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Drug ReportsPonesimod
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 Novel Drug Approvals 2021
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
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
PONVORYVanda PharmaceuticalsN-213498 RX2021-03-18
10 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
ponvoryNew Drug Application2024-10-30
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
PONESIMOD, PONVORY, JANSSEN PHARMS
2026-03-18NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ponesimod, Ponvory, Janssen Pharms
102200232035-12-10U-3103
90620142032-05-06DS, DPU-2774
82737792025-12-17U-2774
RE437282024-11-16DS, DP
90000182024-11-16U-3102
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA50: Ponesimod
HCPCS
No data
Clinical
Clinical Trials
19 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 sclerosisD009103EFO_0003885G35—23139
SclerosisD012598———23128
Relapsing-remitting multiple sclerosisD020529EFO_0003929——2—114
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40—2———2
Graft vs host diseaseD006086—D89.81—1———1
Bronchiolitis obliterans syndromeD000092122———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
PharmacokineticsD010599——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePonesimod
INNponesimod
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 classimmunomodulators
Image (chem structure or protein)Loading
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-ID854107-55-4
RxCUI—
ChEMBL IDCHEMBL1096146
ChEBI ID—
PubChem CID11363176
DrugBankDB12016
UNII ID5G7AKV2MKP (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
No data
Financial
Revenue by drug
$
€
£
â‚£
Ponvory – Vanda Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 531 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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258 adverse events reported
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