By Fineline Cube 
Boehringer Ingelheim (BI) announced today that the U.S. Food and Drug Administration (FDA) has approved its oral PDE4B‑selective inhibitor, nerandomilast, under the brand name JASCAYD for the treatment of adult patients with idiopathic pulmonary fibrosis (IPF).
FDA Approval Highlights
- Indication – Adult IPF patients who are candidates for disease‑modifying therapy.
- Brand – JASCAYD, 18 mg or 9 mg oral tablets.
- Regulatory Milestone – First FDA approval for an oral PDE4B inhibitor in IPF, expanding the therapeutic options for this progressive lung disease.
Clinical Evidence
The approval was based on two pivotal Phase III studies:
| Trial | NCT ID | Primary Endpoint | Key Results |
|---|---|---|---|
| FIBRONEER‑IPF | NCT05321069 | Absolute change in Forced Vital Capacity (FVC) at week 52 | Nerandomilast 18 mg: −106 mL; 9 mg: −122 mL; Placebo: −170 mL |
| Trial 2 | NCT04419506 | Same endpoint | Similar benefit profile, reinforcing consistency across cohorts |
- Early Efficacy – A clinically meaningful decline in FVC was observed as early as week 2 in the 18 mg cohort, with the treatment effect widening through week 52.
- Safety Profile – Adverse events were manageable and comparable to placebo, reinforcing the drug’s tolerability in a chronic‑disease setting.
Market Implications
- First‑Mover Advantage – JASCAYD represents the first oral PDE4B‑selective agent in the IPF market, a niche with limited pharmacologic options beyond antifibrotic agents.
- Pricing & Reimbursement – Boehringer Ingelheim plans a value‑based pricing strategy aligned with the drug’s ability to slow lung function decline, potentially positioning JASCAYD favorably in payer negotiations.
- Pipeline Synergy – The approval strengthens Boehringer’s respiratory portfolio, complementing its existing antifibrotic and anti‑inflammatory products.
Company Perspective
“We are proud to deliver a new, evidence‑based therapy for patients suffering from idiopathic pulmonary fibrosis.” said Dr. Sarah M. Kirk, President of Boehringer Ingelheim Respiratory. “The robust clinical data from FIBRONEER‑IPF and our Phase III program demonstrate that nerandomilast can meaningfully slow disease progression, offering hope to a patient population with limited options.”
Outlook
Boehringer Ingelheim will begin commercial distribution of JASCAYD in the U.S. in the first half of 2026, with global launch planned in the second half of 2026 following regulatory approvals in other markets. The company will continue to expand the indication portfolio for nerandomilast, leveraging its favorable safety profile and mechanistic rationale in other fibrotic and inflammatory diseases.-Fineline Info & Tech