Nerandomilast FDA Approved for Progressive Pulmonary Fibrosis Save

The FDA has approved nerandomilast (Jascayd), a PDE4b inhibitor, to treat adults with progressive pulmonary fibrosis (PPF). Nerandomilast was approved to treat idiopathic pulmonary fibrosis (IFP) in October 2025.  

PPF is a a life-threatening, progressive lung condition, leading to a continuous decline in lung function. PPF affects up to 100,000 people in the U.S. and is linked to an underlying clinical interstitial lung disease (ILD) diagnosis, such as autoimmune ILD or hypersensitivity pneumonitis.

Approval is based on the results of the FIBRONEER-ILD, a randomized, double-blind, placebo-controlled study that enrolled 1,178 adults with PPF treated for at least 52 weeks. Nerandomilast significantly slower rates of lung function decline compared to placebo, with change in forced vital capacity (FVC) as the primary endpoint at 52 weeks.  Moreover, treated patients had fewer events of either interstitial lung disease exacerbations, respiratory hospitalizations, or death over the course of the trial.

The recommended dosages for Jascayd are 9 mg or 18 mg orally twice a day, approximately 12 hours apart.

The safety of Jascayd in patients with PPF was generally consistent with that previously observed, and is believed to be better tolerated than nintenib.  Side effects include diarrhea, decreased weight, decreased appetite, and nausea. 

From the Package Insert:

• Indications: IPF and Progressive Pulmonary Fibrosis in adults
• Dosage: Recommended 18 mg orally twice daily approximately 12 hours
  apart with or without food. Reduce dose to 9 mg twice daily for patients who are unable to
  tolerate 18 mg twice daily, except in patients taking concomitant pirfenidone (use at normal dose)
• Contraindications: none
• Adverse effects: Most common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.  Diarrhea and weight loss was more commonly observed in patients taking neranomilast concomitantly with nintedanib
• Pregnancy: no available data on JASCAYD use in pregnant women to evaluate for a drug-associated risk