NDAORALTABLETPriority Review
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JASCAYD (nerandomilast) is an oral small-molecule tablet approved October 2025 for interstitial lung disease and idiopathic pulmonary fibrosis. The mechanism of action and pharmacologic class are not yet publicly disclosed. It represents a new treatment option in a fibrotic lung disease category with limited but established competitors.
Launch12.5 years to LOE
Early-stage launch phase creates immediate opportunities for brand, field, and medical affairs teams to establish market presence against entrenched competitors.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Started Aug 2026
466 enrolled
Interstitial Lung Diseases
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)
Started Jul 2026
35 enrolled
Fibrosing Interstitial Lung Disease
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Started Jun 2026
448 enrolled
Systemic Sclerosis
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Started Feb 2026
80 enrolled
Familial Pulmonary FibrosisInterstitial Lung AbnormalitiesInterstitial Lung Diseases
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Started Sep 2025
400 enrolled
Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.