- Nerandomilast (JASCAYD), an oral PDE4B inhibitor, is approved in Japan, the US, China and the UAE, with EU/UK reviews ongoing and further approvals anticipated in 2026.
- Phase III FIBRONEER‑IPF and FIBRONEER‑ILD met their primary endpoint, showing statistically significant slowing of FVC decline versus placebo at week 52.
- A pooled analysis reported a nominal 59% reduction in risk of death for nerandomilast 18 mg versus placebo in patients without existing treatment.
- Most common adverse event was diarrhea (up to 41.3% in the 18 mg group in FIBRONEER‑IPF); discontinuation due to adverse reactions reached 14.0% for 18 mg in FIBRONEER‑IPF.
Approval
Japan’s Ministry of Health, Labour and Welfare approved JASCAYD (nerandomilast) for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF); it is the first oral PDE4B inhibitor with antifibrotic and immunomodulatory effects approved for these indications and the fourth market approval after the US, China and the UAE.
Clinical evidence
Approval was supported by Phase III FIBRONEER‑IPF and FIBRONEER‑ILD, where nerandomilast met the primary endpoint of statistically significant slowing of FVC decline versus placebo at week 52 (FIBRONEER‑IPF: placebo vs nerandomilast 9 mg = 44.9 mL, 18 mg = 68.8 mL; FIBRONEER‑ILD: placebo vs 9 mg = 81.1 mL, 18 mg = 67.2 mL); a pooled analysis showed a nominal 59% reduction in risk of death for nerandomilast 18 mg versus placebo in patients without existing antifibrotic treatment, while the key secondary composite endpoint (acute exacerbation, first respiratory hospitalization, or death) was not met.
Safety
The most common adverse event was diarrhea, typically mild or moderate, reported up to 41.3% in the 18 mg IPF group; discontinuation due to adverse reactions in FIBRONEER‑IPF was 14.0% (18 mg) and 11.7% (9 mg) versus 10.7% for placebo, and in FIBRONEER‑ILD permanent discontinuation was 10.0% (18 mg), 8.1% (9 mg) and 10.2% for placebo.
Market and next steps
Regulatory submissions are under review in the EU, UK and other countries with additional approvals anticipated in 2026; Boehringer Ingelheim is also evaluating nerandomilast in systemic sclerosis and idiopathic inflammatory myopathies.
Disease context
IPF and PPF are progressive fibrosing lung diseases with high mortality; Japan estimates 10,000–30,000 people with IPF, and tolerability concerns with existing antifibrotics lead many patients to avoid or discontinue treatment.
