Jascayd (Nerandomilast) Receives FDA Nod for Idiopathic Pulmonary Fibrosis

The U.S. Food and Drug Administration (FDA) have approved Jascayd (Nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. The approval granted on October 7, 2025, and marks the first new therapy for IPF in more than ten years. The drug is developed and marketed by Boehringer Ingelheim, which also holds marketing authorization for Ofev (Nintedanib), another established antifibrotic therapy.

About Jascayd

Nerandomilast, marketed under the brand name Jascayd, is an oral therapy classified as a selective phosphodiesterase 4B (PDE4B) inhibitor. The approved dosage is 18 mg twice daily. For patients who experience intolerance, the dose may be reduced to 9 mg twice daily, except in those concurrently receiving pirfenidone. The drug was granted Breakthrough Therapy Designation by the FDA for IPF in February 2022 and again in April 2025 for progressive pulmonary fibrosis (PPF), reflecting its potential to address a critical unmet medical need.

Nerandomilast works by inhibiting the PDE4B enzyme, which plays a central role in inflammatory and profibrotic signaling pathways. By increasing intracellular cyclic adenosine monophosphate (cAMP) levels, the drug modulates immune and fibrotic responses in the lung tissue. This dual anti-inflammatory and antifibrotic activity is believed to slow the progression of lung scarring and preserve respiratory function. The mechanism differentiates Jascayd from existing antifibrotics, offering a novel therapeutic approach to IPF management.

About the Disease: Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive interstitial lung disease characterized by irreversible fibrosis of the lung parenchyma. The condition leads to a gradual decline in lung function, resulting in worsening breathlessness, reduced exercise capacity, and eventually respiratory failure. Despite the availability of antifibrotic agents such as Nintedanib and pirfenidone, the disease often continues to progress and mortality remains high, with a median survival of three to five years after diagnosis. The approval of Jascayd introduces a new pharmacological option that may help slow disease progression and improve long-term outcomes for patients living with IPF.

Clinical Evidence

The FDA’s approval of Jascayd is supported by data from two randomized, double-blind, placebo-controlled Phase 3 trials (NCT05321069) and (NCT04419506). conducted as part of Boehringer Ingelheim global FIBRONEER-IPF program. These pivotal studies enrolled adult patients with idiopathic pulmonary fibrosis and assessed the efficacy and safety of Nerandomilast compared with placebo. The primary endpoint in both trials was the absolute change from baseline in Forced Vital Capacity (FVC) in mL at week 52, a key indicator of lung function in IPF.

Across these studies, treatment with Nerandomilast resulted in a significantly smaller decline in FVC compared with placebo, indicating the drug’s ability to slow the loss of lung capacity. The adjusted mean decline in patients receiving 18 mg or 9 mg Nerandomilast was -106 mL and -122 mL, respectively, as compared to -170 mL in the placebo group. FIBRONEER-IPF trial showed consistent benefits in lung function preservation. Moreover, discontinuation rates were comparable between the Nerandomilast and placebo groups, indicating good overall tolerability. While the full peer-reviewed data are yet to be published, early reports suggest that the treatment offers a favorable balance of efficacy and safety.