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

Efficacy and Safety of FTY720 for Acute Stroke

Phase 2

Completed

Conditions: Vascular Accident
Stroke
Cerebral Stroke
Stroke, Acute
Ischemic Cerebrovascular Accident

Interventions: Drug: Fingolimod

First Posted Date: 2013-12-05

Last Posted Date: 2018-10-17

Lead Sponsor: Tianjin Medical University General Hospital

Target Recruit Count: 22

Registration Number: NCT02002390

Locations: 🇨🇳
Tianjin Medical University General Hospital, Tianjin, Tianjin, China

Safety and Efficacy of Fingolimod in MS Patients in China

Phase 3

Withdrawn

Conditions: Multiple Sclerosis (Relapsing Remitting)

Interventions: Drug: Placebo (6mos) + open label fingolimod (6 mos)
Drug: fingolimod

First Posted Date: 2013-09-12

Last Posted Date: 2017-04-21

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01941004

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Phase 3

Active, not recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Fingolimod
Drug: Interferon beta-1a
Drug: Placebo capsule
Drug: Placebo i.m. injection

First Posted Date: 2013-07-04

Last Posted Date: 2025-05-13

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 240

Registration Number: NCT01892722

Locations: 🇺🇸
AMO Corporation, Tallahassee, Florida, United States
🇺🇸
UAB Childrens Hospital Harbor Center Neurology Dept, Birmingham, Alabama, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States

and more 9 locations

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

Gilenya in Amyotrophic Lateral Sclerosis (ALS)

Phase 2

Completed

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Gilenya
Other: Placebo

First Posted Date: 2013-02-07

Last Posted Date: 2016-07-01

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT01786174

Locations: 🇺🇸
Georgia Regents University, Augusta, Georgia, United States
🇺🇸
Methodist Neurological Institute, Houston, Texas, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 1 locations

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