Fingolimod

Generic Name: Fingolimod

Brand Names: Gilenya, Tascenso, Fingolimod Accord

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₃₃NO_₂

CAS Number: 162359-55-9

Unique Ingredient Identifier: 3QN8BYN5QF

Background: Multiple sclerosis, or MS, is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects. Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis. It was developed by Novartis and initially approved by the FDA in 2010. Fingolimod was also studied for the treatment of COVID-19, the disease caused by infection with the SARS-CoV-2 virus.

Indication: Fingolimod is indicated for the treatment of patients aged 10 and above with relapsing forms of multiple sclerosis, which may include clinically isolated syndrome, relapsing-remitting disease, as well as active secondary progressive disease.

Associated Conditions: Relapsing Multiple Sclerosis (RMS)

Associated Therapies: Alternative Treatment

Clinical Trials

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Completed

Conditions: Multiple Sclerosis
Skin Cancer
Skin Cancer Melanoma
Skin Cancers - Basal Cell Carcinoma
Skin Cancer, Squamous Cell
Multiple Sclerosis (MS) - Relapsing-remitting

Interventions: Drug: Fingolimod
Drug: Natalizumab
Drug: Dimethyl fumarate (DMF)
Drug: Alemtuzumab
Drug: Teriflunomide

First Posted Date: 2024-11-26

Last Posted Date: 2024-11-26

Lead Sponsor: University of British Columbia

Target Recruit Count: 4000

Registration Number: NCT06705608

Phase 2 Study of Fingolimod in Lung Cancers

Phase 2

Not yet recruiting

Conditions: Small-cell Lung Cancer
Non Small Cell Lung Cancer

Interventions: Drug: Fingolimod 0.5 milligram (mg) [Gilenya]

First Posted Date: 2024-05-21

Last Posted Date: 2025-04-23

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 38

Registration Number: NCT06424067

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Phase 3

Recruiting

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Drug: Fingolimod
Drug: Ozanimod
Other: Placebo

First Posted Date: 2024-05-10

Last Posted Date: 2025-05-04

Lead Sponsor: Celgene

Target Recruit Count: 194

Registration Number: NCT06408259

Locations: 🇺🇸
Local Institution - 0110, Phoenix, Arizona, United States
🇺🇸
Local Institution - 0114, Loma Linda, California, United States
🇺🇸
Local Institution - 0053, Tampa, Florida, United States

and more 28 locations

Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

Phase 1

Not yet recruiting

Conditions: Intracerebral Hemorrhage

Interventions: Drug: Fingolimod

First Posted Date: 2023-10-18

Last Posted Date: 2023-10-18

Lead Sponsor: Tang-Du Hospital

Target Recruit Count: 40

Registration Number: NCT06087965

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Recruiting

Conditions: Multiple Sclerosis

Interventions: Biological: Alemtuzumab
Drug: Diroximel Fumarate
Drug: Fingolimod
Drug: Glatiramer acetate
Biological: Interferon beta
Biological: Natalizumab
Biological: Ocrelizumab
Biological: Ofatumumab
Drug: Ozanimod
Biological: Peginterferon beta-1a
Drug: Ponesimod
Drug: Siponimod

First Posted Date: 2023-01-18

Last Posted Date: 2025-01-30

Lead Sponsor: Biogen

Target Recruit Count: 1178

Registration Number: NCT05688436

Locations: 🇺🇸
OptumInsight, Eden Prairie, Minnesota, United States

Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt

Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

First Posted Date: 2022-06-21

Last Posted Date: 2024-08-23

Lead Sponsor: Hikma Pharmaceuticals LLC

Target Recruit Count: 30

Registration Number: NCT05423769

Locations: 🇪🇬
Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital, Alexandria, Egypt
🇪🇬
Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC), Cairo, Egypt

Fingolimod for Type 2 Diabetes Mellitus

Phase 4

Recruiting

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Fingolimod
Drug: guideline-based treatment for DM

First Posted Date: 2022-04-01

Last Posted Date: 2024-07-30

Lead Sponsor: General Hospital of Shenyang Military Region

Target Recruit Count: 40

Registration Number: NCT05307731

Locations: 🇨🇳
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China

Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

Phase 2

Conditions: Interstitial Fibrosis
Kidney Transplant; Complications
Kidney Transplant Failure and Rejection
Kidney Transplant Failure
Kidney Transplant Rejection
Kidney Failure, Chronic
Graft Rejection