Intercept 
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  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Enrollment open:  Obeticholic Acid for Prevention in Barrett's Esophagus (clinicaltrials.gov) -  Aug 3, 2023   
    P2,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Congenital Hepatic Fibrosis in Adulthood (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_3031;    
    He was subsequently trialed on budesonide and obeticholic acid without clinical improvement...His liver enzymes normalized and pruritus improved with cholestyramine...Due to the risk of developing CCA, surveillance should be performed. Clinicians should consider CHF as a differential in adults with portal hypertension and chronic liver disease of unclear etiology.
  • ||||||||||  Review, Journal:  An integrated view of anti-inflammatory and antifibrotic targets for the treatment of NASH. (Pubmed Central) -  Jul 18, 2023   
    Extrahepatic inflammatory signals from the circulation, adipose tissue or gut are targets of hormonal agonists (semaglutide, tirzepatide, FGF19/FGF21 analogues), microbiota or lifestyle interventions...In advanced fibrosis, cell therapy with restorative macrophages or reprogrammed T-cells (e.g., CAR T) may accelerate repair through HSC deactivation or killing, or by enhancing matrix degradation. Heterogeneity of disease - either due to genetics or divergent disease drivers - is an obstacle to defining effective drugs for all patients with NASH that will be incrementally overcome.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Trial completion date, Trial primary completion date:  Obeticholic Acid for Prevention in Barrett's Esophagus (clinicaltrials.gov) -  Jul 17, 2023   
    P2,  N=30, Not yet recruiting, 
    Heterogeneity of disease - either due to genetics or divergent disease drivers - is an obstacle to defining effective drugs for all patients with NASH that will be incrementally overcome. Trial completion date: Apr 2024 --> Aug 2025 | Trial primary completion date: Apr 2024 --> Aug 2025
  • ||||||||||  Review, Journal:  New Treatment Paradigms in Primary Biliary Cholangitis. (Pubmed Central) -  Jun 26, 2023   
    Symptom management is essential, and encouragingly, PPAR agonists reduce itch; IBAT inhibition (eg, linerixibat) also appears promising for pruritus...Collectively the PBC therapeutic landscape is exciting. Therapy goals are increasingly proactive, individualized and aspire to rapidly achieve normal serum tests and quality of life with prevention of end-stage liver disease.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Review, Journal:  Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores. (Pubmed Central) -  Jun 15, 2023   
    Ursodiol, the first drug approved for PBC, has changed the natural history of this disease and improved patient outcomes...In 2016, obeticholic acid (OCA) became the second drug to be approved by the FDA, predominantly based on improvement in alkaline phosphatase (ALP) levels...Several drugs are currently being evaluated as therapeutic options for PBC, with improvement in ALP being a main endpoint. In this review, we will discuss the impact of new therapies on GLOBE scores in patients with PBC.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Primary biliary cholangitis: Epidemiology, prognosis, and treatment. (Pubmed Central) -  Jun 6, 2023   
    Novel and repurposed drugs are currently at different stages of clinical development not only for the treatment of PBC but also for its symptomatic management. Here, we summarize the most up-to-date data regarding the epidemiology, prognosis, and treatment of PBC, providing clinically useful information for its holistic management.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  The choleretic role of TUDCA exacerbates ANIT-induced cholestatic liver injury through the FXR/BSEP pathway. (Pubmed Central) -  Jun 5, 2023   
    Obeticholic acid (OCA) was used as a positive control...TUDCA also upregulated anion exchanger 2 (AE2) protein expression, protecting cholangiocytes against excessive toxic BAs. Our results showed that TUDCA aggravated cholestatic liver injury via the FXR/BSEP pathway when bile ducts were obstructed, although TUDCA inhibited apoptotic activity and protected cholangiocytes against excessive toxic BAs.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Oligochitosan-based nanovesicles for nonalcoholic fatty liver disease treatment via the FXR/miR-34a/SIRT1 regulatory loop. (Pubmed Central) -  May 29, 2023   
