The oral PDE4B inhibitor is the first new treatment authorized in the EU for idiopathic pulmonary fibrosis in over a decade and for progressive pulmonary fibrosis in more than five years. Phase III trials showed that it slowed decline in lung function in both conditions.

The European Commission has approved nerandomilast (Jascayd; Boehringer Ingelheim, Ingelheim am Rhein, Germany) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.^1,2

The decision, announced on July 17, 2026, follows approvals in the USA for IPF in October 2025 and PPF in December 2025, in Japan in May 2026 and in the UK in July 2026.

Don’t miss out on hearing about our latest peer-reviewed articles, expert opinions, conference news, podcasts and more.

Register Register

IPF and PPF are progressive fibrosing lung diseases characterized by irreversible scarring of lung tissue, causing breathlessness, cough and declining lung function. Both conditions can lead to hospitalization and death within a few years of diagnosis.²

Treatment options have historically been limited. Pirfenidone and nintedanib are established antifibrotic treatments for IPF, while nintedanib is also authorized for PPF, although adverse effects can complicate long-term treatment for some patients.

Nerandomilast is an oral preferential inhibitor of phosphodiesterase 4B (PDE4B), an enzyme expressed in the lungs that plays a role in fibrosis and inflammation. By preferentially inhibiting PDE4B, nerandomilast is intended to reduce both processes and has a different mechanism of action from existing antifibrotic treatments.²

The approval was supported by two Phase III, randomized, double-blind, placebo-controlled trials: FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082). Together, the trials enrolled 2,355 adults with IPF or PPF.^1–4

Participants received nerandomilast 9 mg or 18 mg twice daily, or placebo, for at least 52 weeks, either as monotherapy or in addition to existing background antifibrotic treatment. At baseline, approximately 78% of participants with IPF and 44% of those with PPF were receiving background treatment. The primary endpoint in both trials was absolute change from baseline in forced vital capacity (FVC) at week 52.

In FIBRONEER-IPF, adjusted mean FVC decline at week 52 was 115 mL with nerandomilast 18 mg and 139 mL with nerandomilast 9 mg, compared with 183 mL with placebo. The adjusted differences versus placebo were 68 mL and 45 mL, respectively, and were statistically significant.^2,3

In FIBRONEER-ILD, adjusted mean FVC decline was 99 mL with nerandomilast 18 mg and 85 mL with nerandomilast 9 mg, compared with 166 mL with placebo. The corresponding adjusted differences versus placebo were 67 mL and 81 mL.^2,4

Both studies therefore met their primary endpoint with both nerandomilast doses. However, neither trial met its key secondary composite endpoint of time to first acute exacerbation, respiratory hospitalization or death. Analyses across the clinical programme suggested a possible reduction in mortality, although this finding requires confirmation in longer-term studies.^2–4

The recommended dose is 18 mg twice daily. This may be reduced to 9 mg twice daily in patients who are unable to tolerate treatment because of diarrhoea or weight loss. However, the dose should not be reduced in patients receiving concomitant pirfenidone because pirfenidone lowers exposure to nerandomilast and efficacy was not demonstrated with the lower dose in this subgroup.²

The most commonly reported adverse events were diarrhoea and weight loss. Overall, the safety profile was considered manageable across the clinical programme.

“In the FIBRONEER trials, Jascayd was well tolerated and slowed lung function decline, supporting its potential for long-term use,” said Anna-Maria Hoffmann-Vold, Professor of Rheumatology at the University of Zurich and Oslo University Hospital and an investigator in the FIBRONEER programme.

“This is imperative in conditions like IPF and PPF, which can worsen suddenly and unpredictably. Maintaining lung function for longer can therefore make a meaningful difference in clinical practice.”¹

Following EU marketing authorization, decisions on pricing and reimbursement will be made separately by individual member states. Nerandomilast has also been approved in the UK, where NICE is currently assessing its clinical and cost effectiveness for use within the National Health Service.⁵

For clinicians managing IPF and PPF, nerandomilast provides an additional oral treatment with a distinct mechanism of action. Its effect on clinical outcomes such as acute exacerbations, hospitalization and survival will require further evaluation through longer-term follow-up and real-world evidence.

References

1. Boehringer Ingelheim. European Commission approves Jascayd, bringing well-tolerated, novel oral treatment for IPF and PPF to the EU. Press release. July 17, 2026. Available at: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/european-commission-approves-jascayd-novel-treatment-ipf-ppf
2. European Medicines Agency. New medicine for two types of pulmonary fibrosis. May 22, 2026. Available at: https://www.ema.europa.eu/en/news/new-medicine-two-types-pulmonary-fibrosis (accessed July 17, 2026).
3. Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2025;392:2193–2202. doi:10.1056/NEJMoa2414108.
4. Maher TM, Assassi S, Azuma A, et al. Nerandomilast in patients with progressive pulmonary fibrosis. N Engl J Med. 2025;392. doi:10.1056/NEJMoa2503643.
5. Medicines and Healthcare products Regulatory Agency. Nerandomilast (Jascayd) approved to treat adult patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. July 8, 2026. Available at: https://www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis (accessed July 17, 2026).