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

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.