nintedanib / Generic mfg. - LARVOL DELTA

Targeting the epithelium in pulmonary fibrosis. (PubMed, Eur Respir Rev) - "Consequently, drug discovery has focused on the activity of scar-forming fibroblasts, with some success shown by the pharmaceutical agents nintedanib and pirfenidone, and more recently nerandomilast. Here, we review the advances made in "omic" technologies, the approaching spatial profiling revolution, current and future functional cell systems, novel in vivo models, how we assign disease-relevance to test systems via computational gene set enrichment analysis, and link all these elements to clinically relevant biomarkers. We show how epithelial populations, identified and validated through cutting-edge technologies, may provide targets for the next wave of therapeutics for patients with IPF."

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

Association of the lower-lobe volume ratio on three-dimensional computed tomography with disease progression in idiopathic pulmonary fibrosis. (PubMed, Respir Investig) - "s: The 3D-CT-derived b-LLV/TLV ratio was independently associated with clinical events in patients with IPF receiving nintedanib. A risk score incorporating the b-LLV/TLV ratio may enhance prediction of short-term clinical outcomes beyond conventional prognostic factors."

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

Targeting vascular endothelial growth factor and its receptors in non-small cell lung cancer for improved treatment strategies. (PubMed, J Recept Signal Transduct Res) - "Anti-angiogenic therapy, for instance, with monoclonal antibodies like bevacizumab and ramucirumab, as well as multi-targeted tyrosine kinase inhibitors (TKIs) like nintedanib and anlotinib has been shown to improve the management of NSCLC. Angiogenesis-associated biomarkers, despite extensive research, have not been seen to have a clinical impact in the management and treatment of NSCLC because of the heterogeneous characteristics and the dynamic regulation of the cascade. This review summarizes current VEGF/VEGFR-targeted therapies in NSCLC, mechanisms of resistance, and future directions toward biomarker-guided therapeutic optimization."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The effect of Nintedanib on KL-6 levels in patients with interstitial lung disease: A systematic review and meta-analysis. (PubMed, Autoimmun Rev) - "Anti-fibrotic therapy appears to stabilize KL-6 in ILD, supporting its prognostic utility. Baseline lung function may influence the KL-6 response. Larger, standardized prospective studies are needed to clarify KL-6's role as a dynamic biomarker of treatment response in ILD."

Journal • Retrospective data • Review • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology

Transcriptomic analysis reveals lipid metabolism and macrophage involvement associated with nintedanib treatment in a rat bleomycin model. (PubMed, Br J Pharmacol) - "The study highlighted two distinct protective effects of nintedanib on lung fibrosis. One well-known on mesenchymal cells and matrix-related components. Plus, one related to the involvement of the pneumocyte-macrophage paracrine lipid axis, where oxidized lipids alter macrophage activities, leading to the formation of lipid-filled macrophages. This may open new research directions."

Journal • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases

Low-Dose vs. Standard-Dose Nintedanib at Initiation in Fibrosing ILD: A Target-Trial Emulation of Treatment Persistence and Lung Function. (PubMed, Ann Am Thorac Soc) - "In this target-trial emulation, starting at 100 mg twice daily improved 12-month treatment persistence. One-year FVC %predicted estimates among survivors were broadly similar but imprecise and should be interpreted with caution; a start-low, escalate-as-tolerated policy warrants prospective evaluation."

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

Sales for OFEV, used to treat idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases, increased 5.4%* to EUR 3.8 billion. (The Manila Times)

Sales • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nintedanib Eye Drops Inhibit Alkali Burn-Induced Corneal Neovascularization Via RAP1/MEK/ERK Signaling Pathway. (PubMed, Invest Ophthalmol Vis Sci) - "Topical NTD administration effectively reduced alkali burn-induced CNV, which was related to the RAP1/MEK/ERK pathway. NTD could be an effective treatment strategy for CNV post-alkali injury."

Journal • Inflammation • Ocular Inflammation • CD31 • HIF1A • KDR • LYVE1 • PECAM1 • RAP1A

A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University

New P4 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Clinically validated markers of extracellular matrix remodeling are altered by anti-inflammatory and anti-fibrotic compounds in a human skin ex vivo model (AAD 2026) - "Within 24 hours, the skin was processed as 3 mm full-thickness punch biopsies, including epidermis, dermis, and hypodermis, and cultured in five replicates for 48 hours in serum-free medium with either the matrix metalloproteinase (MMP) inhibitor, GM6001 (10 µM), or the anti-fibrotic compound Nintedanib (10 µM)...Data varied dependent on donor. We found that an MMP-inhibitor and anti-fibrotic decreased biomarkers of ECM remodeling in a human skin ex vivo model and may potentially be used as a tool for evaluating anti-inflammatory and anti-fibrotic compounds in a 3D skin structure."

