Dipentum

Ulcerative Colitis

Treatment

2 FDA approvals

17 Active Studies for Dipentum

What is Dipentum

Olsalazine

The Generic name of this drug

Treatment Summary

Olsalazine is a medication used to reduce inflammation in the intestines. It is derived from salicylic acid and is converted by bacteria in the colon into mesalamine, which works to reduce inflammation in patients with inflammatory bowel disease and ulcerative colitis.

Dipentum

is the brand name

Dipentum Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Dipentum

Olsalazine

1990

5

Approved as Treatment by the FDA

Olsalazine, also known as Dipentum, is approved by the FDA for 2 uses which include Ulcerative Colitis and Ulcerative Colitis .

Ulcerative Colitis

Helps manage Ulcerative Colitis

Ulcerative Colitis

Helps manage Ulcerative Colitis

Effectiveness

How Dipentum Affects Patients

Olsalazine is a drug used to treat Inflammatory Bowel Disease and Ulcerative Colitis, both of which cause inflammation, frequent diarrhea, rectal bleeding, and abdominal pain. Olsalazine works by delivering a special form of a medicine (mesalazine or 5-aminosalicylic acid) to the large intestine, where it can reduce the inflammation and symptoms.

How Dipentum works in the body

Olsalazine is taken orally and is turned into mesalamine, which helps treat ulcerative colitis. The exact way it works is still unknown, but it seems to work on the site of the inflammation, not throughout the body. Mesalamine may help reduce inflammation by blocking a type of enzyme that produces substances that can cause inflammation.

When to interrupt dosage

The prescribed dosage of Dipentum is contingent upon the diagnosed condition. The amount of dosage varies, as per the method of delivery (e.g. Capsule, gelatin coated or Oral) indicated in the table beneath.

Condition

Dosage

Administration

Ulcerative Colitis

, 250.0 mg

Oral, , Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule, Capsule - Oral

Warnings

There are 20 known major drug interactions with Dipentum.

Common Dipentum Drug Interactions

Drug Name

Risk Level

Description

Macimorelin

Major

The therapeutic efficacy of Macimorelin can be decreased when used in combination with Olsalazine.

Methotrexate

Major

The serum concentration of Methotrexate can be increased when it is combined with Olsalazine.

Mifamurtide

Major

The therapeutic efficacy of Mifamurtide can be decreased when used in combination with Olsalazine.

Neomycin

Major

The risk or severity of nephrotoxicity can be increased when Olsalazine is combined with Neomycin.

Omacetaxine mepesuccinate

Major

The risk or severity of bleeding can be increased when Olsalazine is combined with Omacetaxine mepesuccinate.

Dipentum Toxicity & Overdose Risk

Tests have found that giving mice, rats, and dogs a single oral dose of up to 5g/kg, and 2g/kg respectively, is not lethal.

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

96 active trials are being conducted to assess the efficacy of Dipentum in treating Ulcerative Colitis.

Condition

Clinical Trials

Trial Phases

Ulcerative Colitis

14 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 4, Phase 1

Dipentum Reviews: What are patients saying about Dipentum?

5

Patient Review

6/29/2010

Dipentum for Ulcerative Colitis currently Without Symptoms

Dipentum has been by far the best medication I've tried for my ulcerative colitis. It doesn't have any of the nasty side effects that other medications did, and it's helped me more than anything else I've tried.

5

Patient Review

12/31/2008

Dipentum for Ulcerative Colitis currently Without Symptoms

This drug has been a life saver for me. I've been taking it for over 12 years to manage my colitis, and it's worked wonders. I was able to get off of steroids thanks to this medication, and I haven't had any flareups since starting it.

5

Patient Review

4/11/2011

Dipentum for Ulcerative Colitis currently Without Symptoms

I've been using this medicine for over a decade and it's worked great, but the price has increased three-fold in the last year. If anyone else has experienced this, please let me know.

5

Patient Review

11/18/2015

Dipentum for Ulcerated Colon

I've been taking this drug for almost 30 years and it has done wonders for me. However, in the last year or so, the price has skyrocketed. I used to be able to get a three-month supply for $100, but now it costs me nearly $300. And if I didn't have insurance, it would cost me $1,500 per month! I know that other people are experiencing similar problems, and I hope that somebody comes out with a generic soon.

5

Patient Review

6/22/2015

Dipentum for Ulcerative Colitis currently Without Symptoms

This medication has been absolutely integral in managing my Ulcerative Colitis. I was shocked and disappointed to learn that the manufacturer has discontinued it; hopefully there will be a replacement available soon.

5

Patient Review

12/20/2013

Dipentum for Inflammatory Bowel Disease

This treatment is amazing! I have rectal bleeding with burning pain and bloating and abdominal distention, but when I take Dipentum, I get relief almost immediately. It's my go-to whenever I have a flare-up, and it always does the job for me.

5

Patient Review

7/14/2018

Dipentum for Inflammatory Bowel Disease

I've been using this medication for over 30 years now and I can say with certainty that it's never given me any problems. In contrast, I have experienced negative side effects from other medications.

5

Patient Review

1/26/2010

Dipentum for Crohn's Disease

Dipentum has been a game changer for me. I've been taking it regularly for 18 years with minimal side effects.

5

Patient Review

7/19/2008

Dipentum for Ulcerative Colitis currently Without Symptoms

I've been on this medication for about fifteen years and, in my opinion, it's been working great.

