CHMP backs nerandomilast for IPF and PPF in EU
Decision brief
Answer first · skim in under a minute
The EMA’s CHMP has issued a positive opinion recommending marketing authorization for Jascayd (nerandomilast) in the EU for adults with IPF and PPF. For BD teams and investors, the key catalyst is the next European Commission decision and how the asset fits into the fibrosis treatment landscape.
Key questions this brief answers
- What changed?
- Is nerandomilast already approved in the US?
- What is nerandomilast's mechanism of action?
- What clinical trials are ongoing?
- What should teams watch next?
The EMA's CHMP has issued a positive opinion recommending marketing authorization for Jascayd (nerandomilast) in the EU for adults with IPF and PPF. Nerandomilast is a phosphodiesterase 4 (PDE4) inhibitor. The next step is a European Commission decision on the CHMP recommendation.
Contents15 sections
CHMP backs nerandomilast for IPF and PPF in EU
CHMP positive opinion advances Jascayd toward EU approval
The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Jascayd (nerandomilast), a drug developed by Boehringer Ingelheim, for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). This positive opinion represents a regulatory milestone and sets the stage for a final European Commission decision.
Nerandomilast mechanism of action is a PDE4 inhibitor
Nerandomilast is a phosphodiesterase 4 (PDE4) inhibitor. The drug targets this enzyme as part of its mechanism of action in fibrotic lung disease.
FDA labeling provides US context for IPF and PPF
In the United States, Jascayd (nerandomilast) is indicated for the treatment of idiopathic pulmonary fibrosis in adult patients and the treatment of progressive pulmonary fibrosis in adult patients. The oral formulation is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Clinical development continues across fibrotic lung disease programs
Trial NCT06806592 is recruiting patients with interstitial lung disease related to rheumatic diseases. Trial NCT07497087 is planned to test nerandomilast in systemic sclerosis but is not yet recruiting.
The FIBRONEER-ACT trial (NCT07540988) is evaluating nerandomilast in fibrosing interstitial lung disease at risk for disease progression and is not yet recruiting. Trial NCT07201922 is recruiting patients with a family history of pulmonary fibrosis to assess whether nerandomilast can slow lung changes. A long-term follow-up study (NCT06238622) is recruiting participants from prior nerandomilast trials in IPF and PPF.
Key Takeaways
- The CHMP has issued a positive opinion recommending marketing authorization for Jascayd (nerandomilast) for adults with IPF and PPF in the EU.
- Nerandomilast is a phosphodiesterase 4 (PDE4) inhibitor indicated for both IPF and PPF.
- Phase 3 trials are recruiting or planned in interstitial lung disease related to rheumatic diseases, systemic sclerosis, fibrosing interstitial lung disease at risk for disease progression, familial pulmonary fibrosis, and a long-term follow-up in IPF and PPF.
- The next regulatory milestone is a European Commission decision on the CHMP recommendation.
What to watch next
The immediate milestone is the European Commission's formal decision on the CHMP recommendation. Longer-term catalysts include data readouts from ongoing Phase 3 trials in interstitial lung disease related to rheumatic diseases, systemic sclerosis, fibrosing interstitial lung disease at risk for disease progression, and familial pulmonary fibrosis.
As of March 2026, nerandomilast is not under approval review by Swissmedic in Switzerland.
Drug Snapshot
| Drug | Nerandomilast |
|---|---|
| Generic name | NERANDOMILAST |
| Manufacturer | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Route | ORAL |
| Indication | 1 INDICATIONS AND USAGE JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients. |
Regulatory Summary
- Approved indication: 1 INDICATIONS AND USAGE JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.
- Boehringer Ingelheim Pharmaceuticals, Inc. develops Nerandomilast
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT06806592 | A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases | RECRUITING | PHASE3 | Boehringer Ingelheim |
| NCT07497087 | A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis | NOT_YET_RECRUITING | PHASE3 | Boehringer Ingelheim |
| NCT07540988 | FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression | NOT_YET_RECRUITING | PHASE3 | Boehringer Ingelheim |
| NCT07201922 | A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis | RECRUITING | PHASE3 | Boehringer Ingelheim |
| NCT06238622 | A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast | RECRUITING | PHASE3 | Boehringer Ingelheim |
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| Contineum Therapeutics | idiopathic pulmonary fibrosis | 1 |
| George Papanicolaou Hospital | idiopathic pulmonary fibrosis | 1 |
| University of Chicago | idiopathic pulmonary fibrosis | 1 |
| First Affiliated Hospital of Wenzhou Medical University | idiopathic pulmonary fibrosis | 1 |
| Vicore Pharma AB | idiopathic pulmonary fibrosis | 1 |
Timeline
- Recruiting trial NCT06806592 (PHASE3)
- Not_Yet_Recruiting trial NCT07497087 (PHASE3)
- Not_Yet_Recruiting trial NCT07540988 (PHASE3)
- Recruiting trial NCT07201922 (PHASE3)
- Recruiting trial NCT06238622 (PHASE3)
Frequently Asked Questions
What changed?
The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in the European Union. The next step is a European Commission decision.
Is nerandomilast already approved in the US?
Jascayd (nerandomilast) is indicated in the United States for the treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in adult patients.
What is nerandomilast's mechanism of action?
Nerandomilast is a phosphodiesterase 4 (PDE4) inhibitor.
What clinical trials are ongoing?
Trial NCT06806592 is recruiting patients with interstitial lung disease related to rheumatic diseases. Trial NCT07497087 is planned for systemic sclerosis but is not yet recruiting. Trial NCT07540988 (FIBRONEER-ACT) is evaluating fibrosing interstitial lung disease at risk for disease progression and is not yet recruiting. Trial NCT07201922 is recruiting patients with a family history of pulmonary fibrosis. Trial NCT06238622 is a long-term follow-up study recruiting participants from prior nerandomilast trials in IPF and PPF.
What should teams watch next?
Monitor the European Commission's formal decision on the CHMP recommendation and data readouts from ongoing Phase 3 trials.
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