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Refractory celiac disease (RCD) is a complex autoimmune disorder much like the more common celiac disease but, unlike celiac disease, it is resistant or unresponsive to at least 12 months of treatment with a strict gluten-free diet. Gliadin, a component of the wheat storage protein gluten, together with similar proteins in barley and rye, are the villains that trigger the immune reaction in celiac disease. The diagnosis of RCD is made by exclusion, especially of any other disorder that can affect the huge number of thread-like projections that line the interior of the intestine (intestinal villi), such as intestinal lymphoma, Crohn's disease, small intestinal bacterial overgrowth or hypogammaglobulinemia.
Biomarker and diagnostic research for refractory celiac disease has been reported in the published literature.
No approved treatments are currently available for refractory celiac disease. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for refractory celiac disease, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for refractory celiac disease. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: Unknown (Unknown prevalence).
1 clinical trial registered, 1 recruiting. Interventions under study include other interventions. Research is primarily sponsored by academic and government institutions.
78 publications have been identified in PubMed for refractory celiac disease. Research spans Clinical Trial Publication (29%), Review / Meta-Analysis (24%), and Case Report / Case Series (14%).
Research Type | Count | % of Total |
|---|---|---|
Clinical study results | 23 | 29% |
Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 3:00 PM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Designated
Exclusivity End |
|---|
Designation Status |
|---|
human immunoglobulin (IgG1K) monoclonal antibody that binds to interleukin 15 | human immunoglobulin (IgG1K) monoclonal antibody that binds to interleukin 15 | Amgen Inc. | 2018 | — | Withdrawn |
Gene therapy approaches for refractory celiac disease have been reported in the published literature.
1 trial found
Research summaries |
19 |
24% |
Patient case studies | 11 | 14% |
Laboratory research | 10 | 13% |
Testing and diagnosis research | 7 | 9% |
Disease patterns and progression | 5 | 6% |
New treatment approaches | 2 | 3% |
Other research | 1 | 1% |
Yang Y (2026). [PMID: 41349355](https://pubmed.ncbi.nlm.nih.gov/41349355/). *Nutrition (Burbank, Los Angeles County, Calif.)*. [Clinical Trial Publication]
Haddadin TM (2026). [PMID: 41814048](https://pubmed.ncbi.nlm.nih.gov/41814048/). *Molecular and cellular pediatrics*. [Basic Science / Preclinical]
Alhashemi M (2026). [PMID: 41543995](https://pubmed.ncbi.nlm.nih.gov/41543995/). *The American journal of case reports*. [Review / Meta-Analysis]
Lüke J (2026). [PMID: 41745092](https://pubmed.ncbi.nlm.nih.gov/41745092/). *Diseases (Basel, Switzerland)*. [Clinical Trial Publication]
Munasinghe S (2026). [PMID: 40998009](https://pubmed.ncbi.nlm.nih.gov/40998009/). *Cellular and molecular gastroenterology and hepatology*. [Basic Science / Preclinical]
Malamut G (2026). [PMID: 42002153](https://pubmed.ncbi.nlm.nih.gov/42002153/). *Gastroenterology*. [Basic Science / Preclinical]
Alfadhli Y (2026). [PMID: 41438188](https://pubmed.ncbi.nlm.nih.gov/41438188/). *Case reports in gastroenterology*. [Case Report / Case Series]
Ye ZY (2026). [PMID: 41783069](https://pubmed.ncbi.nlm.nih.gov/41783069/). *Frontiers in medicine*. [Clinical Trial Publication]
Wang X (2026). [PMID: 41870087](https://pubmed.ncbi.nlm.nih.gov/41870087/). *mSystems*. [Clinical Trial Publication]
Cheng Q (2026). [PMID: 42130353](https://pubmed.ncbi.nlm.nih.gov/42130353/). *Zhongguo Dang Dai Er Ke Za Zhi*. [Clinical Trial Publication]