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

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

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

Phase 4

Completed

Conditions: Relapsing Forms of Multiple Sclerosis

Interventions: Drug: Fingolimod
Drug: Standard MS DMTs

First Posted Date: 2010-10-07

Last Posted Date: 2014-02-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 1053

Registration Number: NCT01216072

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

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Phase 3

Completed

Conditions: Relapsing Forms of Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2010-09-14

Last Posted Date: 2021-04-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 4125

Registration Number: NCT01201356

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

Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)

Phase 3

Completed

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Fingolimod
Biological: Seasonal influenza vaccine
Biological: Tetanus toxoid vaccine

First Posted Date: 2010-09-13

Last Posted Date: 2012-06-19

Lead Sponsor: Novartis

Target Recruit Count: 138

Registration Number: NCT01199861

Locations: 🇨🇭
Novartis Investigational Site, Basel, Switzerland
🇬🇧
Novartis Investigative Site, Stoke-on-Trent, United Kingdom

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Phase 3

Completed

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: FTY720

First Posted Date: 2010-05-21

Last Posted Date: 2017-02-23

Lead Sponsor: Novartis

Target Recruit Count: 2417

Registration Number: NCT01127750

Locations: 🇩🇪
Neuroscience Research of the Berkshires, Krefeld, Germany
🇬🇧
Novartis Investigational Site, Truro, United Kingdom
🇩🇪
Novarris Investigative Site, Berlin, Germany

and more 3 locations

A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: Placebo
Drug: FTY720

First Posted Date: 2008-11-05

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis

Target Recruit Count: 36

Registration Number: NCT00785083

Locations: 🇬🇧
Novartis Investigator Site, Manchester, United Kingdom

This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.

Phase 3

Terminated

Conditions: Primary Progressive Multiple Sclerosis

Interventions: Drug: Placebo
Drug: FTY720

First Posted Date: 2008-08-11

Last Posted Date: 2017-06-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 970

Registration Number: NCT00731692

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

An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

Phase 2

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod

First Posted Date: 2008-05-01

Last Posted Date: 2013-09-04

Lead Sponsor: Novartis

Target Recruit Count: 143

Registration Number: NCT00670449

Locations: 🇯🇵
Novartis Investigative Site, Wakayama, Japan

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

Phase 2

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: FTY720
Drug: Placebo

First Posted Date: 2007-09-28

Last Posted Date: 2011-04-21

Lead Sponsor: Novartis

Target Recruit Count: 171

Registration Number: NCT00537082

Locations: 🇯🇵
Novartis, Iwate, Japan
🇯🇵
Novartis Investigative Site, Wakayama, Japan
🇯🇵
Novartis Investigative site, Sapporo-shi, Hokkaido, Japan

Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

First Posted Date: 2006-12-28

Last Posted Date: 2010-06-04

Lead Sponsor: Novartis

Target Recruit Count: 39

Registration Number: NCT00416845

Locations: 🇺🇸
Novartis Investigative Site, East Hanover, New Jersey, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy