FDA Approves Nerandomilast (JASCAYD) for Two Fibrotic Pulmonary Diseases

In October 2025 the Food and Drug Administration (FDA) approved nerandomilast (JASCAYD) for idiopathic pulmonary fibrosis, a rare, serious and progressive lung disease with limited treatment options.[1]

In December 2025 the FDA broadened the approval to include progressive pulmonary fibrosis, a chronic disease that gradually leads to irreversible scarring of the lungs.[2]

Nerandomilast is an oral medication that is taken twice daily with or without food.

Background on the lung diseases

Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are incurable interstitial lung diseases. The diseases are characterized by inflammation, fibrosis or both, of the tissues around the alveoli (air sacks) in the lungs. In both diseases the tissues around the air sacs become thick and stiff for unknown reasons.[3] Progressive pulmonary fibrosis is a term used to describe fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis. Over time, both diseases lead to chronic coughing and difficulty breathing; patients may experience acute intensification of symptoms.

Typically, idiopathic pulmonary fibrosis is diagnosed in adults who are 60 to 70 years of age; the risk is higher for those who smoke or have a family history of the disease.

Two antifibrotic therapies, nintedanib (OFEV) and pirfenidone (ESBRIET and generics), can slow lung-function decline but do not halt disease progression.[4] Nintedanib, first approved in 2014, is approved for both diseases. Pirfenidone, also first approved in 2014, is only approved for idiopathic pulmonary fibrosis. The medications have gastrointestinal adverse effects that limit their use. Some patients taking nintedanib may experience photosensitivity as well.

Nerandomilast

Nerandomilast inhibits phosphodiesterase 4B, an enzyme involved in the inflammatory and fibrotic signaling pathway in the lungs. Common adverse reactions include diarrhea, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea and dizziness. A 30-day supply costs about $16,000.[5]

Clinical studies supporting approval

FDA approval of nerandomilast for idiopathic pulmonary fibrosis was based on the results of two double-blind trials. In the larger phase 3 trial,[6] 1,177 eligible adults were randomized to receive nerandomilast 9 mg or 18 mg or placebo twice daily. About three-quarters of the patients were also taking nintedanib or pirfenidone; these background antifibrotic treatments could be continued during the trial.

At 52 weeks, the adjusted mean changes from baseline in forced vital capacity (a measure of the maximum amount of air that a person can forcefully exhale after taking the deepest possible breath) with the 18-mg dose, the 9-mg dose and placebo were -114.7 milliliters (mL), -138.6 mL and -183.5 mL, respectively. Although nerandomilast moderately slowed the rate of lung function decline when compared with placebo, it did not reduce the risk of acute exacerbations, respiratory hospitalization or death.

The approval of nerandomilast for progressive pulmonary fibrosis was based on the results of a phase 3 double-blind trial.[7] Like the idiopathic pulmonary fibrosis trials, eligible adults were randomly assigned to nerandomilast 9 mg or 18 mg or placebo twice daily for at least 52 weeks. Participants could continue background nintedanib therapy.

For the 1,176 participants who received at least one dose of drug or placebo, the adjusted mean change in forced vital capacity at week 52 was -98.6 mL, -84.6 mL and -165.8 mL in the 18-mg dose, 9-mg dose and placebo groups, respectively. As was the case for idiopathic pulmonary fibrosis, although nerandomilast moderately slowed the rate of lung function decline, a decrease in the incidence of a first acute exacerbation of interstitial lung disease, respiratory hospitalization or death was not established.

In both trials the most frequently reported adverse event was diarrhea, which was more common in the nerandomilast groups than in the placebo groups.

What You Can Do

If you have interstitial lung disease, seek care from a pulmonary physician. Discuss the treatment options with your clinician, including the lung function effects and the gastrointestinal adverse events associated with the available medications. Nerandomilast is a new medication; it is not yet known whether the drug has serious adverse effects with long-term use.

Moreover, it has yet to be established whether the drug can reduce the risk of acute exacerbation, respiratory hospitalization or death from idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. Public Citizen’s Health Research Group has classified nerandomiliast as Do Not Use for Seven Years.
 

References

[1] Food and Drug Administration. FDA approves drug to treat idiopathic pulmonary fibrosis. October 7, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis. Accessed January 20, 2026.

[2] Food and Drug Administration. FDA approves drug to treat chronic, progressive lung disease. December 19, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-chronic-progressive-lung-disease. Accessed January 20, 2026.

[3] National Institute of Health. What is idiopathic pulmonary fibrosis? https://www.nhlbi.nih.gov/health/idiopathic-pulmonary-fibrosis. Accessed January 7, 2026.

[4] Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. May 18, 2025. 2025;392:2193-2202. Accessed January 5, 2026.

[5] Nerandomilast (Jascayd) for idiopathic pulmonary fibrosis. Medical Letter. 2025;67(1744): 207-208. December 22, 2025.

[6] Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. May 18, 2025. 2025;392:2193-2202. Accessed January 5, 2026.

[7] Maher TM, Assassi S, Azuma A, et al. Nerandomilast in patients with progressive pulmonary fibrosis. N Engl J Med. May 19, 2025. 2025;392:2203-2214. Accessed January 5, 2026.