Mayzent(siponimod)
Mayzent (siponimod) is a small molecule pharmaceutical. Siponimod was first approved as Mayzent on 2019-03-26. It is used to treat relapsing-remitting multiple sclerosis in the USA. It has been approved in Europe to treat 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 sphingosine 1-phosphate receptor 4 and sphingosine 1-phosphate receptor 3.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Mayzent (discontinued: Siponimod)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mayzent | New Drug Application | 2025-08-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SIPONIMOD FUMARIC ACID, MAYZENT, NOVARTIS | |||
| 2025-03-01 | M-274 | ||
| 2024-03-26 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 1 | 2 | 1 | 9 | 12 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 2 | 1 | 1 | 2 | 6 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 3 | 4 | — | 15 | 21 |
| Sclerosis | D012598 | — | — | — | 3 | 4 | — | 14 | 20 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 2 | — | 6 | 8 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatomyositis | D003882 | EFO_0000398 | M33 | — | 2 | — | — | — | 2 |
| Polymyositis | D017285 | EFO_0003063 | M33.2 | — | 2 | — | — | — | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | 1 | — | — | — | 1 |
| Hemorrhagic stroke | D000083302 | — | — | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Siponimod |
| INN | siponimod |
| Description | Siponimod, sold under the brand name Mayzent, is a selective sphingosine-1-phosphate receptor modulator for oral use that is used for multiple sclerosis (MS). It is intended for once-daily oral administration.
|
| Classification | Small molecule |
| Drug class | immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1 |
Identifiers
| PDB | — |
| CAS-ID | 1230487-00-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2336071 |
| ChEBI ID | — |
| PubChem CID | 44599207 |
| DrugBank | DB12371 |
| UNII ID | RR6P8L282I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
S1PR3
S1PR3
Organism
Homo sapiens
Gene name
S1PR3
Gene synonyms
C9orf108, C9orf47, EDG3
NCBI Gene ID
Protein name
sphingosine 1-phosphate receptor 3
Protein synonyms
Endothelial differentiation G-protein coupled receptor 3, endothelial differentiation, sphingolipid G-protein-coupled receptor, 3, G protein-coupled receptor, endothelial differentiation gene-3, S1P receptor 3, S1P receptor Edg-3, S1P receptor EDG3, Sphingosine 1-phosphate receptor Edg-3, uncharacterized protein C9orf47
Uniprot ID
Mouse ortholog
S1pr3 (13610)
sphingosine 1-phosphate receptor 3 (Q9Z0U9)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Mayzent – Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,758 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,850 adverse events reported
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