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  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Trial completion date, Trial primary completion date:  Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT (clinicaltrials.gov) -  Mar 19, 2020   
    P=N/A,  N=70, Recruiting, 
    Trial completion date: Mar 2020 --> Aug 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Risk stratification and treatment of primary biliary cholangitis. (Pubmed Central) -  Mar 10, 2020   
    Along these lines, improved understanding of the condition's pathophysiology has allowed the development of newer drugs, including obeticholic acid and fibrates. This review offers a perspective on risk stratification and treatment for these patients, from ursodeoxycholic acid to second-line treatments.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Preclinical, Journal:  Obeticholic acid ameliorates dyslipidemia but not glucose tolerance in a mouse model of gestational diabetes. (Pubmed Central) -  Feb 22, 2020   
    In conclusion, OCA administration can normalize plasma cholesterol levels in a mouse model of GDM. However, the absence of several of the effects of OCA in pregnant mice indicate that the agonistic action of OCA is not sufficient to overcome many metabolic consequences of the pregnancy-associated reduction in FXR activity.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Review, Journal:  Bile Acid Receptor Therapeutics Effects on Chronic Liver Diseases. (Pubmed Central) -  Feb 19, 2020   
    Attention will also be brought to the gut/liver axis during chronic liver damage and its treatment with bile acid receptor modulators. Overall, these studies lend evidence to the importance of bile acids and their receptors on liver disease establishment and progression.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Review, Journal:  New treatments/targets for primary biliary cholangitis. (Pubmed Central) -  Feb 13, 2020   
    While ursodeoxycholic acid has been established as standard of care for PBC in the last few decades, significant advances in second-line treatment options have recently been made and new therapeutic developments are currently under evaluation. The purpose of this article is to provide the clinician with an overview of the current treatment options and future opportunities for patients with PBC.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept, NN1213 / Novo Nordisk
    Trial completion date, Trial primary completion date:  Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (clinicaltrials.gov) -  Feb 12, 2020   
    P=N/A,  N=45, Recruiting, 
    The purpose of this article is to provide the clinician with an overview of the current treatment options and future opportunities for patients with PBC. Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
  • ||||||||||  modafinil / Generic mfg.
    Retrospective data, Review, Journal:  Treatment of Fatigue in Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis. (Pubmed Central) -  Feb 9, 2020   
    While there is some improvement in fatigue with liver transplantation, there is a lack of high-quality evidence supporting the efficacy of any other intervention in the treatment of PBC-related fatigue. Further research into the underlying pathophysiology may help guide future trials.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Trial termination:  Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) -  Jan 30, 2020   
    P2,  N=19, Terminated, 
    This can be used as a benchmark for monitoring and identifying unmet needs to improve treatment in Italy. Completed --> Terminated; Post-marketing reports of hepatotoxicity associated with obeticholic acid emerged in June 2017, investigators temporarily halted patient recruitment June 2017.
  • ||||||||||  Review, Journal:  What is the (right) target for non-alcoholic fatty liver disease (NAFLD)? (Pubmed Central) -  Jan 22, 2020   
    A number of phase 3 clinical trials are currently ongoing including Elafibranor, a dual PPAR α/δ agonist, Cenicriviroc, a CCR2/CCR5 chemokine antagonist, the nuclear bile acid receptor FXR agonist obeticholic acid, Aramchol, a fatty acid bile acid conjugate that modulates SCD-1, and Resmetrion, a liver-specific THR-β agonist...the ASK-1 inhibitor Selonsertib or the caspase inhibitor Emricasan have shown negative results...The complex pathophysiology of the disease, which combines inflammation, metabolism and fibrosis, has led to the fact that even combinations of several substances are investigated with different modes of action. This review summarizes pivotal clinical trials for patients with NASH in the absence of cirrhosis which are recruiting in the fall of 2019.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Journal:  Pharmacologic management of primary sclerosing cholangitis: what's in the pipeline? (Pubmed Central) -  Jan 16, 2020   
    Other agents including obeticholic acid, nor-ursodeoxycholic acid, and monoclonal antibodies are also under investigation...Nevertheless, some agents currently being tested have demonstrated therapeutic potential. We await validation and prospective data on these agents in hopes of modifying the disease course for patients in the future.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Obeticholic acid for the treatment of NASH. (Pubmed Central) -  Jan 12, 2020   
    Our findings implicate that TGR5 might be considered as a potential therapeutic target for the treatment of OA. No abstract available
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  A Microphysiological System for Studying Nonalcoholic Steatohepatitis. (Pubmed Central) -  Jan 10, 2020   
    The MPS model displays a phenotype akin to advanced NAFLD or NASH and has utility as a tool for exploring mechanisms underlying the disease. Furthermore, we demonstrate that in co-culture the PNPLA3 I148M mutation alone can cause hepatic stellate cells to enhance the overall NASH disease phenotype.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Obeticholic acid: towards first approval for NASH. (Pubmed Central) -  Jan 1, 2020   
    Our findings provide new evidence for the interaction of FXR and Nrf2 signaling and novel option for the intervention of DCM. No abstract available
  • ||||||||||  Prevention and pharmacological interventions in NAFLD/NASH (Paris) -  Dec 29, 2019 - Abstract #ATTD2020ATTD_214;    
    A second approach is targeting the oxidative stress, inflammation and injury via use of antioxidants (vitamin E), medications with a target in the TNF α pathway, and immune modulators (eg. cenicriviroc)...Finally, antifibrotics are tested. Conclusions In the next few years several medications may become available to treat patients with NAFLD across the entire spectrum of disease, although their long-term safety and efficacy remain to be established.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Review, Journal:  Pharmacological treatment of NASH (Pubmed Central) -  Dec 26, 2019   
    About 60 new molecules are under investigation in NASH and have 4 different types of mechanism of action: metabolic, oxidative stress/apoptosis, anti inflammatory and anti fibrotic. A phase 3 trial evaluating obeticholic acid have shown a 72 weeks duration treatment improved significantly fibrosis.
  • ||||||||||  low molecular weight dextran sulfate (ILB) / TikoMed, bile acid cholic acid (INT-777) / Intercept
    Journal:  Genistein protects against DSS-induced colitis by inhibiting NLRP3 inflammasome via TGR5-cAMP signaling. (Pubmed Central) -  Dec 20, 2019   
    The effects of Genistein in dextran sulfate sodium (DSS)-induced murine colitis via targeting NLRP3 inflammasome was investigated in this study...Moreover, Genistein treatment down-regulated production of caspase-1 and IL-1β and increased intracellular cAMP level, which were similar to the treatment for INT-777, a semi-synthetic TGR5 agonist, in phorbol myristate acetate (PMA)-differentiated monocytic THP-1 cells and U937 cells...In conclusion, our study unveils that Genistein was able to inhibit NLRP3 inflammasome via TGR5-cAMP signaling in macrophages. It therefore might be a potential effective drug for inflammatory bowel diseases.