    STATEMENT OF SIGNIFICANCE: This study proposed a strategy to construct oligochitosan-derivated nanovesicles to co-deliver obeticholic acid and miR-34a antagomir for NAFLD treatment. Based on the FXR/miR-34a/SIRT1 action loop, this nanovesicle effectively exerted a synergetic effect of OCA and anta-miR-34a to significantly regulate lipid deposition and recover liver function in NAFLD mice.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Treatment of Hepatitis E. (Pubmed Central) -  May 28, 2023   
    Liver support devices are intended to support liver function until such time as native liver function recovers, or until LT. LT is widely considered as irreplaceable and definitive treatment for liver failure, particularly for patients who do not improve with supportive measures to sustain life.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Preclinical, Journal:  Fatty Acids and Bilirubin as Intrinsic Autofluorescence Serum Biomarkers of Drug Action in a Rat Model of Liver Ischemia and Reperfusion. (Pubmed Central) -  May 17, 2023   
    The role of these fluorophores as intrinsic biomarkers of pharmacological actions has been investigated here in rats administered with obeticholic acid (OCA), a Farnesoid-X Receptor (FXR) agonist, proven to counteract the increase of serum bilirubin in hepatic ischemia/reperfusion (I/R) injury...OCA greatly reversed the effects observed in the I/R group, confirmed by the biochemical analysis of bilirubin and fatty acids. These results are consistent with a relationship between OCA anti-inflammatory effects and the acknowledged roles of fatty acids as precursors of signaling agents mediating damaging responses to harmful stimuli, supporting serum autofluorescence analysis as a possible direct, real-time, cost-effective tool for pharmacological investigations.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Bile acid interactions with neurotransmitter transporters. (Pubmed Central) -  May 14, 2023   
    The exposure to obeticholic acid (OCA), a semi-synthetic BA, elicits an inward current (I) in the DAT, the GABA transporter 1 (GAT1), and the glycine transporter 1 (GlyT1b); this current is proportional to the current generated by the substrate, respective to the transporter...The physiological significance is that it could possibly avoid the accumulation of small depolarizations in the cells expressing the neurotransmitter transporter. This achieves better transport efficiency in the presence of a saturating concentration of the neurotransmitter and enhances the action of the neurotransmitter on their receptors when they are present at reduced concentrations due to decreased availability of transporters.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
    Trial completion date, Trial primary completion date, Combination therapy:  Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (clinicaltrials.gov) -  Apr 25, 2023   
    P2a,  N=60, Recruiting, 
    In conclusion, the results showed that activation of FXR can alleviate LPS-induced endometritis by inhibiting ferroptosis, and FXR may be a potential therapeutic target for treating endometritis. Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jan 2023 --> Aug 2024
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept, NN1213 / Novo Nordisk
    Trial completion, Enrollment change:  Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (clinicaltrials.gov) -  Apr 25, 2023   
    P=N/A,  N=30, Completed, 
    Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jan 2023 --> Aug 2024 Recruiting --> Completed | N=45 --> 30
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Potential therapeutic action of Tauroursodeoxycholic acid against cholestatic liver injury via hepatic Fxr/Nrf2 and CHOP-DR5-caspase-8 pathway. (Pubmed Central) -  Apr 14, 2023   
    In the present study, cholestasis was induced with a cholic acid (CA)-supplemented diet or ?-naphthyl isothiocyanate (ANIT) gavage in wild-type and Farnesoid X Receptor (FXR) deficient mice, using obeticholic acid (OCA) as control...We confirmed that TUDCA protected against cholestatic liver injury by alleviating BAs burden of dually activating hepatic Fxr and Nrf2. Moreover, inhibiting CHOP-DR5-caspase-8 pathway contributed to the anti-apoptotic effect of TUDCA in cholestasis.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Prognostic significance of liver stiffness progression in primary biliary cholangitis (Stolz 1) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2344;    
    LSM values on UDCA are associated with LSM progression in the youngest patients and those with inadequate biochemical response to UDCA. Figure: Adjusted risk of adverse clinical events associated with LSM progression over time.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Incidence and median times to onset and resolution of pruritus adverse events in a phase 3 study of obeticholic acid in patients with nonalcoholic steatohepatitis (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1938;    