Preclinical • Aesthetic Medicine • Dermatopathology • Hidradenitis Suppurativa • Immunology • Scleroderma • Systemic Sclerosis

Investigation of the Effects of Nintedanib in Liver Damage Induced by CCl4 in Rats (APASL 2026) - No abstract available

Preclinical

Real-world treatment and response patterns in patients with metastatic non-small cell lung cancer in Spain: REVEAL study (ELCC 2026) - "Among NSQ platinum-based CT was more frequent after 1L double IO+CT (45.7%, 16/35) than after 1L IO+CT (10.4%, 5/48) whereas docetaxel ± nintedanib predominated after 1L IO+CT (54.2%, 26/48 vs 25.7%, 9/35). ORR, DOR, PFS, OS and time on treatment were higher with IO combos vs CT. Further follow-up is needed to assess 2L and beyond.Editorial acknowledgement Medical writing and editorial assistance was provided by María Yuste, Evidenze Health España S.L.U, funded by Bristol Myers Squibb."

Clinical • HEOR • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Real-world clinical, molecular, treatment patterns and outcomes of rare mutations in lung cancer from community oncology centres in Western India (ELCC 2026) - "Among mutated cases receiving targeted therapy, MET alterations (n=12) were treated with crizotinib, capmatinib & tepotinib (each n=4); KRAS co-mutations (n=13) mainly received bevacizumab-based regimens (n=6), followed by trametinib (n=2) & Nintedanib (n=1); BRAF-altered tumors (n=7) were mainly treated with chemotherapy & few were targeted with dabrafenib + trametinib (n=3); RET mutations (n=8) received cabozantinib & selpercatinib (each n=3); HER2 alterations (n=21) were mainly managed with trastuzumab -based regimens (n=13). With a median follow-up of 16.3 months, median overall survival (mOS)for the cohort was 13.9 mo(95% CI 10.6–17.1; mOS for single mutation was 15.9 mo vs 12.3 mo for co-mutations (p=0.637).mOS by mutation subtype was 14.3 mo (95% CI 0.0–68.6) for MET, 35.0 mo (95% CI NA–NA) for RET, 13.7 mo (95% CI 8.7–18.7) for BRAF, 10.3 mo (95% CI 2.4–18.2) for HER2, while KRAS/TP53 mutations had mOS of 13.1mo (95% CI 9.4–16.8).Conclusions This..."

Clinical • IO biomarker • Real-world • Real-world evidence • Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • PD-L1 • RET • ROS1 • TP53

REFRACTORY DIGITAL ULCERS AND CHRONIC OSTEOMYELITIS COMPLICATING DIFFUSE SYSTEMIC SCLEROSIS: A REAL-LIFE CASE (SSWC 2026) - "Digital ulcers were refractory to nifedipine 60 mg/day, prompting escalation to alprostadil in 2013 and iloprost in 2016, both initially effective...Sildenafil (up to 150 mg/day, 2024–2025) proved ineffective. Bosentan, initiated in January 2025, was discontinued after re-hospitalization in August 2025 for multiple ulcers and chronic osteomyelitis of the right fifth digit...Osteomyelitis developed in the right second digit in 2019, requiring multiple antibiotic courses (flucloxacillin, amoxicillin–clavula- nate, clindamycin, trimethoprim–sulfamethoxazole) following Staphylococcus aureus isolation, with relapse in 2020 managed with ciprofloxacin...Mycophenolate mofetil (2017–2019) was used for progressive skin fibrosis and NSIP but discontinued due to recurrent osteomyeli- tis. Nintedanib (2021–2024) was initiated for progressive pulmonary fibrosis but withdrawn due to severe diarrhea and weight loss... This case illustrates the complex therapeutic challenges in SSc..."

Clinical • Cardiovascular • Fibrosis • Hepatology • Hypotension • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Musculoskeletal Diseases • Orthopedics • Pneumonia • Primary Biliary Cholangitis • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • Venous Ulcer

Bexotegrast for treatment of idiopathic pulmonary fibrosis (BEACON-IPF): study protocol for a multinational, phase 2b/3, double-blind, randomised, multicentre, controlled trial. (PubMed, BMJ Open Respir Res) - P2 | "Background therapy with pirfenidone or nintedanib is permitted in ≤70% of the study population. Study results will be disseminated in peer-reviewed journals and international conferences targeted to medical, academic and patient communities. NCT06097260."

Journal • P2/3 data • P2b data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Nerandomilast attenuates idiopathic inflammatory myopathy-associated interstitial lung disease via inhibiting proliferation and differentiation of B cells. (PubMed, Front Immunol) - "Mice were treated with Nerandomilast (5 or 12.5 mg/kg, twice daily) or Nintedanib (60 mg/kg, once daily) as a positive control. Its efficacy is mechanistically linked to the direct modulation of B cells, achieved by elevating intracellular cAMP and subsequently reprogramming key signaling networks to inhibit B cell activation, proliferation, and pathogenic differentiation into antibody-producing plasma cells. These findings highlight Nerandomilast as a promising candidate for the treatment of IIM-ILD."

