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thanks, Robert! sounds promising! i'm glad they fast tracked it.
 
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Thought I should provide a little updated summary of which drugs currently are in the Pipeline for IBS-C, concerning only 505B1&505B2 filings at the FDA or corresponding agencies. Drugs mentioned above which are being investigated for chronic constipation, obstruction etc. are also included in the list but they would have to be used off-label. You can find information about ongoing trials below the Pipeline.

If you're aware of any other drugs under development please comment below. (Can't create a table in this forum so excuse the less beautiful columns)

Pipeline:

Name/ dev.Code----------Company--------------------------Mechanism of Action --------------------------------- IBS sub-type----------------------------Status------------------------Ongoing Trial--

Olorinab----------------Arena Pharmaceuticals--------------CB2 agonist---------------------------------------------------IBS-Pain----------------------------Phase 2B ongoing--------------NCT04043455----

Tenapanor-------------Ardelyx-----------------------------------NHE3 Inhibitor------------------------------------------------IBS-C--------------------------------FDA Approved as IBSRELA

SYN-010---------------Synthetic Biologics--------------------HMG-CoA reductase inhibitors--------------------------IBS-C---------------------------------Phase 2 ongoing----------------NCT03763175

Naronapride-----------Renexxion-------------------------------5-HT4 agonist------------------------------------------------IBS-C---------------------------------Phase 2

Blautix------------------4D Pharma PLC-----------------------Gastrointestinal microbiome modulators---------------IBS-Pain----------------------------Phase 2----------------------------NCT03721107

TD-8954---------------Theravance Biopharma--------------5-HT4 agonist-------------------------------------------------Motility disorders------------------Phase 2

RQ-00000010--------RaQualia---------------------------------5HT-4 agonist-------------------------------------------------Motility disorders------------------Phase 1

Drugs in ongoing trials

Olorinab (APD371), is a painkiller for all IBS sub-types (78% of patients suffer from abdominal pain). It is currently under development by Arena Pharmaceuticals and has now entered into another Phase 2 Clinical Trial (NCT04043455). Olorinab lessens pain by targeting the Cannabinoid Type 2 Receptor (CB2). The compound is peripherally acting and highly selective which means it lacks psychotropic effect (it doesn't make you high), which is quite important when targeting the Cannabinoid system. Last year Arena published results of an exploratory Phase 2a safety and efficacy trial, which showed a good safety profile and an average pain reduction of 82% in patients with Crohn's Disease in remission, suffering the same type of pain IBS patients do.

To participate in the Phase 2 study, click here to get further information from Arena or give them a call if you're in the US at 855-634-0290.

SYN-010 is a reformulation of the already approved drug Lovastatin, which is intended to reduce methane-production by certain microorganisms (M. smithii) to combat bloating, pain and constipation in patients with IBS-C. By using a delayed release formula it's designed to act primarily in the intestinal lumen while avoiding systemic absorption and thus enhancing its efficacy. SYN-010 is being developed by Synthetic Biologics and is currently in Phase 2 clinical trials (NCT03763175).

To participate in the Phase 2 study, click here to contact Synthetic Biologics.

Blautix is a single-strain human gut commensal bacteria which is being investigated for the treatment of IBS. By its distinct metabolism Blautix consumes gases which are known to cause bloating, abdominal pain and changes in bowel frequency. 4D Pharma is currently conducting a Phase 2 clinical trial (NCT03721107) to see if Blautix is effective in both IBS-C and IBS-D patients.

To participate in the Phase 2 study, click here to get more information.
 

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thanks, Robert, for all your work on this--appreciate it! very informative.
 
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I have just signed up for a clinical trial in Boston (at Beth Israel Hospital) for the vibrating pill that aids in constipation.

I go for the first evaluation on January 6, but I passed the priliminary phone interview today.

I have to say, I am super excited! I found out about this by googling clinical trials for constipation in Massachusetts. I cannot find this on the clinical trial.gov website.

During the trial, you cannot take any prescription medicine or over the counter laxatives. However she said that if I don't produce a bowel movement in 3 consecutive days, I would be able to take a laxative as a "rescue." I found that kind of funny - 3 days without a bowel movement is totally normal for me - definitely not a scary situation that I would need "rescuing" from...

I will update with more info next month!!

This gives me hope - if anything I will have access to some GI doctors for free. The interviewer knows the doctor who gave me my colonoscopy on December 3, and said doctor is part of the study. They will examine me, do blood work, etc - maybe this can shed some light on my issues... fingers crossed ...
 

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oh that's great! hope it helps you. good luck! and thanks for keeping us posted.
 

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I have just signed up for a clinical trial in Boston (at Beth Israel Hospital) for the vibrating pill that aids in constipation.

