Numerous clinical trials have evaluated the safety and efficacy of fingolimod across neurological conditions, primarily relapsing-remitting multiple sclerosis, stroke, and amyotrophic lateral sclerosis. Spanning Early Phase I to Phase IV, these studies are sponsored by major pharmaceutical companies such as Novartis and Biogen alongside academic centers like Massachusetts General Hospital. The overall portfolio reflects diverse recruitment statuses, including completed, active not recruiting, terminated, and withdrawn trials.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07483632 | NOT_YET_RECRUITING | Relapsing Forms of Multiple Sclerosis |
Biogen |
2026-11-16 | PHASE3 |
| NCT06408259 | RECRUITING | Multiple Sclerosis, Relapsing-Remitting |
Bristol-Myers Squibb |
2025-04-08 | PHASE3 |
| NCT07220252 | RECRUITING | Relapsing Multiple Sclerosis |
TG Therapeutics, Inc. |
2026-07-01 | PHASE2; PHASE3 |
| NCT04480853 | RECRUITING | Multiple Sclerosis |
Novartis Pharmaceuticals |
2020-10-12 | PHASE4 |
| NCT05285878 | ENROLLING_BY_INVITATION | Interstitial Fibrosis; Kidney Transplant; Complications; Kidney Transplant Rejection; Kidney Transplant Failure and Rejection; Kidney Transplant Failure; Kidney Failure, Chronic; Graft Rejection |
The Methodist Hospital Research Institute |
2022-07-28 | PHASE2 |
| NCT06424067 | RECRUITING | Non Small Cell Lung Cancer; Small-cell Lung Cancer |
Medical University of South Carolina |
2025-05-01 | PHASE2 |
| NCT03500328 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis, Relapsing-Remitting |
Johns Hopkins University |
2018-05-02 | |
| NCT04926818 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis (MS) |
Novartis Pharmaceuticals |
2021-10-05 | PHASE3 |
| NCT05307731 | RECRUITING | Diabetes Mellitus, Type 2 |
General Hospital of Shenyang Military Region |
2022-03-15 | PHASE4 |
| NCT04675762 | UNKNOWN | Stroke; Inflammation |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2021-01-15 | PHASE2 |
| NCT06087965 | UNKNOWN | Intracerebral Hemorrhage |
Tang-Du Hospital |
2023-10-11 | PHASE1; PHASE2 |
| NCT05123703 | ACTIVE_NOT_RECRUITING | Relapsing-remitting Multiple Sclerosis |
Hoffmann-La Roche |
2022-05-19 | PHASE3 |
| NCT04667949 | COMPLETED | Relapsing Multiple Sclerosis (RMS) |
Novartis Pharmaceuticals |
2021-02-20 | PHASE4 |
| NCT04353492 | COMPLETED | Relapsing Multiple Sclerosis |
Novartis Pharmaceuticals |
2020-07-14 | PHASE3 |
| NCT02769689 | UNKNOWN | Multiple Sclerosis |
University Hospital, Clermont-Ferrand |
2019-06-12 | PHASE4 |
| NCT04088630 | COMPLETED | Intracerebral Hemorrhage; Cerebral Edema; Stroke Hemorrhagic; Intracerebral Hemorrhage, Hypertensive; Intracerebral Hemorrhage Intraparenchymal |
Wake Forest University Health Sciences |
2020-08-07 | EARLY_PHASE1 |
| NCT04629872 | UNKNOWN | Stroke Inflammation |
Ning Wang, MD., PhD. |
2020-11-12 | PHASE2 |
| NCT04718064 | UNKNOWN | Stroke |
The Affiliated Hospital of Xuzhou Medical University |
2021-02-01 | |
| NCT03943498 | COMPLETED | Chemotherapy-Induced Peripheral Neuropathy; Numbness; Pain; Tingling |
Mayo Clinic |
2019-05-24 | EARLY_PHASE1 |
| NCT04657744 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2020-08-10 | PHASE1 |
| NCT04280588 | WITHDRAWN | Coronavirus Disease (COVID-19) |
First Affiliated Hospital of Fujian Medical University |
2020-02-22 | PHASE2 |
| NCT03941743 | COMPLETED | Breast Carcinoma |
Mayo Clinic |
2019-12-12 | PHASE1 |
| NCT05141669 | Completed | Multiple Sclerosis |
Novartis Pharmaceuticals|Novartis |
2020-05-18 | -- |
| NCT02232061 | COMPLETED | Multiple Sclerosis |
Novartis Pharmaceuticals |
2014-09-29 | PHASE4 |
| NCT03345940 | TERMINATED | Relapsing Remitting Multiple Sclerosis |
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
2017-04-30 | PHASE4 |
