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Jascayd (NERANDOMILAST)
Jascayd works by inhibiting the activity of phosphodiesterase 4, an enzyme involved in the inflammatory response.
At a glance
| Generic name | NERANDOMILAST |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C, and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP). Nerandomilast exerts both antifibrotic and immunomodulatory effects as PDE4B inhibition elevates intracellular cAMP levels and reduces the expression of profibrotic growth factors and inflammatory cytokines, which are overexpressed in IPF and PPF.
Approved indications
- Idiopathic Pulmonary Fibrosis
- Progressive Pulmonary Fibrosis
Common side effects
- Diarrhea
- COVID-19
- Upper respiratory tract infection
- Depression
- Weight decreased
- Decreased appetite
- Nausea
- Fatigue
- Headache
- Vomiting
- Back pain
- Dizziness
Drug interactions
- Strong CYP3A Inhibitors
- Moderate or Strong CYP3A Inducers
- Pirfenidone
- Strong CYP3A Inhibitors
- Moderate or Strong CYP3A Inducers
- Pirfenidone
- Strong CYP3A Inhibitors
- Moderate or Strong CYP3A Inducers
- Pirfenidone
- Strong CYP3A Inhibitors
- Moderate or Strong CYP3A Inducers
- Pirfenidone
Key clinical trials
- A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (PHASE2)
- A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases (PHASE3)
- A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (PHASE3)
- A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (PHASE3)
- A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis (PHASE3)
- 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 (PHASE3)
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Jascayd CI brief — competitive landscape report
- Jascayd updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI