Understanding Jascayd in the Treatment Landscape
Boehringer Ingelheim (BI) has recently secured European marketing authorization for Jascayd (nerandomilast) for the treatment of both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
This is particularly significant because Jascayd is the first new treatment approved in over a decade for IPF and in more than five years for PPF in EU markets, says GlobalData, a leading intelligence and productivity platform.
PPF is a clinical phenotype that describes worsening fibrosis in the lungs over time after an interstitial lung disease (ILD) diagnosis other than IPF, and despite treatment. The only other currently approved antifibrotic to treat PPF in Europe is BI’s Ofev (nintedanib).
The EU approval also validates BI’s decision to run the FIBRONEER program as coordinated, dual indication clinical trials to accelerate market penetration. This mirrors Jascayd’s launch sequence in the US, where the FDA approved the drug for IPF in October 2025 and for PPF in December 2025.
Connor Daniels, Healthcare Analyst at GlobalData, comments: “Jascayd has been designed to be a successor to Ofev when its patent expires in 2026 and to help defend BI’s market share after generic nintedanib entry. However, it is important to note that although both of BI’s assets have demonstrated efficacy in slowing disease progression, they do not stop or reverse fibrosis, and patients continue to experience a gradual decline in respiratory function and increased morbidity, highlighting an unmet need in the PPF space.”
Jascayd is a first-in-class phosphodiesterase 4B (PDE4B) inhibitor that has been designed to have isoform selectivity to retain the antifibrotic and anti-inflammatory effects of PDE4 inhibition while avoiding the tolerability constraints that have limited previous nonselective PDE4 inhibitors in respiratory diseases. In the pivotal Phase III FIBRONEER-ILD trial, both arms significantly slowed forced vital capacity (FVC) decline versus placebo, with discontinuation rates (10% in the 18mg arm and 8.1% in the 9mg arm) comparable to those in the placebo arm (10.2%).
Daniels adds: “The superior tolerability profile demonstrated in the trial is likely to be the main differentiator against the existing standard of care, as patient compliance is currently a significant issue.”
Although Jascayd’s approval is welcome news for patients, the need for disease-modifying therapies remains in the PPF market. As a result, many investigational programs are ongoing to explore novel targets to slow fibrosis, such as Bristol Myers Squibb’s lysophosphatidic acid receptor 1 antagonist admilparant and United Therapeutics’ prostacyclin receptor agonist Tyvaso (treprostinil), both of which are in Phase III clinical trials.
However, few assets are currently in Phase III trials due to the heterogeneous nature of PPF, making it difficult to identify specific targets that will work in broad patient populations. This variability also makes it challenging to design clinical trials with appropriate endpoints to clearly demonstrate the efficacy of potential assets.
Daniels concludes: “BI is currently investigating Jascayd’s utility in treating systemic sclerosis and idiopathic inflammatory myopathy in Phase III clinical trials, suggesting that the company has a platform strategy across fibrotic and rheumatic indications. This signals that PDE4B inhibition is emerging as a validated modality worth watching beyond this most recent launch.”
