FDA Approves JASCAYD® (Nerandomilast) for Idiopathic Pulmonary Fibrosis — First New Therapy in Over a Decade

The U.S. FDA has approved JASCAYD® (nerandomilast), Boehringer Ingelheim’s oral, selective phosphodiesterase-4B (PDE4B) inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.

This marks the first new therapeutic approval for IPF in more than ten years, following a decade dominated by antifibrotics nintedanib and pirfenidone.

A New Oral Option in a Long-Stagnant Field

Nerandomilast represents a novel mechanism of action distinct from existing antifibrotics.

By selectively inhibiting PDE4B, the drug modulates inflammatory and fibrotic signaling pathways in lung tissue, aiming to slow disease progression while maintaining oral convenience.

The FDA approval is based on results from the global Phase III FIBRONEER-IPF trial, which met its primary endpoint of slowing the decline in forced vital capacity (FVC) versus placebo at 52 weeks.

Efficacy and Safety Findings

Across more than 1,100 participants, nerandomilast reduced FVC decline by approximately 64 mL compared with placebo, regardless of background antifibrotic use.

Discontinuation rates were comparable to placebo—an encouraging result given the class-wide tolerability challenges historically associated with PDE4 inhibitors.

The most frequent adverse events were diarrhea, weight loss, nausea, and mood-related effects; diarrhea risk increased when co-administered with nintedanib, prompting labeling caution.

The approved dose is 18 mg orally twice daily, with reduction to 9 mg BID for patients unable to tolerate the full dose or receiving strong CYP3A inhibitors.

Regulatory and Clinical Context

The FDA approval follows positive topline results reported in May 2025, when Boehringer confirmed both FIBRONEER-IPF and its companion FIBRONEER-ILD (progressive pulmonary fibrosis, PPF) study met primary endpoints.

Together, these trials form one of the largest late-stage IPF/PPF development programs to date.

Outside the U.S., regulatory submissions are underway globally, including the EU and Asia-Pacific regions. In China, nerandomilast’s IPF filing was accepted by the NMPA/CDE on February 24, 2025 (priority review), and a second filing for progressive pulmonary fibrosis (PPF) was accepted on May 14, 2025, based on FIBRONEER-ILD results.

Boehringer also presented a pooled analysis at the European Respiratory Society (ERS 2025) congress suggesting a nominal reduction in all-cause mortality across the combined IPF and PPF populations—though not yet statistically conclusive after adjustment.

Commercial and Competitive Landscape

JASCAYD enters a market valued at more than US $4 billion annually, currently dominated by Ofev® (nintedanib) and Esbriet® (pirfenidone).

While those agents remain standards of care, both are limited by gastrointestinal toxicity and modest efficacy.

Nerandomilast’s once-novel oral profile and placebo-like discontinuation rates may improve long-term adherence and broaden use beyond specialist centers.

Analysts expect Boehringer to leverage its established Ofev infrastructure for launch synergy while positioning JASCAYD as a next-generation, complementary option rather than an immediate replacement.

If FIBRONEER-ILD supports a broader PPF label, the company could effectively expand into the wider fibrosing-lung-disease continuum.

What to Watch Next

• Label expansion and combination data: Whether Boehringer will pursue co-administration or head-to-head studies against antifibrotics.
• Post-marketing safety monitoring: Mood-related adverse events and diarrhea management will be closely tracked.
• Regulatory progression outside the U.S.: Approvals in Europe and Asia could reshape global treatment access by 2026.
• Validation of mortality signal: Publication of the pooled FIBRONEER analysis may further define nerandomilast’s clinical value.

Bottom Line

The approval of JASCAYD (nerandomilast) marks a turning point in pulmonary fibrosis therapeutics—the first FDA greenlight in over a decade for this fatal lung disease.

Its differentiated PDE4B mechanism, oral dosing, and manageable safety profile could extend treatment access to a broader IPF population and set the stage for the next generation of antifibrotic innovation worldwide.

References

1. FDA. FDA approves drug to treat idiopathic pulmonary fibrosis. October 7, 2025.
2. JASCAYD (nerandomilast) Prescribing Information. NDA 218764, FDA, 2025.
3. Boehringer Ingelheim. FIBRONEER Phase III Trials Slowed Lung Function Decline in IPF and PPF. Press release, May 19, 2025.
4. Boehringer Ingelheim. Nerandomilast (PDE4B inhibitor) program pages. Accessed October 2025.
5. AJMC, HCPLive, FirstWord Pharma coverage on FDA approval, October 2025.