nintedanib / Generic mfg. - LARVOL DELTA

A prospective, multicenter phase II clinical study of nintedanib in preventing radiation pneumonitis in unresectable NSCLC (ESMO Asia 2025) - "Nintedanib combined with sequential radiotherapy and immune maintenance therapy shows good safety and definite efficacy in patients with unresectable NSCLC, which is worthy of further research and exploration."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nintedanib liberates CD8+T cell trapping in scirrhous hepatocellular carcinoma by inhibiting LUM+α-SMA+cancer-associated fibroblasts (ESMO Asia 2025) - "The combination of nintedanib and PD-1 monoclonal antibody shows better efficacy in SHCC, suggesting that nintedanib can be a potential drug for treating SHCC and enhancing immune response."

IO biomarker • Hepatocellular Cancer • Oncology • Solid Tumor • CD8

Population Pharmacokinetics and Exposure-Response Model-Based Bayesian Extrapolation of FVC-Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Partial extrapolation from adult to pediatric patients showed that the pre-defined pediatric dosing regimen resulted in similar nintedanib exposures compared to the efficacious exposures in adults. ER models suggested a similar beneficial treatment effect of nintedanib on FVC in children and adults."

Journal • PK/PD data • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis (clinicaltrials.gov) - P=N/A | N=2000 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Initiation date: Jun 2023 ➔ Jun 2025

Trial initiation date • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Gender-age-physiology stage and body mass index are useful predictors of nintedanib discontinuation and prognosis in patients with idiopathic pulmonary fibrosis and progressive fibrotic interstitial lung diseases. (PubMed, BMC Pulm Med) - "GAP stage and BMI can be useful for predicting prognosis and future nintedanib discontinuation in patients with IPF and PF-ILDs. Nintedanib treatment may be considered in patients with IPF and PF-ILDs in an earlier stage of the disease."

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

Biotechnology-based therapies for mitigation of pulmonary fibrosis: an update. (PubMed, Drug Discov Today) - "The treatment for PF is currently limited to two drugs: nintedanib and pirfenidone. This review provides key insights on biotechnology-based advancements for PF, namely monoclonal antibodies, peptides, nucleic acids and stem cell therapy. We also underscore the obstacles and prospective developments in biotechnology-derived therapeutics for PF."

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

Hydronidone Mitigates Pulmonary Fibrosis by Regulating the TGF-β/Smad2/3 Axis in in Vitro and in Vivo Models. (PubMed, ACS Pharmacol Transl Sci) - "Although antifibrotic drugs like nintedanib and pirfenidone can slow disease progression, their clinical benefits remain modest...In an in vivo manner, a bleomycin (BLM)-induced PF mouse model was employed...Hydronidone effectively reduces pulmonary fibrotic marker expression and improves lung function at lower doses (25 and 50 mg/kg) than pirfenidone (100 mg/kg) without compromising the safety profile. These findings support its potential as a promising antifibrotic agent and warrant further clinical investigation."

Journal • Preclinical • Fibrosis • Immunology • Liver Cirrhosis • Pulmonary Disease • Respiratory Diseases • SMAD2 • SMAD4 • TGFB1

Oxidative hypoxia drives TGF-β1-induced fibrosis under normoxia. (PubMed, Redox Biol) - "ACF-2 effectively reduced fibrotic markers in vitro and attenuated bleomycin-induced pulmonary fibrosis in vivo, demonstrating superior efficacy compared with nintedanib. These findings establish oxidative hypoxia as a central mechanism of fibrosis progression and highlight PHD2 as a promising therapeutic target, while introducing ACF-2 as a mechanism-based antifibrotic lead."

Journal • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • HIF1A • NOX4 • TGFB1

Impact of Dosing on Functional and Clinical Outcomes of Patients With Progressive Pulmonary Fibrosis Treated With Nintedanib: Data From a Real-World, Multicentric, Italian Study. (PubMed, Arch Bronconeumol) - No abstract available

Clinical data • Journal • Real-world evidence • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of nintedanib outcomes in rheumatoid arthritis associated interstitial lung disease (RA-ILD) and idiopathic pulmonary fibrosis (IPF) (BTS WM 2025) - "These include conventional synthetic DMARDs such as Methotrexate and Sulfasalazine as well as biological agents such as Adalimumab and Rituximab. Our results support Nintedanib delaying progression of disease. We demonstrate a higher rate of treatment cessation in the RA-ILD group than was seen in the INBUILD study warranting more research to understand whether this relates to disease severity at initiation or the co-prescription of DMARDs."

