JASCAYD (nerandomilast)
Jascayd treats idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in adult patients. It helps patients with these chronic lung conditions by targeting the biological pathways responsible for lung scarring and inflammation. This therapy is prescribed to manage the progression of these fibrotic diseases.
How JASCAYD Works
This drug works by blocking the phosphodiesterase 4 (PDE4) enzyme, specifically targeting the PDE4B subtype. By inhibiting this enzyme, it increases levels of cyclic adenosine monophosphate (cAMP) within cells, which helps lower the production of inflammatory cytokines and growth factors. This dual action provides both antifibrotic and immunomodulatory effects to slow the damage associated with pulmonary fibrosis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-10-07
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
JASCAYD Approval History
What JASCAYD Treats
2 indicationsJASCAYD is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Idiopathic Pulmonary Fibrosis
- Pulmonary Fibrosis
JASCAYD Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to JASCAYD
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06238622 FIBRONEER™-ON | 1305-0031 2023-507353-15-00 | Ph 3 | recruiting | 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 |
| NCT07540988 | 1305-0152 U1111-1337-1080, 2026-526028-38 | Ph 3 | not yet recruiting | FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression |
| NCT07366034 | 1305-0022 2025-523369-32-00, 1111-1326-6351 | Ph 3 | not yet recruiting | A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD) |
| NCT06806592 | 1305-0046 2024-512849-17-00, U1111-1305-5857 | Ph 3 | recruiting | A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases |
| NCT07201922 | 1305-0069 2025-522383-33, U1111-1322-6453 | Ph 3 | recruiting | A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis |
| NCT06139302 results posted | 1305-0038 | Ph 1 | completed | A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men |
| NCT06393127 results posted | 1305-0037 2023-509950-67-00, U1111-1301-0834 | Ph 1 | completed | A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body |
| NCT07100964 | 1305-0119 2025-521279-30-00, U1111-1320-6353 | Ph 1 | completed | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood |
| NCT07081932 | 1305-0113 2025-521104-21-00, U1111-1321-0860 | Ph 1 | completed | A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JASCAYD FDA Label Details
Indications & Usage
FDA Label (PDF)JASCAYD is indicated for the treatment of Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis.
JASCAYD Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for JASCAYD
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 28 active patents
Trial Analysis
- • 10 total trials
- • Stage: Expansion
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment