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Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis: Clinical Efficacy, Safety, and Place in Therapy

医学 特发性肺纤维化 不利影响 内科学 间质性肺病 肺纤维化 进行性疾病 吡非尼酮 临床试验 肺动脉高压 指南 肺功能测试 重症监护医学 呼吸道疾病 疾病 随机对照试验 肺活量 胃肠病学 任天堂 临床研究阶段 外科 囊性纤维化 中止 纤维化
作者
Phuoc (Tyler) Bui,Erin St. Onge,Hanna Sotolongo-Miranda,Tala Trabulsi
出处
期刊:Annals of Pharmacotherapy [SAGE Publishing]
卷期号:: 10600280261447319-10600280261447319
标识
DOI:10.1177/10600280261447319
摘要

OBJECTIVE: To describe nerandomilast, a preferential phosphodiesterase 4B inhibitor indicated for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. DATA SOURCES: A PubMed search was conducted from origin to mid-April 2026 using the terms nerandomilast, Jascyd, BI 1015550, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis, and interstitial lung disease. Phase 2 and 3 clinical trials, prescribing information, pooled analyses, and relevant guideline documents were included. STUDY SELECTION AND DATA EXTRACTION: Two phase 3 randomized controlled trials evaluating nerandomilast in IPF and progressive pulmonary fibrosis were reviewed, along with regulatory prescribing information. DATA SYNTHESIS: In the FIBRONEER-ILD and FIBRONEER-IPF trials, nerandomilast reduced forced vital capacity decline at 52 weeks compared with placebo. Treatment effects were observed in patients receiving background antifibrotic therapy and those treated with nerandomilast alone. Secondary time-to-event outcomes were not statistically significant. Diarrhea was the most common adverse event and occurred more frequently with nerandomilast, while serious adverse events were similar across treatment groups.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Nerandomilast targets inflammatory and profibrotic pathways distinct from currently available antifibrotic therapies and may be used as monotherapy or in combination with existing agents. Its role is best understood as disease stabilization rather than reversal of established fibrosis. CONCLUSION AND RELEVANCE: Nerandomilast represents an additional therapeutic option for patients with IPF and progressive pulmonary fibrosis. Ongoing long-term and real-world data will further clarify its place in clinical practice.
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