MedPath

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

Overview

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.

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)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Solco Healthcare US, LLC
43547-003
ORAL
0.5 mg in 1 1
10/7/2022
Zydus Lifesciences Limited
70771-1603
ORAL
0.5 mg in 1 1
9/26/2023
Camber Pharmaceuticals, Inc.
31722-889
ORAL
0.5 mg in 1 1
12/27/2023
Skya Health, LLC
73086-300
ORAL
0.5 mg in 1 1
3/14/2024
Novartis Pharmaceuticals Corporation
0078-0607
ORAL
0.5 mg in 1 1
8/16/2019
Novartis Pharmaceuticals Corporation
0078-0965
ORAL
0.25 mg in 1 1
8/16/2019
Biocon Pharma Inc.
70377-019
ORAL
0.5 mg in 1 1
2/9/2024
Glenmark Pharmaceuticals Inc., USA
68462-166
ORAL
0.5 mg in 1 1
9/5/2023
Mylan Pharmaceuticals Inc.
0378-4525
ORAL
0.5 mg in 1 1
7/15/2021
Teva Pharmaceuticals, Inc.
0480-7820
ORAL
0.5 mg in 1 1
2/15/2024

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FINCORD CAPSULES 0.5 MG
SIN16528P
CAPSULE, GELATIN COATED
0.5 MG
6/29/2022
Gilenya Capsule 0.5mg
SIN14153P
CAPSULE
0.5mg
5/30/2012
GILENYA CAPSULE 0.25mg
SIN15761P
CAPSULE
0.25mg
8/5/2019

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Fingolimod Hydrochloride Capsules
国药准字HJ20190044
化学药品
胶囊剂
2/28/2024
Fingolimod Hydrochloride Capsules
国药准字J20190024
化学药品
胶囊剂
9/27/2019
Fingolimod Hydrochloride Capsules
H20191019
化学药品
胶囊剂
8/20/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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