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 | 2025-09-25 |
| fingolimod hydrochloride | ANDA | 2024-02-20 |
| gilenya | New Drug Application | 2025-08-22 |
| tascenso odt | New Drug Application | 2025-03-25 |
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
136 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 | 18 | 25 | 40 | 88 |
| Sclerosis | D012598 | — | — | — | 5 | 14 | 18 | 31 | 67 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 2 | 15 | 22 | 12 | 50 |
| Nerve degeneration | D009410 | — | — | — | — | — | 1 | — | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | 1 | — | 1 |
| Fatigue | D005221 | — | 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 |
| Thinness | D013851 | — | R63.6 | — | — | 1 | — | — | 1 |
| 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 |
| Psychology rejection | D012059 | — | — | — | — | 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 | — | N19 | 1 | 1 | — | — | — | 2 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 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 | — | 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 | — | G64 | 1 | — | — | — | — | 1 |
| Hypesthesia | D006987 | — | — | 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 | — | G31.84 | — | — | — | — | 3 | 3 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 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 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | — | — | — | 1 | 1 |
| Demyelinating diseases | D003711 | — | — | — | — | — | — | 1 | 1 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | — | — | — | 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
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
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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 17,591 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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91,199 adverse events reported
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