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Gilenya(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
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Gilenya (generic drugs available since 2019-12-04)
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
Labels
FDA
EMA
Brand Name
Status
Last Update
gilenyaNew Drug Application2020-10-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
relapsing-remitting multiple sclerosisEFO_0003929D020529
Agency Specific
FDA
EMA
Expiration
Code
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE, ACCORD HLTHCARE
2023-03-20PC
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE, GLENMARK PHARMS LTD
2023-03-20PC
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE, STRIDES PHARMA
2023-03-20PC
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE, TEVA PHARMS USA
2023-03-20PC
Patent Expiration
Patent
Expires
Flag
FDA Information
Fingolimod Hydrochloride, Gilenya, Novartis
95922082032-03-30DPU-2315
105431792027-12-25U-2719
91874052027-06-25U-2613
83242832026-03-29DP
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA27: Fingolimod
HCPCS
No data
Clinical
Clinical Trials
92 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35599930
Relapsing-remitting multiple sclerosisD020529EFO_00039291715225
CognitionD003071EFO_000392511
DepressionD003863F33.911
Type 2 diabetes mellitusD003924EFO_0001360E1111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney transplantationD0160304811
Chronic inflammatory demyelinating polyradiculoneuropathyD020277EFO_1000868G61.8111
Chronic progressive multiple sclerosisD02052811
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9314
InflammationD00724933
Renal insufficiencyD051437HP_0000083N19112
Covid-19D000086382U07.111
Rett syndromeD015518F84.2111
UveitisD014605EFO_1001231H20.911
Amyotrophic lateral sclerosisD000690EFO_0000253G12.2111
SchizophreniaD012559EFO_0000692F2011
Optic neuritisD009902EFO_0007405H4611
AsthmaD001249EFO_0000270J4511
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Cerebral hemorrhageD00254311
Hypertensive intracranial hemorrhageD02029911
Hemorrhagic strokeD00008330211
Brain edemaD001929EFO_1000845G93.611
PainD010146EFO_0003843R5211
HypesthesiaD006987HP_000347411
Breast neoplasmsD001943EFO_0003869C5011
GlioblastomaD005909EFO_000051511
AstrocytomaD001254EFO_000027111
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medication adherenceD055118EFO_000634411
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)
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Identifiers
PDB
CAS-ID162359-55-9
RxCUI1012892
ChEMBL IDCHEMBL314854
ChEBI ID63115
PubChem CID107970
DrugBankDB08868
UNII ID3QN8BYN5QF (ChemIDplus, GSRS)
Target
Agency Approved
S1PR1
S1PR1
S1PR5
S1PR5
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
TRPM7
TRPM7
KCNJ5
KCNJ5
S1PR3
S1PR3
S1PR2
S1PR2
S1PR4
S1PR4
Organism
Homo sapiens
Gene name
TRPM7
Gene synonyms
CHAK1, LTRPC7
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily M member 7
Protein synonyms
Channel-kinase 1, Long transient receptor potential channel 7, LTRPC ion channel family member 7, LTrpC-7, LTrpC7, transient receptor potential-phospholipase C-interacting kinase
Uniprot ID
Mouse ortholog
Trpm7 (58800)
transient receptor potential cation channel subfamily M member 7 (Q923J1)
Variants
Clinical Variant
No data
Financial
Gilenya - Novartis
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,729 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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