nintedanib / Generic mfg. - LARVOL DELTA

A Prospective, Multicenter, Exploratory Clinical Study of Tislelizumab Combined With Nintedanib for Consolidation Treatment of LS-SCLC (IASLC-WCLC 2026) - "In the ADRIATIC study, durvalumab was associated with any-grade pneumonia in 38.2% of patients (3.1% grade 3-4). Secondary endpoints include1-y PFS rate, incidence of radiation pneumonitis, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory endpointsare potential prognostic and predictive biomarkers."

Clinical • IO biomarker • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Isatin-based Strategies for Microbial Infections: A Multifaceted Perspective. (PubMed, Rev Recent Clin Trials) - "The clinical approval of numerous isatin-based drugs, including sunitinib and nintedanib, for the treatment of cancer, as well as the evaluation of other drugs, like TD-1792 and Ro 23-9424, for the treatment of infectious diseases, demonstrate the translational success of this scaffold. This review focuses on significant advancements, procedures, and potential treatments in isatin-based antimicrobial research."

Journal • Infectious Disease • Oncology

Nanocarrier-Enabled siRNA Therapy for Pulmonary Fibrosis: Pharmacological Rationale, Delivery Barriers, and Translational Opportunities. (PubMed, Int J Nanomedicine) - "Nintedanib and pirfenidone slow functional decline but do not reverse established fibrosis. We also consider single-target and multitarget strategies, pulmonary and systemic administration, disease-model limitations, and early clinical experience. The resulting target-to-delivery framework defines the evidence required before pulmonary siRNA nanomedicines can enter informative clinical testing."

Journal • Review • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Case Report: Invasive mucinous adenocarcinoma mimicking interstitial pneumonia with autoimmune features: diagnostic pitfalls and reflections. (PubMed, Front Immunol) - "After one week, chest CT showed no resolution; mycophenolate mofetil and nintedanib were added. As an exclusionary diagnosis, IPAF must be established only after thorough exclusion of infection, malignancy, and other causes. Immunosuppressive therapy should not be initiated based solely on autoantibody positivity and ILD imaging."

Journal • Cough • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatology • Solid Tumor • Napsin A • NKX2-1

Nerandomilast in Idiopathic Inflammatory Myopathy-Associated Interstitial Lung Disease: Subgroup Analysis of the Phase III FIBRONEER™-ILD Trial (ACR Convergence 2026) - "PPF was defined using INBUILD criteria.2 Concomitant nintedanib was permitted if the dose was stable. In this exploratory subgroup analysis of the FIBRONEER™-ILD trial, nerandomilast showed consistent trends toward reduced FVC decline and disease progression in patients with IIM-ILD. These findings, despite the small sample size, suggest that nerandomilast may have therapeutic potential in IIM-ILD."

P3 data • Idiopathic Pulmonary Fibrosis • Infectious Disease • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases

VERANDA™-SSc: Design of a Phase III, Double-blind, Randomized, Placebo-controlled Trial Evaluating the Safety and Efficacy of Oral Nerandomilast Treatment on Halting Disease Progression in Systemic Sclerosis (ACR Convergence 2026) - "The VERANDA™-SSc trial is a novel time-to-event-driven Phase III study evaluating the efficacy and safety of nerandomilast in patients with SSc, a disease for which there are no widely licensed pharmacological treatments targeting overall disease progression."

Clinical • P3 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Scleroderma • Suicidal Ideation • Systemic Sclerosis • Vasculitis

Early Treatment Pathways Improve Outcomes in Severe Autoimmune Diseases: Systematic Review and Evidence Synthesis of 430 Studies (ACR Convergence 2026) - "Rituximab maintenance therapy significantly reduced relapse compared with azathioprine (HR 0.36, 95% CI 0.23-0.57), while avacopan-based protocols achieved sustained remission in 71.0% versus 56.1% of patients receiving conventional glucocorticoid regimens (difference 12.5%, 95% CI 2.6-22.3; p=0.007). In EGPA, mepolizumab significantly increased remission rates (OR 12.0, 95% CI 2.7-53.0). In SSc-ILD, nintedanib reduced annual forced vital capacity decline by 41 mL/year and multiple trials demonstrated preservation of pulmonary function with cyclophosphamide-, mycophenolate-, and tocilizumab-based treatment protocols. In SLE, anifrolumab improved BICLA response rates versus placebo (59.4% vs 43.9%; p=0.02), while lupus nephritis studies demonstrated significant reductions in adverse renal outcomes (HR 0.12, 95% CI 0.031-0.39).Overall, evidence supporting morbidity reduction (184 studies) exceeded evidence for mortality reduction (122 studies), indicating that prevention..."

