Boehringer Ingelheim’s Jascayd has received European marketing authorisation for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, expanding treatment options for patients with progressive lung disease.

New treatment approved for IPF and PPF

Jascayd (nerandomilast) has been authorised in Europe for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), according to analysis from GlobalData.

The approval makes Jascayd the first new treatment for IPF approved in the European Union in more than a decade and the first new treatment for PPF in more than five years, according to the intelligence and analytics company.

PPF is a clinical phenotype in which lung fibrosis continues to worsen following a diagnosis of an interstitial lung disease other than IPF.

The approval gives clinicians another antifibrotic treatment option in a disease area where progression can lead to declining lung function and significant morbidity.

Boehringer Ingelheim’s Ofev (nintedanib) is currently the other approved antifibrotic treatment for PPF in Europe, according to GlobalData.

Connor Daniels, healthcare analyst at GlobalData, said: “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.”

Daniels added that while both treatments have demonstrated an ability to slow disease progression, they do not stop or reverse fibrosis, leaving an unmet need for therapies that can alter the underlying course of PPF.

FIBRONEER programme supports dual indication strategy

The European approval follows the development of Jascayd through the FIBRONEER clinical programme, which evaluated the drug in both IPF and PPF.

GlobalData said the coordinated development programme could help Boehringer Ingelheim establish Jascayd across the two indications.

The strategy follows the drug’s US regulatory path, with the FDA approving Jascayd for IPF in October 2025 and PPF in December 2025, according to GlobalData.

Jascayd is a selective phosphodiesterase 4B (PDE4B) inhibitor designed to target the antifibrotic and anti-inflammatory effects associated with PDE4 inhibition while aiming to avoid some of the tolerability issues associated with non-selective PDE4 inhibitors.

In the Phase 3 FIBRONEER-ILD trial, both Jascayd treatment groups significantly slowed the decline in forced vital capacity (FVC) compared with placebo, according to GlobalData’s analysis.

Treatment discontinuation rates were 10% for the 18mg dose and 8.1% for the 9mg dose, compared with 10.2% for placebo.

Daniels said the drug’s tolerability could be an important differentiator in the market.

“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,” Daniels said.

Pulmonary fibrosis pipeline remains active

Despite the arrival of a new treatment option, GlobalData said the PPF market continues to have a need for therapies that can modify disease progression more effectively.

Several investigational programmes are targeting different biological pathways involved in fibrosis.

Bristol Myers Squibb is developing admilparant, a lysophosphatidic acid receptor 1 antagonist, while United Therapeutics is investigating Tyvaso (treprostinil), a prostacyclin receptor agonist. Both programmes are in Phase 3 clinical development, according to GlobalData.

The development of new treatments for PPF is complicated by the heterogeneous nature of the disease, with patients experiencing progression through different underlying interstitial lung diseases.

This variability can make it difficult to identify targets that are effective across broad patient populations and to design clinical trials with endpoints capable of clearly demonstrating treatment benefit.

Boehringer Ingelheim is also investigating Jascayd in other conditions, including systemic sclerosis and idiopathic inflammatory myopathy, in Phase 3 clinical trials.

Daniels said the wider development programme suggests the company is exploring PDE4B inhibition across fibrotic and rheumatic diseases.

“BI is currently investigating Jascayd’s utility in treating systemic sclerosis and idiopathic inflammatory myopathy in Phase 3 clinical trials, suggesting that the company has a platform strategy across fibrotic and rheumatic indications,” Daniels said.

The European approval therefore represents not only a new treatment option for patients with IPF and PPF, but also a potential expansion of PDE4B inhibition into a wider range of diseases involving fibrosis and inflammation.

For the pulmonary fibrosis field, however, the continuing challenge will be to develop treatments that do more than slow the decline in lung function and can address the underlying mechanisms driving progressive disease.