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 approval date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bylvay
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bylvay | New Drug Application | 2024-02-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Cholestasis | D002779 | HP_0001396 | K83.1 | 2 | 1 | 2 | — | 1 | 6 |
| Intrahepatic cholestasis | D002780 | — | — | 2 | — | 1 | — | 1 | 4 |
| Alagille syndrome | D016738 | EFO_0004151 | Q44.71 | 2 | — | 2 | — | — | 4 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| 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 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
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
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Additional graphs summarizing 167 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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114 adverse events reported
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