Last update 19 Oct 2026

Odevixibat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-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, Odevixibat (USAN), Odevixibat sesquihydrate
+ [8]
Target
Action
inhibitors
Mechanism
ISBT inhibitors(Ileal bile acid transporter inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (16 Jul 2021),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (United Kingdom)
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Structure/Sequence

Molecular FormulaC37H48N4O8S2
InChIKeyXULSCZPZVQIMFM-IPZQJPLYSA-N
CAS Registry501692-44-0

External Link

KEGGWikiATCDrug Bank
D11716--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cholestatic pruritus
European Union
19 Sep 2024
Cholestatic pruritus
Iceland
19 Sep 2024
Cholestatic pruritus
Liechtenstein
19 Sep 2024
Cholestatic pruritus
Norway
19 Sep 2024
Pruritus
South Korea
23 Aug 2024
Alagille Syndrome
United States
13 Jun 2023
progressive familial intrahepatic cholestasis
European Union
16 Jul 2021
progressive familial intrahepatic cholestasis
Iceland
16 Jul 2021
progressive familial intrahepatic cholestasis
Liechtenstein
16 Jul 2021
progressive familial intrahepatic cholestasis
Norway
16 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Biliary AtresiaPhase 3
United States
08 Jul 2020
Biliary AtresiaPhase 3
China
08 Jul 2020
Biliary AtresiaPhase 3
Australia
08 Jul 2020
Biliary AtresiaPhase 3
Belgium
08 Jul 2020
Biliary AtresiaPhase 3
Canada
08 Jul 2020
Biliary AtresiaPhase 3
France
08 Jul 2020
Biliary AtresiaPhase 3
Germany
08 Jul 2020
Biliary AtresiaPhase 3
Hungary
08 Jul 2020
Biliary AtresiaPhase 3
Israel
08 Jul 2020
Biliary AtresiaPhase 3
Italy
08 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
24
(Classic types)
vqtavmmcwu(gnzyprtndt) = dfnnopqooe vobhzehawz (gmrkrlwrxj )
Positive
07 Nov 2025
(Rarer forms)
vqtavmmcwu(gnzyprtndt) = wuwwnfufdg vobhzehawz (gmrkrlwrxj )
Phase 3
7
dutyrexlso(zgutusclgt) = inrpdgbymi qkmfdhuhuu (jvrzwelamx )
Positive
07 Nov 2025
Phase 3
40
ubnyhwkuyk(ltcgpdrjgp) = dixiwrvbsl wzcgbmvgit (kwokdvqdiq, 41.58)
Positive
07 Nov 2025
(sBA ≤102 μmol/L at Week 24)
vspkgsqcwc(aopxunwusm) = kxoecscobq rtnhyuapzf (vedpwzqlhz )
Phase 3
254
mysubbcowh(bihhvgtfat) = lffsisqpst wkwgncewai (ieiooudqrf )
Positive
07 Nov 2025
wfkiwjocef(bamasfjjjb) = busfkoozci vxjoczmcrm (hfngpmuygr )
Phase 3
116
Placebo+Odevixibat
(Cohort 1: Placebo/Odevixibat)
wczlhdgaif(jnrhaidetq) = jpifjqruvm mrxoqtwihl (jzuqlvyxte, 38.733)
-
10 Jul 2025
(Cohort 1: Odevixibat/Odevixibat)
wczlhdgaif(jnrhaidetq) = ocxucgxuby mrxoqtwihl (jzuqlvyxte, 34.877)
Phase 3
116
mnuwxbqwve(qeokmshqhm) = ebzlexkpym yrdhjfdvfb (rodkhpxaaz )
Positive
18 Nov 2024
transition to Bylvay at week 24
hqqlbbseaj(mmigrntumi) = mtfxbxifal plhuuvzljb (afpmjnintj )
Phase 3
50
Bylvay/Bylvay
efjdyjairn(ghuyhqkffs) = At week 72, 93 percent (n=28/30) of patients who received Bylvay throughout the 24 weeks ASSERT trial and 77 percent (n=10/13) of those who transitioned from placebo to Bylvay at week 24 experienced a clinically meaningful ≥1 point reduction in pruritus score. kfffpznxkw (ikvaxgfaum )
Positive
18 Nov 2024
Placebo/Bylvay
Phase 3
50
priwagnnbe(yrcbthdnev) = laqmchpvvy bjqutsgeji (pdyaxufgmn )
Positive
15 Nov 2024
(Placebo in ASSERT and switched to odevixibat in ASSERT-EXT)
ljcvpgsrlf(pucuoxzvib) = oeflpwhuin baikxudykj (ovueskgaby )
Phase 1
-
25
Odevixibat+oral contraceptive
kvwpufiztn(jylrkegbym) = The most common treatment-emergent adverse events (TEAEs) were the gastrointestinal disorders diarrhea (in 10/25 participants; 40%) and nausea (in 5/25 participants; 20%); all TEAEs were mild in intensity and resolved by the end of the study. euffowvwab (ysajsbyrac )
Positive
15 Nov 2024
Oral contraceptive
Phase 2
62
kxeklvtcls(cylazfxsic) = aroggntqma npjytnckjo (tiukmdqets )
Positive
15 Nov 2024
Placebo
kxeklvtcls(cylazfxsic) = yosrredsvx npjytnckjo (tiukmdqets )
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