Linaclotide

Irritable Bowel Syndrome, chronic idiopathic constipation (CIC)

Treatment

3 FDA approvals

3 Active Studies for Linaclotide

What is Linaclotide

Linaclotide

The Generic name of this drug

Treatment Summary

Linaclotide is a medication used to treat irritable bowel syndrome (IBS). It is an amino acid-based drug made of fourteen different amino acids that are linked together with three disulfide bonds. The FDA approved this drug on August 30, 2012.

Linzess

is the brand name

image of different drug pills on a surface

Linaclotide Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Linzess

Linaclotide

2012

5

Approved as Treatment by the FDA

Linaclotide, also known as Linzess, is approved by the FDA for 3 uses including Constipation-predominant Irritable Bowel Syndrome (IBS-C) and Irritable Bowel Syndrome .

Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Helps manage Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Irritable Bowel Syndrome

Helps manage Constipation-predominant Irritable Bowel Syndrome (IBS-C)

chronic idiopathic constipation (CIC)

Helps manage chronic idiopathic constipation (CIC)

Effectiveness

How Linaclotide Affects Patients

Linaclotide has been observed to cause changes in the shape and texture of stools, as measured by the Bristol Stool Form Scale.

How Linaclotide works in the body

Linaclotide helps people with IBS, especially constipation, by speeding up the movement of food through the intestines and increasing fluid in the gut. It does this by activating a protein called guanylate cyclase-C, which triggers a chain reaction that causes a type of cell to release more chloride and bicarbonate. This reaction also helps reduce pain in the gut by increasing a molecule called cGMP, which acts on the pain-sensing nerves.

When to interrupt dosage

The prescribed dosage of Linaclotide is contingent upon the recognized illness. The measure of dosage also differs in accordance with the mode of delivery, as indicated in the table below.

Condition

Dosage

Administration

chronic idiopathic constipation (CIC)

, 0.29 mg, 0.145 mg, 0.072 mg

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

Irritable Bowel Syndrome

, 0.29 mg, 0.145 mg, 0.072 mg

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

Warnings

Linaclotide has two contraindications, and taking it is not recommended for those with any of the conditions listed in the following table.

Linaclotide Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Gastrointestinal obstruction

Do Not Combine

There are 20 known major drug interactions with Linaclotide.

Common Linaclotide Drug Interactions

Drug Name

Risk Level

Description

Alloin

Minor

The risk or severity of adverse effects can be increased when Linaclotide is combined with Alloin.

Bisacodyl

Minor

The risk or severity of adverse effects can be increased when Linaclotide is combined with Bisacodyl.

Bisoxatin

Minor

The risk or severity of adverse effects can be increased when Linaclotide is combined with Bisoxatin.

Calcium polycarbophil

Minor

The risk or severity of adverse effects can be increased when Linaclotide is combined with Calcium polycarbophil.

Carboxymethylcellulose

Minor

The risk or severity of adverse effects can be increased when Linaclotide is combined with Carboxymethylcellulose.

Linaclotide Toxicity & Overdose Risk

Taking Linzess may cause side effects in some patients, such as diarrhea, abdominal pain, passing gas, and bloating. These effects occur in 2% or more of those taking the drug.

image of a doctor in a lab doing drug, clinical research

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

Five ongoing trials are analyzing the effectiveness of Linaclotide in providing relief from chronic idiopathic constipation (CIC).

Condition

Clinical Trials

Trial Phases

Irritable Bowel Syndrome

3 Actively Recruiting

Phase 2, Phase 3

chronic idiopathic constipation (CIC)

1 Actively Recruiting

Phase 2, Phase 3

Linaclotide Reviews: What are patients saying about Linaclotide?

5

Patient Review

10/16/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I was surprised to read about all the negative experiences people have had. For me, this treatment began working within three hours. I had several bouts of diarrhea, but it was never painful and it really cleaned me out. I would recommend being near a toilet for at least five hours after taking the medication, as you will likely need to use it frequently. This treatment didn't make my stomach bloated; if anything, it did the opposite.

5

Patient Review

10/16/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I was surprised to hear that other people have had such negative experiences with this medication. For me, it started working within three hours and I had several bouts of heavy diarrhea. It never bothered my stomach, though, and actually made me feel much cleaner. I would recommend being near a toilet for at least five hours after taking the medication, as you will likely not have any solid movements during that time.

4.3

Patient Review

5/22/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I've had chronic constipation for a long time, and my doctor recommended Linzess. The first pill took effect in about three hours, and yes, like others have said it causes diarrhea. But I can say that it really cleans me out and makes me feel much better.

4.3

Patient Review

5/22/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I've had chronic constipation for most of my life, and my doctor recommended Linzess. The first pill took effect after about three hours, and yes, it caused diarrhea (sometimes explosively). However, it really cleans me out and makes me feel much better.

3.7

Patient Review

10/25/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

When I first started this medication, it helped a lot. However, after a while it stopped being as effective. Now, I only take it when I need to and that works better for me.

3.7

Patient Review

10/25/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

This medication helped me at first, but then I started to develop a tolerance. Now I only take it when I really need it and that seems to work better for me.

3

Patient Review

10/5/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

Unfortunately, this didn't work for my IBS-C. I tried taking it twice a day at 290 mcg and saw no results. It also made me incredibly dehydrated and gave me hemorrhoids.

3

Patient Review

10/6/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I've been taking linzess 290 mcg daily for two years to help with my IBS-C, but it seems like it's stopped working recently. I'm still having to take other medications (colace, miralax) and I haven't seen any improvement in days. Hoping to find a different option soon.

3

Patient Review

10/6/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I've been taking this for two years now and, unfortunately, it doesn't seem to be as effective as it once was. I'm still struggling with constipation despite also taking other measures like Miralax and Colace. If you're thinking of trying this, be aware that it may not provide long-term relief.

3

Patient Review

10/5/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I'm honestly disappointed in this treatment for IBS-C. It didn't work for me, even when taking it twice a day at 290 mcg. You have to drink a ton of water to not dehydrate, and it can cause hemorrhoids which then bleed. I'm going back to fiber and Miralax; it's also cheaper and doesn't made my life worse.

2

Patient Review

8/25/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I unfortunately had very negative side effects while taking this medication. I would have to run to the bathroom multiple times after taking just one dose. It was also incredibly expensive, and not covered by my insurance.

2

Patient Review

9/13/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I am currently taking this medication and it has been an incredibly difficult 14 days. I have struggled with breathing, gas, and what I believe may be a heart attack. This experience has been absolutely nightmarish.

2

Patient Review

8/25/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I tried this treatment for two weeks, and it unfortunately gave me really bad diarrhea. Three times after taking the medication at the highest dosage, I had to run to the bathroom. It's also pretty pricey (600 dollars) and not covered by my insurance.

2

Patient Review

9/13/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I am currently experiencing some very intense side effects after taking this medication for two weeks. I am struggling to breathe and am in a lot of pain. This has been an absolute nightmare.

1.7

Patient Review

6/12/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

I would not recommend this drug to anyone. It was watery and made a mess all over the bathroom. I had severe stomach pain afterwards that lasted for six hours. There has got to be a better solution out there.

1.7

Patient Review

6/12/2022

Linaclotide for Chronic Difficulty having a Bowel Movement

This was by far the most terrible medication I have ever had the displeasure of using. It's nothing but water and made an absolute mess everywhere. One day is more than enough for me, I'd rather die than use this again. Six hours later and I'm still in pain. If you're considering this, please be very careful.

1

Patient Review

8/28/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

The first time I took LINZES, I had to run to the bathroom. Unfortunately, I didn't make it and ended up making a mess. Since then, I've been having constant urges to go to the bathroom. It's horrible!

1

Patient Review

8/28/2022

Linaclotide for Irritable Bowel Syndrome with Constipation

I had an immediate reaction to LINZES the first time I took it and ran to the bathroom. Unfortunately, I didn't make it in time and had to clean up afterwards. The urge to go has been constant since then and it's incredibly annoying.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about linaclotide

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

How long does it take for linaclotide to work?

"If you're constipated, you can typically expect relief within a week. For those with IBS-C, abdominal pain and other symptoms like discomfort and bloating typically begin to improve within the first week, and these improvements continue over the course of 12 weeks."

Answered by AI

Is LINZESS just a laxative?

"It's designed to work in different areas of your intestine and bowels.

LINZESS is designed to work differently than other medications by targeting different areas of the intestine and bowels. It is the first approved treatment in its class."

Answered by AI

Is linaclotide the same as LINZESS?

"Linzess helps to relieve symptoms of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) by working on the muscles in the intestine."

Answered by AI

Clinical Trials for Linaclotide

Image of Children's Hospital Los Angeles in Los Angeles, United States.

Maralixibat for Cystic Fibrosis and Constipation

1 - 18
All Sexes
Los Angeles, CA

Chronic constipation is a feature of children with cystic fibrosis (CF). This is postulated to be a result of inhibition of secretory activity of the gastrointestinal luminal cells due to ineffective chloride channel function. Typical laxatives that work as osmotic agents fail to produce adequate relief in this population. Maralixibat is a non-systemic bile acid transport inhibitor (IBATi) that acts by interrupting bile acid reabsorption in the ileum thus interrupting the normal enterohepatic circulation. This interruption results in a larger volume of bile acids reaching the colon and being excreted in stool. Bile acids are known to decrease bowel transit time, increase mucosal permeability and secretions, as well as alter gut microbiota resulting in diarrhea. The overarching hypothesis of the study is that Maralixibat will improve stool consistency in children (Age \<18 years) with cystic fibrosis and constipation (Bristol Stool Scale \<4). Specifically, we aim to test the hypothesis that IBATi improves the consistency of stool to Bristol scale \>4 in children with CF and constipation. We will recruit a total of 20 patients with CF and constipation (defined as Bristol Stool Scale \<4 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks.) Design is a 'Within-Subjects' study by which each enrolled patient will take Maralixibat for 2 weeks total in addition to their stable laxative regimen during the study. Stool consistency \& ease of defecation will be recorded before and during the study period by families of enrolled patients via materials provided by the investigators. Stool consistency and ease of defecation will be compared before and after initiation of Maralixibat. The primary endpoint: Improvement in stool consistency to Bristol scale \>4 in children with CF and constipation. The secondary endpoint: Improvement in ease of defecation in children with CF and constipation. This will be measured via survey using a standardized scale (Bristol Stool Scale) and questionnaires developed by the research team. Analysis will involve comparison of pre-intervention to post-intervention stool consistency \& survey

Phase 2 & 3
Waitlist Available

Children's Hospital Los Angeles

Jaya Punati, MD