Jascayd (nerandomilast) / Boehringer Ingelheim - LARVOL DELTA

Nerandomilast in Autoimmune-Associated Interstitial Lung Diseases: Translating Evidence from Progressive Pulmonary Fibrosis Studies. (PubMed, J Clin Med) - "The safety profile appears mainly characterized by gastrointestinal adverse events, with ongoing evaluation of neuropsychiatric safety and drug interactions in complex autoimmune populations. Overall, nerandomilast represents a promising investigational strategy bridging antifibrotic and immunomodulatory mechanisms, warranting further dedicated studies in SARD-ILD."

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

VERANDA™-SSc: A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (clinicaltrials.gov) - P3 | N=448 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P3 trial • Immunology • Scleroderma • Systemic Sclerosis

Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial. (PubMed, Eur Respir J) - "In the FIBRONEER-ILD trial in patients with PPF, nerandomilast reduced the risk of clinically important outcomes, including death, over the whole trial. Nerandomilast had a favourable safety and tolerability profile."

Journal • Immunology • Pulmonary Disease • Respiratory Diseases

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

Evolving management of SARD-ILD : Current challenges and emerging treatment options for rheumatoid-associated interstitial lung diseases (PubMed, Z Rheumatol) - "Promising results from ongoing clinical studies provide new therapeutic perspectives for SARD-ILD and PPF and may significantly improve prognosis and disease burden in the future."

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

FIBRONEER™-ON: A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast (clinicaltrials.gov) - P3 | N=1700 | Recruiting | Sponsor: Boehringer Ingelheim | N=551 ➔ 1700

Enrollment change • 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

Industry Payments and Prescribing Patterns of Antifibrotic Therapy for Idiopathic Pulmonary Fibrosis in the United States. (PubMed, Respir Med) - "As of 2025, three antifibrotic drugs (pirfenidone, nintedanib, and nerandomilast) are approved for treatment. Receipt of drug-specific general payments was significantly associated with higher proportions of sponsored drug prescriptions for nintedanib (OR: 2.28; 95% CI: 2.15-2.41) and pirfenidone (OR: 1.94; 95% CI: 1.84-2.06). These findings highlight potential industry influence on clinical decision-making given clinical equipoise between antifibrotic agents."

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

Safety and tolerability of nerandomilast in patients with autoimmune disease–related progressive pulmonary fibrosis in the FIBRONEER-ILD trial (EULAR 2026) - No abstract available

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

Predicting long-term survival benefit of nerandomilast in patients with progressive pulmonary fibrosis (PPF) (EULAR 2026) - No abstract available

Clinical • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy of nerandomilast in patients with autoimmune interstitial lung diseases and progressive pulmonary fibrosis in the FIBRONEER-ILD trial (EULAR 2026) - No abstract available

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

A Phase III, Double-blind, Randomised, Placebo-controlled Trial Evaluating the Safety and Efficacy of Oral Nerandomilast Treatment on Halting Disease Progression in Systemic Sclerosis (EULAR 2026) - No abstract available

Clinical • P3 data • Immunology • Scleroderma • Systemic Sclerosis

Targeting autoimmunity: Phosphodiesterase inhibitors as immunomodulators-a review of current insights and future direction. (PubMed, Autoimmun Rev) - "Emerging PDE-targeted agents, including ibudilast and the PDE4B-selective inhibitor nerandomilast, combine immunomodulatory and antifibrotic properties. These compounds have demonstrated clinical benefit and improved tolerability in patients with progressive fibrotic lung disease, highlighting the therapeutic potential of isoform-selective PDE inhibition. Collectively, targeting the NO-cGMP-cAMP signaling axis provides a unifying mechanistic framework for the treatment of vascular, immune, and fibrotic manifestations of rheumatic disease, positioning PDE inhibition as an emerging pillar of modern translational rheumatology."

Journal • Review • Cardiovascular • CNS Disorders • Dermatology • Fibrosis • Hypertension • Immunology • Inflammation • Inflammatory Arthritis • Interstitial Lung Disease • Psoriasis • Psoriatic Arthritis • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies

Boehringer Ingelheim’s Jascayd (Nerandomilast) Launches in Shanghai – First PDE4B Inhibitor for Idiopathic Pulmonary Fibrosis (flcube.com) - "The drug, which received China marketing authorization in October 2025, offers multifaceted anti-fibrotic, vascular protective, and immunomodulatory effects with a favorable safety profile designed to address the high discontinuation rates associated with existing therapies."

