Jascayd (nerandomilast) / Boehringer Ingelheim - LARVOL DELTA

China’s National Medical Products Administration (NMPA) has approved JASCAYD (nerandomilast) as the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years… (The Manila Times) - "The approval is based on results from the pivotal Phase III clinical trial FIBRONEERTM-ILD."

China approval • Pulmonary Disease

Nerandomilast as the first PDE4B-selective therapy in idiopathic pulmonary fibrosis. (PubMed, Trends Pharmacol Sci) - No abstract available

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

Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER™-ON). (PubMed, BMC Pulm Med) - P3 | "This trial will provide information on the long-term safety, tolerability and efficacy of nerandomilast in patients with IPF and PPF."

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

Nerandomilast. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

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

Efficacy and Safety of Nerandomilast in East Asian Patients with Progressive Pulmonary Fibrosis: A Subgroup Analysis of the Randomized, Double-Blind, Placebo-Controlled, Phase 3 FIBRONEER-ILD Study (APSR 2025) - "The randomized, double-blind, Phase 3 trial FIBRONEERTM-ILD evaluated efficacy and safety of nerandomilast in patients with Progressive Pulmonary Fibrosis (PPF), with/without background nintedanib. Conclusion : In EA patients with PPF, nerandomilast 9 and 18 mg BID both slowed FVC decline and had an acceptable safety and tolerability profile. These findings are generally consistent with overall population, supporting the efficacy and safety of nerandomilast in EA patients with PPF."

Clinical • P3 data • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Nerandomilast in East Asian Patients with Idiopathic Pulmonary Fibrosis: A Subgroup Analysis of the Randomized, Double- Blind, Placebo-Controlled, Phase 3 FIBRONEER™-IPF Study (APSR 2025) - "Methods : Patients with IPF were randomized 1:1:1 to receive nerandomilast 9 mg BID, nerandomilast 18 mg BID, or placebo BID, and stratified by background antifibrotic use (nintedanib/pirfenidone vs none). Serious adverse events occurred in 32.4%, 31.8% and 31.1% of patients in the placebo, nerandomilast 9 mg BID and nerandomilast 18 mg BID groups, respectively, over 52 weeks. Conclusion : Nerandomilast slowed lung function decline in East Asian patients with IPF with acceptable safety and tolerability, consistent with the overall population."

Clinical • P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Nerandomilast, a PDE4B inhibitor, alleviates silica-induced lung inflammation and fibrosis by inhibition of NLRP3 inflammasome and TGF-β/Smad signalling. (PubMed, Br J Pharmacol) - "These findings suggest that nerandomilast, a PDE4B inhibitor, may be a promising treatment for silicosis, which currently lacks effective therapies."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • NLRP3 • TGFB1

Rethinking idiopathic pulmonary fibrosis management: clinical impact of nerandomilast as a new therapeutic agent. (PubMed, Ann Med Surg (Lond)) - No abstract available

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

Efficacy and Safety of Nerandomilast in Patients with Autoimmune Disease-Related Progressive Pulmonary Fibrosis: Subgroup Analysis of the FIBRONEER-ILD trial (ACR Convergence 2025) - "Patients taking nintedanib (at a stable dose for ≥12 weeks) or not taking nintedanib (for ≥8 weeks) were eligible to participate. Cyclophosphamide, tocilizumab, mycophenolate, or rituximab were not permitted at enrolment but could be initiated after 6 months to manage worsening systemic disease. Prednisone >15 mg/day (or equivalent) was not permitted at enrolment but could be prescribed during the trial for acute exacerbation of ILD or after 6 months to manage worsening systemic disease... In the FIBRONEER-ILD trial, the efficacy of nerandomilast on slowing decline in FVC in patients with autoimmune ILDs was consistent with that observed in the overall trial population. Nerandomilast had an acceptable safety and tolerability profile."

Clinical • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

EFFECT OF NERANDOMILAST IN US PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS: SUBGROUP ANALYSIS OF THE FIBRONEER-IPF TRIAL (CHEST 2025) - " Patients with IPF were randomized 1:1:1 to receive nerandomilast 9 mg bid, nerandomilast 18 mg bid, or placebo, stratified by use of nintedanib/pirfenidone vs neither. In US patients in the FIBRONEER-IPF trial, nerandomilast 9 mg bid and 18 mg bid slowed the decline in FVC over 52 weeks and had acceptable safety and tolerability. CLINICAL IMPLICATIONS: Among US patients receiving standard of care therapy for IPF, addition of nerandomilast slows disease progression."

