Bylvay(odevixibat)
Bylvay (odevixibat) is a small molecule pharmaceutical. Odevixibat was first approved as Bylvay on 2021-07-16. It is used to treat pruritus in the USA. It has been approved in Europe to treat intrahepatic cholestasis. It is known to target ileal sodium/bile acid cotransporter.
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FDA Novel Drug Approvals 2021
Commercial
Trade Name
FDA
EMA
Bylvay
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Odevixibat
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BYLVAY | Albireo Pharma | N-215498 RX | 2021-07-20 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bylvay | New Drug Application | 2021-07-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pruritus | HP_0000989 | D011537 | L29 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ODEVIXIBAT, BYLVAY, ALBIREO | |||
| 2028-07-20 | ODE-363 | ||
| 2026-07-20 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Mock data
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Alagille syndrome | D016738 | Q44.7 | 2 | — | 2 | — | — | 4 | |
| Biliary atresia | D001656 | EFO_0004217 | Q44.2 | — | — | 2 | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 name | ODEVIXIBAT |
| INN | odevixibat |
| Description | Odevixibat, sold under the trade name Bylvay. It was developed by Albireo Pharma. It is a medication for the treatment of various cholestatic diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome.
|
| Classification | Small molecule |
| Drug class | ileal bile acid transporter (IBAT) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)N[C@@H](CC)C(=O)O)c3ccc(O)cc3)cc2S(=O)(=O)N1 |
Identifiers
| PDB | — |
| CAS-ID | 501692-44-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297588 |
| ChEBI ID | — |
| PubChem CID | 10153627 |
| DrugBank | DB16261 |
| UNII ID | 2W150K0UUC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLC10A2
SLC10A2
Organism
Homo sapiens
Gene name
SLC10A2
Gene synonyms
ASBT, ISBT, NTCP2
NCBI Gene ID
Protein name
ileal sodium/bile acid cotransporter
Protein synonyms
Apical sodium-dependent bile acid transporter, ASBT, IBAT, ileal apical sodium-dependent bile acid transporter, ileal bile acid transporter, Ileal Na(+)/bile acid cotransporter, Ileal sodium-dependent bile acid transporter, ISBT, Na(+)-dependent ileal bile acid transporter, Na+/taurocholate cotransporting polypeptide 2, Sodium/taurocholate cotransporting polypeptide, ileal, solute carrier family 10 (sodium/bile acid cotransporter family), member 2, solute carrier family 10 (sodium/bile acid cotransporter), member 2, Solute carrier family 10 member 2
Uniprot ID
Mouse ortholog
Slc10a2 (20494)
ileal sodium/bile acid cotransporter (Q925U7)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 71 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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