FDA announced its approval of Boehringer Ingelheim’s Jascayd (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF). Jascayd’s approval makes it the first approved new therapy treatment for IPF in over 10 years, and with IPF being a rare, serious, and progressive disease with no cure and limited treatments, the approval marks a significant step in supporting those suffering from the disease.

FDA’s approval of Jascayd was a data backed decision

FDA based its approval on results collected from two Phase III trials, Fibroneer-IPF and Fibroneer-ILD.¹ Jascayd’s efficiency was evaluated in both randomized, double-blind, placebo-controlled trials of adults with IPF.¹ The primary endpoint was the absolute change from baseline in Forced Vital Capacity, which is the maximum amount of air a person can forcefully exhale after taking the deepest possible breath.¹ Results indicated that Participants administered with Jascayd had significantly reduced FVC decline when compared to participants treated with the placebo.¹ Jascayd’s recommended dosage is 18 mg orally twice a day, administered 12 hours apart.¹ Jascayd' dosage may be reduced for intolerability to 9 mg twice daily, except in patients who also are taking pirfenidone.¹

What were the results from the phase III Fibroneer-IPF trial?

During the trial, patients (Fibroneer-IPF, n=1177) were randomized and received Jascavd 9mg twice per day, 18mg twice per day, or placebo.² Trial data was pooled, and changes in FVC spanning 76 weeks, along with clinically relevant outcomes (acute exacerbations, respiratory hospitalization, and death) were analyzed, with analyses including the overall population and subgroups of patients through use of background therapy at baseline.²

Results of phase III trial portrayed a 43% reduced risk of death and was observed in patients who received 18mg of Jascavd.² Additionally, patients administered with 18mg Jascavd without background therapy, displayed a reduction in the risk of death, by 59%. ² The reduction in risk of death was also seen in patients taking background nintedanib and saw a 41% reduction in the risk of death.

Trial results yielded the most common side effects associated with Jascayd, which includes the following:

• Diarrhea
• Covid-19
• Upper respiratory tract infection
• Depression
• Weight decrease
• Suppressed appetite
• Nausea
• Fatigue
• Headache
• Vomiting
• Back pain
• Dizziness

Boehringer Ingelheim’s statement regarding the phase III Fibroneer-IPF trial

“For people living with pulmonary fibrosis, mortality remains unacceptably high, with every second person dying within 5 years of diagnosis,” said Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim. “As the first Phase III trial program to demonstrate a nominally significant reduction in the risk of death in progressive pulmonary fibrosis, Fibroneer heralds a significant advance for this group of patients, who face a devastating diagnosis and very limited treatment options.”

Sources

1. FDA approves drug to treat idiopathic pulmonary fibrosis U.S. Food and Drug Administration October 7, 2025 https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis?utm_source=dlvr.it&utm_medium=twitter
2. Pooled data presented at ERS: nerandomilast monotherapy linked to nominally significant reduction in risk of death in IPF and PP Boehringer Ingelheim September 29, 2025 https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/nerandomilast-monotherapy-ipf-ppf-death-reduction