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

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.

Authors

Institutions

Publication Details

Journal
Annals of Pharmacotherapy
Published
2026-05-18
DOI
https://doi.org/10.1177/10600280261447319
Primary Topic
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Phuoc (Tyler) Bui, Erin St. Onge, Hanna Sotolongo-Miranda, Tala Trabulsi
Annals of Pharmacotherapy
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
article

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

Phuoc (Tyler) Bui, Erin St. Onge, Hanna Sotolongo-Miranda, Tala Trabulsi
article en

Abstract

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.

Annals of Pharmacotherapy
University of Central Florida (US), Florida College (US)
Openalex Percentile: Top 6%
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.