout 2024, we accomplished the milestones we outlined at the beginning of the year, including delivering robust revenues as we exited the year with an annual run rate of $300 million ,” said Michael Castagna , PharmD, Chief Executive Officer of MannKind Corporation . “We are thrilled to have welcomed Dominic Marasco as President, Endocrine Business Unit, positioning Afrezza for further growth, including a planned submission this summer to seek approval in the pediatric population. In our orphan lung clinical programs, nintedanib DPI is progressing to the next phase of development and our Phase 3 trial of clofazimine inhalation suspension in NTM lung disease is expected to meet the interim enrollment target by the end of 2025.” 4Q 2024 Business Update and Upcoming Milestones Afrezza® INHALE-1 Pediatric Phase 3 clinical trial Six-month safety and efficacy results announced Requested meeting with the U.S. Food and Drug Administration ("FDA") in 1H 2025 to discuss data submission for potential approval of Afrezza in the pediatric population Expect twelve-month data set with safety extension in 1H 2025 Anticipate supplemental new drug application filing in 1H 2025 pending FDA feedback Clofazimine Inhalation Suspension Phase 3 (ICON-1) global clinical trial (MNKD-101) Approximately 70% of anticipated sites have been activated in four countries ( U.S. , Japan , Australia , South Korea ) Patients randomized in two countries ( U.S. and Australia ) Expect to meet the interim enrollment target by YE 2025 Nintedanib DPI Phase 1 clinical trial (MNKD-201) Successfully completed Phase 1 trial, demonstrating nintedanib DPI was well tolerated with no serious adverse events or study drug discontinuation reported Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into next phase of development Commercial – Endocrine Business Unit Announced the appointment of Dominic Marasco as President, Endocrine Business Unit Afrezza INHALE-3 Phase 4 clinical trial 17-week data published in Diabetes Care; 30-week data manuscripts expected to be published in 1H 2025 Inhaled insulin recognized as comparable to injectable insulin in the American Diabetes Association ® Standards of Care in Diabetes – 2025 Label application to update initial Afrezza conversion dose submitted to FDA Afrezza approved in India for adults; expect to ship in 4Q 2025 once Cipla obtains registration certificate and import license; earned $1.1M regulatory milestone Corporate and Financial: Strong Balance Sheet Cash, cash equivalents and investments as of December 31, 2024 totaled $203 million Eliminated principal of $236 million across three debt instruments during 2024 resulting in: Remaining outstanding debt balance of $36 million in 2.5% senior convertible notes due 2026 Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stock Interest expense savings of $9 million through the respective maturity dates Remaining outstanding debt balance of $36 million in 2.5% senior convertible notes due 2026 Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stock Interest expense savings of $9 million through the respective maturity dates Fourth Quarter and Full Year 2024 Financial Results Revenues Total revenues for the fourth quarter and full year 2024 rose due to increases in revenue from royalties, collaborations and services, and commercial sales. The rise in royalties was primarily due to higher patient demand for Tyvaso DPI. Collaborations and services revenue grew due to increased manufacturing of Tyvaso DPI for United Therapeutics Corporation ("UT"). Net revenues for Afrezza and V-Go increased primarily as a result of improved gross-to-net percentages and higher demand and, to a lesser extent, pricing for Afrezza, partially offset by a decrease in V-Go product demand. Operating Expenses and Other Financial Highlights Cost of revenue – collaborations and services was $14.8 million for the fourth quarter of 2024, compared to $12.0 million for the same period in 2023, an increase of 24%. For the full year 2024, cost of revenue – collaborations and services was $59.2 million , compared to $41.9 million , an increase of 41%. These increases are primarily the result of increased manufacturing volume of Tyvaso DPI. Research and development ("R&D") expenses were $11.1 million for the fourth quarter of 2024 compared to $9.2 million for the same period in 2023, an increase of 21%. For the full year 2024, R&D expenses were $45.9 million compared to $31.3 million , an increase of 47%. The increases were primarily attributable to development activities including the ICON-1 clinical study, a Phase 1 clinical study of MNKD-201, and personnel costs primarily due to increased headcount resulting from the Pulmatrix Transaction. Selling, general and administrative ("SG&A") expenses were $24.0 million for the fourth quarter of 2024 compared to $20.5 million for the same period in 2023, an increase of 17%. For the full year 2024, SG&A expenses remained consistent compared to the same period in 2023. This was primarily attributable to a loss of $1.4 million for estimated returns associated with sales of V-Go that pre-date MannKind's acquisition of the product and increases in personnel costs, professional fees and promotional activities, offset by a decrease in selling expenses related to sales force restructuring activities completed during the first quarter of 2024. For the fourth quarter of 2024, MannKind reported net income of $7.4 million , or $0.03 earnings per share – basic, compared to net income of $1.4 million , or $0.01 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported net income of $27.6 million , or $0.10 earnings per share – basic, compared to net loss of $11.9 million , or $0.04 loss per share – basic for the same period in 2023. For the fourth quarter of 2024, MannKind reported non-GAAP net income of $23.0 million , or $0.08 earnings per share – basic, compared to non-GAAP net income of $7.1 million , or $0.02 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported non-GAAP net income of $67.7 million , or $0.25 earnings per share – basic, compared to non-GAAP net income of $5.9 million , or $0.03 earnings per share – basic for the same period in 2023. For a reconciliation of GAAP reported net income (loss) and net income (loss) per share for basic weighted average shares to these non-GAAP measures, please see the end of this press release. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 4:30 p.m. Eastern Time . The webcast will be accessible via a link on MannKind’s website. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind's expectations about the development of Afrezza for the pediatric population, MNKD-101 and MNKD-201, including the expected timing for data readouts, regulatory filings, meetings with the FDA and patient enrollment timelines; expectations regarding the commercialization of Afrezza in India , including the estimated timing for the shipment of product; and MannKind being positioned for further growth. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; risks associated with competition; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024 , being filed with the SEC later today, and subsequent periodic reports on Form 10- Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. Tyvaso DPI is a trademark of United Therapeutics Corporation. AFREZZA, MANNKIND , and V-GO are registered trademarks of MannKind Corporation . _________________(1) Diluted weighted average shares ("DWAS") differs from basic weighted average shares due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes. For the year ended December 31, 2024 , DWAS included 9,429 shares issuable upon exercise or vesting of outstanding share-based payments. 6,967 shares issuable upon conversion of our senior convertible notes were excluded as their effect would be antidilutive. Non-GAAP Measures To supplement our consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share - basic, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. The following table reconciles our financial measures for net income (loss) and net income (loss) per share ("EPS") for basic weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation: _________________(1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Source: MannKind

