Nerandomilast, sold under the brand name Jascayd, is a medication used for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. It is a phosphodiesterase 4 (PDE4) inhibitor. It is taken by mouth. Common side effects include diarrhea, decreased weight, decreased appetite, and nausea. Nerandomilast was approved for medical use in the United States in October 2025. The US Food and Drug Administration considers it to be a first-in-class medication.
Medical uses Nerandomilast is indicated for the treatment of idiopathic pulmonary fibrosis and for the treatment of progressive pulmonary fibrosis. Idiopathic pulmonary fibrosis affects the tissue surrounding the air sacs, or alveoli, in the lungs. It develops when this lung tissue becomes thick and stiff. Over time, these changes can cause permanent lung scarring (fibrosis) that makes it more difficult to breathe. Progressive pulmonary fibrosis is a chronic disease characterized by gradual, irreversible scarring of the lungs, which can lead to progressive breathing difficulties. Progressive pulmonary fibrosis is an umbrella term that can describe progressive lung scarring in many interstitial lung diseases.
Side effects Side effects include diarrhea, decreased weight, decreased appetite, and nausea.
History The efficacy of nerandomilast for the treatment of idiopathic pulmonary fibrosis was evaluated in two randomized, double-blind, placebo-controlled trials of adults with idiopathic pulmonary fibrosis. The efficacy of nerandomilast for the treatment of progressive pulmonary fibrosis was demonstrated in FIBRONEER-ILD (NCT05321082), a randomized, double-blind, placebo-controlled study that enrolled 1,178 adults with progressive pulmonary fibrosis. Participants were randomly assigned 1:1:1 to receive twice daily administration of nerandomilast 9 mg, nerandomilast 18 mg, or placebo, for at least 52 weeks.
Society and culture
Legal status Nerandomilast was approved for medical use in the United States in October 2025. The US Food and Drug Administration granted the application for nerandomilast an orphan drug designation for the idiopathic pulmonary fibrosis indication and breakthrough therapy designation for the progressive pulmonary fibrosis indication. In May 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Jascayd, intended for the treatment of adults with idiopathic pulmonary fibrosis or adults with progressive pulmonary fibrosis. The applicant for this medicinal product is Boehringer Ingelheim International GmbH.
Names Nerandomilast is the international nonproprietary name. Nerandomilast is sold under the brand name Jascayd.
References
External links Clinical trial number NCT05321069 for "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)" at ClinicalTrials.gov Clinical trial number NCT04419506 for "A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)" at ClinicalTrials.gov Clinical trial number NCT05321082 for "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)" at ClinicalTrials.gov