Review • ANCA Vasculitis • Dermatomyositis • Eosinophilic Granulomatosis With Polyangiitis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Langerhans Cell Histiocytosis • Lupus • Lupus Nephritis • Myositis • Nephrology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Scleroderma • Systemic Sclerosis • Vasculitis • IFIH1

Comparative Effectiveness of Tocilizumab vs Nintedanib in Systemic Sclerosis-Associated Interstitial Lung Disease: A Propensity-Matched Real-World Study (ACR Convergence 2026) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Characteristics of Patients Receiving Nintedanib: A Real-World SSc-ILD Cohort Study in the EUSTAR Registry (ACR Convergence 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Interstitial Lung Disease • Systemic Sclerosis

Effect of Nintedanib Associated to Abatacept in Rheumatoid Arthritis-Associated Interstitial Lung Disease. National Multicenter Study of 526 Patients. (ACR Convergence 2026) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Nintedanib in Progressive Systemic Sclerosis-Associated Interstitial Lung Disease on Background Immunosuppression: Real-World Outcomes, Treatment Escalation, and Risk Stratification (ACR Convergence 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Late Breaking Abstract - OGG1 organocatalytic switches attenuate fibrotic remodelling in patient-derived fibrotic lung slices (ERS 2026) - "Nintedanib and pirfenidone were included as reference antifibrotic comparators. OGG1 organocatalytic switching identifies candidate antifibrotic compounds in patient-derived fibrotic lung tissue. These data support ORCAs as a novel therapeutic concept for progressive fibrotic ILD/DPLD. *ChatGPT used for drafting; authors reviewed/edited and take responsibility."

Clinical • Late-breaking abstract • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Real-world safety of nintedanib and pirfenidone (ERS 2026) - "Overall, the pattern of adverse events was consistent with those reported in pivotal clinical trials, while the observed discontinuation rates highlight the importance of tolerability in routine clinical practice. Larger real-world studies are warranted to further explore comparative tolerability."

Clinical • Real-world • Real-world evidence • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Mechanotransduction measurements in fibrotic human precision-cut lung slices to reveal drug-induced tissue softening mechanisms (ERS 2026) - "Conclusions Our data defines a novel mechanical-biomechanical feedback loop mediating Nintedanib's PCLS softening mechanism. Our combined experimental and modeling approach is readily extended to resolve candidate drug function directly in PF tissue."

Fibrosis • Pulmonary Disease • Respiratory Diseases • MMP7 • TGFB1

Anti-remodelling effects of formyl peptide receptor agonism in a novel precision-cut lung slice model of pulmonary arterial hypertension (ERS 2026) - " PCLS from agarose-inflated lungs were treated with a pulmonary hypertension cocktail (PHC=TNFα, TGF-β, PDGF-AB, ET-1) ± FPR agonist (Cmpd17b, BMS-986235), sildenafil, iloprost or nintedanib (hPCLS only)... Our novel PCLS model mimics phenotypic changes in PAH. Different FPR agonists show varied inhibition of PHC-induced inflammation, fibrogenesis and vascular remodelling in mPCLS and hPCLS. FPR agonism may modify disease progression in PAH, more comprehensively than current therapies."

Cardiovascular • Inflammation • Pulmonary Arterial Hypertension • Respiratory Diseases • IL6 • TGFB1 • TNFA

COMPARATIVE EFFECTIVENESS OF PIRFENIDONE, NINTEDANIB, AND NO ANTIFIBROTIC THERAPY IN IDIOPATHIC PULMONARY FIBROSIS: A PROPENSITY SCORE-MATCHED ANALYSIS OF 10-YEAR MORTALITY (CHEST 2026) - No abstract available

HEOR • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Patient-reported adverse events and management of antifibrotic therapy in IPF: A multicenter, cross-sectional real-world study. (PubMed, Ther Adv Respir Dis) - "Adverse events and their management were compared between pirfenidone and nintedanib users.ResultsAmong 470 patients, 50.6% used pirfenidone and 49.4% nintedanib. Female sex and the presence of comorbidities were associated with a higher frequency of certain adverse events. Supportive treatment and dose adjustments are crucial for maintaining adherence."

