FDA Approves JASCAYD as First Dual-Action Drug for Progressive Pulmonary Fibrosis

The US Food and Drug Administration (FDA) has approved JASCAYD (nerandomilast) for adults with progressive pulmonary fibrosis (PPF). This marks the first time a preferential phosphodiesterase 4B (PDE4B) inhibitor with both immunomodulatory and antifibrotic effects has been cleared for treating the condition in the USA. The drug is now available in the US, Japan, and the EU after receiving approvals in late 2025 and early 2026.

PPF is a severe lung disease affecting up to 100,000 people in the US and as many as 5.6 million worldwide. It often develops in patients with underlying interstitial lung diseases (ILDs), such as autoimmune ILD or hypersensitivity pneumonitis. Clinical trials demonstrated that JASCAYD slowed the decline in lung function among PPF patients, with discontinuation rates similar to those on placebo.

An exploratory analysis also found a nominally significant reduction in acute ILD flare-ups for those taking the drug compared to placebo. A prespecified survival review suggested a trend favouring JASCAYD, with hazard ratios for all-cause mortality at 0.51 for both tested doses versus placebo.

The most frequently reported side effects in PPF patients matched those seen in idiopathic pulmonary fibrosis (IPF) cases. Diarrhoea occurred more often when JASCAYD was combined with nintedanib, but symptoms were mostly mild to moderate and appeared within the first three months of treatment. Notably, the FDA-approved label for JASCAYD does not include a 'Warnings and Precautions' section.

JASCAYD is now an approved treatment option for PPF in multiple regions, including the US, Japan, and the EU. Its dual mechanism targets both inflammation and fibrosis, offering a new approach for patients with this progressive lung disease. The drug's safety profile and early survival data will continue to be monitored as it enters wider clinical use in the USA.