| NCT03257358 | COMPLETED | Relapsing Multiple Sclerosis |
Novartis Pharmaceuticals |
2017-09-19 | PHASE4 |
| NCT01705236 | COMPLETED | Relapsing Remitting Multiple Sclerosis RRMS |
Novartis Pharmaceuticals |
2012-08-20 | PHASE4 |
| NCT01201356 | COMPLETED | Relapsing Forms of Multiple Sclerosis |
Novartis Pharmaceuticals |
2010-09-13 | PHASE3 |
| NCT02956200 | WITHDRAWN | Stroke; Inflammation |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2016-11 | PHASE2 |
| NCT01633112 | TERMINATED | Relapsing-remitting Multiple Sclerosis (RRMS) |
Novartis Pharmaceuticals |
2012-08-09 | PHASE3 |
| NCT02061137 | COMPLETED | Rett's Syndrome |
University Hospital, Basel, Switzerland |
2013-08 | PHASE1; PHASE2 |
| NCT02490930 | COMPLETED | Glioblastoma; Anaplastic Astrocytoma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2015-07 | EARLY_PHASE1 |
| NCT01892722 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis |
Novartis Pharmaceuticals |
2013-07-26 | PHASE3 |
| NCT01941004 | WITHDRAWN | Multiple Sclerosis (Relapsing Remitting) |
Novartis Pharmaceuticals |
2014-06 | PHASE3 |
| NCT03345940 | Terminated | Relapsing Remitting Multiple Sclerosis |
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta|Patient-Centered Outcomes Research Institute|Universita degli Studi di Genova |
2017-04-30 | Phase 4 |
| NCT02575365 | TERMINATED | Cognition; Brain Volume Loss |
Novartis Pharmaceuticals |
2016-02-16 | PHASE4 |
| NCT02373098 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2015-03-31 | PHASE4 |
| NCT01585298 | COMPLETED | Multiple Sclerosis |
Novartis Pharmaceuticals |
2012-04-29 | PHASE4 |
| NCT02720107 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2016-05-12 | PHASE4 |
| NCT01625182 | COMPLETED | Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
Novartis Pharmaceuticals |
2012-12-22 | PHASE3 |
| NCT05684016 | COMPLETED | Multiple Sclerosis, Relapsing-Remitting |
George Washington University |
2013-12 | |
| NCT02939079 | COMPLETED | Multiple Sclerosis |
Isfahan University of Medical Sciences |
2015-04 | PHASE2; PHASE3 |
| NCT01779700 | COMPLETED | Schizophrenia |
Indiana University |
2013-01 | PHASE2 |
| NCT02342704 | TERMINATED | Relapsing-Remitting Multiple Sclerosis |
Biogen |
2014-11-30 | PHASE4 |
| NCT02325440 | UNKNOWN | Relapsing Remitting Multiple Sclerosis |
University Hospital Muenster |
2014-03 | PHASE4 |
| NCT01647880 | TERMINATED | Multiple Sclerosis |
Charite University, Berlin, Germany |
2013-07 | PHASE2; PHASE3 |
| NCT02575365 | Terminated | Cognition|Brain Volume Loss |
Novartis Pharmaceuticals|Novartis |
2016-02-16 | Phase 4 |
| NCT03757338 | COMPLETED | Healthy Volunteers |
Asofarma S.A.I. y C. |
2015-10-23 | PHASE1 |
| NCT05145621 | COMPLETED | Bioequivalence; Safety |
Alembic Pharmaceuticals Ltd. |
2015-10-29 | PHASE1 |
| NCT01755871 | TERMINATED | Relapsing Remitting Multiple Sclerosis |
Heinrich-Heine University, Duesseldorf |
2013-01 | PHASE4 |
| NCT01498887 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-12-24 | PHASE4 |
| NCT02307838 | COMPLETED | Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis |
Novartis Pharmaceuticals |
2014-06 | PHASE4 |
| NCT01333501 | COMPLETED | Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-05 | PHASE4 |
| NCT01623596 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2012-06-08 | PHASE4 |
| NCT00731692 | TERMINATED | Primary Progressive Multiple Sclerosis |
Novartis Pharmaceuticals |
2008-07-28 | PHASE3 |
| NCT02048072 | COMPLETED | Multiple Sclerosis; Autonomic Nervous System Dysfunction |
Jochen Vehoff |
2013-07 | PHASE4 |
| NCT01578330 | COMPLETED | Multiple Sclerosis; Relapsing-Remitting |
Novartis Pharmaceuticals |
2012-10 | PHASE4 |
| NCT02193217 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Tanabe Pharma Corporation |
