Data updated: Jun 28, 2026
FINGOLIMOD
Trial Activity: Mature 9 active trials
CNS
Development Insights
Novartis Pharmaceuticals conducting 23 trials (59%)
30 indications explored (Broad Platform)
→ multiple sclerosis (9 trials)
→ relapsing-remitting multiple sclerosis (5 trials)
→ relapsing remitting multiple sclerosis (5 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FINGOLIMOD Approval History
No approval records found
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Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07220252 | TG1101-RMS-PED304 2025-522257-19-00 | Ph 2, Ph 3 | not yet recruiting | Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis |
| NCT04926818 NEOS | CBAF312D2301 | Ph 3 | active not recruiting | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT06408259 | IM047-050 2022-501332-42, U1111-1281-5433 | Ph 3 | recruiting | Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis |
| NCT04480853 SPRING | CFTY720DTW03 | Ph 4 | recruiting | Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis |
| NCT07483632 VOYAGE | 272MS304 2023-509409-60 | Ph 3 | not yet recruiting | A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT05123703 Operetta 2 | WN42086 2020-004128-41, 2023-506516-40-00 | Ph 3 | active not recruiting | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) |
| NCT01892722 results posted | CFTY720D2311 2011-005677-23 | Ph 3 | active not recruiting | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT05307731 | Y(2021)071 | Ph 4 | recruiting | Fingolimod for Type 2 Diabetes Mellitus |
| NCT05285878 | PRO00022269 U1111-1226-4680 | Ph 2 | enrolling by invitation | Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation |
| NCT03941743 | MC18C1 NCI-2019-02741, MC18C1 | Ph 1 | completed | Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer |
| NCT03257358 FLUENT results posted | CFTY720DUS40 | Ph 4 | completed | A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod |
| NCT02956200 FAMTAIS | YAN-2016-047 | Ph 2 | withdrawn | Combinating Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke |
| NCT01201356 results posted | CFTY720D2399 2010-020515-37 | Ph 3 | completed | Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis |
| NCT02232061 results posted | CFTY720D2409 | Ph 4 | completed | Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks |
| NCT01623596 PREFERMS results posted | CFTY720DUS09 | Ph 4 | completed | Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. |
| NCT01705236 PASSOS results posted | CFTY720DDE15TS | Ph 4 | completed | A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya® |
| NCT03345940 PRAG-MS | 2017-000559-26 | Ph 4 | terminated | Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis |
| NCT01633112 ASSESS results posted | CFTY720D2312 | Ph 3 | terminated | MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone |
| NCT02939079 results posted | 293396 | Ph 2, Ph 3 | completed | Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients |
| NCT01779700 STEP results posted | 11T-001 | Ph 2 | completed | Fingolimod in Schizophrenia Patients |
| NCT02720107 results posted | CFTY720DDE01E1 | Ph 4 | completed | Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01) |
| NCT02002390 | IRB2013-054-02 | Ph 2 | completed | Efficacy and Safety of FTY720 for Acute Stroke |
| NCT01625182 results posted | CFTY720I2201 2011-005280-24 | Ph 3 | completed | Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. |
| NCT02342704 REVEAL results posted | 101MS408 2013-004622-29 | Ph 4 | terminated | Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants |
| NCT01941004 | CFTY720D2315 | Ph 3 | withdrawn | Safety and Efficacy of Fingolimod in MS Patients in China |
| NCT01621269 ENGYNE | CFTY720DDE12 | Ph 4 | withdrawn | ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon |
| NCT01333501 Cognition results posted | CFTY720DIT01 2010-023023-19 | Ph 4 | completed | Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms |
| NCT01310166 Biobank | CFTY720DDE01 2010-022066-28 | Ph 4 | completed | Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis |
| NCT01420055 GRACE | CFTY720DFR03 2011-001280-49 | Ph 4 | completed | Fingolimod -Response According to Coping - Evaluation |
| NCT01755871 BiobankII | FINGOHHU | Ph 4 | terminated | Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis |
| NCT01578330 results posted | CFTY720DTR01 | Ph 4 | completed | A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 |
| NCT01317004 EPOC results posted | CFTY720DIT02 2010-024017-31 | Ph 4 | completed | Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change |
| NCT01497262 results posted | CFTY720D2325 | Ph 3 | completed | Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis |
| NCT01436643 REGAIN results posted | CFTY720DDE06 2011-001692-39 | Ph 4 | terminated | Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression |
| NCT01534182 EPOC results posted | CFTY720DRU01 | Ph 4 | completed | Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) |
| NCT01499667 TOFIINGO results posted | CFTY720D2324 2011-001442-15 | Ph 3 | terminated | Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod |
| NCT01216072 EPOC results posted | CFTY720DUS01 | Ph 4 | completed | A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis |
| NCT00670449 results posted | CFTY720D1201E1 | Ph 2 | completed | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis |
| NCT01199861 results posted | CFTY720D2320 2010-019028-30 | Ph 3 | completed | Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 FDA Label Details
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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