Urso 250

obese experiencing rapid weight loss, Cholelithiasis, Liver Cirrhosis, Biliary
Treatment
3 FDA approvals
14 Active Studies for Urso 250

What is Urso 250

Ursodeoxycholic acidThe Generic name of this drug
Treatment SummaryUrsodeoxycholic acid is a bile acid found naturally in bears. It is used to treat gallstones and helps to alter the composition of bile. Ursodeoxycholic acid is used as a medication to promote the flow of bile from the gallbladder.
Actigallis the brand name
image of different drug pills on a surface
Urso 250 Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Actigall
Ursodeoxycholic acid
1987
100

Approved as Treatment by the FDA

Ursodeoxycholic acid, otherwise known as Actigall, is approved by the FDA for 3 uses which include gallstone formation and obese experiencing rapid weight loss .
gallstone formation
obese experiencing rapid weight loss
Cholelithiasis

Effectiveness

How Urso 250 Affects PatientsUrsodiol (also known as ursodeoxycholic acid) is a type of acid made by bacteria in the intestine. It helps digest fat and regulates cholesterol levels by slowing down the rate at which cholesterol is absorbed. It also breaks down micelles, which are clusters of cholesterol. Doctors use ursodeoxycholic acid to help dissolve gallstones without surgery.
How Urso 250 works in the bodyUrsodeoxycholic acid helps reduce elevated liver enzyme levels by improving the flow of bile and protecting liver cells. We aren't sure exactly how it works, but it appears to reduce the amount of cholesterol in bile, allowing cholesterol-based gallstones to dissolve. It also prevents cholesterol from forming in the first place.

When to interrupt dosage

The proposed dosage of Urso 250 is contingent upon the determined disorder, which includes Primary Biliary Cholangitis, Cholelithiasis and obese experiencing swift weight loss. The measure of dosage varies, in accordance with the administration strategy featured in the table below.
Condition
Dosage
Administration
obese experiencing rapid weight loss
, 300.0 mg, 250.0 mg, 500.0 mg, 0.0002 mg/mg, 10.0 mg, 200.0 mg, 400.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Dental, Paste, Paste - Dental
Cholelithiasis
, 300.0 mg, 250.0 mg, 500.0 mg, 0.0002 mg/mg, 10.0 mg, 200.0 mg, 400.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Dental, Paste, Paste - Dental
Liver Cirrhosis, Biliary
, 300.0 mg, 250.0 mg, 500.0 mg, 0.0002 mg/mg, 10.0 mg, 200.0 mg, 400.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Dental, Paste, Paste - Dental

Warnings

Urso 250 Contraindications
Condition
Risk Level
Notes
Cholangitis
Do Not Combine
Pancreatitis
Do Not Combine
Biliary Fistula
Do Not Combine
Calcinosis
Do Not Combine
Bile duct structure
Do Not Combine
Urinary Bladder Calculi
Do Not Combine
Urinary Bladder Calculi
Do Not Combine
Cholecystitis
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Ursodeoxycholic Acid may interact with Pulse Frequency
There are 20 known major drug interactions with Urso 250.
Common Urso 250 Drug Interactions
Drug Name
Risk Level
Description
Capmatinib
Major
The serum concentration of Capmatinib can be decreased when it is combined with Ursodeoxycholic acid.
Rimegepant
Major
The metabolism of Rimegepant can be increased when combined with Ursodeoxycholic acid.
Astemizole
Moderate
Ursodeoxycholic acid may decrease the excretion rate of Astemizole which could result in a higher serum level.
Atazanavir
Moderate
Ursodeoxycholic acid may decrease the excretion rate of Atazanavir which could result in a higher serum level.
Atenolol
Moderate
Ursodeoxycholic acid may decrease the excretion rate of Atenolol which could result in a higher serum level.
Urso 250 Toxicity & Overdose RiskUrsodeoxycholic acid overdose has not been reported. Patients on doses of 16-20mg/kg/day have not exhibited any symptoms in studies lasting 6-37 months. The toxic dose in rats is greater than 5000mg/kg and in mice it is greater than 7500mg/kg. If an overdose occurs, it is likely that the patient will experience diarrhea, which should be treated with symptom relief.
image of a doctor in a lab doing drug, clinical research

Urso 250 Novel Uses: Which Conditions Have a Clinical Trial Featuring Urso 250?

