FDA Approves Nerandomilast for Progressive Pulmonary Fibrosis

The FDA today approved nerandomilast (Jascayd; Boehringer Ingelheim) for the treatment of progressive pulmonary fibrosis (PPF) in adults, according to a press release from the company.¹

The approval was based on the pivotal phase 3 FIBRONEER-ILD (NCT05321082) trial, in which nerandomilast slowed lung function decline in PPF and had similar discontinuation rates to placebo.² Nerandomilast, a preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects, is a first-in-class option and the second FDA-approved therapy for PPF.¹

In FIBRONEER-ILD, the adjusted mean change from baseline to 52 weeks in forced vital capacity (FVC)—the study's main end point—was –98.6 mL (95% CI, −123.7 to −73.4) and −84.6 mL (95% CI, −109.6 to −59.7) in patients receiving nerandomilast at 18 mg or 9 mg doses, respectively.² In the placebo group, the adjusted mean decline was −165.8 mL (95% CI, −190.5 to −141.0).

A total of 1176 patients received nerandomilast in the trial, and 43.5% of those patients were on background nintedanib therapy at baseline.² Diarrhea was the most common adverse event (AE), occurring in 36.6% of the patients in the 18-mg nerandomilast group and 29.5% in the 9-mg group vs 24.7% of those in the placebo group.

“Progressive pulmonary fibrosis is linked to underlying clinical ILD [interstitial lung disease] 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, professor and director of rheumatology at McGovern Medical School, UTHealth Houston, said in a statement.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].”

In a prespecified analysis of overall survival (OS) in FIBRONEER-ILD, there was a trend in favor of nerandomilast, according to the press release.¹ The HRs for all-cause mortality in the 18-mg and 9-mg nerandomilast cohorts were 0.51 (95% CI, 0.34-0.78) and 0.51 (95% CI, 0.34-0.78), respectively, compared with placebo at up to 114 weeks.

The approval marks the second for nerandomilast in recent months. In October 2025, the PDE4B inhibitor was approved for the treatment of adults with idiopathic pulmonary fibrosis (IPF), making it the first novel IPF therapy in more than a decade.³ Its approval in IPF was supported by data from the randomized, placebo-controlled, double-blind FIBRONEER-IPF trial (NCT05321069) and from Trial 2 (NCT04419506).

Whereas IPF is characterized by progressive lung scarring from an unknown cause, PPF is linked with an underlying clinical ILD diagnosis.¹ Both represent areas of unmet clinical need.

“People living with progressive pulmonary fibrosis often carry a heavy burden that others don’t always see,” Scott Staszak, president and CEO of the Pulmonary Fibrosis Foundation, said.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. U.S. FDA approves JASCAYD (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. News release. Boehringer Ingelheim. 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. Maher TM, Assassi S, Azuma A, et al. Nerandomilast in patients with progressive pulmonary fibrosis. N Engl J Med. 2025;392(22):2203-2214. doi:10.1056/NEJMoa2503643

3. McNulty R. FDA approves nerandomilast for idiopathic pulmonary fibrosis. AJMC^®. October 7, 2025. Accessed December 19, 2025. https://www.ajmc.com/view/fda-approves-nerandomilast-for-idiopathic-pulmonary-fibrosis