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obeticholic acid + bezafibrate
- Development stage
- Phase 2
- Lead developer
- Alfasigma
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
Obeticholic acid + bezafibrate is a fixed-dose combination therapy under development for the treatment of primary biliary cholangitis (PBC). Obeticholic acid is a potent and selective farnesoid X receptor (FXR) agonist that regulates bile acid metabolism, reduces hepatic inflammation, and decreases fibrogenesis. Bezafibrate acts as a pan-agonist of peroxisome proliferator-activated receptors (PPAR alpha, delta, gamma), which are nuclear receptors involved in lipid metabolism and anti-inflammatory pathways. The combination targets two distinct but complementary pathways implicated in PBC pathogenesis—FXR and PPAR—offering synergistic effects on bile acid synthesis and clearance. Clinical studies have shown that this combination can normalize key liver biomarkers associated with improved clinical outcomes in PBC patients who are inadequately responsive to standard therapies[1][2][4][5][6].
- Brand names
- Ocaliva plus bezafibrate
- Other names
- obeticholic acid/bezafibrateOCA-bezafibrate
02
Targets
FXR (Farnesoid x-activated receptor)PPARA (Peroxisome proliferator-activated receptor alpha)PPARD (Peroxisome proliferator–activated receptor delta)PPARG (Peroxisome proliferator-activated receptor gamma)
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