PHASE1 | |
| NCT02002390 | COMPLETED | Stroke; Vascular Accident; Cerebral Stroke; Ischemic Cerebrovascular Accident; Stroke, Acute |
Tianjin Medical University General Hospital |
2012-10 | PHASE2 |
| NCT01791192 | WITHDRAWN | Acute Noninfectious Posterior, Intermediate, or Pan Uveitis |
Novartis Pharmaceuticals |
2013-11 | PHASE2 |
| NCT01786174 | COMPLETED | Amyotrophic Lateral Sclerosis |
Massachusetts General Hospital |
2013-08 | PHASE2 |
| NCT01490840 | TERMINATED | Fatigue in Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-11 | PHASE4 |
| NCT01621269 | WITHDRAWN | Multiple Sclerosis |
Novartis Pharmaceuticals |
2013-06 | PHASE4 |
| NCT01317004 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-05 | PHASE4 |
| NCT01757691 | TERMINATED | Acute Demylelinating Optic Neuritis |
Novartis Pharmaceuticals |
2013-08 | PHASE2 |
| NCT01497262 | COMPLETED | Multiple Sclerosis |
Novartis Pharmaceuticals |
2012-02 | PHASE3 |
| NCT01436643 | TERMINATED | Depression; Relapsing-remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-11 | PHASE4 |
| NCT01709812 | WITHDRAWN | Relapsing-remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2013-07 | PHASE4 |
| NCT01420055 | COMPLETED | Multiple Sclerosis, Relapsing-Remitting |
Novartis Pharmaceuticals |
2011-08 | PHASE4 |
| NCT01534182 | COMPLETED | Relapsing Remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2012-01 | PHASE4 |
| NCT01499667 | TERMINATED | Relapsing Remitting Multiple Sclerosis (RRMS) |
Novartis Pharmaceuticals |
2011-09 | PHASE3 |
| NCT01216072 | COMPLETED | Relapsing Forms of Multiple Sclerosis |
Novartis Pharmaceuticals |
2010-08 | PHASE4 |
| NCT01310166 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Novartis Pharmaceuticals |
2011-02 | PHASE4 |
| NCT00670449 | COMPLETED | Multiple Sclerosis |
Novartis |
2008-04 | PHASE2 |
| NCT01127750 | COMPLETED | Relapsing Multiple Sclerosis |
Novartis |
2010-05 | PHASE3 |
| NCT00340834 | COMPLETED | Multiple Sclerosis |
Novartis |
2006-05 | PHASE3 |
| NCT00355134 | COMPLETED | Multiple Sclerosis |
Novartis |
2006-06 | PHASE3 |
| NCT00662649 | COMPLETED | Multiple Sclerosis |
Novartis |
2008-02 | PHASE3 |
| NCT01199861 | COMPLETED | Relapsing Multiple Sclerosis |
Novartis |
2010-08 | PHASE3 |
| NCT00333138 | COMPLETED | Multiple Sclerosis |
Novartis |
2003-05 | PHASE2 |
| NCT00537082 | COMPLETED | Multiple Sclerosis |
Novartis |
2007-09 | PHASE2 |
| NCT00289978 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Novartis |
2006-01 | PHASE3 |
| NCT00785083 | COMPLETED | Asthma |
Novartis |
2008-09 | PHASE2 |
| NCT00731523 | COMPLETED | Renal Insufficiency |
Novartis |
2008-07 | PHASE1 |
| NCT00416845 | COMPLETED | Healthy |
Novartis |
2006-10 | PHASE1 |
| NCT00239798 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2004-11 | PHASE2 |
| NCT00239811 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2004-04 | PHASE3 |
| NCT00239863 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00099749 | COMPLETED | Kidney Transplantation |
Novartis Pharmaceuticals |
2003-11 | PHASE2; PHASE3 |
| NCT00098735 | COMPLETED | Kidney Transplantation |
Novartis Pharmaceuticals |
2004-04 | PHASE3 |
| NCT00099801 | COMPLETED | Kidney Transplantation |
Novartis Pharmaceuticals |
2005-01 | PHASE3 |
| NCT00239876 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2005-05 | PHASE3 |
| NCT00099736 | COMPLETED | Kidney Transplantation |
Novartis Pharmaceuticals |
2003-05-07 | PHASE3 |
| NCT00239785 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2003-04 | PHASE3 |
| NCT00239902 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2002-05 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-03-19)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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