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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Novartis Pharmaceuticals
FDA Novel Drug Approvals 2019
Commercial
Trade Name
FDA
EMA
Mayzent
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Siponimod fumaric acid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MAYZENT | Novartis | N-209884 RX | 2019-03-26 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mayzent | New Drug Application | 2021-01-23 |
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
20 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 | — | — | 1 | 2 | 2 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 2 | — | 4 | 6 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 2 | 1 | — | — | 3 |
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 |
| Cerebral hemorrhage | D002543 | — | 1 | — | — | — | 1 | ||
| Hemorrhagic stroke | D000083302 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 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
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
S1PR4
S1PR4
S1PR3
S1PR3
Organism
Homo sapiens
Gene name
S1PR4
Gene synonyms
EDG6
NCBI Gene ID
Protein name
sphingosine 1-phosphate receptor 4
Protein synonyms
Endothelial differentiation G-protein coupled receptor 6, endothelial differentiation, lysophosphatidic acid G-protein-coupled receptor, 6, S1P receptor 4, S1P receptor Edg-6, Sphingosine 1-phosphate receptor Edg-6
Uniprot ID
Mouse ortholog
S1pr4 (13611)
sphingosine 1-phosphate receptor 4 (Q9Z0L1)
Variants
Clinical Variant
No data
Financial
Mayzent - Novartis
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,053 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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36 adverse events reported
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