NDAORALCAPSULEPriority Review
Approved
Sep 2010
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GILENYA (fingolimod HCl) is an oral small-molecule sphingosine-1-phosphate receptor modulator approved in 2010 for multiple sclerosis. It works by sequestering lymphocytes in lymphoid tissues, reducing their migration to the central nervous system and reducing MS relapses. GILENYA represents a paradigm shift from injectable disease-modifying therapies to first-in-class oral MS treatment.
$125MPart D
PeakStable
5.9 years to LOEGILENYA remains at peak lifecycle stage with solid Part D spending of $125M in 2023, indicating a mature franchise requiring experienced commercial teams focused on retention and lifecycle management.
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 (13)
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
Started Feb 2021
98 enrolled
Relapsing Multiple Sclerosis (RMS)
Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).
Started Aug 2020
34 enrolled
Healthy
Gilenya's Impact on Cognitive Function and Thalamic Volumes
Started Oct 2017
20 enrolled
Multiple Sclerosis
Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)
Started Sep 2014
216 enrolled
Multiple Sclerosis
Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya
Started Mar 2014
15 enrolled
Relapsing Remitting Multiple Sclerosis
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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.