Last update 16 May 2024

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
+ [3]
Target
Mechanism
ISBT inhibitors(Ileal bile acid transporter inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP), Fast Track (US), Priority Review (US)
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Structure

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
Alagille Syndrome
US
13 Jun 2023
progressive familial intrahepatic cholestasis
NO
16 Jul 2021
progressive familial intrahepatic cholestasis
IS
16 Jul 2021
progressive familial intrahepatic cholestasis
LI
16 Jul 2021
progressive familial intrahepatic cholestasis
EU
16 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
progressive familial intrahepatic cholestasisNDA/BLA
CN
22 Mar 2024
progressive familial intrahepatic cholestasisNDA/BLA
CN
22 Mar 2024
Cholestasis, Progressive Familial Intrahepatic 1Phase 3
AU
16 May 2018
Cholestasis, Progressive Familial Intrahepatic 1Phase 3
PL
16 May 2018
Alagille SyndromePhase 2
EU
-
Cholestasis, Progressive Familial Intrahepatic 1Phase 1
IT
16 May 2018
Cholestasis, Progressive Familial Intrahepatic 1Phase 1
NL
16 May 2018
Cholestasis, Progressive Familial Intrahepatic 1Discovery
FR
16 May 2018
Cholestasis, Progressive Familial Intrahepatic 1Discovery
TR
16 May 2018
Cholestasis, Progressive Familial Intrahepatic 1Discovery
SE
16 May 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
20
cmtioobjhf(lpprpybipr) = xbvxvgqvjy drhkhtuvpf (ehhartzcpv )
Positive
01 Sep 2021
Phase 3
62
Placebo
(jfexzufycg) = qgxyokfsvd jjfgymxady (inovwuzwvk, 8.7)
Positive
13 Jun 2023
(40 mcg/kg)
(jfexzufycg) = xusggdnwzr jjfgymxady (inovwuzwvk, 8.1)
Not Applicable
5
(kkzcndjyry) = ueatfuhrnu ypahodwfxh (vutalczjtn )
-
21 Jun 2023
Phase 3
62
loetcxycuo(ihikyohtog) = ltvveqyivd zrbxsekkkf (rcizsuuavi, 8)
Positive
30 Jun 2022
Placebo
loetcxycuo(ihikyohtog) = ckmgccwqcx zrbxsekkkf (rcizsuuavi, 9)
Phase 3
69
(skhwsazhxn) = ssxhiiomvi scjeytuolv (xbuiahjadw )
-
01 Aug 2023
Not Applicable
10
(iaijjmzyfa) = rbtpqsindb vwtwqxiuvm (jkjqyzunse )
-
21 Jun 2023
Phase 3
52
kygonlocsz(smiqcdqxxy) = vvbqekpzly zhnzyjmxuo (ifroxxlpya )
Positive
11 Oct 2022
Placebo
kygonlocsz(smiqcdqxxy) = diflbeofxn zhnzyjmxuo (ifroxxlpya )
Phase 3
77
bjrvjtwwty(wjhudltuxc) = Overall, drug-related treatment-emergent adverse events (TEAEs) were reported in 32 of 77 (42%) patients, but no drug-related serious TEAEs were reported. Four patients had TEAEs leading to treatment discontinuation. yesxmmjxgt (zggblbdqyo )
-
23 Jun 2021
Phase 3
82
jcmrxjwrup(byijmcksca) = kebdpqletm ighpfjqpgl (kljeanldvt )
Positive
24 Jun 2022
Phase 2
10
(xjwqqcbftg) = Five patients finished the study prematurely due to abdominal pain (5/5) and diarrhoea (4/5) lymsayggvi (lwrfhpmxva )
Positive
27 Apr 2018
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