Phase 1Phase 3Financial StatementExecutive ChangeDrug Approval

10 Feb 2025

·www.fiercebiotech.com

Boehringer widens fibrosis drug\'s approval path after boosting lung function in 2nd phase 3 trial

German drugmaker Boehringer Ingelheim didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.\n Boehringer Ingelheim has cemented the potential of its idiopathic pulmonary fibrosis (IPF) drug with a second phase 3 win in a related lung disease leading the drugmaker to expand the indications it will seek FDA approval for.The FIBRONEER-ILD trial saw 1,178 patients with progressive pulmonary fibrosis (PPF) receive either a 9 mg or 18 mg dose of the PDE4B inhibitor nerandomilast or placebo twice a day for 52 weeks. The study hit its primary endpoint of demonstrating an absolute change from baseline in forced vital capacity—a measure of the volume of air that a patient can breathe out—Boehringer said in a Feb. 10 release.The German drugmaker didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.“Initial data readouts of the FIBRONEER trials support a generally consistent safety and tolerability profile when compared to the phase 2 IPF study, with overall adverse events comparable to those seen in the placebo group,” the company said.Armed with the latest results, Boehringer said it will request that FDA and global regulators approve nerandomilast as a treatment for PPF, a type of interstitial lung disease. The company has already said it will seek approval for nerandomilast in IPF after proclaiming a win in a phase 3 trial for that lung disease in September 2024. Again, the company opted to hold back any concrete data from that trial for later in this year.When it comes to managing IPF, physicians already have Boehringer’s Ofev and Roche’s Esbriet. However, those drugs only slow the progression of fibrosis, while attempts to produce molecules that further slow, or ideally stop, progression have failed to prove their worth.By targeting phosphodiesterase 4B (PDE4B), nerandomilast is meant to have a mechanistic advantage over the incumbent products. Targeting PDE4 drives anti-inflammatory and antifibrotic effects, but attempts to develop oral inhibitors of the enzyme in respiratory diseases have been hindered by class-related systemic adverse events such as diarrhea and headaches.“The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis,” Shashank Deshpande, Head of Human Pharma at Boehringer, said in the release. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”

