Date: Oct 7, 2025 - Agency: U.S. Food and Drug Administration

Attribution: The FDA posted this approval on its Drugs News & Events page on Oct 7, 2025. The same day, the product label was published in Drugs@FDA. The drug also appears on the FDA’s Novel Drug Approvals 2025 list and the Notable Approvals page. 

Summary

The FDA approved Jascayd (nerandomilast) tablets for adults with idiopathic pulmonary fibrosis (IPF). This is the first new therapy for IPF in more than 10 years, as stated in the FDA’s announcement. 
U.S. Food and Drug Administration

What The Approval Is Based On?

According to the FDA’s news post, the decision relied on two randomized, double-blind, placebo-controlled trials. Patients on Jascayd showed a smaller decline in forced vital capacity (FVC) than those on placebo. 

How To Use It?

Per the official FDA label, the recommended dose is 18 mg by mouth twice daily, about 12 hours apart. For patients who cannot tolerate that dose, 9 mg twice daily may be used, except when taken with pirfenidone. With strong CYP3A inhibitors, reduce to 9 mg twice daily. Avoid use with strong or moderate CYP3A inducers. 
FDA Access Data

Safety Profile

The FDA label lists common adverse reactions that occurred in trials, including diarrhea, upper respiratory tract infection, COVID-19, depression, decreased appetite and weight, nausea, fatigue, headache, vomiting, back pain, and dizziness. Diarrhea was the most frequent reason for discontinuation in the pivotal study. 

Where Does This Fit For Clinics?

The FDA announcement notes that IPF is a serious, progressive lung disease with limited treatments. This approval adds another option to help slow the decline in lung function. Practices should check the FDA label for drug–drug interactions and monitor tolerability when starting therapy.