On October 7, 2025, the U.S. Food and Drug Administration (FDA) officially approved Boehringer Ingelheim’s oral tablet nerandomilast (brand name Jascayd) for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF). This marks the first FDA approval of a new IPF therapy since nintedanib (Ofev) and pirfenidone (Esbriet) were approved in 2014, representing a major breakthrough after more than a decade of stagnation in this therapeutic field.

IPF is a rare, progressive interstitial lung disease of unknown cause. Patients typically present with symptoms such as dyspnea, chronic cough, and weight loss, and the disease carries a poor prognosis. Since no curative treatments are available, current therapy focuses on slowing the decline of lung function.

Jascayd (nerandomilast) is the world’s first selective phosphodiesterase 4B (PDE4B) inhibitor to reach the market. By inhibiting PDE4B enzyme activity, it increases intracellular cyclic adenosine monophosphate (cAMP) levels, thereby reducing the expression of pro-inflammatory and pro-fibrotic cytokines. This dual anti-inflammatory and anti-fibrotic mechanism differentiates it from earlier non-selective PDE4 inhibitors, offering comparable efficacy with markedly improved tolerability and fewer gastrointestinal adverse effects such as nausea, vomiting, and diarrhea.

The FDA approval was supported by two randomized, double-blind, placebo-controlled Phase III clinical trials. The FIBRONEER-IPF study enrolled 1,177 patients who were randomized 1:1:1 to receive Jascayd 9 mg, 18 mg, or placebo twice daily for up to 91 weeks. Results showed that Jascayd significantly slowed the decline in lung function: at Week 52, the mean decline in forced vital capacity (FVC) was 106 mL in the 18 mg group and 122 mL in the 9 mg group, compared with 170 mL in the placebo group. A second trial (NCT04419506) further confirmed the efficacy, demonstrating a 91 mL (95% CI: 44–138) smaller reduction in FVC after 12 weeks compared with placebo.

The most common adverse events included diarrhea, upper respiratory tract infection, COVID-19, headache, and fatigue, most of which were mild to moderate and manageable. The drug’s benefit was consistent regardless of whether patients were concurrently receiving background antifibrotic therapy with nintedanib or pirfenidone.

The approval of Jascayd establishes a new “three-drug era” for IPF treatment, alongside nintedanib and pirfenidone. With nintedanib’s patent expiring in 2029 and pirfenidone facing generic competition, Jascayd not only fills a mechanistic gap but also provides a valuable alternative for patients intolerant or unresponsive to existing therapies.

Boehringer Ingelheim received Breakthrough Therapy Designation from the FDA in February 2022 based on promising Phase II data. The company submitted a marketing application for IPF and progressive pulmonary fibrosis (PPF) indications to China’s National Medical Products Administration (NMPA) in February 2025, which is currently under priority review. Approval in China is anticipated within the next one to two years, potentially improving treatment accessibility for patients in the region.

Nerandomilast is protected by the PCT application WO2013026797A1, covering its compound, crystalline form, and therapeutic use across 34 countries and regions, most of which have already granted patents. In China, the corresponding patent (publication number CN103889970B) is valid until August 17, 2032.