Table 1.
Summary of clinical trials focusing on orally administered Ab delivery described in this review.
| # | Administrated Drug | Formulation/Co-Administrated Drug | Disease | Sponsor | Phase | Study Start Date | Study Completion Date | ClinicalTrials.gov Identifier (accessed on 23 January 2021) |
Status | References |
|---|---|---|---|---|---|---|---|---|---|---|
| (i) | Oral V565 | Crohn’s disease | VHsquared Ltd. | Phase 2 | December 2016 | December 2018 | NCT02976129 | Unknown | - | |
| (ii) | Oral V565 | Capsule | Ulcerative colitis | VHsquared Ltd. | Phase 1 | October 2017 | October 2017 | NCT03705117 | Completed | - |
| (iii) | Oral AVX-470 | Enteric-coated capsule | Ulcerative colitis | Avaxia Biologics, Incorporated | Phase 1 | February 2013 | December 2013 | NCT01759056 | Completed | [23] |
| (iv) | Oral muromonab-CD3 | Omeprazole | Ulcerative colitis | Brigham and Women’s Hospital | Phase 1 Phase 2 |
April 2011 | May 2013 | NCT01287195 | Completed | [24] |
| (v) | Oral foralumab | Omeprazole | NASH, NAFLD, Type 2 diabetes mellitus |
Tiziana Life Sciences, PLC | Phase 2 | December 2017 | June 2019 | NCT03291249 | Withdrawn | [25] |
| (vi) | Oral muromonab-CD3 | NASH | Hadassah Medical Organization | Phase 2 | September 2010 | April 2011 | NCT01205087 | Completed | [26] | |
| (vii) | Oral anti-CD3 mAb | Omeprazole | Chronic hepatitis C | Inspira Medical AB | Phase 2 | November 2011 | October 2013 | NCT01459419 | Unknown | - |
| (viii) | Oral omalizumab | Milk allergy | Hugh A Sampson, MD | Phase 2 | August 2010 | October 2015 | NCT01157117 | Completed | [27] | |
| (ix) | Oral omalizumab | Peanut Allergy | Lynda Schneider | Phase 1Phase 2 | February 2011 | September 2013 | NCT01290913 | Completed | [28] | |
| (x) | Subcutaneous omalizumab | Peanut Allergy, Multi-food Allergy |
National Institute of Allergy and Infectious Diseases | Phase 3 | July 2019 | December 2023 | NCT03881696 | Recruiting | - | |
| (xi) | Oral AGY | Capsule | Celiac disease | Igy Inc. | Phase 1 | May 2014 | August 2015 | NCT01765647 | Completed | - |
| (xii) | Oral AGY | Capsule | Celiac disease | Igy Inc. | Phase 2 | October 2019 | December 2022 | NCT03707730 | Recruiting | - |
| (xiii) | Oral Oralgam | Autistic Disorder, Gastrointestinal Diseases | PediaMed Pharmaceuticals | Phase 2 | April 2005 | June 2006 | NCT00110708 | Unknown | [29] | |
| (xiv) | Oral TAO1 | Tablet | Common Cold | Theranor s.p.r.l | Phase 1Phase 2 | September 2012 | August 2013 | NCT01651715 | Completed | [30] |
| (xv) | Oral anti-influenza antibody | Tablet | Influenza | Hadassah Medical Organization | Phase 1 | January 2010 | January 2011 | NCT01026350 | Unknown | - |
| (xvi) | Oral anti-CsbD bovine IgG, Oral anti-CS17 bovine IgG |
Diarrhea | Johns Hopkins Bloomberg School of Public Health | Phase 2 | January 2007 | October 2007 | NCT00524004 | Completed | [31] | |
| (xvii) | Oral anti-CFA/I bovine IgG, Oral anti-CfaE bovine IgG |
Diarrhea | Johns Hopkins Bloomberg School of Public Health | Phase 1 | March 2006 | October 2006 | NCT00435526 | Completed | [32] | |
| (xviii) | Oral SBI | Mucositis | MercyOne Des Moines Medical Center | Phase 2 | January 2020 | December 2021 | NCT04239261 | Recruiting | - | |
| (xix) | Oral SBI | HIV-associated enteropathy | Entera Health, Inc | Not applicable | April 2013 | September 2014 | NCT01828593 | Completed | [33] | |
| (xx) | Oral SBI | Female reproductive cancer | Mayo Clinic | Phase 2 | October 2013 | October 2021 | NCT01867606 | Active, not recruiting | - | |
| (xxi) | Oral SBI | Advanced COPD with cachexia | Medical University of South Carolina | Not Applicable | December 2013 | April 2016 | NCT02067377 | Completed | - | |
| (xxii) | Oral SBI | Diarrhea-predominant irritable bowel syndrome | Mayo Clinic | Not Applicable | June 2014 | November 2016 | NCT02163213 | Completed | - | |
| (xxiii) | Oral SBI | Irritable bowel syndrome | Louisiana State University Health Sciences Center in New Orleans | Not Applicable | March 2017 | March 2017 | NCT02609529 | Completed | - | |
| (xxiv) | Oral antibodies in colostrum | Clostridium difficile-associated diarrhea | Hadassah Medical Organization | Phase 2Phase 3 | September 2011 | November 2013 | NCT00747071 | Withdrawn | - | |
| (xxv) | Oral mAbs | Enteric nanoparticles | Systemic treatment | Under analysis in Tashima lab | - |