Obeticholic acid, also known as 6-ethylchenodeoxycholic acid, is a new derivative of chenodeoxycholic acid (CDCA) in human primary bile acid. It directly regulates the expression of bile acid-related genes through multiple mechanisms to affect the synthesis, secretion, transport and absorption of bile acid, and is used to treat PBC and non-alcoholic fatty liver disease.
The raw materials are used in medical research, pharmaceuticals, health care and other fields.
| Test Item | Specification | Results |
| Assay | 98.0% ~ 102.0% (Calculated on the anhydrous basis) | 98.6% |
| Appearance | White to almost white solid | White solid |
| Identification | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. |
Conforms |
| Water | ≤ 2.0% | 1.4% |
| Heavy metal | ≤ 20 ppm | Conforms |
| Related substances | ACS9037-1 ≤ 0.15% | 0.04% |
| ACS9037-9 ≤ 0.15% | Not detected | |
| Other single impurity ≤ 0.15% | 0.08% | |
| Total impurities ≤ 1 % | 0.18% | |
| Residual solvent | Heptane ≤ 0.5% | Not detected |
| Methylene chloride ≤ 0.06% | Not detected | |
| Ethyl acetate ≤ 0.5% | Not detected | |
| Acetonitrile ≤ 0.041% | 0.0045% | |
| Toluene ≤ 0.089% | Not detected | |
| Conclusion: | Meet the standard | |
What is obeticholic acid used for?
1. Obeticholic acid inhibits bile acid synthesis and can be used to treat primary biliary cirrhosis and non-alcoholic fatty liver disease. It is the first drug indicated for the treatment of cholestatic liver disease. Suitable for patients who are intolerant to ursodeoxycholic acid.
2. It is currently considered a selective FXR (bile acid receptor) agonist, and studies have found that it may also be a potent inhibitor of FATP5.
3. Phase III clinical studies have proven that obeticholic acid can significantly improve the histological characteristics of NASH and is generally well tolerated.
Obeticholic acid 25 mg significantly improved fibrosis and disease progression in NASH patients:
4. It has positive effects on key components of fibrosis and non-alcoholic steatohepatitis disease activity, as well as other markers of hepatocellular damage (ALT and AST) and oxidative stress (GGT).
1. Applied in pharmaceuticals. Obeticholic acid is the only drug approved by the FDA in recent years for the treatment of primary biliary cirrhosis.
2. Applied in clinical studies of patients with non-alcoholic steatohepatitis.
Reference
[1]. Younossi Zobair M,Ratziu Vlad,Loomba Rohit et al. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial.[J] .Lancet, 2019, 394: 2184-2196.
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