• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Ocaliva (obeticholic acid)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Ocaliva (obeticholic acid)

  • Profile

Profile

Contact Information

Contact: Intercept Pharmaceutical
Website: www.ocaliva.com

Currently Enrolling Trials

    Show More

    General Information

    Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist.

    Ocaliva is specifically indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

    Mechanism of Action

    Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist. FXR is a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.

    Side Effects

    Adverse effects associated with the use of Ocaliva may include, but are not limited to, the following:

    • Pruritus
    • Fatigue
    • Abdominal pain and discomfort
    • Rash
    • Oropharyngeal pain
    • Dizziness
    • Constipation
    • Arthralgia
    • Thyroid function abnormality
    • Eczema

    Dosing/Administration

    Ocaliva is supplied as tablets for oral administration. The recommended starting dosage of Ocaliva is 5 mg orally once daily in adult patients who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least one year or are intolerant to UDCA. Dosage Titration: If an adequate reduction in ALP and/or total bilirubin has not been achieved after three months of Ocaliva 5 mg once daily, and the patient is tolerating Ocaliva, increase the dosage of Ocaliva to 10 mg once daily. The maximum recommended dosage of Ocaliva is 10 mg once daily. Please see drug label for specific dose adjustments.

    Clinical Trial Results

    FDA Approval

    The FDA approval of Ocaliva was based on the phase 3 POISE trial, which studied the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, UDCA. The POISE data showed that Ocaliva, at both a 10-mg dose and a 5-mg dose titrated to 10 mg, met the trial's primary end point of achieving a reduction in serum ALP to below a threshold of 1.67 times the upper limit of normal, with a minimum of 15 percent reduction in ALP level from baseline and a normal bilirubin level after 12 months of therapy. Pruritus was the most frequently reported adverse event associated with Ocaliva treatment. In a group of patients who initiated Ocaliva at a 5-mg once-daily dose and titrated up to 10 mg once daily, one patient (1 percent) discontinued from the study due to pruritus as compared to seven patients (10 percent) in the 10-mg dose group and after 12 months of treatment, efficacy was essentially equivalent to those patients who started the study at the 10-mg dose.

     

    Approval Date: 2016-05-01
    Company Name: Intercept Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing