basiliximab
Trade name: Simulect
mAbapprovedOrphan Drug FDA
Approved
May 12, 1998
Basiliximab, sold under the brand name Simulect, is a monoclonal antibody used to prevent rejection in kidney transplants. It is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is used in combination with other medicines used to prevent organ rejection. — Wikipedia
Clinical trial activity
100 trials · 99 clinical orgs · 1 marketing orgs
Phase 1
10
Phase 2
53
Phase 3
22
Phase 4
31
Earliest trial started May 1, 2000 (NCT00235300)
Timeline
1990s
Indications
Approved for
Studied for
- Allografts · Phase 2
- Amyotrophic Lateral Sclerosis · Phase 2
- Anemia, Aplastic · Phase 2
- beta-Thalassemia · Phase 4
- Brain Neoplasms · Phase 1
- Colitis, Ulcerative · Phase 2
- Corneal Transplantation · Phase 2
- COVID-19 · Phase 2
- Cytokine Release Syndrome · Phase 2
- Cytomegalovirus Infections · Phase 4
- Dermatomyositis · Phase 2
- Diabetes Mellitus, Type 1 · Phase 3
- Diabetic Nephropathies · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Emphysema · Phase 3
- Everolimus · Phase 2/Phase 3
- Glioblastoma · Phase 2
- Glomerulonephritis · Phase 4
- Graft Rejection · Phase 4
- Graft vs Host Disease · Phase 4
- Hematologic Neoplasms · Phase 2
- Hemoglobinuria, Paroxysmal · Phase 2
- Hodgkin Disease · Phase 2
- Infections · Phase 3
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 4
- Kidney Tubular Necrosis, Acute · Phase 1/Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liver Cirrhosis · Phase 4
- Liver Transplantation · Phase 4
- Lung Diseases · Phase 2
- Lymphoma, Extranodal NK-T-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Multiple Myeloma · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Organ Transplantation · Phase 2
- Ovulation Induction · Phase 4
- Pharmacological and Toxicological Phenomena · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Myelofibrosis · Phase 2
- Prostatic Neoplasms · Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Reperfusion Injury · Phase 3
- Sclerosis · Phase 2
- Uremia · Phase 1/Phase 2
- Uveitis · Phase 2
Mechanism of action
Approval history
- approvedMay 12, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaBasiliximab ↗
- NCATS9927MT646M ↗
- ChEMBLCHEMBL1201439 ↗
Also known as
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- basiliximab
- baxiliximab
- chi 621
- chi-621
- chimeric mouse-human anticd25
- chrft5
- sdz chi 621
- sdz-chi-621
- sdz-chi-621
- simulect
- simulect
- simulect
- simulect
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06480630 | Phase 2 | Jul 1, 2024 | Anhui Medical University, Anhui Province Cancer Hospital |
| NCT05385432 | Phase 4 | Jan 15, 2023 | University Hospital, Tours |
| NCT06066840 | Phase 4 | Aug 1, 2022 | Nanjing Medical University, Nanjing University, Nantong University, Soochow University |
| NCT05139004 | Phase 1 | Dec 15, 2021 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT04871607 | Phase 2 | Nov 1, 2021 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT05013034 | Phase 2 | Oct 15, 2021 | Fort Worth Clinical Sciences Working Group, Texas Christian University |
| NCT04773392 | Phase 4 | Feb 28, 2021 | University of Southern California, Veloxis Pharmaceuticals |
| NCT04404127 | Phase 4 | Jun 30, 2020 | King Faisal University |
| NCT04337593 | Phase 2 | Jun 1, 2020 | Capital Medical University |
| NCT04104438 | Phase 4 | Nov 1, 2019 | University of California, Los Angeles |
| NCT04009525 | Phase 4 | Jun 1, 2019 | Guangxi Medical University, Guizhou Medical University, Hacettepe University, Hainan People's Hospital, Jiao Tong University, Liuzhou General Hospital, Peking University, People's Liberation Army of China, The First People's Hospital of Yunan Province |
| NCT03794492 | Phase 4 | Mar 31, 2018 | Ajou University, Chong Kun Dang Pharmaceutical |
| NCT03789006 | Phase 4 | Mar 21, 2018 | University of Khartoum |
| NCT03192657 | Phase 2 | Jul 1, 2017 | Jiao Tong University |
| NCT03171831 | Phase 4 | Apr 1, 2017 | Guangxi Medical University, Hacettepe University |
| NCT02464878 | Phase 2 | Jan 1, 2017 | Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Iowa |
| NCT02921789 | Phase 2 | Dec 22, 2016 | Astellas, Kyowa Hakko Kirin |
| NCT03006419 | Phase 4 | Dec 1, 2016 | Government of Mexico, UMAE Veracruz |
| NCT02723786 | Phase 2 | Aug 27, 2016 | GlaxoSmithKline |
| NCT02561767 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2015 | Guangzhou Medical University, Sun Yat-Sen University |
Showing 20 of 100 trials
Page 1 / 5
Organizations
Research & Development (99)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 28 | 20 | 4 | 2001 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 12 | 11 | 3 | 2001 |
| Astellas | For profit | 9 | 8 | 3 | 2005 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 8 | 0 | 3 | 2006 |
| Emory University | Academic/Hospital | 5 | 1 | 2 | 2006 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 2 | 2007 |
| People's Liberation Army of China | Government | 4 | 2 | 2 | 2014 |
| Cerimon Pharmaceuticals | For profit | 3 | 3 | 1 | 2007 |
| City of Hope National Medical Center | Academic/Hospital | 3 | 3 | 2 | 2012 |
| Duke University | Academic/Hospital | 3 | 3 | 3 | 2007 |
| Genzyme | For profit | 3 | 1 | 3 | 2000 |
| Guangxi Medical University | Academic/Hospital | 3 | 2 | 1 | 2014 |
| Hacettepe University | Academic/Hospital | 3 | 1 | 1 | 2014 |
| Harvard University | Academic/Hospital | 3 | 1 | 2 | 2001 |
| Jiao Tong University | Academic/Hospital | 3 | 2 | 3 | 2005 |
| University of Alberta | Academic/Hospital | 3 | 0 | 2 | 2006 |
| Uppsala University | Academic/Hospital | 3 | 0 | 2 | 2006 |
| Ajou University | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Clinical Trials in Organ Transplantation | Government | 2 | 0 | 1 | 2011 |
| Fujian Medical University | Academic/Hospital | 2 | 0 | 2 | 2005 |
99 organizations
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