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Common variable immunodeficiency (CVID) comprises a heterogeneous group of diseases characterized by a significant hypogammaglobulinemia of unknown cause, failure to produce specific antibodies after immunizations and susceptibility to bacterial infections, predominantly caused by encapsulated bacteria.
Biomarker and diagnostic research for common variable immunodeficiency has been reported in the published literature.
No approved treatments are currently available for common variable immunodeficiency. An additional 4 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for common variable immunodeficiency, 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 common variable immunodeficiency. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
18 clinical trials registered, 9 recruiting. Interventions under study include drug therapy, other interventions, procedural interventions, and biologic therapy. Pipeline includes 1 PHASE4, 10 PHASE2, 1 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT04339777](https://clinicaltrials.gov/study/NCT04339777) |
Data assembled from 5 of 12 sources · Last updated Sep 18, 2026, 12:38 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Designated
Exclusivity End |
|---|
Designation Status |
|---|
Leniolisib | Leniolisib | Pharming Technologies B.V. (Pharming Technologies B.V. is a subsidiary of Pharming Group N.V.) | 2025 | — | Designated |
IgA extracted from human milk | IgA extracted from human milk | Lactiga US, Inc. | 2024 | — | Designated |
B Lymphocyte Stimulator | B Lymphocyte Stimulator | Human Genome Sciences, Inc. | 2001 | — | Withdrawn |
Loxoribine | Loxoribine | R. W. Johnson Pharmaceutical Research Institute | 1992 | — | Withdrawn |
Gene therapy approaches for common variable immunodeficiency have been reported in the published literature.
18 trials found
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity |
PHASE2 |
National Cancer Institute (NCI) |
RECRUITING |
[NCT07255157](https://clinicaltrials.gov/study/NCT07255157) | Peripheral Helper T-cells in Common Variable ImmunoDeficiency | NA | University Hospital, Bordeaux | RECRUITING |
[NCT07284641](https://clinicaltrials.gov/study/NCT07284641) | Hematopoietic Stem Cell Transplantation (HSCT) for Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD) | PHASE2 | Paul Szabolcs | RECRUITING |
[NCT02579967](https://clinicaltrials.gov/study/NCT02579967) | Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies | PHASE2 | National Cancer Institute (NCI) | RECRUITING |
[NCT04925375](https://clinicaltrials.gov/study/NCT04925375) | Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease | PHASE2 | Children's Hospital Medical Center, Cincinnati | RECRUITING |
261 publications have been identified in PubMed for common variable immunodeficiency. Kisho has analyzed 179 by research type. Research spans Review / Meta-Analysis (26%), Basic Science / Preclinical (22%), and Epidemiology / Natural History (20%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 46 | 26% |
Laboratory research | 39 | 22% |
Disease patterns and progression | 36 | 20% |
Patient case studies | 34 | 19% |
Testing and diagnosis research | 11 | 6% |
Clinical study results | 7 | 4% |
Other research | 3 | 2% |
New treatment approaches | 3 | 2% |
Yu AJS (2026). [PMID: 41846912](https://pubmed.ncbi.nlm.nih.gov/41846912/). *Front Immunol*. [Case Report / Case Series]
Urdea D (2026). [PMID: 42221876](https://pubmed.ncbi.nlm.nih.gov/42221876/). *World Allergy Organ J*. [Case Report / Case Series]
Sadi Aykan F (2026). [PMID: 41598442](https://pubmed.ncbi.nlm.nih.gov/41598442/). *J Clin Med*. [Basic Science / Preclinical]
Cunningham-Rundles C (2026). [PMID: 41274495](https://pubmed.ncbi.nlm.nih.gov/41274495/). *Ann Allergy Asthma Immunol*. [Review / Meta-Analysis]
Tokunaga R (2026). [PMID: 42219311](https://pubmed.ncbi.nlm.nih.gov/42219311/). *Intern Med*. [Case Report / Case Series]
Huq ME (2026). [PMID: 33085281](https://pubmed.ncbi.nlm.nih.gov/33085281/). *Unknown Journal*. [Review / Meta-Analysis]
Miranda-Bautista J (2026). [PMID: 41324469](https://pubmed.ncbi.nlm.nih.gov/41324469/). *Clin Transl Gastroenterol*. [Diagnostic / Biomarker]
Pescador Ruschel MA (2026). [PMID: 31747194](https://pubmed.ncbi.nlm.nih.gov/31747194/). *Unknown Journal*. [Review / Meta-Analysis]
Butler K (2026). [PMID: 41782401](https://pubmed.ncbi.nlm.nih.gov/41782401/). *Curr Opin Gastroenterol*. [Review / Meta-Analysis]
Matson EM (2026). [PMID: 42219089](https://pubmed.ncbi.nlm.nih.gov/42219089/). *J Allergy Clin Immunol*. [Basic Science / Preclinical]