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AboutPricing
Drug ReportsOdevixibat
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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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
digestive system diseasesD004066
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
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
BYLVAYIpsenN-215498 RX2021-07-20
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bylvayNew Drug Application2025-03-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pruritus—D011537L29
Agency Specific
FDA
EMA
Expiration
Code
ODEVIXIBAT, BYLVAY, IPSEN
2030-06-13ODE-436
2028-07-20ODE-363
2026-07-20NCE
2026-06-13I-918
Patent Expiration
Patent
Expires
Flag
FDA Information
Odevixibat, Bylvay, Ipsen
115835392041-11-12U-3186
109750462039-06-20DP
113651822039-06-20U-3186, U-3187, U-3648, U-3649
118012262039-06-20DP
118021152039-06-20DP
96940182031-11-08U-3186, U-3187, U-3648, U-3649
100116332031-11-08U-3186, U-3187, U-3648, U-3649
100936972031-11-08U-3186, U-3187, U-3648, U-3649
104871112031-11-08U-3186, U-3187, U-3648, U-3649
109819522031-11-08U-3186, U-3187, U-3648, U-3649
117320062031-11-08U-3186, U-3187, U-3648, U-3649
ATC Codes
A: Alimentary tract and metabolism drugs
— A05: Bile and liver therapy drugs
— A05A: Bile therapy drugs
— A05AX: Other drugs for bile therapy in atc
— A05AX05: Odevixibat
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873——————11
Rare diseasesD035583——————11
Breast feedingD001942——————11
Alagille syndromeD016738EFO_0004151Q44.71————11
Intrahepatic cholestasisD002780——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOdevixibat
INNodevixibat
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 classileal bile acid transporter (IBAT) inhibitors
Image (chem structure or protein)Loading
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-ID501692-44-0
RxCUI—
ChEMBL IDCHEMBL4297588
ChEBI ID—
PubChem CID10153627
DrugBankDB16261
UNII ID2W150K0UUC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLC10A2
SLC10A2
Organism
Homo sapiens
Gene name
SLC10A2
Gene synonyms
ASBT, ISBT, NTCP2
NCBI Gene ID
6555
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
Q13839
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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Additional graphs summarizing 226 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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215 adverse events reported
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