maralixibat hydrochloride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| ileal bile acid transporter (IBAT) inhibitors, bile acid reabsorption inhibitors | 5473 | 716313-53-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Ileal sodium/bile acid cotransporter | Transporter | INHIBITOR | IC50 | 9.55 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |