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

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.

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