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

Case Report: Telitacicept for interstitial lung disease associated with idiopathic inflammatory myopathies: an observational study. (PubMed, Front Pharmacol) - "Four patients with severe ILD were treated with a combination of rituximab (RTX) (375 mg/m2/week for 4 weeks) and telitacicept (160 mg/week). One patient was administered additional nintedanib for pulmonary fibrosis due to insufficient improvement in lung function. Telitacicept demonstrates substantial clinical efficacy in the treatment of IIM-associated ILD, accompanied by a low infection rate and a favorable safety profile."

Journal • Observational data • Dermatomyositis • Immunology • Infectious Disease • Interstitial Lung Disease • Musculoskeletal Pain • Myositis • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • IFIH1

N-phenylquinazolin-4-amine-based EGFR TKIs suppress pulmonary fibrosis by modulating the EGFR/ERBB3 axis in epithelial-macrophage interaction. (PubMed, Commun Biol) - "This study evaluates N-phenylquinazolin-4-amine-based EGFR tyrosine kinase inhibitors (TKIs) in murine models of bleomycin- and radiation-induced PF...Dacomitinib more effectively suppressed TNF-α, IFN-γ, and IL-6 than nintedanib, suggesting a feedback loop driving fibrosis. Elevated phosphorylated EGFR/ERBB3 in RIPF and IPF tissues, and EGFR-related gene expression in epithelial cells from IPF single-cell RNA-seq data, further support clinical relevance. These findings highlight the importance of targeting immune-epithelial EGFR/ERBB3 signaling and support EGFR TKIs as a promising antifibrotic strategy."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • ERBB3 • EREG • IFNG • IL6 • NRG1 • TNFA

First Report of Trametinib-Nintedanib Combination in KRAS G12D-Mutated Pancreatic Cancer: Efficacy and Fatal Hemorrhagic Complication: A Case Report. (PubMed, Clin Case Rep) - "This is the first report of trametinib-nintedanib for a 57-year-old KRAS G12D-mutated recurrent pancreatic ductal adenocarcinoma. He had transient remission (lower CA19-9, stable lesions) but died of gastrointestinal bleeding, showing efficacy and bleeding risk."

Journal • Gastroenterology • Hematological Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • KRAS

Artesunate attenuates pulmonary fibrosis by suppressing fibroblast senescence through inhibition of the STAT3/p53 signaling pathway. (PubMed, Toxicol Appl Pharmacol) - "Art demonstrates therapeutic potential for IPF by inhibiting fibroblast senescence through STAT3/p53 signaling axis suppression."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CDKN1A • TGFB1

Comparison of in vitro migration assays evaluating nintedanib's migration inhibitory effects on melanoma cells. (PubMed, Sci Rep) - "Single-cell tracking enabled high-resolution phenotypic profiling, including cell-specific features such as size and shape, resulting in consistently high classification accuracy. These findings highlight the importance of selecting appropriate assay formats to accurately evaluate migration behavior and the therapeutic efficacy of anti-migratory compounds."

Journal • Preclinical • Melanoma • Oncology • Solid Tumor

Pharmacokinetic changes of nintedanib in collagen-induced arthritic rats are related to reduction of intestinal P-glycoprotein expression. (PubMed, Drug Metab Dispos) - "SIGNIFICANCE STATEMENT: Rheumatoid arthritis significantly increases the drug concentration of nintedanib. These data suggest that rheumatoid arthritis may be caused by reducing the expression of P-glycoprotein by affecting the C-Jun N-terminal kinase signaling pathway."

Journal • PK/PD data • Preclinical • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • IL6 • MAPK8

Impact of virtual nurse/pharmacist-led monitoring in patients with interstitial lung disease (ILD) on antifibrotic treatment in a UK ILD specialist centre (BTS WM 2025) - "Background Antifibrotic medications are prescribed for Idiopathic Pulmonary Fibrosis (Pirfenidone or Nintedanib) and Progressive Fibrosing ILD (Nintedanib) with the aim of slowing disease progression. Conclusion Our preliminary ILD data demonstrates an annual increase in length of antifibrotic treatment since 2020, which could be related to the initiation of virtual RN/RPh-led monitoring. A comparative analysis of pre-initiation data would provide further insights into the role of RN/RPh in improving antifibrotic tolerance, as well as explore other variables that may influence sustained therapy maintenance."

