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

Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

Phase 4

Terminated

Conditions: Depression
Relapsing-remitting Multiple Sclerosis

Interventions: Drug: Fluoxetine
Drug: Venlafaxine
Drug: Citalopram
Drug: Fingolimod

First Posted Date: 2011-09-20

Last Posted Date: 2014-09-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 54

Registration Number: NCT01436643

Locations: 🇩🇪
Novartis Investigative Site, Zwickau, Germany

Fingolimod -Response According to Coping - Evaluation

Phase 4

Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Drug: fingolimod

First Posted Date: 2011-08-19

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 189

Registration Number: NCT01420055

Locations: 🇫🇷
Novartis Investigative Site, Tours Cedex, France

Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod
Drug: Interferon beta 1b

First Posted Date: 2011-04-12

Last Posted Date: 2017-03-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 151

Registration Number: NCT01333501

Locations: 🇮🇹
Novartis Investigative Site, Napoli, Italy

Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Standard MS DMT
Drug: Fingolimod

First Posted Date: 2011-03-16

Last Posted Date: 2015-06-22

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 61

Registration Number: NCT01317004

Locations: 🇮🇹
Novartis Investigative Site, Novara, Italy

Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Phase 4

Completed

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2011-03-08

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 447

Registration Number: NCT01310166

Locations: 🇩🇪
Novartis Investigative Site, Wolfenbüttel, Germany

The Gilenya Pregnancy Registry

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2011-01-28

Last Posted Date: 2025-01-22

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 312

Registration Number: NCT01285479

Locations: 🇬🇧
Novartis Investigative Site, Nottingham, United Kingdom

Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: fingolimod

First Posted Date: 2011-01-24

Last Posted Date: 2012-09-06

Lead Sponsor: Novartis

Target Recruit Count: 64

Registration Number: NCT01281657

Locations: 🇺🇸
Caritas St. Elizabeth's Hospital, Boston, Massachusetts, United States
🇺🇸
Swedish Neuroscience Institute, Seattle, Washington, United States
🇺🇸
University of Miami, Miami, Florida, United States

and more 40 locations