NDAORALTABLETPriority Review
Approved
Oct 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JASCAYD (nerandomilast) is a newly approved oral small-molecule tablet from Boehringer Ingelheim that launched in October 2025. The mechanism of action and specific indication have not been publicly disclosed in available data. Patient population and therapeutic use case remain to be determined pending full prescribing information.
Growth12.3 years to LOE
Early-stage launch with no competitors identified suggests focused team building phase; budget allocation and headcount growth likely in Year 1–2.
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 (11)
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
This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtypes, With the Aim of Providing Clinicians With Assurance That This is an Appropriate Therapeutic Combination.
Started Jun 2026
120 enrolled
Pulmonary FibrosisInterstitial Lung Disease (ILD)
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
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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.