GILENYA (fingolimod hydrochloride)
GILENYA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
How GILENYA Works
Fingolimod is metabolized into its active form, fingolimod-phosphate, which binds to sphingosine 1-phosphate receptors 1, 3, 4, and 5. This process blocks lymphocytes from exiting the lymph nodes, effectively reducing the number of these cells circulating in the peripheral blood. The drug's therapeutic effect in multiple sclerosis is thought to result from this reduction in lymphocyte migration into the central nervous system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-09-21
- Patent Cliff
- 2032
- Revenue
- $154M (Q4-2023)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GILENYA Approval History
What GILENYA Treats
3 indicationsGILENYA is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
GILENYA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
What's emerging in GILENYA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GILENYA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GILENYA
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03941743 | MC18C1 NCI-2019-02741, MC18C1 | Ph 1 | completed | Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer |
| NCT04657744 | GRC/1/19/786 | Ph 1 | completed | 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). |
| NCT01786174 results posted | 2013P000313 | Ph 2 | completed | Gilenya in Amyotrophic Lateral Sclerosis (ALS) |
| NCT02048072 ANSG results posted | ANSG 1.8 | Ph 4 | completed | Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS |
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.
GILENYA FDA Label Details
Indications & Usage
FDA Label (PDF)GILENYA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
Pro Intelligence Preview
Deep insights for GILENYA
Revenue Insights
- • Q4-2023: $154M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 6 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
Competitive Landscape
- • 13 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