Etrasimod
Velsipity (etrasimod) is a small molecule pharmaceutical. Etrasimod was first approved as Velsipity on 2023-10-12. It is used to treat ulcerative colitis in the USA. The pharmaceutical is active against sphingosine 1-phosphate receptor 1. In addition, it is known to target sphingosine 1-phosphate receptor 4 and sphingosine 1-phosphate receptor 5.
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Start date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| velsipity | New Drug Application | 2025-08-18 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ETRASIMOD ARGININE, VELSIPITY, PFIZER | |||
| 2028-10-12 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 3 | 2 | — | 4 | 9 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 4 | 2 | — | 3 | 9 |
| Ulcer | D014456 | MPATH_579 | — | — | 3 | 2 | — | 2 | 7 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | 1 | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | — | — | 1 |
| Eczema | D004485 | — | L30.9 | — | 1 | 1 | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | — | — | — | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 1 | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 1 | — | — | — | 1 |
| Alopecia | D000505 | — | L64 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Etrasimod |
| INN | etrasimod |
| Description | Etrasimod is an organic heterotricyclic compound that is 1,2,3,4-tetrahydrocyclopenta[b]indole substituted by carboxymethyl and [4-cyclopentyl-3-(trifluoromethyl)phenyl]methoxy groups at positions 3R and 7, respectively. It is a potent and functional antagonist of the sphingosine-1-phosphate-1 (S1P1) receptor (IC50 = 1.88 nM in CHO cells). It has a role as an antibacterial agent, a sphingosine-1-phosphate receptor 1 antagonist, an immunosuppressive agent and an anti-inflammatory drug. It is a member of (trifluoromethyl)benzenes, a member of cyclopentanes, an aromatic ether, a monocarboxylic acid and an organic heterotricyclic compound. It is a conjugate acid of an etrasimod(1-). |
| Classification | Small molecule |
| Drug class | immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)C[C@H]1CCc2c1[nH]c1ccc(OCc3ccc(C4CCCC4)c(C(F)(F)F)c3)cc21 |
Identifiers
| PDB | — |
| CAS-ID | 1206123-37-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3358920 |
| ChEBI ID | — |
| PubChem CID | 44623998 |
| DrugBank | DB14766 |
| UNII ID | 6WH8495MMH (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
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 444 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,224 adverse events reported
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