Ocaliva

Liver Cirrhosis, Biliary, ursodiol, ursodiol
Treatment
4 FDA approvals
13 Active Studies for Ocaliva

What is Ocaliva

Obeticholic acidThe Generic name of this drug
Treatment SummaryObeticholic acid is a medication used to treat primary biliary cirrhosis (PBC), a progressive and chronic condition that can lead to liver failure. It was approved for this use in 2016 and is usually used in combination with ursodeoxycholic acid. In 2021, the FDA updated its prescribing information to warn against its use in patients with advanced cirrhosis due to a risk of liver failure. Obeticholic acid is currently being considered for FDA approval to treat non-alcoholic liver steatohepatitis (NASH). If approved, it will be available for this use in 2020.
Ocalivais the brand name
Ocaliva Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ocaliva
Obeticholic acid
2016
2

Approved as Treatment by the FDA

Obeticholic acid, also known as Ocaliva, is approved by the FDA for 4 uses which include Primary Biliary Cholangitis and ursodiol .
Primary Biliary Cholangitis
Used to treat Primary Biliary Cholangitis in combination with Ursodeoxycholic acid
ursodiol
Used to treat Inadequate response to UDCA (ursodeoxycholic acid) in combination with Ursodeoxycholic acid
Liver Cirrhosis, Biliary
Used to treat Primary Biliary Cholangitis in combination with Ursodeoxycholic acid
ursodiol

Effectiveness

How Ocaliva Affects PatientsObeticholic acid is thought to help reduce inflammation and scarring of the liver caused by Primary Biliary Cirrhosis. However, it is not yet known if taking this drug improves the survival rate of those affected.
How Ocaliva works in the bodyPrimary biliary cirrhosis is an autoimmune disorder that damages the bile ducts and liver. Obeticholic acid is a drug used to combat this condition by decreasing the amount of bile in the liver. It does this by binding to a receptor in the liver and intestinal cells, called the farnesoid X receptor. This process helps reduce inflammation and cirrhosis of the liver caused by too much bile.

When to interrupt dosage

The advised measure of Ocaliva is contingent upon the determined condition, including ursodiol, Primary Biliary Cholangitis and ursodiol. The quantity of dosage fluctuates, corresponding to the technique of delivery (e.g. Tablet, film coated - Oral or Tablet) specified in the following table.
Condition
Dosage
Administration
Liver Cirrhosis, Biliary
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet - Oral, Tablet
ursodiol
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet - Oral, Tablet
ursodiol
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet - Oral, Tablet

Warnings

Ocaliva has four contraindications, therefore it should not be utilized if you are suffering from any of the conditions in the subsequent table.Ocaliva Contraindications
Condition
Risk Level
Notes
complete biliary obstruction
Do Not Combine
Hypertension, Portal
Do Not Combine
Fibrosis
Do Not Combine
Fibrosis
Do Not Combine
There are 20 known major drug interactions with Ocaliva.
Common Ocaliva Drug Interactions
Drug Name
Risk Level
Description
Zolmitriptan
Minor
The metabolism of Zolmitriptan can be decreased when combined with Obeticholic acid.
(R)-warfarin
Moderate
The therapeutic efficacy of (R)-warfarin can be decreased when used in combination with Obeticholic acid.
(S)-Warfarin
Moderate
The therapeutic efficacy of (S)-Warfarin can be decreased when used in combination with Obeticholic acid.
6-O-benzylguanine
Moderate
The metabolism of 6-O-benzylguanine can be decreased when combined with Obeticholic acid.
8-azaguanine
Moderate
The metabolism of 8-azaguanine can be decreased when combined with Obeticholic acid.
Ocaliva Toxicity & Overdose RiskThe highest amount of obeticholic acid recorded in a healthy person is 500 mg, with 250 mg given over 12 days. Side effects of taking obeticholic acid include itching and increased liver enzymes. Taking more than the recommended dose could lead to further liver damage, fluid buildup, worsening of existing bile duct conditions, and jaundice. If someone overdoses on obeticholic acid, they should be monitored closely and given supportive care.

Ocaliva Novel Uses: Which Conditions Have a Clinical Trial Featuring Ocaliva?

11 active experiments are being conducted to investigate the potential of Ocaliva to ameliorate Primary Biliary Cholangitis, ursodiol and ursodiol-related ailments.
Condition
Clinical Trials
Trial Phases
Liver Cirrhosis, Biliary
13 Actively Recruiting
Phase 3, Phase 2, Phase 1, Not Applicable
ursodiol
0 Actively Recruiting
ursodiol
0 Actively Recruiting

Patient Q&A Section about ocaliva

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How long do you take Ocaliva?

"The recommended dosage for OCALIVA is 5 mg orally once daily for 3 months, with an increase to 10 mg once daily if tolerated and based on response. Starting with a dosage of 10 mg once daily is not recommended, as it increases the risk of pruritus."

Answered by AI

What is Ocaliva used for?

"Ocaliva is a medication used to treat primary biliary cholangitis, a rare and chronic liver disease. Ocaliva has been shown to improve a certain blood test that is used to measure liver problems. It is available in 5 mg and 10 mg tablets."

Answered by AI

What is obeticholic acid used for?

"Obeticholic acid is used to either treat primary biliary cholangitis on its own, or in combination with ursodiol. This is for people who cannot take ursodiol or were not treated successfully with it in the past."

Answered by AI

Is Ocaliva a specialty drug?

"A specialty pharmacy is a pharmacy that specializes in particular types of medication, as opposed to your local pharmacy which carries a more general range of drugs. A specialty pharmacy would coordinate the delivery of a drug like OCALIVA® (obeticholic acid), which is a specialized medication."

Answered by AI

Clinical Trials for Ocaliva

Image of University of Alberta in Edmonton, Canada.

Mind-Body Wellness Program for Primary Biliary Cirrhosis

40 - 75
Female
Edmonton, Canada
Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for PBC are not yet well understood. This study will test a 10-week online wellness program designed for women with PBC. The program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. Some participants will also receive nutrition guidance on the Mediterranean diet to see if it adds extra benefits. The study will evaluate feasibility via recruitment, adherence, and retention. To assess acceptability, participants will provide feedback through surveys and interviews. The study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices. The results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with PBC manage their symptoms and improve their quality of life.
Recruiting
Has No Placebo
University of Alberta
Image of Topgraphy Health, Inc. in Los Angeles, United States.

Elafibranor for Primary Biliary Cholangitis

18+
All Sexes
Los Angeles, CA
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Phase 3
Waitlist Available
Topgraphy Health, Inc. (+22 Sites)Ipsen Medical DirectorIpsen
Have you considered Ocaliva clinical trials? We made a collection of clinical trials featuring Ocaliva, we think they might fit your search criteria.Go to Trials
Have you considered Ocaliva clinical trials? We made a collection of clinical trials featuring Ocaliva, we think they might fit your search criteria.Go to Trials
Image of GSK Investigational Site in Sacramento, United States.

Linerixibat for Cholestasis

18 - 80
All Sexes
Sacramento, CA
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 \[NCT01899703\], 201000 GLIMMER \[NCT02966834\] (group 1) or 212620 GLISTEN \[NCT00210418\]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
Phase 3
Waitlist Available
GSK Investigational Site (+13 Sites)GSK Clinical TrialsGlaxoSmithKline
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