Boehringer’s Jascayd Scores Second FDA Approval in Lung Fibrosis

The FDA has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults.

Jascayd is the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic activity approved for this indication in the US.

Jascayd first received FDA approval in October 2025 for idiopathic pulmonary fibrosis (IPF), the most common form of the disease, making this its second indication.

Jascayd’s approval in IPF marked the first new treatment for the disease in more than a decade, ending a dry spell that followed the 2014 approvals of Boehringer’s Ofev (nintedanib) and Roche’s Esbriet (pirfenidone). For the rarer PPF subset, Ofev had been the only on-label option since its 2020 expanded indication covering interstitial lung disease (ILDs) with a progressive phenotype.

PFF is a chronic, life-threatening condition characterized by relentless scarring (fibrosis) of lung tissue that leads to irreversible decline in lung function. It can occur on its own or in association with a range of ILDs, including autoimmune ILDs, hypersensitivity pneumonitis and other scarring disorders of the lung.

PPF affects up to 100,000 people in the US and 5.6 million worldwide, with many patients experiencing delayed diagnosis and limited treatment options.

The FDA based its decision on data from the Phase III FIBRONEER-ILD clinical trial, the largest study conducted to date in adults with PPF.

Patients treated with Jascayd showed a significantly slower decline in lung function compared with those on placebo, as measured by forced vital capacity (FVC) at 52 weeks, a key indicator of respiratory performance. Patients receiving Jascayd, at either the 18 mg or 9 mg dose, experienced about half the loss in FVC seen in the placebo group, specifically a decline of -86 mL and -69 mL, respectively, compared to -152 mL in the placebo group.

The key secondary composite endpoint, time to first acute ILD exacerbation, respiratory-related hospitalization or death during the blinded trial period, showed no statistically significant difference between either Jascayd dose and placebo.

But an exploratory analysis found that the 18 mg dose of Jascayd was associated with a nominally significant reduction in the risk of acute ILD events and hospitalization over the blinded trial period, which lasted up to 109 weeks.

Related: Jascayd (Nerandomilast) Gains FDA Approval as First IPF Therapy in 10 Years

“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The US approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” said Boehringer’s head of human pharma, Shashank Deshpande, in a press release.

By reducing lung function decline, Jascayd may help preserve quality of life and delay the progression of symptoms that significantly impact daily living.

While Boehringer’s long-standing presence in IPF should support Jascayd’s launch, it remains unclear whether the newcomer can displace Ofev, which generated $4 billion in sales last year.

Analysts at Leerink expect “solid uptake” for Jascayd but note its more modest effect on lung function leaves room for future competitors.

Boehringer anticipates further global approvals for Jascayd in 2026, with regulatory applications for both IPF and PPF under review in Europe, the UK, Japan and other markets. In China, regulators granted approval to the drug in IPF in October following its FDA approval in the US.