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 a...

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

Study of FTY720 in Patients With Uveitis

Phase 2

Withdrawn

Conditions: Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Interventions: Drug: FTY720
Drug: Oral Corticosteroid

First Posted Date: 2013-02-13

Last Posted Date: 2017-04-20

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01791192

Fingolimod in Schizophrenia Patients

Phase 2

Completed

Conditions: Schizophrenia

Interventions: Drug: placebo
Drug: Fingolimod

First Posted Date: 2013-01-30

Last Posted Date: 2019-04-16

Lead Sponsor: Indiana University

Target Recruit Count: 40

Registration Number: NCT01779700

Locations: 🇺🇸
Prevention and Recovery Center, Indianapolis, Indiana, United States
🇺🇸
Center for NeuroImaging, Indianapolis, Indiana, United States
🇺🇸
Larue D Carter Memorial Hospital, Indianapolis, Indiana, United States

Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis

Phase 4

Terminated

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2012-12-24

Last Posted Date: 2016-06-09

Lead Sponsor: Heinrich-Heine University, Duesseldorf

Target Recruit Count: 8

Registration Number: NCT01755871

Locations: 🇩🇪
Heinrich Heine Universität Düsseldorf, Düsseldorf, Nord-Rhein Westfahlen, Germany

A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis RRMS

Interventions: Drug: Fingolimod

First Posted Date: 2012-10-12

Last Posted Date: 2020-03-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 87

Registration Number: NCT01705236

Locations: 🇨🇭
Novartis Investigative Site, Zuerich, Switzerland

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Phase 3

Terminated

Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions: Drug: glatiramer acetate
Drug: fingolimod

First Posted Date: 2012-07-04

Last Posted Date: 2019-05-28

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 1064

Registration Number: NCT01633112

Locations: 🇵🇷
Novartis Investigative Site, Guaynabo, Puerto Rico

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Phase 3

Completed

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions: Drug: Placebo Comparator
Drug: Fingolimod

First Posted Date: 2012-06-21

Last Posted Date: 2017-10-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 106

Registration Number: NCT01625182

Locations: 🇬🇧
Novartis Investigative Site, Newcastle Upon Tyne, United Kingdom

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Disease Modifying therapy
Drug: Fingolimod

First Posted Date: 2012-06-20

Last Posted Date: 2021-01-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 881

Registration Number: NCT01623596

Locations: 🇵🇷
Novartis Investigative Site, Guaynabo, Puerto Rico

ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Phase 4

Withdrawn

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2012-06-18

Last Posted Date: 2017-04-20

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01621269

STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: FTY720

First Posted Date: 2012-04-25

Last Posted Date: 2019-09-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 6998

Registration Number: NCT01585298

Locations: 🇩🇪
Novartis Investigative Site, Öhringen, Germany

A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720

Phase 4

Completed

Conditions: Relapsing-Remitting
Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2012-04-16

Last Posted Date: 2016-06-07

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 42

Registration Number: NCT01578330

Locations: 🇹🇷
Novartis Investigative Site, Uskudar / Istanbul, Turkey

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