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First Licensed Celiac Treatment Heads to Phase 3 Trials

A drug to treat celiac disease could very well be just around the corner. Alba Therapeutics is on the FDA fast track, and we're here to share with you all of the details of this exciting development! 

Since celiac disease still continues to cause pain even for those on a strict gluten-free diet, there is a high demand for adjunctive therapies and treatment options. Enter Alba Therapeutics, who have developed a treatment for celiac disease that is the first to enter phase 3 clinical trials, and could be available before we know it. 

Who is Alba Therapeutics? 

Alba Therapeutics is a Maryland based biopharmaceutical company focused on the development of treatments for autoimmune and inflammatory diseases. They have decided to focus their research specifically on celiac disease, and for the past 10 years have been developing Larazotide Acetate, a compound aimed to help individuals with celiac disease by fighting leaky gut and other symptoms experienced due to gluten ingestion. Alba's multiple clinical trials have consistently demonstrated a reduction in symptoms of celiac disease in more than 800 patients. Alba has recently renamed the compound INN-202. 

What Exactly Does This Drug Do?

INN-202, or Larazotide Acetate, helps to regulate tight junctions, which are located in the bowel, and in healthy people remain closed except to shed dead cells. In individuals with celiac disease, the presence of gluten causes these tight junctions to remain open, thus leading to an inflammatory downward spiral of symptoms that eventually destroys the intestinal villi (tiny, finger-like projections that are crucial in aiding the body's absorption of vital nutrients). 

Alba Therapeutics' research suggests that larazotide acetate helps to keep the tight junctions closed when taken before a meal, thus reducing or stopping the domino effect of symptoms and intestinal damage. 

Does This Mean We'll Be Able to Eat Gluten?

Unfortunately, the compound would work in conjunction with a gluten-free diet, not in place of it. By taking it before a meal, the idea would be to minimize any effects of accidental gluten ingestion. 

Research shows that up to 65% of those with celiac disease who are on a strict gluten-free diet continue to be exposed to and to suffer from accidental gluten exposure. Because the symptoms of gluten exposure can be so painful and socially debilitating, these types of treatments are especially important. 

When Will It Be Available? 

Alba has been designated by the FDA to have "fast track status," and is set to start phase 3 clinical trials in "late 2016." This makes INN-202 potentially the first treatment that will be available to the public to combat celiac disease. 

And what does phase 3 even mean? Basically, this is the final countdown. Alba has already passed the tests with flying colors regarding whether this drug works to treat symptoms of gluten exposure - now it's just some final rounds of safety tests and (fingers crossed) this product can be made available to the public.

This is very exciting news! We hope to bring you updates about Larazotide Acetate later on this year, as well as news regarding the other celiac treatments currently being developed. 

 Learn more about supplements for people with Celiac and gluten-sensitivity.



Donna Marshall:

This is exciting. I can’t wait.

Sep 07, 2016


Will this work for people who have dermatitis herpeteformis? This is my reaction to gluten and I am super sensitive. I have been gluten free for 5 years now.

Sep 06, 2016


Sounds hopefull; diagnosed 20+ years I’d be most interested to know if and when this becomes available

Sep 06, 2016

Marianne marston:

Oh thank goodness. 15 years since diagnosis and despite the strictest gfd there has barely been a day without pain or other symptoms. I cannot wait for this to become available. My only concern is that, living in England I have to hope the NHS considers pain relief of coeliacs important enough to provide the drug. My husband has chronic kidney problems first diagnosed last October, he only got to have the ct scan he needs for accurate diagnosis 3 weeks ago. I can’t see something as “minor” as a leaky gut getting prioritised :-(

Sep 06, 2016

Pam Wagner :

I was misdiagnosed for 10 horrible years, I was ready to die. I have severe Celiac and have GF for 17 years. The cross contamination is always a problem. This medication could make my life so much better. I wonder about side effects or contraindication. So excited this is on the fast track.

Sep 06, 2016

Farah Hamid:

That’s great news !!
Please keep me updated.
My daughter was diagnosed with coeliac disease 3years ago and come struggled to come to terms with it.
She is 13years old now.
This drug could be what she needs

Sep 06, 2016


Even on a Gluten free diet I have pain daily. Usually my pain level is anywhere from a 6-8 for the last 9 years. Please keep me posted on when this is available to try. My daughter whose 20 and now grand daughter are being tested for unexplained abdominal pain. My daughters endoscopy doesn’t show celiac but is in pain every time she eats. Hoping this will help her too.

Jul 19, 2016

Teri L:

Please keep me updated. Last month was my 25th year of being Celiac and gluten free. I’m looking foward to someday not having side effects.

Jul 18, 2016

Pam Santos:

Diagnosed 3/12 with Celiac disease and in 2014 Refractory 2. Will INN-202 help with refractory as well

Jul 18, 2016

Terry Williams :

Yes I have celiac disease and this news is exiting to hear, please keep me updated on when this medicine becomes available, Thanks Terry Williams

Jun 06, 2016

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