Launch non-US • Idiopathic Pulmonary Fibrosis

Experimental drug Nerandomilast shows promise against rare autoimmune lung disease (Daijiworld) - "A new experimental drug, Nerandomilast, has shown potential in reducing lung inflammation and fibrosis in preclinical models of Idiopathic Inflammatory Myopathy–Associated Interstitial Lung Disease (IIM-ILD), offering hope for improved treatment options for the rare condition...The study found that treatment with Nerandomilast significantly improved disease indicators in the experimental model. Researchers observed notable reductions in muscle inflammation, lung inflammation and pulmonary fibrosis in treated mice."

Preclinical • Inflammation • Interstitial Lung Disease

Network meta-analysis of pharmacological treatments for idiopathic pulmonary fibrosis: evaluating effects on lung function. (PubMed, Front Pharmacol) - "N-acetylcysteine (NAC) combined with Roxithromycin (RXM) was the most effective intervention for improving Vital Capacity (VC) (SUCRA: 88.8%) and Forced Expiratory Volume in 1 s/Forced Vital Capacity (FEV1/FVC) (SUCRA: 97.45%). Ambroxol was the most effective intervention for improving Total Lung Capacity (TLC) (SUCRA: 82.52%), while Thalidomide was the most effective intervention for improving Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (SUCRA: 90.93%)...Additionally, future research should examine the long-term effectiveness of new drugs like Nerandomilast and Pamrevlumab, while also improving comprehensive assessments of synergistic changes across various pulmonary function indicators. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251148658."

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

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Aug 2026 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Management of Progressive Pulmonary Fibroses - 2025 Update (PubMed, Dtsch Med Wochenschr) - "Recent advances in progressive pulmonary fibrosis treatment include three major developments: Nerandomilast, a selective PDE4B inhibitor, demonstrated significant reduction in FVC decline in Phase III trials for both IPF and PPF, with improved tolerability compared to current antifibrotics and expected EMA approval in 2026. Inhaled treprostinil received FDA approval in May 2025 as the first specific therapy for PH-ILD in the US, based on the INCREASE study showing improved exercise capacity, with ongoing TETON studies investigating its antifibrotic potential in IPF/PPF. Additionally, German guidelines propose expanded PPF progression criteria beyond international definitions to include more clinical parameters and prevent therapy exclusion of relevant patient groups. These developments mark the first potential new antifibrotic options in over a decade and promise multimodal treatment approaches combining systemic and inhaled therapies."

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

EFFICACY AND SAFETY OF NERANDOMILAST IN PATIENTS WITH SYSTEMIC SCLEROSIS- ASSOCIATED INTERSTITIAL LUNG DISEASE: SUBGROUP ANALYSIS OF THE FIBRONEER-ILD TRIAL (SSWC 2026) - "Patients not taking nintedanib (>=8 weeks) or on a stable dose (>=12 weeks) were eligible. Cyclophosphamide, tocilizumab, mycophenolate, or rituximab were not permitted but could be initiated after 6 months for worsening systemic disease. Prednisone >15 mg/day (or equivalent) was not permitted but could be prescribed during the trial for acute ILD exacerbation or after 6 months for worsening systemic disease... In the FIBRONEER-ILD trial, nerandomilast slowed the decline in FVC and had an acceptable safety and tolerability profile in patients with PPF. This post-hoc subgroup analysis, while underpowered, showed consistent findings in patients with SSc-ILD."

Clinical • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Pde4b Inhibitor Nerandomilast Ameliorates Steroid-resistant Asthma by Suppressing Macrophage Extracellular Trap Release (ATS 2026) - No abstract available

Asthma • Immunology • Respiratory Diseases

Nerandomilast Attenuates Pulmonary Fibrosis by Promoting Alveolar Epithelial Cell Differentiation (ATS 2026) - No abstract available

Immunology • Pulmonary Disease • Respiratory Diseases

Safety and Efficacy of Nerandomilast in Patients With Pulmonary Fibrosis; A Systematic Review and Meta-Analysis of Randomized Controlled Trials (ATS 2026) - No abstract available

Retrospective data • Review • Immunology • Pulmonary Disease • Respiratory Diseases

Predicting Long-Term Survival Benefit of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis (ATS 2026) - No abstract available

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