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.

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.