JASCAYD (nerandomilast) Wins EU Approval for IPF & PPF
Contents10 sections
The European Commission has approved JASCAYD (nerandomilast), Boehringer Ingelheim's oral treatment for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Cleared in July 2026 after a positive CHMP opinion on 21 May 2026, it is the EU's first oral, preferential PDE4B inhibitor for these scarring lung diseases.
Key Takeaways
The European Commission granted EU marketing authorisation for JASCAYD (nerandomilast) in adults with IPF and PPF.
It is the EU's first oral, preferential PDE4B inhibitor — and the first new IPF treatment approved in the EU in over a decade.
Approval rests on the Phase III FIBRONEER program (2,355 patients), where JASCAYD slowed lung-function decline versus placebo.
A mortality secondary endpoint was not formally met, though a numerical reduction in deaths was seen across both trials.
JASCAYD at a glance
Field | Detail |
|---|---|
Drug | JASCAYD (nerandomilast) |
Company | Boehringer Ingelheim |
Decision | EC marketing authorisation (follows CHMP positive opinion, 21 May 2026) |
Indication | Adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) |
Class | First oral, preferential PDE4B inhibitor approved in the EU |
Dose | 18 mg twice daily, oral (may reduce to 9 mg twice daily) |
Evidence | FIBRONEER-IPF and FIBRONEER-ILD Phase III trials (2,355 patients) |
What did the European Commission approve?
The European Commission granted marketing authorisation for JASCAYD (nerandomilast) to treat adults with IPF and adults with PPF, Boehringer Ingelheim said in Boehringer Ingelheim's EU approval announcement. The company called it the first new IPF treatment approved in the EU in over a decade, and the first for PPF in more than five years.
The decision follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), adopted on 21 May 2026, as recorded on the EMA's Jascayd assessment page.
How does nerandomilast work?
Nerandomilast belongs to the PDE4 inhibitor class and preferentially blocks an enzyme called PDE4B. That enzyme is active in the lungs and drives fibrosis and inflammation. By blocking it, the drug reduces both processes, according to the EMA's May 22 announcement.
The EMA noted that JASCAYD has a different mechanism of action from existing IPF and PPF medicines. That makes it a new option for patients who have had few alternatives.
What the FIBRONEER trials showed
Approval rests on the Phase III FIBRONEER program, which Boehringer Ingelheim describes as the largest clinical trial program conducted in IPF and PPF to date. The EMA reviewed two main studies involving 2,355 patients. The primary endpoint was the decline in lung function over one year, measured by forced vital capacity (FVC).
In the IPF study, FVC fell about 115 ml on 18 mg twice daily and 139 ml on 9 mg twice daily, versus 183 ml on placebo. In the PPF study, the declines were about 99 ml and 85 ml, versus roughly 166 ml on placebo. In both trials, JASCAYD slowed the loss of lung function.
What remains uncertain?
The picture is not all positive. The key secondary endpoint was not met in either trial. Boehringer Ingelheim reported a numerical reduction in mortality across both studies, reaching nominal significance only in FIBRONEER-ILD, per Boehringer Ingelheim's May CHMP statement.
So the survival benefit is suggestive, not proven. Long-term outcomes and real-world use will show how much the FVC gains matter for patients.
Dosing and safety
The recommended dose is 18 mg twice a day, taken orally. It can be cut to 9 mg twice a day if a patient cannot tolerate diarrhoea, the EMA said. JASCAYD does not require liver monitoring, and as monotherapy it showed discontinuation rates similar to placebo.
Related NovaPharma coverage
Frequently Asked Questions
What did the European Commission approve for pulmonary fibrosis?
The European Commission granted marketing authorisation for JASCAYD (nerandomilast), Boehringer Ingelheim's oral treatment for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It follows a positive CHMP opinion adopted on 21 May 2026.
How does nerandomilast work?
Nerandomilast is an oral, preferential PDE4B inhibitor. By blocking the PDE4B enzyme in the lungs, it reduces both fibrosis and inflammation. That mechanism differs from existing IPF and PPF medicines, so it offers patients a new treatment option.
How effective is JASCAYD in the FIBRONEER trials?
In two Phase III studies of 2,355 patients, JASCAYD slowed the decline in lung function (forced vital capacity) over 52 weeks versus placebo. In IPF, FVC fell about 115 ml on 18 mg twice daily versus 183 ml on placebo. A mortality secondary endpoint was not formally met.
Primary Sources
Regulatory catalyst tracker
Track PDUFA dates, approval milestones, and label updates for nerandomilast.
Unlock full calendar →Boehringer Ingelheim pipeline snapshot
One-screen view of active programs, phases, and recent catalysts from public sources.
Investor brief
Download a one-page summary of regulatory impact and competitive context.
Explore drug hub →Entity graph
Continue Exploring
Open the drugs, companies, and topics behind this story.
This article follows our editorial standards. Report a correction via editorial contact.