$Boehringer widens fibrosis drug\'s approval path after boosting lung function in 2nd phase 3 trial$

Phase 3Phase 2Clinical Result

10 Feb 2025

·www.pharmaceutical-technology.com

Boehringer seeks approval of lung disease drug after second Phase III success

Boehringer Ingelheim has announced a Phase III trial of its investigational lung disease drug nerandomilast has met its primary endpoint. Image credit: Tada Images / Shutterstock Boehringer Ingelheim’s lung disease drug nerandomilast has been successful in a Phase III study paving the way for the company to seek approval for the asset in a second condition. Topline data from the Phase III FIBRONEER-ILD trial (NCT05321082) shows that nerandomilast improved lung function in patients with progressive fibrosing interstitial lung diseases (PF-ILDs), excluding those with idiopathic pulmonary fibrosis (IPF). The company previously ran a separate IPF study, which supported its new drug application (NDA) submission last year. While the company said the placebo-controlled trial met the primary endpoint of change from baseline in forced vital capacity (FVC) at week 52, it did not disclose data detailing the change, which will be shared in Q2 2025. The study enrolled 1,178 adult patients who were allowed to continue receiving Ofev (nintedanib), a tyrosine kinase inhibitor (TKI) also developed by Boehringer, during the study. Off the back of the trial data, Boehringer Ingelheim will submit a NDA for nerandomilast to the US Food and Drug Administration (FDA) and other health authorities for approval in patients with progressive pulmonary fibrosis (PPF). Head of human pharma and member of the board of managing directors at Boehringer Ingelheim, Shashank Deshpande, said: “The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in PPF. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.” The FIBRONEER-ILD results come five months after a separate Phase III trial of nerandomilast in patients with IPF (NCT05321069), called the FIBRONEER-IPF, also met its primary endpoint of FVC change at 52 weeks. Boehringer Ingelheim has already submitted a separate NDA to the FDA and other agencies for approval of nerandomilast in IPF. Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). The therapy was granted FDA Breakthrough Therapy Designation for the treatment of IPF in February 2022. Boehringer dominates IPF space Boehringer’s Ofev is the standard of care (SOC) and one of only two drugs approved for IPF. The drug is also approved to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other chronic interstitial lung diseases. In 2023, Boehringer tried to expand its label further with a supplementary NDA submission for paediatric ILD based on data from the Phase III InPedILD (NCT05285982) study, but it was refused by the FDA in March 2024. However, in December 2024, the European Medicine Agency went another way and recommended the label expansion, but at a reduced dose due to adverse events (AEs). Ofev’s competitor on the IPF and PPF market, Roche’s Esbiret (pirfenidone) , saw its sales drop dramatically in 2023, making the company $229.4m compared to the $1.14bn in sales in 2021. This drop was largely attributable to the availability of generic versions of the drug in 2022. There are no generic versions of Ofev available yet, and its sales in 2023 reached $3.8bn increasing by 12.8% compared to the previous year. If approved, nerandomilast could likely be Ofev’s successor in the lung diseases space for Boehringer.

Phase 3NDADrug ApprovalBreakthrough TherapyClinical Result

100 Deals associated with Nintedanib esylate

External Link

KEGG	Wiki	ATC	Drug Bank
D10396 D10481	Nintedanib esylate	L01XE31	DB09079

R&D Status

Approved

10 top approved records.

