Odevixibat 600microgram capsules
Requires a prescription from a doctor or prescriber
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Safety monitoring data
Yellow Card reports
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Suspected adverse reactions reported for Odevixibat
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Odevixibat
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1 branded products available
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Bylvay 600microgram capsules
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(1)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & safety information
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 8 · Randomised trials: 2 · 2021–2026
Showing the 50 most relevant studies, sorted by most relevant.
Richard J Thompson, Henrik Arnell, Reha Artan, et al.
The Lancet Gastroenterology & Hepatology, 2022
- Cholestasis
- Cholestasis, Intrahepatic
- Pruritus
Nadia Ovchinsky, Madeleine Aumar, Alastair Baker, et al.
The Lancet Gastroenterology & Hepatology, 2024
- Alagille Syndrome
- Pruritus
- Methylamines
Nina Komaniecka, Sonia Maroszek, Maria Droździk, et al.
International Journal of Molecular Sciences, 2024
- Sodium-Glucose Transporter 2 Inhibitors
- Membrane Transport Proteins
- Sodium-Glucose Transporter 2
Membrane transporters interact not only with endogenous substrates but are also engaged in the transport of xenobiotics, including drugs. While the coordinated function of uptake (solute carrier family—SLC and SLCO) and efflux (ATP-binding cassette family—ABC, multidrug and toxic compound extrusion family—MATE) transporter system allows vectorial drug transport, efflux carriers alone achieve barrier functions. The modulation of transport functions was proved to be effective in the treatment strategies of various pathological states. Sodium–glucose cotransporter-2 (SGLT2) inhibitors are the drugs most widely applied in clinical practice, especially in the treatment of diabetes mellitus and heart failure. Sodium taurocholate co-transporting polypeptide (NTCP) serves as virus particles (HBV/HDV) carrier, and inhibition of its function is applied in the treatment of hepatitis B and hepatitis D by myrcludex B. Inherited cholestatic diseases, such as Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC) can be treated by odevixibat and maralixibat, which inhibit activity of apical sodium-dependent bile salt transporter (ASBT). Probenecid can be considered to increase uric acid excretion in the urine mainly via the inhibition of urate transporter 1 (URAT1), and due to pharmacokinetic interactions involving organic anion transporters 1 and 3 (OAT1 and OAT3), it modifies renal excretion of penicillins or ciprofloxacin as well as nephrotoxicity of cidofovir. This review discusses clinically approved drugs that affect membrane/drug transporter function.
Abstract licence: CC BY
S. Yi, Insook Kim, Rebecca Hager, et al.
Gastro Hep Advances, 2024
Farrah E. Flattmann, Farhan S Mohiuddin, A. Singh, et al.
Cureus, 2024
Mayur Porwal, Arvind Kumar, V. Rastogi, et al.
Current drug research reviews, 2023
Chaowapong Jarasvaraparn, Minna Rodrigo, Christopher Hartley, et al.
Expert Opinion on Pharmacotherapy, 2024
- Alagille Syndrome
- Bile Acids and Salts
- Ileum
2026
Richard J. Thompson, R. Artan, U. Baumann, et al.
JHEP Reports, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
2.36 hours
Mechanism
Progressive familiar intrahepatic cholestasis (PFIC) is a group of autosomal rec…
Food interactions
1 warning
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
7.2 mg
Half-life
7.2 mg
[L34793]
Protein binding
99%
[L34793]…
Volume of distribution
[A236808][L34793]…
Metabolism
10%
[L34793]…
Elimination
82.9%
[L34793]
The dose recovered in the feces is 97% unchanged parent compound.
[L34793]
Clearance
[A236808][L34793]…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Odevixibat was granted FDA and Health Canada approval on 20 July 2021 and 13 November 2023 respectively.[L34793][L49535]
[L46826][L49530]
It is also indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille Syndrome.
[L46826]
Odevixibat may not be effective in patients with PFIC type 2 with ABCB11 variants since these patients lack a functional bile salt export pump.
[L34793]
Known interactions with other medications. Always consult a healthcare professional.
Showing 4 of 4 interactions
[L34793]
If patients experience an overdose, initiate treatment with symptomatic and supportive measures.
The ileal sodium/bile acid cotransporter is a transport glycoprotein responsible for reabsorption of 95% of bile acids in the distal ileum.[A236808] Odevixibat is a reversible inhibitor of the ileal sodium/bile acid contransporter.[A236808][L34793] Patients taking odevixibat for a week experienced a 56% reduction in bile acid area under the curve with a 3 mg once daily dose.[A236808] A 1.5 mg daily dose lead to a 43% reduction in bile acid area under the curve.[A236808]
The decreased reabsorption of bile acids, leads to reduced stimulation of FXR, which reduces expression of FGF19, reducing binding of FGF19 to FGF4R, decreasing inhibition of bile acid synthesis.[A236808] Further synthesis of bile acids that will not be reabsorbed in the intestine contributes to lowering low density lipoprotein levels.[A236808]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L34793]
The majority of adult and pediatric patients, given a therapeutic dose, do not have detectable plasma concentrations of odevixibat.
[A236808][L34793]
[L34793]
[L34793]
Odevixibat is >99% protein bound in vitro.
[L34793]
[A236808][L34793]
Therefore, a volume of distribution has not been calculated.
[A236808][L34793]
[L34793]
The exact structure of the metabolite has not been characterized as a primary endpoint of the clinical trial was to characterize the structure of metabolites accounting for >10% of the dose in plasma, urine, or feces.
[L34798]
No metabolites have been identified at such a high concentration.
[L34793]
[L34793]
The dose recovered in the feces is 97% unchanged parent compound.
[L34793]
[A236808][L34793]
Therefore, the clearance has not been calculated.
[A236808][L34793]
Proteins and enzymes this drug interacts with in the body
PMID:7592981 PMID:9458785 PMID:9856990
Transports various bile acids, unconjugated or conjugated, such as cholate and taurocholate .
PMID:7592981 PMID:9458785 PMID:9856990
Also responsible for bile acid transport in the renal proximal tubules, a salvage mechanism that helps conserve bile acids (Probable). Works collaboratively with the Na(+)-taurocholate cotransporting polypeptide (NTCP), the organic solute transporter (OST), and the bile salt export pump (BSEP), to ensure efficacious biological recycling of bile acids during enterohepatic circulation PMID:33222321
Proteins that transport this drug across cell membranes
PMID:2897240 PMID:35970996 PMID:8898203 PMID:9038218 PMID:35507548
Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins .
PMID:8898203
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells PMID:2897240 PMID:35970996 PMID:9038218
ATC A05AX05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Odevixibat
Additional database identifiers
Drugs Product Database (DPD)
23889
ChemSpider
8329135
BindingDB
77040
HUGO Gene Nomenclature Committee (HGNC)
HGNC:10906
GeneCards
SLC10A2
GenBank Gene Database
U10417
GenBank Protein Database
595399
Guide to Pharmacology
960
UniProt Accession
NTCP2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:40
GenAtlas
ABCB1
GeneCards
ABCB1
GenBank Gene Database
M14758
GenBank Protein Database
307180
Guide to Pharmacology
768
UniProt Accession
MDR1_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q76415200), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.