Odevixibat information

Odevixibat
Clinical data
Trade names	Bylvay
Other names	A4250
AHFS/Drugs.com	Monograph
MedlinePlus	a621049
License data	US DailyMed: Odevixibat;
Routes of; administration	By mouth
ATC code	A05AX05 (WHO) ;
Legal status
Legal status	CA: ℞-only; US: ℞-only; EU: Rx-only;
Identifiers
	IUPAC name (2S)-2-{[(2R)-2-[({[3,3-Dibutyl-7-(methylsulfanyl)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid;
CAS Number	501692-44-0;
PubChem CID	10153627;
IUPHAR/BPS	11194;
DrugBank	DB16261;
ChemSpider	8329135;
UNII	2W150K0UUC;
KEGG	D11716;
ChEMBL	ChEMBL4297588;
CompTox Dashboard (EPA)	DTXSID601336860 ;
Chemical and physical data
Formula	C37H48N4O8S2
Molar mass	740.93 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CCCCC1(CCCC)CN(C2=CC=CC=C2)C2=CC(SC)=C(OCC(=O)N[C@@H](C(=O)N[C@@H](CC)C(O)=O)C3=CC=C(O)C=C3)C=C2S(=O)(=O)N1;
	InChI InChI=1S/C37H48N4O8S2/c1-5-8-19-37(20-9-6-2)24-41(26-13-11-10-12-14-26)29-21-31(50-4)30(22-32(29)51(47,48)40-37)49-23-33(43)39-34(25-15-17-27(42)18-16-25)35(44)38-28(7-3)36(45)46/h10-18,21-22,28,34,40,42H,5-9,19-20,23-24H2,1-4H3,(H,38,44)(H,39,43)(H,45,46)/t28-,34+/m0/s1; Key:XULSCZPZVQIMFM-IPZQJPLYSA-N;

Odevixibat, sold under the brand name Bylvay, is a medication for the treatment of progressive familial intrahepatic cholestasis.^[5]^[8] It is taken by mouth.^[5] Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT).^[8]^[9]^[10] It was developed by Albireo Pharma.^[11]

The most common side effects include diarrhea, abdominal pain, hemorrhagic diarrhea, soft feces, and hepatomegaly (enlarged liver).^[8]

Odevixibat was approved for medical use in the United States and in the European Union in July 2021.^[5]^[6]^[7]^[12]^[13] The U.S. Food and Drug Administration considers it to be a first-in-class medication.^[14]

^ "Details for: Bylvay". Health Canada. 30 October 2023. Retrieved 3 March 2024.
^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada. 22 December 2023. Retrieved 3 January 2024.
^ "Regulatory Decision Summary for Bylvay". Drug and Health Products Portal. 23 October 2023. Retrieved 2 April 2024.
^ "Summary Basis of Decision for Bylvay". Drug and Health Products Portal. 1 September 2012. Retrieved 9 May 2024.
^ ^a ^b ^c ^d "Bylvay- odevixibat capsule, coated pellets". DailyMed. U.S. National Library of Medicine. Archived from the original on 29 July 2021. Retrieved 28 July 2021.
^ ^a ^b "Bylvay EPAR". European Medicines Agency (EMA). 20 April 2021. Archived from the original on 29 July 2021. Retrieved 28 July 2021.
^ ^a ^b "Bylvay". Union Register of medicinal products. Archived from the original on 24 July 2021. Retrieved 23 July 2021.
^ ^a ^b ^c "First treatment for rare liver disease". European Medicines Agency (EMA) (Press release). 21 May 2021. Retrieved 21 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ "Odevixibat". Albireo Pharma. Archived from the original on 22 May 2021. Retrieved 21 May 2021.
^ Karpen SJ, Kelly D, Mack C, Stein P (September 2020). "Ileal bile acid transporter inhibition as an anticholestatic therapeutic target in biliary atresia and other cholestatic disorders". Hepatology International. 14 (5): 677–689. doi:10.1007/s12072-020-10070-w. PMID 32653991. S2CID 220481607.
^ Deeks ED (October 2021). "Odevixibat: First Approval". Drugs. 81 (15): 1781–1786. doi:10.1007/s40265-021-01594-y. PMC 8550539. PMID 34499340.
^ "Odevixibat: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 September 2021. Retrieved 23 July 2021.
^ "Albireo Announces FDA Approval of Bylvay (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)". Albireo Pharma (Press release). 20 July 2021. Retrieved 23 July 2021 – via GlobeNewswire.
^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.

[1] "Details for: Bylvay". Health Canada. 30 October 2023. Retrieved 3 March 2024.

[2] "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada. 22 December 2023. Retrieved 3 January 2024.

[3] "Regulatory Decision Summary for Bylvay". Drug and Health Products Portal. 23 October 2023. Retrieved 2 April 2024.

[4] "Summary Basis of Decision for Bylvay". Drug and Health Products Portal. 1 September 2012. Retrieved 9 May 2024.

[Bylvay_FDA_label-5] "Bylvay- odevixibat capsule, coated pellets". DailyMed. U.S. National Library of Medicine. Archived from the original on 29 July 2021. Retrieved 28 July 2021.

[Bylvay_EPAR-6] "Bylvay EPAR". European Medicines Agency (EMA). 20 April 2021. Archived from the original on 29 July 2021. Retrieved 28 July 2021.

[EC_Bylvay-7] "Bylvay". Union Register of medicinal products. Archived from the original on 24 July 2021. Retrieved 23 July 2021.

[EMA_PR_20210521-8] "First treatment for rare liver disease". European Medicines Agency (EMA) (Press release). 21 May 2021. Retrieved 21 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[9] "Odevixibat". Albireo Pharma. Archived from the original on 22 May 2021. Retrieved 21 May 2021.

[Karpen_2020-10] Karpen SJ, Kelly D, Mack C, Stein P (September 2020). "Ileal bile acid transporter inhibition as an anticholestatic therapeutic target in biliary atresia and other cholestatic disorders". Hepatology International. 14 (5): 677–689. doi:10.1007/s12072-020-10070-w. PMID 32653991. S2CID 220481607.

[pmid34499340-11] Deeks ED (October 2021). "Odevixibat: First Approval". Drugs. 81 (15): 1781–1786. doi:10.1007/s40265-021-01594-y. PMC 8550539. PMID 34499340.

[12] "Odevixibat: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 September 2021. Retrieved 23 July 2021.

[Albireo_PR_20210720-13] "Albireo Announces FDA Approval of Bylvay (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)". Albireo Pharma (Press release). 20 July 2021. Retrieved 23 July 2021 – via GlobeNewswire.

[New_Drug_Therapy_Approvals_2021-14] Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.

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