I go for the first evaluation on January 6, but I passed the priliminary phone interview today.

I have to say, I am super excited! I found out about this by googling clinical trials for constipation in Massachusetts. I cannot find this on the clinical trial.gov website.

During the trial, you cannot take any prescription medicine or over the counter laxatives. However she said that if I don't produce a bowel movement in 3 consecutive days, I would be able to take a laxative as a "rescue." I found that kind of funny - 3 days without a bowel movement is totally normal for me - definitely not a scary situation that I would need "rescuing" from...

I will update with more info next month!!

This gives me hope - if anything I will have access to some GI doctors for free. The interviewer knows the doctor who gave me my colonoscopy on December 3, and said doctor is part of the study. They will examine me, do blood work, etc - maybe this can shed some light on my issues... fingers crossed ...
MarciaDS,

Any news on the vibrant capsule? I've been excited about this ever since I saw your message last month. Please report in with your experiences and what you think about it.

I tried to get in on a trial last year and I kept getting the runaround and never got in.
 

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I called up the Gastroenterologist in Augusta, GA who is conducting the Vibrant trial this morning and they have accepted me into their trial if I want to do it. It's going to be tough because I have no idea if it will help me, or if I will even get the actual capsules instead of a placebo, and I can't take any of my usual stuff to help me go.

But I'm leaning towards doing it because its such a unique opportunity.
 

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This does seem like a promising treatment. I agree, though, that it could be challenging to take part in the trials. For instance, if it doesn't work, placebo or otherwise, how long can you endure being untreated? I'd find it difficult.
 

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WGButler---that's great that you have been accepted into the vibrant clinical trail if you want to go ahead with it.

from what Marcia said, it sounds like you can take a rescue laxative if you don't have a bm for three consecutive days.

good luck if you do decide to go ahead with it. hope you get the real thing instead of a placebo! and hope it works for you.
 

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Just wanted to remind the forum that SYN-010 is due to conclude its phase 2 study this month and we can expect a press release soon as well. Let's hope it performed well!
 

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thanks, Robert.

yes, let's hope that SYN-010 is an effective drug and will be put on the market soon.
 
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I'll be interested in learning how folks do with Tenapanor, especially those who've not had much luck with other prescription meds. It's availability seems somewhat limited at the moment, and cost usually is dependent on insurance coverage. My Motegrity+MoM is still working well, but I'd like to stay up to date on the new drugs that come out, as every one seems to work for limited time frames. Tenapanor seems more related to the Linzess type of drugs, as it adds liquid to the colon.
 

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Yes that is right, Tenapanor belongs to the so called secretagogues drugs as opposed to prokinetics. There is pre-clinical evidence for some action on the TRPV1 receptor as well which facilitates some pain relief. Linzess pain relief works via cGMP instead. The question is rather how well a patient fits the specific mechanism, so it's probably best to stay on top of the pharmacology in case the G.I. is not sensitive to the fact that patients can be constipated for different reasons.

I'd also like to hear how well patients are responding to the treatment, however I want to stress the fact that there is considerable heterogeneity amongst IBS patients. This means of course that not only will we have people with non secretory issues primarily trying out the medication but also people with minor and major constipation. So I wouldn't be surprised if some will get diarrhea and some will still have an inadequate relief, just because the span of symptom severity is so large.

The statistics seem decent for an IBS study, we can be happy the Placebo group didn't take off above 25% so that's great:

"The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (36.5% vs. 23.7%, p<0.001) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period."

Source: http://ir.ardelyx.com/news-releases/news-release-details/ardelyxs-pivotal-phase-3-study-tenapanor-ibs-c-hits-primary-and
 

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Thanks for your comment. My issue primarily seems to be motility, so I'm hopeful that Motegrity will continue to work. It's not perfect, and I'm beyond the time frame studied in the trials. As I mentioned, I do need an osmotic adjunct, as prokinetics may need more fluid to make BMs easier to pass. Balancing motility and softening can be a little challenging. My theory is that peristalsis requires some bulk to be effective, and too much softness makes stool "squishy" and more difficult to move down and out. I've been through Linzess, Amitiza, and Trulance. I have chronic C and not IBS, nor do I have any pain. I've always had a daily BM, but suffered with them being incomplete or difficult to pass, so I'm more fortunate to many of the other list members. I'm looking forward to the "vibrating" pill, in case my Motegrity fails at some point. I'm unaware of any other prokinetics available now or in the works.
 

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I see, yes if there is no pain than that's clear. Motegrity is a 5HT-4 agonist like most prokinetics getting to market. I think you're right about the combination of the 2 drug classes as well, trial and error will have to keep guiding you.

Other 5HT-4 agonists in development: RQ-00000010, Naronapride and Velusertag.,
 
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