Nerandomilast Approval Breaks Decade-Long Dry Spell for IPF, With Toby Maher, MD, PhD

The United States Food and Drug Administration (FDA) approval of nerandomilast (Jascayd; Boehringer Ingelheim) in October 2025 marks a major milestone in the treatment of idiopathic pulmonary fibrosis (IPF)—the first new therapy for the progressive and often fatal lung disease in more than a decade.1 IPF, a chronic and irreversible fibrotic condition characterized by scarring of lung tissue, has long been a field of unmet medical need, with limited treatment options since nintedanib and pirfenidone were approved in 2014.2 Now, with the FDA’s authorization of nerandomilast in both 9 mg and 18 mg tablet doses, clinicians have a new tool to help slow lung function decline and potentially improve patient outcomes, especially in patients with limited tolerance to existing drugs.

Nerandomilast, a selective phosphodiesterase 4B (PDE4B) inhibitor, represents a novel mechanism of action among antifibrotic therapies. Results from the phase 3 FIBRONEER-IPF trial demonstrated that patients on nerandomilast experienced a significantly smaller decline in forced vital capacity (FVC) compared with placebo—an adjusted mean decline of –106 mL in the 18 mg arm and –122 mL in the 9 mg arm, versus –170 mL for placebo. The drug also showed a favorable safety profile, with fewer discontinuations due to adverse events compared with previously approved antifibrotic agents.3

HCPLive spoke with Toby Maher, MD, PhD, professor of clinical medicine at the Keck School of Medicine of USC and an investigator in the FIBRONEER-IPF study, to discuss the clinical significance of nerandomilast’s approval and what it means for future treatment strategies. He reflects on how the new therapy fits into the evolving IPF landscape, the potential for combination and sequencing approaches, and how the new approval represents a step in the right direction for the IPF field.

"There's still scope for for better efficacy, but I think having more treatment options available means we're going to be able to offer a benefit to more patients. So I think it's really important. I think it's a step in the right direction, and hopefully it won't be another decade before the next drug is approved," Maher said.

Maher's disclosures include Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, FibroGen, Genentech, GSK, Merck, PureTech Health, Sanofi, Trevi Therapeutics, and United Therapeutics.

References

1. Johnson V. Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years. Article. HCPLive. October 7, 2025. https://www.hcplive.com/view/nerandomilast-first-new-fda-approval-idiopathic-pulmonary-fibrosis-over-10-years

2. Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021;18(7):1121-1128. doi:10.1513/AnnalsATS.202007-901OC

3. Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo. Boehringer Ingelheim. May 19, 2025. Accessed May 19, 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/phase-3-trials-nerandomilast-slowed-lung-function-decline-ipf-and-ppf.