65 completed, 8 terminated, 7 unknown, 6 active not recruiting. 28 Phase 3, 26 Phase 4, 22 Phase 2, 8 Phase 1, 3 Early Phase 1.
Follow Fingolimod Hydrochloride: new trials by email Literature Review of Fingolimod Hydrochloride trials Research Report on Fingolimod Hydrochloride
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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) Diroximel Fumarate, Dimethyl Fumarate, Fingolimod - Relapsing Forms of Multiple Sclerosis | Phase 3 | Not yet recruiting | Biogen | 185 | 2026-11-16 | 2026-03-19 |
| Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis Ublituximab, Placebo, Fingolimod - Relapsing Multiple Sclerosis | Phase 2 / Phase 3 | Recruiting | TG Therapeutics, Inc. | 240 | 2026-07-01 | 2026-10-29 |
| Phase 2 Study of Fingolimod in Lung Cancers Fingolimod 0.5 milligram (mg) [Gilenya] - Non Small Cell Lung Cancer, Small-cell Lung Cancer | Phase 2 | Recruiting | Medical University of South Carolina | 38 | 2025-05-01 | 2026-03-30 |
| Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis Ozanimod, Fingolimod, Placebo - Multiple Sclerosis, Relapsing-Remitting | Phase 3 | Recruiting | Bristol-Myers Squibb | 194 | 2025-04-08 | 2026-09-10 |
| Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage Fingolimod - Intracerebral Hemorrhage | Phase 1 / Phase 2 | Unknown | Tang-Du Hospital | 40 | 2023-10-11 | 2023-10-18 |
| Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation Fingolimod, Placebo - Interstitial Fibrosis, Kidney Transplant; Complications | Phase 2 | Enrolling by invitation | The Methodist Hospital Research Institute | 20 | 2022-07-28 | 2025-03-14 |
| A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) Ocrelizumab, Ocrelizumab Placebo, Fingolimod - Relapsing-remitting Multiple Sclerosis | Phase 3 | Active not recruiting | Hoffmann-La Roche | 188 | 2022-05-19 | 2026-07-15 |
| Fingolimod for Type 2 Diabetes Mellitus Fingolimod, guideline-based treatment for DM - Diabetes Mellitus, Type 2 | Phase 4 | Recruiting | General Hospital of Shenyang Military Region | 40 | 2022-03-15 | 2026-09-10 |
| Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt Fingolimod - Relapsing-Remitting Multiple Sclerosis | Completed | Hikma Pharmaceuticals LLC | 30 | 2022-01-19 | 2024-08-23 | |
| Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis Fingolimod, Ofatumumab, Siponimod - Multiple Sclerosis (MS) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 129 | 2021-10-05 | 2026-05-14 |
| A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies Diroximel Fumarate, Alemtuzumab, Fingolimod - Multiple Sclerosis | Active not recruiting | Biogen | 1178 | 2021-09-24 | 2026-10-15 | |
| Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients Fingolimod 0.5mg - Relapsing Multiple Sclerosis (RMS) | Phase 4 | Completed | Novartis Pharmaceuticals | 98 | 2021-02-20 | 2026-01-13 |
| Revascularization Pretreated With Fingolimod in Acute Stroke Fingolimod, placebo - Stroke | Not applicable | Unknown | The Affiliated Hospital of Xuzhou Medical University | 20 | 2021-02-01 | 2021-01-22 |
| Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke Fingolimod, Placebo - Stroke, Inflammation | Phase 2 | Unknown | Second Affiliated Hospital, Zhejiang University, School of Medicine | 118 | 2021-01-15 | 2023-04-18 |
| Fingolimod in Endovascular Treatment of Ischemic Stroke Fingolimod - Stroke Inflammation | Phase 2 | Unknown | Ning Wang, MD., PhD. | 30 | 2020-11-12 | 2022-04-13 |
| Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis Fingolimod - Multiple Sclerosis | Phase 4 | Active not recruiting | Novartis Pharmaceuticals | 14 | 2020-10-12 | 2026-11-02 |
| Relationship Between Oral DMT Burden and Adherence in MS Cladribine, Dimethyl fumarate, Fingolimod - Multiple Sclerosis, Adherence, Medication | Unknown | Monash University | 323 | 2020-09-25 | 2022-08-31 | |
| 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). Sphingomod, Gilenya - Healthy | Phase 1 | Completed | Genuine Research Center, Egypt | 34 | 2020-08-10 | 2020-12-08 |
| Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage Fingolimod, Placebo, Open-label Fingolimod - Intracerebral Hemorrhage, Cerebral Edema | Early Phase 1 | Completed | Wake Forest University Health Sciences | 28 | 2020-08-07 | 2025-01-23 |
| Impact of Fingolimod Adherence on Outcomes Fingolimod - Multiple Sclerosis | Completed | Novartis Pharmaceuticals | 694 | 2020-05-18 | 2021-12-16 |
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Multiple Sclerosis (43) · Multiple Sclerosis, Relapsing-Remitting (30) · Rejection, Psychology (5) · Stroke (5) · Ischemic Stroke (3) · Cerebral Hemorrhage (2) · Inflammation (2) · Neurologic Manifestations (2) · Amyotrophic Lateral Sclerosis (1) · Anxiety Disorders (1) · Asthma (1) · Astrocytoma (1) · Brain Edema (1) · Brain Injuries (1) · Breast Neoplasms (1)
Novartis Pharmaceuticals (43) · Novartis (13) · Biogen (3) · Mayo Clinic (2) · Second Affiliated Hospital, Zhejiang University, School of Medicine (2) · Alembic Pharmaceuticals Ltd. (1) · Bristol-Myers Squibb (1) · First Affiliated Hospital of Fujian Medical University (1) · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (1) · General Hospital of Shenyang Military Region (1) · Genuine Research Center, Egypt (1) · Heinrich-Heine University, Duesseldorf (1) · Hikma Pharmaceuticals LLC (1) · Hoffmann-La Roche (1) · IMPULS Endowment Fund (1)
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Charles L Loprinzi (2) · Ahmed Elshafeey, Ph.D. Pharma (1) · Alan Breier, MD (1) · Amit Bar-Or, MD (1) · Anders Svenningsson, MD, PhD (1) · Anna Fogdell-Hahn, PhD (1) · Annette Langer-Gould, MD, PhD (1) · Bernd Kieseier, Prof. (1) · Brett T Lund, Ph.D. (1) · Christoph Heesen (1)
PMID 23531349, PMID 25245812, PMID 17984842, PMID 26121423, PMID 27733070, PMID 28129749, PMID 15940045, PMID 16971719, PMID 17198261, PMID 18195237, PMID 19847907, PMID 20089952, PMID 20089954, PMID 20937112, PMID 21571593, PMID 22354739, PMID 22494956, PMID 22751847, PMID 23647445, PMID 24051419, PMID 24221641, PMID 24293455, PMID 24475777, PMID 24685276, PMID 25003359, PMID 25424122, PMID 25876471, PMID 25876473, PMID 26111826, PMID 26170105, PMID 26202811, PMID 26265273, PMID 26265274, PMID 26827074, PMID 27121555, PMID 28100182, PMID 28856176, PMID 29560379, PMID 30001923, PMID 30050529, PMID 30207920, PMID 31467033, PMID 31598139, PMID 31941953, PMID 32852530, PMID 33082194, PMID 33407685, PMID 34376508, PMID 34392376, PMID 35379762
2023 (2), P30CA015083 (2), 2017 (1), 2025 (1), UL1TR001420 (1)