FINGOLIMOD HYDROCHLORIDE
FINGOLIMOD HYDROCHLORIDE is indicated for the treatment of Multiple Sclerosis.
How FINGOLIMOD HYDROCHLORIDE Works
Fingolimod is metabolized into an active form that binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. This interaction blocks lymphocytes from exiting the lymph nodes, which reduces the total number of lymphocytes circulating in the peripheral blood. While the exact therapeutic mechanism is unknown, the drug is thought to work by limiting the migration of these cells into the central nervous system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-12-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FINGOLIMOD HYDROCHLORIDE Approval History
What FINGOLIMOD HYDROCHLORIDE Treats
1 indicationsFINGOLIMOD HYDROCHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
FINGOLIMOD HYDROCHLORIDE 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 FINGOLIMOD HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FINGOLIMOD HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FINGOLIMOD HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 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 |
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.
FINGOLIMOD HYDROCHLORIDE FDA Label Details
Indications & Usage
FINGOLIMOD HYDROCHLORIDE is indicated for the treatment of Multiple Sclerosis.
Looking for the branded version?
GILENYA
Full clinical data, patents, trials, and competitive landscape for fingolimod hydrochloride.
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