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Drug ReportsFingolimod
Gilenya(fingolimod)
Fingolimod, Gilenya (fingolimod) is a small molecule pharmaceutical. Fingolimod was first approved as Gilenya on 2010-09-21. It is used to treat relapsing-remitting multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis and relapsing-remitting multiple sclerosis. The pharmaceutical is active against sphingosine 1-phosphate receptor 1 and sphingosine 1-phosphate receptor 5. In addition, it is known to target transient receptor potential cation channel subfamily M member 7, G protein-activated inward rectifier potassium channel 4, sphingosine 1-phosphate receptor 3, sphingosine 1-phosphate receptor 2, and sphingosine 1-phosphate receptor 4.
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Novartis Pharmaceuticals
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Fingolimod, Gilenya, Tascenso (discontinued: Fingolimod)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fingolimod hydrochloride
Tradename
Company
Number
Date
Products
GILENYANovartisN-022527 RX2010-09-21
2 products, RLD, RS
Fingolimod lauryl sulfate
Tradename
Company
Number
Date
Products
TASCENSO ODTCycle PharmaceuticalsN-214962 RX2021-12-23
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
fingolimodANDA2025-03-01
fingolimod hydrochlorideANDA2024-02-20
gilenyaNew Drug Application2024-07-22
tascenso odtNew Drug Application2025-03-25
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Fingolimod Hydrochloride, Gilenya, Novartis
95922082032-03-30DPU-2315
105431792027-12-25U-2719
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA27: Fingolimod
HCPCS
No data
Clinical
Clinical Trials
134 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35—316241457
SclerosisD012598———316241255
Relapsing-remitting multiple sclerosisD020529EFO_0003929———1218333
Nerve degenerationD009410—————1—1
CognitionD003071EFO_0003925————1—1
FatigueD005221—R53.83———1—1
DepressionD003863—F33.9———1—1
Depressive disorderD003866EFO_1002014F32.A———1—1
Neurobehavioral manifestationsD019954EFO_0004364————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney transplantationD016030———38——10
Chronic inflammatory demyelinating polyradiculoneuropathyD020277EFO_1000868G61.81——1——1
PolyradiculoneuropathyD011129EFO_1001116———1——1
Chronic progressive multiple sclerosisD020528EFO_0003840———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rett syndromeD015518Orphanet_778F84.211———1
SyndromeD013577——11———1
UveitisD014605EFO_1001231H20.9—1———1
PanuveitisD015864EFO_1001082H44.11—1———1
NeuritisD009443———1———1
Optic neuritisD009902EFO_0007405H46—1———1
AsthmaD001249EFO_0000270J45—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1———12
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825—G31.84————22
Cognition disordersD003072——————11
Neurocognitive disordersD019965—F09————11
Disease progressionD018450——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFingolimod
INNfingolimod
Description
Fingolimod is an aminodiol that consists of propane-1,3-diol having amino and 2-(4-octylphenyl)ethyl substituents at the 2-position. It is a sphingosine 1-phosphate receptor modulator used for the treatment of relapsing-remitting multiple sclerosis. A prodrug, fingolimod is phosphorylated by sphingosine kinase to active metabolite fingolimod-phosphate, a structural analogue of sphingosine 1-phosphate. It has a role as an immunosuppressive agent, a prodrug, an antineoplastic agent, a sphingosine-1-phosphate receptor agonist and a CB1 receptor antagonist. It is an aminodiol and a primary amino compound. It is a conjugate base of a fingolimod(1+).
Classification
Small molecule
Drug classimmunomodulators
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Identifiers
PDB—
CAS-ID162359-55-9
RxCUI—
ChEMBL IDCHEMBL314854
ChEBI ID63115
PubChem CID107970
DrugBankDB08868
UNII ID3QN8BYN5QF (ChemIDplus, GSRS)
Target
Agency Approved
S1PR1
S1PR1
Organism
Homo sapiens
Gene name
S1PR1
Gene synonyms
CHEDG1, EDG1
NCBI Gene ID
Protein name
sphingosine 1-phosphate receptor 1
Protein synonyms
CD363, Endothelial differentiation G-protein coupled receptor 1, endothelial differentiation, sphingolipid G-protein-coupled receptor, 1, S1P receptor 1, S1P receptor Edg-1, Sphingosine 1-phosphate receptor Edg-1, sphingosine 1-phosphate receptor EDG1
Uniprot ID
Mouse ortholog
S1pr1 (13609)
sphingosine 1-phosphate receptor 1 (Q9R235)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Gilenya – Novartis
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,587 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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89,693 adverse events reported
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