Siponimod fumaric acid
Mayzent (siponimod fumaric acid) is a small molecule pharmaceutical. Siponimod fumaric acid was first approved as Mayzent on 2019-03-26. It has been approved in Europe to treat relapsing-remitting multiple sclerosis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mayzent | New Drug Application | 2024-07-23 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SIPONIMOD FUMARIC ACID, MAYZENT, NOVARTIS | |||
| 2025-03-01 | M-274 | ||
| 2024-03-26 | NCE | ||
HCPCS
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Clinical
Clinical Trials
31 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 | — | 3 | 4 | 2 | 15 | 23 |
| Sclerosis | D012598 | — | — | — | 3 | 4 | 2 | 15 | 23 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 1 | 2 | 1 | 8 | 11 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 2 | 1 | 6 | 9 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 2 | 1 | 1 | 2 | 6 |
Indications Phases 3
No data
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 fumaric acid |
| 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.CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1.O=C(O)/C=C/C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 1230487-00-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298150 |
| ChEBI ID | — |
| PubChem CID | 44599207 |
| DrugBank | DB12371 |
| UNII ID | RR6P8L282I (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Mayzent – Novartis
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,675 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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8,190 adverse events reported
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