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    Scott Adams

    Emerging Celiac Disease Treatments: Will Any Allow Gluten Consumption Again? (+Video)

    Reviewed and edited by a celiac disease expert.

    Could any of these treatments eventually replace the gluten-free diet?

    Emerging Celiac Disease Treatments: Will Any Allow Gluten Consumption Again? (+Video) - Save it for a rainy day. by Neal. is licensed under CC BY 2.0.++ Watch the Video ++
    Caption: ++ Watch the Video ++

    Celiac.com 07/07/2025 - For the 1% of the global population with celiac disease, even trace amounts of gluten can trigger debilitating symptoms and long-term intestinal damage. While a strict gluten-free diet remains the only treatment, scientists are now closer than ever to developing therapies that could repair gut damage, reduce symptoms, or even allow limited gluten consumption. This article explores the most promising drugs in development—including their potential to revolutionize celiac disease management—and answers the critical question: Could any of these treatments eventually replace the gluten-free diet?

    Below, we break down the most promising FDA-tracked therapies, their mechanisms, and whether they could one day allow celiac patients to safely eat gluten again.

    1. Immunic Inc. – IMU-856 (SIRT6 Modulator)

    Celiac.com Sponsor (A12):
    Mechanism: Targets SIRT6, a protein involved in gut barrier repair and inflammation control.

    Potential Benefits:

    • May accelerate intestinal healing in celiac patients.
    • Could reduce long-term complications from accidental gluten exposure.

    Gluten Tolerance?
    No – IMU-856 does not block the immune response to gluten. It may help minimize damage but won't allow regular gluten consumption.

    Status: Phase 2 trials (NCT05754743), results expected 2024/2025.

    2. Teva Pharmaceuticals – TEV-53408 (Kappa Opioid Receptor Agonist)

    Mechanism: Activates kappa opioid receptors (KOR) to reduce gut inflammation and permeability.

    Potential Benefits:

    • Could lessen symptoms (diarrhea, pain) from gluten exposure.
    • May protect against minor cross-contamination.

    Gluten Tolerance?
    No – Like IMU-856, it doesn't stop the autoimmune attack. Best for symptom relief, not gluten freedom.

    Status: Phase 2 completed (NCT04437875), awaiting results.

    3. Takeda Pharmaceuticals – TAK-062 (Kuma062, Super Potent Glutenase)

    Mechanism: An enzyme that rapidly breaks down gluten before it triggers an immune response.

    Potential Benefits:

    • If taken with meals, could neutralize small amounts of gluten.
    • Might allow occasional gluten consumption (e.g., dining out safely).

    Gluten Tolerance?
    Partial – The most promising candidate for limited gluten eating, but not a full "cure."

    Status: Phase 2b trials (NCT05078970), potential approval 2026+.

    4. Zedira / Falk Pharma – ZED1227 (Transglutaminase 2 Inhibitor)

    Mechanism: Blocks tTG2, the enzyme that modifies gluten into its immune-triggering form.

    Potential Benefits:

    • Could prevent gluten-induced intestinal damage.
    • Works upstream of the immune response.

    Gluten Tolerance?
    Unlikely – May reduce harm but doesn't eliminate the immune reaction entirely.

    Status: Phase 2b completed, awaiting next steps.

    5. Cour Pharmaceuticals – CNP-101 (Immune Tolerance Therapy)

    Mechanism: Uses nanoparticles to "retrain" the immune system to tolerate gluten.

    Potential Benefits:

    • If successful, could induce long-term immune tolerance, mimicking a "cure."

    Gluten Tolerance?
    Best chance for true gluten freedom – But still early-stage.

    Status: Currently in Phase 2a (previously showed promise in Phase 1).

    6. Provention Bio / Sanofi – PRV-015 (Anti-IL-15 Antibody)

    Mechanism: Blocks IL-15, a cytokine that drives gluten-induced inflammation.

    Potential Benefits:

    • Could reduce refractory celiac disease symptoms.

    Gluten Tolerance?
    No – Focuses on symptom control, not immune tolerance.

