Ponvory(ponesimod)
Ponvory (ponesimod) is a small molecule pharmaceutical. Ponesimod was first approved as Ponvory on 2021-03-18. 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
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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
Ponvory
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ponesimod
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PONVORY | Vanda Pharmaceuticals | N-213498 RX | 2021-03-18 | 10 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ponvory | New Drug Application | 2025-04-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PONESIMOD, PONVORY, JANSSEN PHARMS | |||
| 2026-03-18 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 2 | — | 1 | 1 | 4 |
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 | 3 | — | 2 | 8 |
| Sclerosis | D012598 | — | — | — | 2 | 3 | — | — | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 2 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ponesimod |
| INN | ponesimod |
| Description | Ponesimod, sold under the brand name Ponvory, is a medication for the treatment of multiple sclerosis. It is a sphingosine-1-phosphate receptor modulator.
|
| Classification | Small molecule |
| Drug class | immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC/N=C1\S/C(=C\c2ccc(OC[C@H](O)CO)c(Cl)c2)C(=O)N1c1ccccc1C |
Identifiers
| PDB | — |
| CAS-ID | 854107-55-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1096146 |
| ChEBI ID | — |
| PubChem CID | 11363176 |
| DrugBank | DB12016 |
| UNII ID | 5G7AKV2MKP (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
$
€
£
â‚£
Ponvory – Vanda Pharmaceuticals
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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 673 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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309 adverse events reported
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