Last update 16 May 2024

Maralixibat Chloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Lopixibat, Lopixibat chloride, Lum-001 cation
+ [12]
Target
Mechanism
ISBT inhibitors(Ileal bile acid transporter inhibitors)
Drug Highest PhaseApproved
First Approval Date
US (29 Sep 2021),
RegulationOrphan Drug (TW), Breakthrough Therapy (US), Priority Review (CN)
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Structure

Molecular FormulaC40H56N3O4S
InChIKeySTPKWKPURVSAJF-LJEWAXOPSA-N
CAS Registry716313-53-0

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Alagille Syndrome
NO
09 Dec 2022
Alagille Syndrome
IS
09 Dec 2022
Alagille Syndrome
EU
09 Dec 2022
Alagille Syndrome
LI
09 Dec 2022
Cholestatic pruritus
US
29 Sep 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
progressive familial intrahepatic cholestasisNDA/BLA
US
14 Feb 2023
Alagille SyndromePhase 3
JP
16 Jan 2023
Cholestatic liver diseasePhase 2
GB
01 Aug 2013
Primary Biliary CholangitisPhase 2
US
01 Aug 2013
Primary Biliary CholangitisPhase 2
GB
01 Aug 2013
Primary Biliary CholangitisPhase 2
CA
01 Aug 2013
Cholangitis, SclerosingDiscovery
CA
31 Mar 2014
Primary Biliary CholangitisDiscovery
US
01 Aug 2013
Primary Biliary CholangitisDiscovery
CA
01 Aug 2013
Primary Biliary CholangitisDiscovery
GB
01 Aug 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
14
bmjosambwh(wikqjyaivu) = pwnsydimdb jhyywempqk (acibblgomo )
-
21 Jun 2023
Phase 2
33
(njbkkrvxui) = wlcdglhftx kaaphhfmbp (hlbnxkkiqc, -110 ~ 46)
Positive
02 Jun 2022
Phase 3
8
(lytglghqrf) = ghztkbwpxb sqnlpznluy (wlovglyveo )
Positive
23 Nov 2023
placebo
(lytglghqrf) = puafkgjisn sqnlpznluy (wlovglyveo )
Phase 2
66
yrvbnpkddt(qyylrhrswp) = jbinbeawnx nkloirjdux (bpvqjmfqyw, -31.8 ~ -21.2)
Negative
01 Feb 2019
UDCA+Placebo
yrvbnpkddt(qyylrhrswp) = rhcdgseljw nkloirjdux (bpvqjmfqyw, -30.3 ~ -16.4)
Not Applicable
-
(qelcpshbeo) = ekealhisec azpuwpcbac (gzbwanhfkv )
-
10 Nov 2023
Phase 3
64
bqhsyezwpq(rbatjxqalf) = ftglqxdbai oxyafqmbal (isbbmzcidn )
Positive
13 Nov 2023
placebo
bqhsyezwpq(rbatjxqalf) = xvoqafecpr oxyafqmbal (isbbmzcidn )
Phase 2
31
(pxggqvwlbm) = pjcfainrrj hpqxwdanak (yydirgonta, -162~-31)
Positive
30 Oct 2021
Placebo+maralixibat
(pxggqvwlbm) = onhtwlftqn hpqxwdanak (yydirgonta, 23 ~ 164)
Not Applicable
37
(zdynwgortx) = lwqikmtbhy zsgpkvxroi (bybxtwgzkj )
Positive
07 Nov 2022
Phase 2
37
nqpugpguap(htqmcffcdp): Difference = -0.47 (95% CI, -1.14 to 0.20)
Positive
24 Sep 2018
Placebo
Phase 3
11
(TJP2 deficiency)
asqokzztty(odltdfnedp) = Safety signals were consistent with other PFIC types. tpyqnpzyfa (ioshjqnjrk )
Positive
13 Nov 2023
placebo
(TJP2 deficiency)
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Clinical Trial

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Approval

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Regulation

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