    Status: Phase 2 completed, development status unclear.

    Which Treatments Could Eventually Allow Gluten Consumption?

    Drug
    Company
    Mechanism
    Gluten Tolerance Potential
    IMU-856
    Immunic Inc.
    SIRT6 modulator (gut repair)
    No
    TEV-53408
    Teva Pharma
    KOR agonist (symptom relief)
    No
    TAK-062
    Takeda
    Gluten-digesting enzyme
    Partial (best bet)
    ZED1227
    Zedira/Falk
    tTG2 inhibitor
    Unlikely
    CNP-101
    Cour Pharma
    Immune tolerance therapy
    Possible long-term cure
    PRV-015
    Provention/Sanofi
    Anti-IL-15 antibody
    No

    Conclusion: Is a "Gluten-Free Diet-Free" Future Possible?

    • Short-term (2025-2027): TAK-062 (glutenase) offers the best chance for limited gluten consumption, while IMU-856 and TEV-53408 may help with symptom control.
    • Long-term (2030+): CNP-101 (immune tolerance therapy) could be the first true "cure," but it's still in early testing.

    For now, strict gluten avoidance remains necessary, but the pipeline is promising. 

    The future of celiac disease treatment is brighter than ever. While no therapy yet offers complete gluten freedom, drugs like TAK-062 (for occasional gluten exposure) and CNP-101 (a potential long-term immune reset) could dramatically improve quality of life. As these treatments progress through clinical trials, celiac patients may soon have options beyond strict dietary avoidance.

    Want to stay updated? Subscribe to our eNewsletter alerts—we’ll continue tracking these breakthroughs as they move closer to FDA approval.

    Watch the video version of this article:



    User Feedback

    Recommended Comments



    Shelley22

    I am glad that there are so many things that are so many studies out there.

    I thought that CNP-101, or TAK-101 was already in phase 2 studies. Also, I have read some conflicting comments that KAN-101 was very recently terminated early, even though it has shown very promising results. A participant was told that they are losing too much funding from our current administration (which is absolutely abhorrent). Does anyone know what the real story is? 

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    Lotte18

    I find it rather annoying to see the "1% of the global population," endlessly repeated when the latest study out of Italy puts it at 1.6%.  Why are we downplaying our own importance here?

    "An Italian study found that 1 in every 60 children has celiac disease, a rate higher than expected. The study, led by Elena Lionetti, conducted a mass screening of children age 5-11 from eight different Italian provinces and found the overall prevalence of celiac disease to be 1.6%, a much greater percentage than previously thought."

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    Scott Adams

    You bring up a valid and important point. The persistent citation of the "1% of the global population" figure can indeed feel outdated, especially when newer, well-conducted studies like the one from Italy suggest that the actual prevalence—particularly in children—may be significantly higher. The Italian study by Elena Lionetti showing a 1.6% rate in screened children highlights how undiagnosed celiac disease still is, and that mass screenings reveal a more accurate picture than symptom-based diagnoses alone. However, more studies are needed to confirm that the overall global prevalence is higher than 1%, which is why the default level cited is still 1%.

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    Lotte18

    How about we turn the tables and start using the 1.6% until that is challenged with these so called "needed" studies?  I for one feel trust Elena Lionetti's study.  It was a mass screening and no one is contesting it so why not go with that?  If there are doubters out there they can cough up the research dollars to prove otherwise.  We should not be voluntarily downplaying ourselves.  It's absurd.

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    Scott Adams

    It is a single study done on children within a single country in Europe, so it's results can't be projected onto the entire world for both adults and children, and over all ethnic groups in the world. The 1% figure is an approximation based on the results of many studies that have been done worldwide on both adults and children.

