Clinical Trials

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overall portfolio reflects diverse recruitment statuses, including completed, active not recruiting, terminated, and withdrawn trials.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)

Check the FTY720 (Fingolimod) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fingolimod functions as a sphingosine-1-phosphate receptor agonist that leads to receptor downregulation and blocks lymphocyte trafficking out of secondary lymphoid organs. By sequestering circulating lymphocytes within lymph nodes and inhibiting auto-immune neuroinflammation, this compound demonstrates clinical relevance in the management of multiple sclerosis and stroke.

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>).

Note: Technical data last updated: Sep 1, 2026.