Journal • Immunology • Inflammation • Interstitial Lung Disease • Myositis • Pneumonia • Pulmonary Disease • Respiratory Diseases • STAT3

Safety and Efficacy of Nerandomilast in Patients With Pulmonary Fibrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Clin Respir J) - "Nerandomilast appears to slow lung function decline in pulmonary fibrosis without added safety risks. Although a lower pooled risk of mortality was observed, individual trials were not powered for mortality outcomes, and event rates were low; therefore, this finding should be interpreted cautiously. Given the heterogeneity of pulmonary fibrosis phenotypes and trial designs, further large-scale RCTs should explore standardized outcomes, subgroup effects, and combination strategies with nintedanib or pirfenidone."

Clinical • Journal • Retrospective data • Review • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

EPISTOP: Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Dr. Romain Lazor | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hematological Disorders

ANTIFIBROTICS IN RHEUMATOID ARTHRITIS-INTERSTITIAL LUNG DISEASE: COMPARATIVE STUDY OF NINTEDANIB VS PIRFENIDONE. NATIONAL MULTICENTER STUDY OF 107 PATIENTS (EULAR 2026) - No abstract available

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

Pleuroparenchymal Fibroelastosis Complicated by Pulmonary Alveolar Proteinosis After Peripheral Blood Stem Cell Transplantation. (PubMed, Respirol Case Rep) - "Despite corticosteroids, tacrolimus, and subsequent antifibrotic therapy with nintedanib, the disease gradually progressed, and the patient ultimately died of acute exacerbation triggered by SARS-CoV-2 infection. This case highlights a rare coexistence of PPFE and PAP after PBSCT and underscores the potential role of chronic graft-versus-host disease and immune dysregulation in their pathogenesis."

Journal • Acute Lymphocytic Leukemia • Chronic Graft versus Host Disease • Cough • Fibrosis • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Interstitial Lung Disease • Leukemia • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Transplantation

Combinatorial drug screen identifies therapeutic vulnerabilities of pancreatic cancer subtypes (ESMO-TAT 2026) - "decitabine, oxidative stress inducer elesclomol, and mitogen-activated protein kinase kinase (MEK) inh...rabusertib and AZD7762 ranked among the top combinations with AZD3965...adavosertib also sparked interest, as CHK1 and WEE1 inh... This systematic approach identifies candidate drug pairs for further preclinical testing and highlights translational starting points for developing personalized combination therapies to overcome resistance."

Colon Cancer • Colorectal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CHEK1 • SLC16A1

DELAYED SEROCONVERSION AND PULMONARY INVOLVEMENT IN SLE-SYSTEMIC SCLEROSIS OVERLAP SYNDROME: A CASE REPORT (SSWC 2026) - "The patient was diagnosed with SLE and started on hydroxychloroquine 400 mg/day, pentoxifylline 400 mg three times daily, and nifedipine 30 mg/day, achieving partial symptomatic improvement...Immunosuppressive therapy was initiated with mycophenolate mofetil, titrated to 1000 mg twice daily, alongside with nintedanib 100 mg twice daily, maintaining clinical stability... This case illustrates the diagnostic challenges of overlap syndromes. The delayed seropositivity of anti-Scl70 antibo- dies emphasizes that serology alone may underestimate disease evolution. Anti-Scl70 positivity is known to correlate with a higher risk of interstitial lung disease in SSc, consistent with this patient's pulmonary involvement."

Case report • Clinical • Cardiovascular • Fibrosis • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Lupus • Musculoskeletal Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CRP

DIFFERENTIAL MODULATION OF CXCL4, ANTI-CXCL4 ANTIBODIES AND KL-6 DURING NINTEDANIB THERAPY IN PROGRESSIVE SSC-ILD: ASSOCIATIONS WITH BASELINE AUTOMATED QUANTITATIVE CT AND FUNCTIONAL FEATURES (EULAR 2026) - No abstract available

Interstitial Lung Disease

Development and Evaluation of Benzofuran Oxoacetic Acid Compounds as EPAC1 Activators. (PubMed, J Med Chem) - "In disease-relevant contexts, the series attenuated IL-6/STAT3 signaling in human umbilical vascular endothelial cells and inhibited TGF-β1-induced fibroblast-to-myofibroblast transition (αSMA, Collagen I) with midmicromolar potencies; known drugs, SB525334 and nintedanib, remained more potent, yet nintedanib was markedly more cytotoxic. Across assays, some binding-phenotype disconnects emerged, plausibly reflecting exposure, signaling bias, and cell-context effects. Overall, benzofuran oxoacetic acids provide EPAC-pathway probes with a favorable tolerability window and scope for potency optimization as antifibrotics."

Journal • Fibrosis • Immunology • IL6 • TGFB1

Dynamic in vitro platform for mechanical profiling of human pulmonary aciniform organoids via intraluminal access. (PubMed, Biomaterials) - "Bleomycin treatment induced fibrotic phenotypes, including reduced volume and compliance, mimicking disease-associated mechanical stiffening. Treatment with the antifibrotic drug nintedanib yielded partial mechanical recovery, reflecting the clinically measured treatment response. This human-relevant system models dynamic three-dimensional respiratory biomechanics in vitro, capable of quantitative mechanical and pharmacological testing. Our findings demonstrate that PAcinOs in DENIRO offer a flexible platform for complex lung disease modeling, drug screening and investigation of mechanobiological tissue behavior in vitro."

Journal • Preclinical • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases