FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis

The US Food and Drug Administration has approved Boehringer Ingelheim’s nerandomilast (Jascayd) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults.1

According to a December 19, 2025, release from the Company, the decision makes nerandomilast the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication and was based on results from the phase 3 FIBRONEERTM-ILD clinical trial, the largest clinical trial program in PPF to date.1

“Progressive pulmonary fibrosis is linked to underlying clinical ILD diagnoses including autoimmune ILDs – which can be caused by disorders like rheumatoid arthritis or systemic sclerosis – as well as hypersensitivity pneumonitis, among other conditions,” Shervin Assassi, MD, Director of Rheumatology, McGovern Medical School, UTHealth Houston, said in a press release.1 “These underlying conditions often lead to the lungs being overlooked, yet lung scarring may lead to debilitating and irreversible impact on lung function. This can have a detrimental effect on patients’ lives and highlights the need for new treatment options that can help reduce the decline in lung function, as has been observed with [nerandomilast].”

Nerandomilast is an oral, preferential inhibitor of PDE4B. It was approved by the FDA as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients on September 10, 2025.2

Its use in PPF was explored in the FIBRONEERTM-ILD trial. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at week 52. Results showed nerandomilast demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo.1

The adjusted mean decline in absolute change from baseline in FVC in patients receiving nerandomilast 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group. The respective treatment difference compared with the placebo group was 65 mL (95% CI, 30-101) and 83 mL (95% CI, 48-118).1

The most common adverse reactions in patients with PPF treated with nerandomilast were generally consistent with those observed in patients with IPF.1

The key secondary composite endpoint was the time to the first occurrence of any of the components of the composite endpoint over the blinded duration of the trial, up to 109 weeks, including acute ILD exacerbation, hospitalization for respiratory cause, or death. Overall, there was no statistically significant treatment difference in the hazard ratio (HR) for the nerandomilast 18 mg or 9 mg groups compared to placebo for the key secondary composite endpoint (nerandomilast 18 mg or 9 mg groups, respectively, compared to placebo: HR, 0.77; 95% CI, 0.59-1.01 and HR, 0.88; 95% CI, 0.68-1.14).1

In further exploratory analyses, nerandomilast 18 mg showed a nominally significant reduction in the risk of acute ILD exacerbations over the blinded trial duration compared to placebo (HR, 0.60; 95% CI, 0.38-0.94). It also showed a numerical reduction in the risk of hospitalization for respiratory cause over the blinded trial duration compared to placebo (HR, 0.82; 95% CI, 0.61-1.11).1

Additionally, a prespecified analysis of overall survival at the end of the FIBRONEERTM-ILD trial showed a trend in favor of nerandomilast. The HRs for all-cause mortality until the end of the trial, up to 114 weeks, for nerandomilast 18 mg and 9 mg compared to placebo were 0.51 (95% CI, 0.34-0.78) and 0.51 (95% CI, 0.34-0.78), respectively, although these results were not prespecified for multiplicity control.1

In the trial, nerandomilast was well-tolerated in patients with PPF. In patients taking background nintedanib, diarrhea occurred 49%, 50%, and 37% of patients treated with nerandomilast 18 mg twice daily, nerandomilast 9 mg twice daily, and placebo, respectively. In patients without concomitant use of background nintedanib, diarrhea occurred in 27%, 16%, and 16% of patients using nerandomilast 18 mg twice daily, nerandomilast 9 mg twice daily, and placebo, respectively.1

Diarrhea was the most common adverse reaction associated with treatment discontinuation and occurred most frequently in patients treated with nerandomilast 18 mg (4%) or nerandomilast 9 mg (3%) with background antifibrotic therapy, versus patients receiving placebo (1%) and background antifibrotic therapy. Of note, in patients not receiving concomitant nintedanib, diarrhea led to treatment discontinuation in 1% of patients treated with nerandomilast 18 mg and in no patients receiving nerandomilast 9 mg or placebo.1

“People living with progressive pulmonary fibrosis often carry a heavy burden that others don’t always see,” said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation.1 “A progressive disease condition process like PPF 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.”

References

1. Boehringer Ingelheim. U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. December 19, 2025. Accessed December 19, 2025. https://www.boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-new-treatment-option-adults-ppf

2. Boehringer Ingelheim. U.S. FDA approves Boehringer’s JASCAYD® (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade. September 10, 2025. Accessed December 19, 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade