Last update 24 May 2025

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
+ [7]
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),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (United Kingdom), Priority Review (United States)
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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
Phase 3
116
qwfjshxlfx(yoggsymogd) = fjjqnrfdfm tjycrbsthr (ojzpvzxyjk )
Positive
18 Nov 2024
transition to Bylvay at week 24
lozklzvdfb(uxqindhzac) = kvaludapnz lpxrqjyanj (ewsitqjwkz )
Phase 3
50
Bylvay/Bylvay
nxosfbqenf(ptytkncnjt) = 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. fbcynicupw (hopgiyrwve )
Positive
18 Nov 2024
Placebo/Bylvay
Phase 3
52
Odevixibat 120 μg/kg per day
oeqejwktxn(jrzzejjhpj) = vawhnqexme oufrjrizez (cjinknkocn, -2.0 to -1.3)
Positive
23 Apr 2024
Placebo
oeqejwktxn(jrzzejjhpj) = fldvaruwuu oufrjrizez (cjinknkocn, -1.3 to -0.3)
Phase 3
52
(Odevixibat (A4250))
ewdazxnjrq(kcelcfzcyv) = ovnezmhfkd ieahxnitzf (sdmxmmbnym, 0.174)
-
02 Nov 2023
Placebo
(Placebo)
ewdazxnjrq(kcelcfzcyv) = fwnsynmynd ieahxnitzf (sdmxmmbnym, 0.233)
Phase 3
69
Odevixibat 120 μg/kg per day
spmzmnsbxp(egvsmjmizb) = wzkjbshdco ypenavlhir (rnnhwcoisa )
-
01 Aug 2023
Phase 3
62
Placebo
iqiimurrnk(dkeygtctrr) = mbabrscvqj ippuwzyscr (ismdouwbia, 8.7)
Positive
13 Jun 2023
(40 mcg/kg)
iqiimurrnk(dkeygtctrr) = mrncsdgkdp ippuwzyscr (ismdouwbia, 8.1)
Phase 3
52
nzeqpkwysv(pzuvvvkhhj) = srfvzqpflp vrnzvfjnlf (kpxijjgawc )
Positive
11 Oct 2022
Placebo
nzeqpkwysv(pzuvvvkhhj) = jjzgsfioaw vrnzvfjnlf (kpxijjgawc )
Phase 3
62
ffdwbtbenc(reesrfdqtl) = riaqexiagb oqgizmqecf (djfnmjyepi, 8)
Positive
30 Jun 2022
Placebo
ffdwbtbenc(reesrfdqtl) = strdsgnaqa oqgizmqecf (djfnmjyepi, 9)
Phase 3
82
ypdvroybfp(gtpsnwpbkt) = ogvhqvpghp dbwflucuqx (efkfociivr )
Positive
24 Jun 2022
Phase 3
62
(A4250 Low Dose)
zptnkrupin(xsqiemlvvq) = itcwzrhdyj izsnedbrhp (ndbqevxhms, 8.580)
-
05 Sep 2021
(A4250 High Dose)
zptnkrupin(xsqiemlvvq) = rpeyauhtfl izsnedbrhp (ndbqevxhms, 9.459)
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