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

Antifibrotic prescribing in a tier 2 centre: the ILD integrated clinical care pathway in practice (BTS WM 2025) - "Introduction Nintedanib and pirfenidone reduce the rate of progression in fibrotic lung diseases. ILD Care Pathway [online]. Available from: https://cdn.prod.website-files.com/5e32c31d3ab26b41eba332b2/661fc1e24752a5ebfbbfd567_OneVoiceILD%20Care%20Pathway%20report.pdf"

Clinical • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world multicenter cohort study on tolerability and discontinuation (BTS WM 2025) - "Concomitant mycophenolate mofetil use and baseline gastrointestinal (GI) symptoms were reported in 85.7%. Older age and lower BMI were significant predictors of interruption, while no clear predictors of permanent discontinuation were identified, such as baseline GI symptoms, larger studies are needed to confirm these findings. Most patients were able to resume treatment, underscoring the need for close monitoring with access to healthcare professional support."

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

Real-world evaluation of patient characteristics impacting tolerability of antifibrotic treatment in interstitial lung diseases (BTS WM 2025) - "Background Pirfenidone and Nintedanib are antifibrotic medications licensed in the UK for Idopathetic Pulmonary Fibrosis (IPF), with Nintedanib also approved for Progressive Fibrosis Interstitial Lung Diseases (PFILD). Values represent averages, proportions or percentages corresponding to p-values to indicate significance Conclusion In this real-world cohort, antifibrotic therapy was tolerated by most patients, with better persistence observed in younger individuals and those on Nintedanib. Other baseline factors showed no clear association with tolerability."

Clinical • HEOR • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Coronary Artery Disease • Depression • Diabetes • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hypertension • Immunology • Interstitial Lung Disease • Metabolic Disorders • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases

Impact of tiered service delivery model on antifibrotic adherence and mortality among patients with interstitial lung disease (BTS WM 2025) - "While there was no difference in discontinuation rate between tiers, pirfenidone had a significantly higher discontinuation risk compared to nintedanib (HR 1.60, 95% CI 1.05–2.44, p=0.029). View this table: View inline View popup Download powerpoint Abstract P25 Table 1 Overview of services offered by tier status in Merseyside ILD service Conclusions Our data suggest shared care tiered service delivery for AF delivery is safe, without difference in adherence or mortality between specialist and non-specialist sites. These findings support rollout of tiered service delivery within the UK."

Adherence • Clinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Little women looking into antifibrotic tolerance in relation to weight, dose, female gender and ethnicity (BTS WM 2025) - "It suggests that female gender and older age are predictive factors of intolerance of full dose Nintedanib. These findings warrant further investigation in a UK wide cohort which is planned for 2026, to further explore and consolidate these findings and potentially highlight others including ethnicity which wil be vital to guide clinicians to enable prescription of a dose that will be better tolerated from the outset and improve patient experience."

Clinical • Fibrosis • Pulmonary Disease • Respiratory Diseases

Does routine liver test monitoring for patients established on nintedanib add clinical value? – experience of an UK tertiary ILD centre (BTS WM 2025) - "Reference OFEV® (nintedanib) Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2022."

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

Progression patterns in nintedanib-treated individuals with progressive pulmonary fibrosis (PPF) (BTS WM 2025) - "A ≥10% relative FVC decline alone over that interval was associated with a higher risk of death [HR 2.82 (CI:1.57–5.07)] Download figure Open in new tab Download powerpoint Abstract P22 Figure 1 Conclusions Survival following satisfaction of PPF criteria varies depending on the progression pattern and the underlying disease. Progression defined by ≥10% relative FVC decline is associated with worse outcome both at baseline and if experienced as a subsequent event after commencing nintedanib therapy."

Clinical • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatology

Defining the antifibrotic mechanisms of treprostinil in pulmonary fibrosis (BTS WM 2025) - "Fibroblast proliferation was also inhibited in a concentration-dependent manner by Treprostinil and there were additive effects when combined with nintedanib, pirfenidone, or nerandomilast. Antifibrotic effects of Treprostinil were detected in IPF derived PCLS. Further studies are ongoing to establish the underlying mechanism as there were additive effects of Treprostinil with established antifibrotic agents which may have important clinical implications."

Cardiovascular • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • RHOA • SERPINE1 • TGFB1