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

PDE4-Selective Inhibition in Chronic Obstructive Pulmonary Disease and Pulmonary Fibrosis: Different Agents or Different Targets? (PubMed, Life (Basel)) - "Highly selective inhibitors of the members of the cAMP-selective cyclic nucleotide phosphodiesterases, or PDE4 family, have shown clinically meaningful activity in two different classes of lung disease: roflumilast in obstructive lung disease, specifically chronic obstructive pulmonary disease (COPD), and nerandomilast in restrictive lung diseases characterized by inflammation/fibrosis of the alveolar interstitium, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)...The emerging data are compatible with PDE4-selective inhibitors having targets of action in a large number of pulmonary cell types, only a subset of which is dysregulated in either COPD or IPF. This suggests that differences between the benefits observed with these individual agents in their various clinical indications reflect differences in disease pathogenesis, rather than proven differences in the enzyme-inhibitory effects of the various PDE4 inhibitors that have been..."

Journal • Review • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

JASCAYD (nerandomilast) approved in China for the treatment of idiopathic pulmonary fibrosis (IPF) (The Manila Times) - "Approval is based on results from Phase III FIBRONEER-IPF trial, which showed statistically significant improvements in the absolute change from baseline in Forced Vital Capacity at 52 weeks with nerandomilast 18 mg and 9 mg versus placebo in adults with idiopathic pulmonary fibrosis (IPF)."

China approval • Idiopathic Pulmonary Fibrosis

In Vitro Antifibrotic Effects of Nerandomilast on Cell Types Relevant to Intestinal Remodeling and Fibrosis in Systemic Sclerosis (ACR Convergence 2025) - "This study demonstrates the potential of nerandomilast as a therapeutic option for GI manifestations in SSc. In vitro, nerandomilast had significant antifibrotic effects on cell types relevant to intestinal remodeling and fibrosis present in SSc. These findings support further investigation of PDE4B inhibition as a targeted approach to managing intestinal fibrosis in SSc."

Preclinical • Fibrosis • Immunology • Myositis • Scleroderma • Systemic Sclerosis • COL1A1 • IL1B

Efficacy and Safety of Nerandomilast in Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. (PubMed, Am J Ther) - No abstract available

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

A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

Orsini Selected as Specialty Pharmacy Partner for Boehringer Ingelheim's JASCAYD (nerandomilast) (PRNewswire)

Commercial • Idiopathic Pulmonary Fibrosis • Immunology

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Boehringer Ingelheim | Recruiting ➔ Completed

Trial completion

The FDA has approved nerandomilast (Jascayd; Boehringer Ingelheim) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) (AJMC) - "Data from the randomized, placebo-controlled, double-blind FIBRONEER-IPF trial (NCT05321069) and from Trial 2 (NCT04419506) supported the approval."

FDA approval • Idiopathic Pulmonary Fibrosis

Nerandomilast in Patients with Pulmonary Fibrosis. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P3 trial • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Nerandomilast in Patients with Pulmonary Fibrosis. (PubMed, N Engl J Med) - No abstract available

Journal • Immunology • Pulmonary Disease • Respiratory Diseases

A new pooled analysis of the FIBRONEER-IPF and FIBRONEER-ILD trials resulted in a nominally significant reduction in the risk of death by 59% in patients who received 18mg nerandomilast without background therapy versus placebo (GlobeNewswire) - "Both FIBRONEER phase III trials, had met their primary endpoint (reduction of lung function decline measured in forced vital capacity) but did not meet their key secondary endpoint (risk of acute exacerbation, hospitalization for respiratory cause, or death); Nerandomilast had a favorable safety and tolerability profile"

P3 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nerandomilast in Patients with Pulmonary Fibrosis. (PubMed, N Engl J Med) - No abstract available

Journal • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Nerandomilast attenuates Pantoea agglomerans-induced hypersensitivity pneumonitis by regulating M1 macrophage and fibroblast (ERS 2025) - "Our findings indicated that nerandomilast could attenuate inflammation and fibrosis in SE-PA- induced HP mice by regulating macrophage polarization and inhibiting fibroblast activation, which provides new insights for the clinical treatment of HP."

Late-breaking abstract • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • TGFB1