Livmarli(maralixibat)
Livmarli (maralixibat) is a small molecule pharmaceutical. Maralixibat was first approved as Livmarli on 2021-09-29. It is used to treat pruritus in the USA. It has been approved in Europe to treat alagille syndrome. It is known to target ileal sodium/bile acid cotransporter.
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Commercial
Trade Name
FDA
EMA
Livmarli
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Maralixibat chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIVMARLI | Mirum Pharmaceuticals | N-214662 RX | 2021-09-29 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| livmarli | New Drug Application | 2024-07-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pruritus | HP_0000989 | D011537 | L29 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MARALIXIBAT CHLORIDE, LIVMARLI, MIRUM | |||
| 2030-03-13 | ODE-429 | ||
| 2028-09-29 | ODE-379 | ||
| 2026-09-29 | NCE | ||
| 2026-03-13 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholestasis | D002779 | HP_0001396 | K83.1 | — | 3 | 5 | — | — | 8 |
| Syndrome | D013577 | — | — | — | 4 | 1 | — | 2 | 7 |
| Alagille syndrome | D016738 | EFO_0004151 | Q44.71 | — | 4 | 1 | — | 2 | 7 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 5 | 1 | — | — | 6 |
| Intrahepatic cholestasis | D002780 | — | — | — | 2 | 4 | — | — | 6 |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | 1 | — | 1 | 2 |
| Fibrosis | D005355 | — | — | — | 1 | 1 | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | 1 | — | — | 1 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | 1 | — | — | — | 1 |
| Biliary atresia | D001656 | EFO_0004217 | Q44.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Maralixibat |
| INN | maralixibat chloride |
| Description | Maralixibat chloride, sold under the brand name Livmarli, is a medication used to treat cholestatic pruritus in people with Alagille syndrome. Maralixibat chloride is an ileal bile acid transporter (IBAT) inhibitor.
|
| Classification | Small molecule |
| Drug class | ileal bile acid transporter (IBAT) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC1(CCCC)CS(=O)(=O)c2ccc(N(C)C)cc2[C@@H](c2ccc(OCc3ccc(C[N+]45CCN(CC4)CC5)cc3)cc2)[C@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 716313-53-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL363392 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16226 |
| UNII ID | V78M04F0XC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLC10A2
SLC10A2
Organism
Homo sapiens
Gene name
SLC10A2
Gene synonyms
ASBT, ISBT, NTCP2
NCBI Gene ID
Protein name
ileal sodium/bile acid cotransporter
Protein synonyms
Apical sodium-dependent bile acid transporter, ASBT, IBAT, ileal apical sodium-dependent bile acid transporter, ileal bile acid transporter, Ileal Na(+)/bile acid cotransporter, Ileal sodium-dependent bile acid transporter, ISBT, Na(+)-dependent ileal bile acid transporter, Na+/taurocholate cotransporting polypeptide 2, Sodium/taurocholate cotransporting polypeptide, ileal, solute carrier family 10 (sodium/bile acid cotransporter family), member 2, solute carrier family 10 (sodium/bile acid cotransporter), member 2, Solute carrier family 10 member 2
Uniprot ID
Mouse ortholog
Slc10a2 (20494)
ileal sodium/bile acid cotransporter (Q925U7)
Variants
No data
Financial
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Livmarli – Mirum Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 153 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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546 adverse events reported
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