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maralixibat hydrochloride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 51 | |||
| kinase-selectivity-class | MAP2K6 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 29, 2021 | FDA | MIRUM PHARMA INC | |
| Dec. 9, 2022 | EMA | MIRUM PHARMACEUTICALS INTERNATIONAL B.V. |
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 |
Related Drugs by ATC class:
A05AX Other drugs for bile therapy 6 drugs
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 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 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 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11260053 | May 26, 2031 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11260053 | May 26, 2031 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11260053 | May 26, 2031 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11260053 | May 26, 2031 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | 12350267 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 11376251 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER 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 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11376251 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12350267 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11376251 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12350267 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11376251 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12350267 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 10512657 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229661 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11376251 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12350267 | Oct. 26, 2032 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 11229647 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER 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 3 MONTHS OF AGE AND OLDER 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) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 11918578 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 11918578 | 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 | 12599602 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | 12599602 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229647 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11497745 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229647 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11497745 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229647 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11497745 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11229647 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 11497745 | Feb. 12, 2040 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | 12296050 | Oct. 5, 2043 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE |
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 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | 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, 2026 | NEW CHEMICAL ENTITY |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | Sept. 29, 2026 | NEW CHEMICAL ENTITY |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | Sept. 29, 2026 | NEW CHEMICAL ENTITY |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | Sept. 29, 2026 | NEW CHEMICAL ENTITY |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | Sept. 29, 2026 | NEW CHEMICAL ENTITY |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | March 13, 2027 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 10MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | March 13, 2027 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 15MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | March 13, 2027 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 20MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | March 13, 2027 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 30MG BASE | LIVMARLI | MIRUM | N219485 | April 10, 2025 | RX | TABLET | ORAL | March 13, 2027 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | Sept. 29, 2028 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 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 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | March 13, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 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) |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | March 13, 2031 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| EQ 9.5MG BASE/ML | LIVMARLI | MIRUM | N214662 | Sept. 29, 2021 | RX | SOLUTION | ORAL | March 13, 2031 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 5 YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| EQ 19MG BASE/ML | LIVMARLI | MIRUM | N214662 | July 24, 2024 | RX | SOLUTION | ORAL | July 24, 2031 | TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
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 |
|---|---|
| CHEMBL363392 | ChEMBL_ID |
| CHEMBL17879 | ChEMBL_ID |
| D10951 | KEGG_DRUG |
| C000722912 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB16226 | DRUGBANK_ID |
| 4040847 | VANDF |
| C5418448 | UMLSCUI |
| CHEBI:748720 | CHEBI |
| 228113-66-4 | SECONDARY_CAS_RN |
| 9831643 | PUBCHEM_CID |
| 350578 | MMSL |
| 39916 | MMSL |
| d09811 | MMSL |
| 018860 | NDDF |
| 018861 | NDDF |
| 11708 | IUPHAR_LIGAND_ID |
| UYB6UOF69L | UNII |
| 10073 | INN_ID |
| 2571073 | RXNORM |
| UYB6UOF69L | INXIGHT DRUGS |
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 | 32 sections |
| Livmarli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 79378-111 | SOLUTION | 19 mg | ORAL | NDA | 32 sections |
| Livmarli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 79378-210 | TABLET | 10 mg | ORAL | NDA | 32 sections |
| Livmarli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 79378-215 | TABLET | 15 mg | ORAL | NDA | 32 sections |
| Livmarli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 79378-220 | TABLET | 20 mg | ORAL | NDA | 32 sections |
| Livmarli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 79378-230 | TABLET | 30 mg | ORAL | NDA | 32 sections |