    P3
    The first pruritus AE associated with OCA generally occurred within the first 3 months of therapy, was mild/moderate, and was manageable with a single drug holiday or addition of antipruritic therapy. Table: Pruritus AEs in patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis in the REGENERATE study Placebo (n = 825) OCA 10 mg (n = 825) OCA 25 mg (n = 827) Patients with treatment-emergent pruritus, n (%) 221 (26.8) 289 (35.0) 476 (57.6) Severity, n (%) Mild 161 (19.5) 180 (21.8) 181 (21.9) Moderate 57 (6.9) 99 (12.0) 238 (28.8) Severe 3 (0.4) 10 (1.2) 57 (6.9) Not related to study drug, n (%) 56 (6.8) 58 (7.0) 39 (4.7) Study drug management for pruritus (all grades) per protocol, n (%) No dose change 204 (24.7) 257 (31.2) 366 (44.3) Interruption 17 (2.1) 34 (4.1) 133 (16.1) Withdrawal 8 (1.0) 14 (1.7) 100 (12.1) Time to event for first pruritus AE, median (Q1, Q3), days Time to onset 191 (69, 478) 100 (23, 372) 44 (15, 158.5) Time to resolution 53 (17, 174) 60 (23, 154) 50 (19, 148) Abbreviations: AE, adverse event; Q1, quartile 1; Q3, quartile 3.
  • ||||||||||  OGB21502 / Onegene
    Effects of a novel tetra-specific drug (OGB21502) in the obese mice model of liver disease (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1932;    
    OGB21502 treatment might also be effective in controlling glucose metabolism by targeting liver, compared to reference therapeutics. The results suggest that OGB21502 may be a promising multi-specific therapeutic option for the treatment of NASH.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Intestinal dysbiosis exacerbates gut barrier dysfunction via inhibiting FXR-FGF15 in intra-abdominal sepsis (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1036;    
    INT-747, an agonist of FXR, was assessed whether improve the phenotype of CLP mice or gut barrier... Intestinal dysbiosis triggers over activation of MyD88 in intestinal epithelial cells in intra- abdominal septic mice, and subsequent inhibited the FXR-FGF15 signalling associated with gut barrier function deteriorated.
  • ||||||||||  Bridging the gap - (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_694;    
    Recently we validated our advanced MPS NASH model using two anti-NASH compounds, Obeticholic acid and Elafibranor...Selonsertib showed no antifibrotic or anti-inflammatory effects in our MPS NASH model at clinically relevant dosage, matching results from phase III STELLAR trials, despite reduced fibrosis and inflammation being detected in alternative 3D spheroid models. Overall, we demonstrate how this NASH liver MPS provides translatable insights into drug efficacy for NASH therapeutics and brings a promising, sensitive alternative for pre-clinical NASH screening to help fast-track decision making and access to the market.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Discovery biomarker to optimize obeticholic acid treatment for non-alcoholic fatty liver disease (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_641;    
    These findings suggest that cyclophilins contribute to many pathophysiologic processes and blocking their modulatory actions with rencofilstat shifts the liver transcriptome and lipidome towards NASH resolution. The upregulated alternative bile acid synthesis pathway or high hepatic CYP7B1 can be a potential biomarker for predicting OCA response.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Risk of decompensated cirrhosis in patients with primary biliary cholangitis under first, second and third-line therapies (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_552;    
    Patients with cirrhosis secondary to PBC under double and triple therapy were at a relatively high risk of decompensation, particularly those receiving OCA, probably because they were sicker at the beginning of the treatment. Serum bilirubin and albumin levels, as well as the presence of diabetes mellitus, predicted the risk of decompensation in patients with OCA.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Modulation of alkaline phosphatase levels by obeticholic acid in clinical trials and cultured human hepatocytes (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_546;    
    The likely mechanism of action elevating plasma ALP is via increased expression of PLD, which may in turn release ALP from the cell surface into the bloodstream. This potential mechanism of action may attenuate the observed mean reduction of ALP believed to reflect improved hepatic function in people living with PBC.