Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

The FDA approved Boehringer Ingelheim's Jascayd (nerandomilast) on October 7, 2025, marking the first new drug approval for idiopathic pulmonary fibrosis (IPF) in over a decade1347.

Jascayd is a twice-daily oral pill indicated for the treatment of adults with IPF, a chronic and progressive lung disease characterized by permanent lung scarring that impairs breathing125.

IPF affects about 100,000 people in the U.S. and is typically diagnosed in adults over 601.

Jascayd works by blocking a protein involved in fibrotic tissue formation, providing a new mechanism of action beyond existing therapies2.

Prior to Jascayd, the last FDA approvals for IPF were for nintedanib (Ofev, also by Boehringer Ingelheim) and pirfenidone, both cleared in 2014 and considered standards of care that slow disease progression but do not cure IPF2.

The approval of Jascayd signals renewed momentum and innovation in a therapeutic area that has seen limited success from investigational treatments in recent years13.

Sources:

1. https://www.biopharmadive.com/news/boehringer-ingelheim-jascayd-fda-approval-idiopathic-pulmonary-fibrosis/802316/

2. https://medcitynews.com/2025/10/boehringer-ingelheim-ipf-fda-approval-idiopathic-pulmonary-fibrosis-nerandomilast-jascayd-pde4/

3. https://www.fiercepharma.com/pharma/boehringer-ingelheim-breathes-new-life-lung-fibrosis-treatment-market-fda-approved-jascayd

4. https://www.europeanpharmaceuticalreview.com/news/266937/boehringer-ingelheim-jascayd-nerandomilast-ipf-fda-approval/

5. https://www.boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-new-treatment-option-adults-ipf

7. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade

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