DeepMed Research

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

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Withdrawn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

Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Interferon beta - 1a (IFN)
Drug: Fingolimod
Drug: Glatiramer acetate (GA)

First Posted Date: 2012-02-16

Last Posted Date: 2014-08-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 298

Registration Number: NCT01534182

Locations: 🇷🇺
Novartis Investigative Site, Yaroslavl, Russian Federation

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

Phase 3

Terminated

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions: Drug: Fingolimod
Drug: Placebo

First Posted Date: 2011-12-26

Last Posted Date: 2014-08-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 142

Registration Number: NCT01499667

Locations: 🇨🇭
Novartis Investigative Site, Basel, Switzerland

Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Fingolimod (FTY720)

First Posted Date: 2011-12-26

Last Posted Date: 2019-01-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 347

Registration Number: NCT01498887

Locations: 🇪🇸
Novartis Investigative Site, Santa Cruz de Tenerife, Spain

Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2011-12-22

Last Posted Date: 2015-03-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 162

Registration Number: NCT01497262

Locations: 🇵🇪
Novartis Investigative Site, San Isidro, Lima, Peru

Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod
Drug: other disease-modifying therapy

First Posted Date: 2011-09-28

Last Posted Date: 2022-01-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 3076

Registration Number: NCT01442194

Locations: 🇵🇷
Novartis Investigative Site, San Juan, Puerto Rico

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