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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
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
Fingolimod lauryl sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TASCENSO ODT | Cycle Pharmaceuticals | N-214962 RX | 2021-12-23 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fingolimod | ANDA | 2024-11-30 |
| fingolimod hydrochloride | ANDA | 2024-02-20 |
| gilenya | New Drug Application | 2024-07-22 |
| tascenso odt | New Drug Application | 2024-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
No data
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 sclerosis | D009103 | EFO_0003885 | G35 | 1 | 6 | 20 | 30 | 40 | 95 |
| Sclerosis | D012598 | — | — | — | 6 | 19 | 30 | 35 | 89 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 1 | 15 | 22 | 12 | 50 |
| Nerve degeneration | D009410 | HP_0002180 | — | — | — | — | 1 | — | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | 1 | — | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 1 | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | 1 | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 1 | — | 1 |
| Neurobehavioral manifestations | D019954 | EFO_0004364 | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | 4 | 8 | — | — | 11 |
| Neuritis | D009443 | — | — | — | 2 | 1 | — | — | 2 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | — | 2 | 1 | — | — | 2 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | — | 1 | — | — | 1 |
| Polyradiculoneuropathy | D011129 | EFO_1001116 | — | — | — | 1 | — | — | 1 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 4 | — | — | 1 | 5 |
| Ischemic stroke | D000083242 | — | — | — | 4 | — | — | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 3 | — | — | — | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 1 | — | — | — | 2 |
| Cerebral hemorrhage | D002543 | — | — | 2 | 1 | — | — | — | 2 |
| Atrophy | D001284 | — | — | — | 1 | — | — | 1 | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | — | — | — | 2 |
| Covid-19 | D000086382 | — | — | — | 1 | — | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | — | — | — | 1 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 2 | 6 |
| Hypertensive intracranial hemorrhage | D020299 | — | — | 1 | — | — | — | — | 1 |
| Hemorrhagic stroke | D000083302 | — | — | 1 | — | — | — | — | 1 |
| Edema | D004487 | HP_0000969 | R60.9 | 1 | — | — | — | — | 1 |
| Brain edema | D001929 | EFO_1000845 | G93.6 | 1 | — | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | — | 1 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | 1 | — | — | — | — | 1 |
| Hypesthesia | D006987 | HP_0003474 | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 3 | 3 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Leukoencephalopathies | D056784 | HP_0002352 | — | — | — | — | — | 1 | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | — | — | — | 1 | 1 |
| Cognition disorders | D003072 | — | — | — | — | — | — | 1 | 1 |
| Neurocognitive disorders | D019965 | — | F09 | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Demyelinating diseases | D003711 | — | — | — | — | — | — | 1 | 1 |
| Basal cell carcinoma | D002280 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fingolimod |
| INN | fingolimod |
| 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 class | immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 162359-55-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL314854 |
| ChEBI ID | 63115 |
| PubChem CID | 107970 |
| DrugBank | DB08868 |
| UNII ID | 3QN8BYN5QF (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 (Q9JLQ1)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Gilenya – Novartis
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,224 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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89,762 adverse events reported
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