Jascayd (nerandomilast)

A twice-daily pill approved by the FDA on October 7, 2025 for adults with idiopathic pulmonary fibrosis, the first new IPF drug in more than a decade, and on December 19, 2025 for progressive pulmonary fibrosis. In its main IPF trial it slowed the loss of lung capacity over a year compared with placebo, and the result for the 18 mg dose held whether patients also took nintedanib, pirfenidone or neither.

Inside cells, an enzyme family called phosphodiesterase 4 (PDE4) breaks down cAMP, a chemical messenger that helps keep inflammation and scar-forming activity in check. Nerandomilast blocks PDE4 and prefers one form of it, PDE4B, by at least ninefold in lab tests. With PDE4B blocked, cAMP stays higher in immune cells and in fibroblasts, the lung cells that lay down scar tissue, and the label describes the result as both antifibrotic and immunomodulatory. Like the other IPF drugs, it slows the loss of lung function rather than reversing scarring that is already there.

Jascayd has no boxed warning, no contraindications and no separate warnings section in its label. In the main IPF trial the most common side effects, for the 18 mg dose, the 9 mg dose and placebo, were diarrhea (42%, 31% and 17%), COVID-19 (13%, 16% and 12%), upper respiratory infection (13%, 11% and 10%), depression-related symptoms, a group that includes suicidal thoughts (12%, 11% and 10%), weight loss (11%, 10% and 8%) and decreased appetite (9%, 9% and 5%). Diarrhea was more common in people also taking nintedanib (62% on 18 mg against 28% on placebo). Side effects led 15% of patients on 18 mg to stop, against 11% on placebo. The trials excluded people with severe depression or suicidal thoughts or behavior, so mention any history of depression before starting^[1].

18 mg by mouth twice a day, about 12 hours apart, with or without food. Tablets can be swallowed whole or dispersed in about 100 mL of water for people who have trouble swallowing. If 18 mg is not tolerated, the dose can drop to 9 mg twice a day, except in people also taking pirfenidone or a moderate CYP3A inducer, who stay on 18 mg because pirfenidone lowers nerandomilast levels. People taking a strong CYP3A inhibitor use 9 mg twice a day, strong CYP3A inducers should be avoided, and it is not recommended with severe liver impairment^[1].

Yes, Nerandomilast (Jascayd) is FDA approved (2025) for the treatment of Idiopathic Pulmonary Fibrosis.

Jascayd is the brand name of nerandomilast, a twice-daily pill from Boehringer Ingelheim. The FDA approved it on October 7, 2025 for adults with idiopathic pulmonary fibrosis and on December 19, 2025 for adults with progressive pulmonary fibrosis. It slows the decline in lung function and works differently from pirfenidone and nintedanib, by blocking an enzyme called PDE4B.

Yes. The main IPF trial allowed patients to stay on nintedanib (Ofev) or pirfenidone, and results for the 18 mg dose were consistent in each group. With pirfenidone the dose should stay at 18 mg twice daily, because pirfenidone lowers nerandomilast levels. With nintedanib, diarrhea was more common, occurring in 62% of patients on 18 mg.

In the main IPF trial, the most common side effects on the 18 mg dose were diarrhea (42% against 17% on placebo), COVID-19, upper respiratory infection, depression-related symptoms including suicidal thoughts (12% against 10%), weight loss and decreased appetite. The label has no boxed warning and no contraindications.

No approved IPF drug reverses scarring. In the FIBRONEER-IPF trial, lung capacity measured as FVC fell 106 mL over a year on the 18 mg dose against 170 mL on placebo, meaning the drug slowed the decline rather than stopping or reversing it.