maralixibat hydrochloride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
ileal bile acid transporter (IBAT) inhibitors, bile acid reabsorption inhibitors 5473 716313-53-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • maralixibat
  • maralixibat hydrochloride
  • livmarli
  • LUM001
  • maralixibat chloride
Maralixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with ALGS and the pathophysiology of pruritus in patients with ALGS is not completely understood. Although the complete mechanism by which maralixibat improves pruritus in ALGS patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids.
  • Molecular weight: 674.96
  • Formula: C40H56N3O4S
  • CLOGP: 6.88
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 70.08
  • ALOGS: -7.47
  • ROTB: 13

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 9, 2022 EMA MIRUM PHARMACEUTICALS INTERNATIONAL B.V.
Sept. 29, 2021 FDA MIRUM PHARMA INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A05AX04 ALIMENTARY TRACT AND METABOLISM
BILE AND LIVER THERAPY
BILE THERAPY
Other drugs for bile therapy
FDA MoA N0000190109 Organic Anion Transporting Polypeptide 2B1 Inhibitors
FDA EPC N0000193957 Ileal Bile Acid Transporter Inhibitor
FDA MoA N0000193958 Ileal Bile Acid Transporter Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Cholestatic pruritus in patients with Alagille syndrome (ALGS) indication 31742004 DOID:9245




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL 11260053 May 26, 2031 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL 11376251 Oct. 26, 2032 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL 11229647 Feb. 12, 2040 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL 11497745 Feb. 12, 2040 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL March 13, 2026 NEW PATIENT POPULATION
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL Sept. 29, 2026 NEW CHEMICAL ENTITY
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL Sept. 29, 2028 FOR TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) 1 YEAR OF AGE AND OLDER
EQ 9.5MG BASE/ML LIVMARLI MIRUM N214662 Sept. 29, 2021 RX SOLUTION ORAL March 13, 2030 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Ileal sodium/bile acid cotransporter Transporter INHIBITOR IC50 9.55 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
9831643 PUBCHEM_CID
D10951 KEGG_DRUG
CHEMBL363392 ChEMBL_ID
CHEMBL17879 ChEMBL_ID
C000722912 MESH_SUPPLEMENTAL_RECORD_UI
11708 IUPHAR_LIGAND_ID
DB16226 DRUGBANK_ID
018860 NDDF
018861 NDDF
4040847 VANDF
C5418448 UMLSCUI
10073 INN_ID
228113-66-4 SECONDARY_CAS_RN
2571073 RXNORM
350578 MMSL
39916 MMSL
d09811 MMSL
UYB6UOF69L UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Livmarli HUMAN PRESCRIPTION DRUG LABEL 1 79378-110 SOLUTION 9.50 mg ORAL NDA 31 sections
Livmarli HUMAN PRESCRIPTION DRUG LABEL 1 79378-110 SOLUTION 9.50 mg ORAL NDA 31 sections
Livmarli HUMAN PRESCRIPTION DRUG LABEL 1 79378-110 SOLUTION 9.50 mg ORAL NDA 31 sections