5

Patient Review

8/5/2008

Dipentum for Ulcerative Colitis currently Without Symptoms

I've been on dipentum for 11 years and have never experienced any negative side effects. I also had a stroke last year, but that hasn't stopped me from continuing to use this medication with great results.

4.3

Patient Review

9/30/2009

Dipentum for Inflammatory Bowel Disease

This treatment has done wonders for my chronic diarrhea and cramping. The only downside is the cost--$250 a month without insurance coverage
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about dipentum

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

Is Dipentum an anti-inflammatory?

"Dipentum is an aminosalicylate, a type of anti-inflammatory drug. It is believed to work by decreasing the production of prostaglandins, which regulates inflammation in the body. This, in turn, decreases inflammation in the intestines, allowing them to heal and preventing flare-ups."

Answered by AI

What is Dipentum used for?

"Dipentum is a drug that is used to treat ulcerative colitis. It is a salicylate anti-inflammatory drug."

Answered by AI

Is Dipentum available?

"Dipentum is not currently available in the United States. Note: There may be illegal online pharmacies selling a generic version of Dipentum. These medications may be counterfeit and potentially unsafe."

Answered by AI

What drug class is Dipentum?

"Dipentum is a 5-Aminosalicylic Acid Derivative."

Answered by AI

Clinical Trials for Dipentum

Image of McMaster Children's Hospital - Digestive Diseases Clinic in Hamilton, Canada.

Vancomycin for Ulcerative Colitis

18+
All Sexes
Hamilton, Canada

This clinical trial tests if oral vancomycin can safely treat active ulcerative colitis (UC) in adults who also have primary sclerosing cholangitis (PSC), a liver condition. The main questions it aims to answer are: * Can oral vancomycin improve UC symptoms as measured by Mayo score at 4 weeks? * Is oral vancomycin safe and tolerable in this patient group? Participants will be compared to see if vancomycin works better than placebo. Participants will: * Take oral vancomycin (250 mg twice daily) or identical placebo capsules for 4 weeks * Have the option for 4 more weeks of open-label vancomycin after the blinded phase * Attend clinic visits at baseline, week 4, and follow-up for Mayo scoring, endoscopy, blood/stool tests, and safety checks * Track treatment adherence and side effects The study primarily assesses if the trial can recruit 14 participants, retain them, achieve good adherence, and follow protocol procedures (feasibility). Secondary goals include safety (adverse events) and early signs of benefit in UC activity, liver tests, and gut bacteria balance. This pilot will guide larger future studies.

Phase 2
Waitlist Available

McMaster Children's Hospital - Digestive Diseases Clinic

Neeraj Narula, MD

Image of MUHC - Montreal General Hospital in Montreal, Canada.

Ustekinumab for Crohn's Disease and Ulcerative Colitis

18+
All Sexes
Montreal, Canada

The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST). The main question it aims to answer is: Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission. Participants will: Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.

Phase 4
Recruiting

MUHC - Montreal General Hospital

Janssen Inc.

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Mirikizumab for Inflammatory Bowel Disease

60 - 99
All Sexes
Lawrence, MA

This research study looks at how safe and effective a medicine called Mirikizumab is for treating older adults (aged 60 and above) who have moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). These two conditions, known as inflammatory bowel diseases (IBD), cause inflammation (swelling and irritation) in the digestive tract. Older adults with these conditions often have other health issues and face increased risks and complications, making it challenging for them to use certain treatments. Mirikizumab is already approved by the FDA for adults with IBD, but there's limited information about how well it works specifically for older adults. This study aims to fill that gap by seeing if Mirikizumab can help these patients safely manage their condition. The study plans to enroll around 150 people from various locations across the United States. Everyone participating will receive Mirikizumab according to the standard, FDA-approved guidelines. The main goal is to see how many participants achieve clinical remission, meaning their symptoms significantly improve or disappear, after 24 weeks of treatment. Researchers will also look at whether this remission lasts up to 48 weeks, how well symptoms are controlled without steroids, how treatment affects indicators of inflammation (such as blood tests), and how the participants feel overall based on their own reports. The safety of Mirikizumab will also be closely monitored throughout the study by regularly checking for any side effects. This study hopes to provide clearer information to help older adults with IBD and their doctors make better treatment decisions, ultimately improving health outcomes and quality of life.

Phase 4
Waitlist Available

Rubix LS

Eli Lilly and Company

Image of Toronto Immune and Digestive Health Institute in North York, Canada.

Healing Circuits™ for Inflammatory Bowel Disease

18 - 75
All Sexes
North York, Canada

The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients. The eligible study participants will be randomly divided into two groups: 1. the group receiving structured mental health support with a social worker and 2. the group receiving structured mental health support via a self-directed online curriculum. Both groups will be receiving the same type of therapy, Healing Circuits™, but the group receiving the therapy via the online self-directed curriculum will be receiving the therapy mostly by web-based video instruction. The two groups will be evaluated over a period of 12 months.

Recruiting
Has No Placebo

Toronto Immune and Digestive Health Institute

Mark Silverberg, MD, PhD

Amgen

Image of Carolina Digestive Diseases- Site Number : 8400013 in Greenville, United States.

SAR441566 for Ulcerative Colitis

18 - 75
All Sexes
Greenville, NC

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Phase 2
Recruiting

Carolina Digestive Diseases- Site Number : 8400013 (+28 Sites)

Sanofi

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Therapy De-escalation for Ulcerative Colitis

18 - 75
All Sexes
Chicago, IL

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

Recruiting
Has No Placebo

University of Chicago

David T Rubin, MD

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