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Drug ReportsSiponimod
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
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
MAYZENTNovartisN-209884 RX2019-03-26
3 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
SIPONIMOD FUMARIC ACID, MAYZENT, NOVARTIS
2025-03-01M-274
2024-03-26NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Siponimod Fumaric Acid, Mayzent, Novartis
84924412030-11-30U-2511
79395192028-08-27DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA42: Siponimod
HCPCS
No data
Clinical
Clinical Trials
27 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 sclerosisD020528EFO_0003840——12136
Relapsing-remitting multiple sclerosisD020529EFO_0003929——21115
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35——2—79
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DermatomyositisD003882EFO_0000398M33—2———2
PolymyositisD017285EFO_0003063M33.2—2———2
Cerebral hemorrhageD002543———1———1
Hemorrhagic strokeD000083302———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD048550——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 nameSiponimod
INNsiponimod
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 classimmunomodulators
Image (chem structure or protein)Loading
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-ID1230487-00-9
RxCUI—
ChEMBL IDCHEMBL2336071
ChEBI ID—
PubChem CID44599207
DrugBankDB12371
UNII IDRR6P8L282I (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
$
€
£
â‚£
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 1,360 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,565 adverse events reported
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