U.S. FDA Greenlights Jascayd as Breakthrough Drug for Lung Fibrosis
Nikhil Prasad Fact checked by:Thailand Medical News Team Oct 15, 2025 3 weeks, 4 days, 22 hours, 49 minutes ago
Medical News: A Milestone Approval After a Decade
The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first new therapy for this devastating lung disease in more than ten years. Developed by its manufacturer as a next-generation anti-inflammatory therapy, Jascayd stands out as the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) ever approved for this condition.
U.S. FDA Greenlights Jascayd as Breakthrough Drug for Lung Fibrosis
The approval comes at an opportune time as the COVID-19 pandemic has led to millions developing lung fibrosis with majority not even aware of what is happening to them till late stages.
Study Trials and Clinical Impact
The approval was based on two large-scale, randomized, double-blind, placebo-controlled clinical trials involving adults diagnosed with IPF. According to this
Medical News report, the trials demonstrated a significant slowing in the decline of lung function. Patients receiving Jascayd at 18 mg or 9 mg doses twice daily experienced an adjusted mean decline in forced vital capacity (FVC) of −106 mL and −122 mL respectively, compared to a −170 mL decline in the placebo group. The drug’s effect appeared as early as the second week and continued to widen the gap between treatment and placebo over the 52-week trial period.
Dosage and Administration
The recommended dosage for Jascayd is 18 mg taken orally twice daily, although some patients who experience intolerance may reduce the dose to 9 mg twice daily. This reduced dosage is not recommended for patients already taking pirfenidone. The drug’s performance shows promising results for those with progressive lung function loss, offering a better safety and tolerability profile compared to some existing antifibrotic treatments.
Side Effects and Safety Profile
The most common side effects reported in 5% or more of participants included diarrhea, COVID-19 infection, upper respiratory tract infection, depression, loss of appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness. Discontinuation due to adverse reactions was slightly higher in the Jascayd group, with 15% of those on the 18 mg dose and 12% on 9 mg discontinuing, compared to 11% in the placebo group.
Expert Insights and Clinical Promise
“Jascayd has proven to slow lung function decline in IPF,” said Dr. Toby Maher, a leading pulmonologist from the University of Southern California in Los Angeles. “It represents a welcome new treatment option with a well-tolerated safety profile for physicians to consider for suitable patients.”
This landmark approval signals a critical turning point for IPF patients, many of whom have had limited options in slowing disease progression. With Jascayd’s introduction, the medical community has gained a potentially transformative t
ool to help improve quality of life and preserve lung function in those battling this chronic and life-threatening illness.
References:
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis
https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade
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Read Also:
https://www.thailandmedical.news/articles/med-news
https://www.thailandmedical.news/articles/pharma-news
https://www.thailandmedical.news/articles/covid19-drugs
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