The United States Food and Drug Administration (USFDA) has approved JASCAYD (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a progressive, rare, and life-threatening lung condition. Limited treatment options are available for treating this lung disease. This drug marks the first new IPF therapy in over a decade. IPF causes thickening and scarring of lung tissue around the alveoli, leading to permanent fibrosis. This leads to difficulty breathing. Common symptoms include chronic cough and shortness of breath. Some patients may also experience acute exacerbations characterized by a sudden worsening of respiratory symptoms. This disease mainly affects adults aged 60-70 years.
Nerandomilast is a selective phosphodiesterase-4B (PDE4B) inhibitor. It acts by increasing intracellular cyclic adenosine monophosphate (cAMP) levels, thereby reducing profibrotic and inflammatory cytokines. This mechanism produces anti-fibrotic and immunomodulatory effects. This drug exhibits 73% oral bioavailability, a 17-hour half-life, and is primarily metabolized by cytochrome P450 3A (CYP3A).
This approval was based on results from the two randomized (FIBRONEER-IPF and Trial 2), double-blind, placebo-controlled clinical trials. These studies evaluated the safety and efficacy of JASCAYD in adult patients with IPF. Â A total of 1,777 adults with IPF (mean age = 70 years, male = 83%, female = 17%) were enrolled in the FIBRONEER-IPF (NCT05321069) study and were randomized in a 1:1 ratio to receive the treatments of JASCAYD 9mg and 18 mg or placebo twice daily for 52 weeks. A total of 147 IPF patients (mean age = 70 years, male = 77%) were enrolled in Trial 2 study and randomized 2:1 to receive JASCAYD 18mg or placebo twice daily for 12 weeks.
In both studies, the primary endpoint was the absolute change in forced vital capacity (FVC) from baseline. In the FIBRONEER-IPF trial, JASCAYD significantly reduced FVC decline compared to placebo at 52 weeks. The mean decline was -106 mL for the 18mg dose, -122 mL for the 9 mg dose, and -170 mL for the placebo, reflecting treatment differences of 64 mL (95% CI: 25, 102) and 48 mL (95% CI: 10, 86), respectively. In Trial 2, patients receiving a JASCAYD 18 mg showed a 91 mL (95% CI: 44, 138) smaller decline in FVC at week 12 compared with the placebo group.
In the FIBRONEER-IPF study, no statistically significant difference was observed between JASCAYD (9mg or 18mg) and placebo with a hazard ratio (HR) of 1.77 (95% CI: 0.86, 1.59) and 1.03 (95% CI: 0.75, 1.41), respectively. All-cause mortality also did not differ significantly between groups (HR 0.66 [95% CI: 0.41–1.08] for 18 mg; 0.95 [95% CI: 0.61–1.49] for 9 mg).
The most frequently reported side effects of JASCAYD, occurring in 5% or more of patients, included dizziness, vomiting, nausea, decreased appetite, back pain, upper respiratory infection, weight loss, COVID-19, fatigue, depression, and diarrhea.
This approval underscores the FDA’s dedication to improving treatment choices and supporting health care progress for all Americans.
References:
- FDA approves drug to treat idiopathic pulmonary fibrosis. Published October 7, 2025. Accessed October 9, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis
- JASCAYD®: Highlights of Prescribing Information. Reference ID: 5672859. Revised: 10/2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218764s000lbl.pdf
