Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Maralixibat
Drug ID BADD_D02570
Description Maralixibat (also known as SHP625, LUM001, and lopixibat) is an ileal bile acid transporter inhibitor, like [odevixibat].[A236823,A239249,L38834] Maralixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome, who are at least 1 year old.[L38834] Previously, patients with cholestatic pruritus associated with Alagille syndrome were treated with antihistamines, [rifampin], [ursodeoxycholic acid], [cholestyramine], [naltrexone], and [sertraline] alone or in combination.[A239249] No clinical trials have been performed to assess the efficacy of these treatments for cholestatic pruritus and treatments were given based on a prescriber's clinical experience.[A239249] Surgical interventions such as partial external bile diversion and ileal exclusion have also been used as treatments.[A239249] Maralixibat represents the first FDA approved treatment for cholestatic pruritus in patients with Alagille syndrome. Maralixibat was granted FDA approval on 29 September 2021.[L38834]
Indications and Usage Maralixibat is indicated in the treatment of cholestatic pruritus in patients with Alagille syndrome who are at least 1 year old.[L38834]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB16226
KEGG ID D10951
MeSH ID Not Available
PubChem ID 9831643
TTD Drug ID DZB84T
NDC Product Code 50193-0423
UNII UYB6UOF69L
Synonyms Not Available
Chemical Information
Molecular Formula C40H56N3O4S+
CAS Registry Number 716313-53-0
SMILES CCCCC1(CS(=O)(=O)C2=C(C=C(C=C2)N(C)C)C(C1O)C3=CC=C(C=C3)OCC4=CC=C(C=C4)C[N+]56CC N(CC5)CC6)CCCC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.0020.003544%
Cough22.02.03.0010.003544%
Diarrhoea07.02.01.0010.007089%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.003544%Not Available
Drug ineffective08.06.01.0060.008861%Not Available
Pruritus23.03.12.0010.026583%
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