Maralixibat - Mirum Pharmaceuticals
Alternative Names: CAN 108; GC-2127A; LIVMARLI; Lopixibat - Mirum Pharmaceuticals; Lopixibat chloride - Mirum Pharmaceuticals; LUM-001; Maralixibat chloride - Mirum Pharmaceuticals; SD-5613; SHP 625; TAK-625Latest Information Update: 12 Jul 2024
At a glance
- Originator Pfizer
- Developer CANbridge Pharmaceuticals; GC Biopharma; Mirum Pharmaceuticals; Pfizer; Takeda
- Class Amines; Anti-inflammatories; Antihyperlipidaemics; Azabicyclo compounds; Benzothiepins; Dioxoles; Hepatoprotectants; Onium compounds; Small molecules
- Mechanism of Action Sodium-bile acid cotransporter inhibitors
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Alagille syndrome; Intrahepatic cholestasis
- Phase II Biliary atresia
- Discontinued Hypercholesterolaemia; Primary biliary cirrhosis; Primary sclerosing cholangitis
Most Recent Events
- 08 Jul 2024 Registered for Intrahepatic cholestasis (In infants, In adolescents, In children, In adults, In the elderly) in Iceland, Norway, Liechtenstein, European Union (PO)
- 31 May 2024 EMA's Committee for Orphan Medicinal Products (COMP) recommends maintenance of Orphan Drug Designation for maralixibat in Intrahepatic cholestasis
- 31 May 2024 Mirum Pharmaceuticals announces its intention receive final decision of CHMP and COMP opinions for Intrahepatic cholestasis (In adolescents, In children, In infants) in the third quarter of 2024