UK approves nerandomilast for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis

The approval introduces the first new antifibrotic therapy for interstitial lung disease in more than a decade.

The MHRA has approved nerandomilast for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).¹ Nerandomilast is an oral, preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects. The approval was supported by positive phase 3 FIBRONEER trial data demonstrating a slower decline in lung function compared with placebo.

New insights are added regularly, covering a broad range of subspecialties and evolving clinical scenarios. Sign up below for Free Access to the latest clinical updates in your specialty!

Register Register

Phase 3 clinical data

The UK approval was supported by results from two phase 3 FIBRONEER trials: FIBRONEER-IPF, which evaluated nerandomilast in patients with idiopathic pulmonary fibrosis, and FIBRONEER-ILD, which assessed the therapy in patients with progressive pulmonary fibrosis.

In FIBRONEER-IPF (NCT05321069), 1,177 patients were randomized to receive nerandomilast 18 mg twice daily, 9 mg twice daily, or placebo.² After 52 weeks, both nerandomilast doses were associated with a smaller decline in forced vital capacity (FVC) compared with placebo, indicating a slower rate of lung function decline.

In FIBRONEER-ILD (NCT05321082), 1,176 patients with progressive pulmonary fibrosis were randomised to receive nerandomilast 9 mg or 18 mg twice daily, or placebo.³ Both doses significantly reduced the decline in forced vital capacity (FVC) over 52 weeks compared with placebo.

Across the two studies, the most frequently reported adverse event was diarrhoea, while serious adverse events occurred at similar rates between treatment groups.

Indication

Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are chronic fibrosing lung diseases characterized by irreversible scarring of the lungs, which impairs oxygen transfer and progressively reduces lung function.⁴ While the cause of IPF is unknown, PPF may develop in association with underlying conditions such as rheumatoid arthritis or systemic sclerosis, following exposure to inhaled substances such as asbestos or mould, or from an unknown cause, and continues to worsen despite appropriate treatment.

Expanding treatment options in pulmonary fibrosis

Nerandomilast is the first new antifibrotic therapy approved for interstitial lung disease in more than a decade. Although existing antifibrotic therapies can slow the decline in lung function, tolerability remains a challenge for some patients. The availability of nerandomilast provides an additional treatment option for adults with IPF and PPF, with its place in clinical practice likely to evolve as experience with the therapy grows.

References

1. Gov.uk. Nerandomilast (Jascayd) approved to treat adult patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis. 2026. [Press release]. Available at: www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis (accessed July 08 2026).
2. Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025;392:2193–2202.
3. Maher TM, Assassi S, Azuma A, et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025;392:2203–14.
4. Boehringer Ingelheim. New analyses from FIBRONEER™ trials suggest survival benefit with nerandomilast in IPF and PPF. 2026. [Press release]. Available at: www.globenewswire.com/news-release/2026/06/18/3313964/ (accessed July 08 2026).