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    Lotte18

    We know that many of those studies are outdated.  The prevalence of new testing capabilities is continually changing the landscape.  And as you say it's an approximation, not gospel.  The real number is unknown and may never be known.  Are we all so complacent that we are just going to keep echoing the 1% figure?  Why aren't we elevating Lionetti's study instead of treating it like a quaint anecdote?  No one in any other country, anywhere in this world benefits from a lesser number.  What if the prevalence of this disease is 1.9% in say Lithuania?  Or 2% in Kentucky?  There may never be conclusive testing done in either place.  The 1% figure is just as much a projection as the 1.6% would be.  Furthermore, if the 1% is supposed to factor in this multiplicity of studies, it should now include the results of Lionetti's study.  Surely her study would increase the percentage by something!  

     

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    Marish

    I have mixed feelings about this.  A total “cure” would be optimal, but anything less might dilute the current market influence for gluten-free foods that Celiac and gluten-intolerance sufferers have now, with products and restaurants offering gluten free foods, and food testing required for certified gluten free labeling.   I also fear that as with any medications, the list of side effects might be unacceptable to some or many and yet it will be perceived that every Celiac sufferer should just take a pill.  Those who might choose not to take medication might be treated harshly, and we might return to the days of just eat what you are given and don’t complain.  

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    trents

    Marish makes a good point. Even if there is an effective "pill" therapy developed, how expensive will it be and will insurances cover it?

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    N00dnutt

    When I was diagnosed in 2013, I did some research and came across an article from the Mayo Clinic. It suggested that approximately 40% of the global population was walking around with undiagnosed Coeliacs or, some level of Gluten Intollerance.

    My Brother, exihibits the same external and Endocrynic patterns as I do, but! insists he is not a Coeliac and refuses to get tested; he added, even if he is, at his age, he has zero intention of changing his diet because he has tried my Gluten Free menu and was like, yeah, nah, not ever going to do that.

    It's not to far a stretch to imagine the Mayo Clinic's revalation, (given the amount of garbage manufacturing companies put in our foods and liquids [Fluoride], [Propyline Glycol]) that their figure will become a reality.

    CNP-101 sounds the most promising, I hope i'm still here in 2030 to see it come to fruition.

    Footnote:

    Australia has a much stricter definition of the term "Gluten Free", it's marker is 20 parts per Million, whereas, many other countries use 40 parts; we also label Oats as "Wheat Free", not "Gluten Free". the consumption of Oats has always been a hot topic of conversation. Coeliac.org cites that any consumption needs to be clinically monitored by your Endocrinologist to ensure you're not doing damage.

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    trents

    @N00dnutt, can you find that article from the Mayo Clinic? That one would be a handy one to have for education purposes.

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    N00dnutt

    Hi @trents. Apologies, I did a search for the article and cannot find it. Given it was a generalised comment in the article, it could have been removed as no citations could be applied to it.
    I did find this other article produced more recently that does not surprise me, given the data it presents.
    https://celiac.org/wp-content/uploads/2018/06/Global-prevalence-of-celiac-disease_GGH_2018.pdf

    This Extract shows global preverlance for celiac disease, not surprising, Australia has 51-75%, shockingly, South America is 76-100%, that concerning:

     

    Screenshot from 2025-07-17 13-26-25.png

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    N00dnutt

    Hi @trents. Apologies, I did a search for the article and cannot find it. Given it was a generalised comment in the article, it could have been removed as no citations could be applied to it.
    I did find this other article produced more recently that does not surprise me, given the data it presents.
    https://celiac.org/wp-content/uploads/2018/06/Global-prevalence-of-celiac-disease_GGH_2018.pdf

    This Extract shows global preverlance for celiac disease, not surprising, Australia has 51-75%, shockingly, South America is 76-100%, that concerning:

    Some information as to how the data was put together.

    Screenshot from 2025-07-17 13-40-29.png

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  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994, and, due to the nearly total lack of information available at that time, was forced to become an expert on the disease in order to recover. In 1995 he launched the site that later became Celiac.com to help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives.  He is co-author of the book Cereal Killers, and founder and publisher of the (formerly paper) newsletter Journal of Gluten Sensitivity. In 1998 he founded The Gluten-Free Mall which he sold in 2014. Celiac.com does not sell any products, and is 100% advertiser supported.


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