The FDA approval of obeticholic acid (OCA, trade name Ocaliva) for the treatment of PBC represents the first advance since the approval of ursodeoxycholic acid in 1997.
However, several important issues need more study. Your voluntary participation in current and upcoming clinical trials for PBC is crucial for researchers to accelerate progress toward therapies that will benefit each and every individual.
Here is a list of currently enrolling and upcoming trials:
1. Intercept OCA (modified bile acid FXR agonist) vs placebo in persons with advanced disease to prove that OCA treatment benefits patient outcomes
2. Intercept OCA (modified bile acid FXR agonist) for patients with significant hepatic impairment due to advanced cirrhosis to determine safe dosing and effectiveness
3. Gilead GS-9674, a non-bile acid FXR agonist, for patients with PBC who do not have cirrhosis.
4. Novartis LJN452A, a non-bile acid FXR agonist being considered for patients with PBC.
5. NGM Biopharmaceuticals NGM282, a modified FGF-19 inhibitor of bile acid synthesis for patients with PBC.