Jascayd gets second FDA approval, this time for progressive pulmonary fibrosis

The FDA has approved Jascayd (nerandomilast) as a treatment for a second lung disease, progressive pulmonary fibrosis, following the drug’s initial approval in October 2025 as a treatment for idiopathic pulmonary fibrosis.

The approval was heralded as an important advance in the treatment of a serious lung condition by the leader of a patient advocacy group.

“A progressive disease condition process like PPF [progressive pulmonary fibrosis] can worsen lung function quickly, and patients have been eagerly awaiting additional treatment options. The FDA approval of nerandomilast for PPF is a welcomed milestone for the community,” Scott Staszak, president and CEO of the Pulmonary Fibrosis Foundation, said in the news release issued by Boehringer Ingelheim, the maker of Jascayd.

Both idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are characterized by lung fibrosis, or scarring, that can seriously reduce lung function, making breathing extremely difficult. Idiopathic pulmonary fibrosis is a chronic interstitial pneumonia of unknown (idiopathic) origin most commonly seen in elderly individuals. Interstitial lung diseases are conditions that affect the interstitium of the lungs, the tissue that surrounds and supports the lungs’ alveoli. Progressive pulmonary fibrosis is a broader category that includes interstitial lung disease (other than idiopathic pulmonary fibrosis) from any cause that is progressing, or worsening. Progressive pulmonary fibrosis is linked to autoimmune interstitial lung disease, which can be caused by disorders such as rheumatoid arthritis or systemic sclerosis and to hypersensitivity pneumonitis, among other conditions, Shervin Assassi, M.D., a professor and director of rheumatology at the McGovern Medical School of UTHealth in Houston, said in the Boehringer Ingelheim press release. “These underlying conditions often lead to the lungs being overlooked, yet lung scarring may lead to debilitating and irreversible impact on lung function,” Assassi said in the news release.

Jascayd is a preferential phosphodiesterase 4B (PDE4B) inhibitor that modulates the immune response and has antifibrotic effects. The FDA approval is based on results from the phase 3 FIBRONEER-ILD clinical trial, which Boehringer Ingelheim describes as “the largest clinical trial program in PPF [progressive pulmonary fibrosis] to date” in the news release.

Other drugs inhibit phosphodiesterase 4, but Jascayd zeroes in on the phosphodiesterase 4B subtype that is found in the lung, a specificity that drug developers hope will result in fewer side effects and make the drug more effective.

The primary end point of the FIBRONEER^-ILD was the absolute change from baseline in forced vital capacity (FVC), a common measure of lung function, a year into the trial.

According to the results reported in the New England Journal of Medicine (NEJM) on May 19, 2025, a total of 1,176 patients received at least one dose of Jascayd or a placebo, of whom nearly half (43.5%) were taking background Ofev (nintedanib), a previously approved medication, at baseline. The adjusted average change in the FVC at week 52 was −98.6 milliliters (mL) among the patients whom the researchers randomly assigned to a higher (18 milligrams [mg]) dose of Jascayd compared with −84.6 mL in the group that was treated with the lower 9-mg dose and −165.8 mL in the placebo group, the results in NEJM showed. The difference between the 18-mg group and the placebo group was 67.2 ml, and the difference between the nerandomilast 9-mg group and the placebo group was 81.1 ml.

The most frequent adverse event was diarrhea, the results reported in NEJM show. More than a third (36.6%) of the patients in the high-dose group reported having diarrhea, compared with 29.5% in the 9-mg group and 24.7% in the placebo group. Serious adverse events occurred in similar percentages of patients in the trial groups.