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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
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 SLU	22 Feb 2024
Lung Diseases, Interstitial	NDA/BLA	United States	Boehringer Ingelheim GmbH	25 Jul 2023
Pterygium	Phase 3	United States	Cloudbreak Therapeutics LLCStartup	30 Jun 2022
Pterygium	Phase 3	China	Cloudbreak Therapeutics LLCStartup	30 Jun 2022
Pterygium	Phase 3	Australia	Cloudbreak Therapeutics LLCStartup	30 Jun 2022
Pterygium	Phase 3	India	Cloudbreak Therapeutics LLCStartup	30 Jun 2022
Pterygium	Phase 3	New Zealand	Cloudbreak Therapeutics LLCStartup	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03820726 (INBUILD-ON, Pubmed \| Lung)	Phase 3	Progressive fibrotic interstitial lung disease	-	Continued Nintedanib	plnplzkefb(gggvxcbcwy) = Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity rxjecdbzbb (tkcluwqxoe ) View more	Positive	01 Dec 2025
NCT03377023 (CTgov)	Phase 1/2	metastatic non-small cell lung cancer	66	Ipilimumab+Nivolumab+Nintedanib (Phase 1-Dose Escalation)	aipwclytlu = qqixgjkdfr soiuhqbkhz (tefcmbuywg, mfoqwvvddn - iugbevivam)	-	25 Mar 2025
				ipilimumab+Nivolumab+Nintedanib (Phase 2 - Arm A)	xcolgsanxh = igjjseoorw rkhwxbxahz (sejucmmidl, xpfqargmzb - obbgfbpfgt) View more
Literature Manual	Phase 2	HER2-negative breast cancer	111	nintedanib	lbshrcjnzv(teodstzenz): P-Value = 0.37	Positive	11 Oct 2024
				paclitaxel
ESMO2024 Manual	Not Applicable	Non-Small Cell Lung Cancer Third line \| Second line	173	Docetaxel with Nintedanib (D+N)	powmtsiyhn(eiezfyugqb) = dvfyhrroda nmfkqatpqd (xlucakngma ) View more	Negative	14 Sep 2024
				Docetaxel with Ramucirumab (D+R)	powmtsiyhn(eiezfyugqb) = zyajvkqxrq nmfkqatpqd (xlucakngma ) View more
NCT02863055 (EORTC-08112-LCG, ESMO2024) Manual	Phase 2	Malignant Pleural Mesothelioma Maintenance	37	Nintedanib 200mg BID	qfnoddytqc(uzdfhhtnww) = hhhbpsqmqq rtiybhvgmw (rmnhlvbnnm ) View more	Negative	14 Sep 2024
				Placebo	qfnoddytqc(uzdfhhtnww) = zabljcjaqe rtiybhvgmw (rmnhlvbnnm ) View more
NCT02902484 (ESMO_GI2024) Manual	Phase 1	Pancreatic Cancer	13	Nintedanib combination with chemotherapy gemcitabine (Gem) and nab-paclitaxel (Nab-P)	pmbnpirovx(bchzsjpzib) = nintedanib was 200 mg twice daily ankkkogsro (bmsnadkjwt ) View more	Positive	27 Jun 2024
EULAR2024	Not Applicable	Lung Diseases, Interstitial	67	Nintedanib 150mg twice daily	wmsoyxhuoe(opswlfpscw) = Adverse events led to NINTE withdrawal in 13 patients qeusnirzoh (iimuohumch ) View more	Positive	05 Jun 2024
NCT02902484 (CTgov)	Phase 1/2	Pancreatic Cancer	14	Nab-paclitaxel+gemcitabine+nintedanib (All Participants)	upvesnkofb = hlsjroncyp azyqfioezb (arutthsuzw, fkevtxxkla - xzmxwezolh)	-	03 Jun 2024
				Nintedanib (Nintedanib 150 mg)	iwysjzwoiu(yupxujplpc) = szjxjysvwk zjqxhssxev (zbwuaksoat, cmgtqqbyho - mdygkvglzy) View more
NCT02299141 (pilot study of nintedanib, Pubmed)	Phase 2	Advanced Lung Non-Small Cell Carcinoma TP53 \| VEGFR1-3 \| PDGFR-A ... View more	20	Nintedanib 200 mg	gtrlvgeiqn(prvyoegroz) = gviyaybnwo owsbvdduaw (yynmwxieke ) View more	Positive	01 Jun 2024
NCT05262751 (CTgov)	Phase 1	-	21	Ofev (Cohort 1: Reference (R))	uoyiuczaan(ysfgobefhv) = bnvxctzwhy lieswrbpqm (lnzurlgzpw, NA) View more	-	29 May 2024
				Nintedanib (Cohort 1: Test Treatment 1 (MR1-1))	uoyiuczaan(ysfgobefhv) = wpmpeyvrpq lieswrbpqm (lnzurlgzpw, NA) View more

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