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

A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma

Early Phase 1

Completed

Conditions: Glioblastoma
Anaplastic Astrocytoma

Interventions: Drug: Fingolimod

First Posted Date: 2015-07-07

Last Posted Date: 2017-09-13

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 5

Registration Number: NCT02490930

Locations: 🇺🇸
The Johns Hopkins University, Baltimore, Maryland, United States

Fingolimod Effect on Cytokine and Chemokine Levels

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Fingolimod 0.5 mg

First Posted Date: 2015-02-26

Last Posted Date: 2019-09-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 126

Registration Number: NCT02373098

Locations: 🇹🇷
Novartis Investigative Site, Istanbul, Turkey

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Phase 4

Terminated

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Drug: natalizumab
Drug: fingolimod

First Posted Date: 2015-01-21

Last Posted Date: 2017-06-09

Lead Sponsor: Biogen

Target Recruit Count: 111

Registration Number: NCT02342704

Locations: 🇬🇧
Research Site, Glasgow, Strathclyde, United Kingdom

Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya

Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Fingolimod
Drug: Natalizumab

First Posted Date: 2014-12-25

Last Posted Date: 2014-12-25

Lead Sponsor: University Hospital Muenster

Target Recruit Count: 15

Registration Number: NCT02325440

Locations: 🇩🇪
Universitaetsklinikum Muenster, Department of Neurology, Muenster, Germany

Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2014-09-04

Last Posted Date: 2021-02-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 6

Registration Number: NCT02232061

Locations: 🇮🇹
Novartis Investigative Site, Napoli, Italy

Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Gilenya

First Posted Date: 2014-08-26

Last Posted Date: 2018-08-22

Lead Sponsor: University of Southern California

Target Recruit Count: 125

Registration Number: NCT02225977

Locations: 🇺🇸
University of Southern California, Department of Neurology, Los Angeles, California, United States

A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

Phase 1

Completed

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Drug: MT-1303-Low
Drug: MT-1303-High
Drug: Placebo
Drug: Fingolimod

First Posted Date: 2014-07-17

Last Posted Date: 2015-02-20

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Target Recruit Count: 81

Registration Number: NCT02193217

Locations: 🇬🇧
Investigational site, Leeds, United Kingdom

Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

Completed

Conditions: Multiple Sclerosis-Relapsing-Remitting

Interventions: Drug: Gilenya

First Posted Date: 2014-05-14

Last Posted Date: 2018-11-09

Lead Sponsor: McGill University

Target Recruit Count: 135

Registration Number: NCT02137707

Locations: 🇨🇦
Dalhousie University Multiple Sclerosis Research Unit, Halifax, Nova Scotia, Canada
🇨🇦
Ottawa General Hospital, Ottawa, Ontario, Canada
🇨🇦
Montreal Neurological Institute, Montreal, Quebec, Canada

and more 3 locations