Thirteen active clinical trials are investigating the potential of Urso 250 to treat Primary Biliary Cholangitis, Cholelithiasis and those obese individuals undergoing rapid weight loss.
Condition
Clinical Trials
Trial Phases
Liver Cirrhosis, Biliary
13 Actively Recruiting
Phase 3, Phase 2, Phase 1, Not Applicable
Cholelithiasis
0 Actively Recruiting
obese experiencing rapid weight loss
0 Actively Recruiting

Urso 250 Reviews: What are patients saying about Urso 250?

5Patient Review
3/27/2011
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
I've been on URSO for almost 20 years now. A couple years ago, my pharmacy gave me a generic brand, and within days I was having severe headaches that progressed to nausea and depression. I couldn't get out of bed. Thankfully, I stopped taking them after just three weeks. Within 12 hours I started feeling better and by the next day I was back to normal. Now I only take the brand name URSO.
5Patient Review
7/1/2010
Urso 250 for Treatment to Prevent Gallstones
This drug has been keeping me alive for seven years and I am very grateful for it.
5Patient Review
9/17/2009
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
I've been on Urso for nine years and they recently switched me to the generic Ursodol. About four days into taking it, I started experiencing a lot of heartburn. Could this be a side effect of the generic?
5Patient Review
8/15/2008
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
5Patient Review
8/1/2009
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
I have Primary Sclerosing Cholangitis and this is the medication I use. In the ten years I've been taking it (2000mg/day), I have never had a bad reaction or side effect. On top of that, my liver functions always improve when my doctor increases my dosage.
5Patient Review
12/13/2009
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
I'm seeing results from this treatment, which is great!
2.3Patient Review
10/12/2010
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
So far, no negative side effects from taking this medication preventatively for gallstones. I've had great results and would recommend to others who have had bypass surgery or are facing a similar situation.
2.3Patient Review
1/14/2011
Urso 250 for Rare Progressive Liver Disease - Primary Biliary Cirrhosis
I've had a hard time finding a doctor to treat my PBC in the Palm Beach County, Florida area. My URSO therapy of 1500 mg per day leads to diarrhea and abdominal pain. I just want take the URSO and get on with my life, but being housebound and lack of a proactive doctor has me at a loss. Any suggestions?
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about urso 250

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

Can Urso be taken on empty stomach?

"If you're unsure if you can break the tablet in half, talk to your doctor. If you are able to break the tablet in half, use the other half of the tablet for your next dose, as instructed by your doctor."

Answered by AI

What is Urso used for?

"Ursodiol is a medication used to treat various conditions related to the gallbladder or liver. These include dissolving certain types of gallstones, preventing gallstones from forming in obese patients who are losing weight rapidly, and treating a certain type of liver disease called primary biliary cholangitis."

Answered by AI

What does Urso do for the liver?

"Ursodiol decreases the production of cholesterol and dissolves cholesterol to prevent stones from forming. Additionally, ursodiol decreases the levels of toxic bile acids that accumulate in primary biliary cirrhosis."

Answered by AI

What is Urso Forte used for?

"Urso Forte tablets are used to treat primary biliary cirrhosis, an autoimmune disorder that causes progressive destruction of the bile ducts in your liver. Urso Forte may also be used to treat other conditions not listed in this medication guide."

Answered by AI

Clinical Trials for Urso 250

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 Urso 250 clinical trials? We made a collection of clinical trials featuring Urso 250, we think they might fit your search criteria.Go to Trials
Have you considered Urso 250 clinical trials? We made a collection of clinical trials featuring Urso 250, 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