Fingolimod
- Generic Name
- Fingolimod
- Brand Names
- Gilenya, Tascenso, Fingolimod Accord
- Drug Type
- Small Molecule
- Chemical Formula
- C19H33NO2
- 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
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
- 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
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
- 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.
- Conditions
- Primary Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo
- 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
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
- First Posted Date
- 2008-08-11
- Last Posted Date
- 2020-12-09
- Lead Sponsor
- Novartis
- Target Recruit Count
- 18
- Registration Number
- NCT00731523
- Locations
- 🇷🇺
Novartis Investigator Site, Moscow, Russian Federation
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
- 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
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- First Posted Date
- 2008-04-21
- Last Posted Date
- 2012-07-12
- Lead Sponsor
- Novartis
- Target Recruit Count
- 920
- Registration Number
- NCT00662649
- Locations
- 🇹🇷
Novartis Investigational Site, Yenisehir/Izmir, Turkey
🇮🇱Novaratis Investigative Site, Ashkelon, Israel
🇬🇧Novartis Investigative Site, Sheffield, United Kingdom
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
- 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
- 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
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
- First Posted Date
- 2006-07-21
- Last Posted Date
- 2012-08-07
- Lead Sponsor
- Novartis
- Target Recruit Count
- 1083
- Registration Number
- NCT00355134
- Locations
- 🇺🇸
University of Pennsylvania, Department of Neurology, Philadelphia, Pennsylvania, United States
🇺🇸Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸Ohio State University, Columbus, Ohio, United States
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
- Conditions
- Multiple Sclerosis
- Interventions
- First Posted Date
- 2006-06-21
- Last Posted Date
- 2017-09-21
- Lead Sponsor
- Novartis
- Target Recruit Count
- 1292
- Registration Number
- NCT00340834
- Locations
- 🇺🇸
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300, Danbury, Connecticut, United States
🇺🇸AMO Corporation, Tallahassee, Florida, United States
🇺🇸Neurological Associates, Pompano Beach, Florida, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.