Maralixibat is a small-molecule, orally administered ileal bile acid transporter (IBAT) inhibitor used as an active pharmaceutical ingredient in the development and manufacture of pharmaceutical formulations for cholestatic liver diseases. It works by inhibiting the reabsorption of bile acids in the ileum, thereby increasing fecal bile acid excretion and reducing the enterohepatic circulation of bile acids.
Maralixibat is used clinically for the treatment of cholestatic pruritus associated with Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC) in appropriate patient populations. It is marketed as LIVMARLI.
Maralixibat is a selective inhibitor of the ileal bile acid transporter (IBAT), also known as the apical sodium-dependent bile acid transporter (ASBT). IBAT is responsible for the reabsorption of bile acids from the terminal ileum.
By inhibiting IBAT, maralixibat reduces intestinal bile acid reabsorption and increases bile acid elimination through feces. This mechanism helps decrease the circulating bile acid pool and is associated with improvement in cholestatic pruritus in indicated patients.
Maralixibat selectively inhibits the ileal bile acid transporter (IBAT/ASBT). This prevents the normal reabsorption of bile acids in the terminal ileum and increases fecal bile acid excretion.
The resulting reduction in enterohepatic bile acid circulation decreases the overall bile acid pool and contributes to the therapeutic effect in cholestatic liver diseases.
Swapproop Drugs and Pharmaceuticals supports the sourcing and supply of Maralixibat API for qualified pharmaceutical manufacturing, formulation development, research, and development requirements.
Maralixibat can be evaluated according to applicable customer specifications, validated analytical methods, and relevant pharmaceutical quality requirements. Technical documentation, quality information, specifications, and commercial details can be provided according to project requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |