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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Events Timeline
5D
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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
Trade Name
FDA
EMA
Bylvay
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pruritus | HP_0000989 | D011537 | L29 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ODEVIXIBAT, BYLVAY, IPSEN | |||
| 2030-06-13 | ODE-436 | ||
| 2028-07-20 | ODE-363 | ||
| 2026-07-20 | NCE | ||
| 2026-06-13 | I-918 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Odevixibat, Bylvay, Ipsen | |||
| 11583539 | 2041-11-12 | U-3186 | |
| 10975046 | 2039-06-20 | DP | |
| 11365182 | 2039-06-20 | U-3186, U-3187, U-3648, U-3649 | |
| 11801226 | 2039-06-20 | DP | |
| 11802115 | 2039-06-20 | DP | |
| 9694018 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
| 10011633 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
| 10093697 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
| 10487111 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
| 10981952 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
| 11732006 | 2031-11-08 | U-3186, U-3187, U-3648, U-3649 | |
HCPCS
No data
Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alagille syndrome | D016738 | EFO_0004151 | Q44.71 | 2 | — | 2 | — | — | 4 |
| Biliary atresia | D001656 | EFO_0004217 | Q44.2 | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | — | K74.3 | 2 | 1 | — | — | — | 3 |
| Cholestasis | D002779 | HP_0001396 | K83.1 | — | 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 |
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 brand name Bylvay, is a medication for the treatment of progressive familial intrahepatic cholestasis. It is taken by mouth. Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). It was developed by Albireo Pharma.
|
| 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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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