Adverse events • Clinical • Journal • Real-world evidence • Anorexia • Fatigue • Idiopathic Pulmonary Fibrosis

CON: not so fast – upfront combination therapy is not yet ready for routine practice (ERS 2026) - "While antifibrotic therapies such as nintedanib and pirfenidone have demonstrated efficacy in slowing disease progression, robust data supporting routine upfront combination therapy remain limited. Emerging therapies, including nerandomilast, have shown promising results in recent trials, but questions remain regarding optimal treatment sequencing, long-term safety, tolerability and cost-effectiveness when used in combination. This presentation will critically review the available evidence, highlight the gaps that still need to be addressed through dedicated clinical trials, and argue that a cautious, stepwise treatment approach remains the most appropriate strategy in current clinical practice for patients with fibrotic interstitial lung disease."

Combination therapy • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Nintedanib for progressive pulmonary fibrosis associated with sarcoidosis: a retrospective preliminary observational report. (PubMed, Respir Investig) - "Our exploratory study yielded two hypotheses; a potential benefit of nintedanib on the FVC annual decline and a possible role for chest CT findings predicting nintedanib efficacy. Unexpected adverse events were not observed."

Journal • Retrospective data • Bronchiectasis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Sarcoidosis

Nintedanib lacks efficacy in a spirometry-confirmed and bleomycin-induced mouse model of idiopathic pulmonary fibrosis (ERS 2026) - "Collectively, these findings challenge the use of nintedanib as a benchmarking drug in the single-dose BLEO-IPF mouse model."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • COL1A1 • LGALS3

Macrophage-fibroblast communication driven by biomechanical stress in the pulmonary profibrotic niche: From signalling transduction to clinical translation. (PubMed, Cells Dev) - "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. 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."

Journal • Review • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

iPSC organoid platform for fibrosis drug-discovery: Terminal/respiratory bronchiole secretory cell–aberrant-progeny crosstalk (ERS 2026) - "Responses to nintedanib, nerandomilast, and investigational new drug (IND) candidates were assessed. This iPSC-derived distal-lung organoid platform quantifies TRB-SC plasticity and epithelial–fibroblast communication relevant to pulmonary fibrosis and supports in vitro evaluation at scale of anti-fibrotic/regenerative candidates. HL001 showed anti-fibrotic activity consistent with alveolar regeneration that supports its FDA Orphan Drug Designation for IPF."

Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PRO: upfront combination therapy in pulmonary fibrosis – start early, target more (ERS 2026) - "Building on current evidence with antifibrotic agents such as nintedanib, pirfenidone and nerandomilast, the presentation will discuss the limitations of monotherapy and the biological rationale for simultaneously targeting multiple profibrotic pathways. Drawing parallels with treatment strategies successfully implemented in other chronic conditions, such as pulmonary arterial hypertension, this presentation will argue that an upfront combination approach could be an effective next step in improving outcomes for patients with fibrotic interstitial lung diseases. Evidence, potential benefits and remaining challenges will be critically examined to support the case for a paradigm shift towards earlier, multitarget treatment strategies."

Combination therapy • Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Randomised controlled trial of partitioned aerobic exercise training using one-leg cycling in patients with idiopathic pulmonary fibrosis. (PubMed, Thorax) - P=N/A | "Partitioning training to a smaller muscle volume (one-leg) improved exercise endurance more than two-leg cycle training in patients with stable moderate-to-severe IPF."

Journal • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Mass spectrometry imaging of nintedanib and nerandomilast in normal and fibrotic mouse lungs and extrapulmonary organs (ERS 2026) - "[Methods] Pulmonary fibrosis was induced in mice by subcutaneous infusion of bleomycin. [Conclusions] MSI provides spatially resolved analysis of antifibrotic drug distribution and retention in normal and fibrotic lungs as well as other organs. This approach may support nonclinical evaluation of novel antifibrotic agents and help relate tissue exposure to efficacy and adverse events."

Preclinical • Fibrosis • Pulmonary Disease • Respiratory Diseases