Drugs / Basiliximab
Basiliximab
also known as
Simulect · Basiliximab (Simulect) · Basiliximabe · CHI-621 · SDZ-CHI-621 · Simulect (basiliximab)
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SIMULECT | — | 2001-03-22 – 2001-03-23 | fda.gov ↗ |
| Approved | EU (EMA) | Simulect | — | 1998-10-09 | europa.eu ↗ |
| Approved | US (FDA) | SIMULECT | — | 1998-05-12 | fda.gov ↗ |
Trials 38 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 73 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07572071 Background | Aug 2025 → Aug 2028 expected | Parkinson disease | Royan Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05139004 Background | Jul 2022 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01476839 Background | Nov 2012 → Jul 2021 | Hodgkins lymphoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT02561767 Background | Oct 2015 → Oct 2016 | acute kidney tubular necrosis | First Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02492490 Comparator | Dec 2014 → Nov 2016 | uremia | Fuzhou General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT02492308 Comparator | Dec 2014 → Dec 2016 | — | Fuzhou General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT00752479 Background | May 2008 → Jul 2013 | — | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded |
| Phase 1/2 | NCT00566813 Comparator | Nov 2004 → Jul 2010 | type 1 diabetes mellitus | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07572669 Background | Sep 2025 → Mar 2027 expected | acute graft versus host disease | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT04871607 Background | Nov 2021 → Oct 2029 expected | Hodgkins lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03663335 Background | Nov 2018 → Oct 2021 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02921789 Background | May 2017 → Dec 2020 | primary focal segmental glomerulosclerosis | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02464878 Background | Jan 2017 → Nov 2022 | type 1 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02723786 Background | Aug 2016 → Mar 2017 | disease related to solid organ transplantation | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT02694770 Comparator | Jul 2016 → Sep 2017 | acute graft versus host disease | AbGenomics B.V Taiwan Branch | Withdrawn | No outcome recorded |
| Phase 2 | NCT02770430 Comparator | Sep 2015 → Sep 2017 | acute graft versus host disease | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 2 | NCT01884571 Background | Oct 2013 → Jan 2016 | amyotrophic lateral sclerosis | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT01780844 Background | Mar 2013 → Jun 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00468403 Background | Oct 2008 → Apr 2012 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00789308 Background | Jul 2008 → Jul 2013 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00790439 Background | Jul 2008 → Oct 2009 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 2 | NCT00543569 Comparator | Feb 2008 → Feb 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00555321 Background | Jan 2008 → Mar 2010 | disease related to solid organ transplantation | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT00464555 Background | Dec 2006 → Nov 2011 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00434850 Background | Oct 2006 → Sep 2011 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00023244 Background | Jan 2001 → Jun 2005 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00235300 Comparator | May 2000 → Apr 2003 | acute transplant rejection | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02241018 Background | Sep 2014 → Sep 2018 | acute graft versus host disease | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01120028 Comparator | Sep 2010 → Feb 2014 | — | University of Oxford | Completed | No outcome recorded |
| Phase 2/3 | NCT00729768 Background | — | — | Genentech, Inc. | Withdrawn | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT05385432 Comparator | Nov 2023 → Dec 2030 expected | transplant rejection | University Hospital, Tours | Recruiting | No outcome recorded |
| Phase 3 | NCT04738981 Background | Feb 2021 → May 2022 | graft versus host disease | Peking University People's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01843348 Background | Dec 2012 → Mar 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01625377 Background | Dec 2012 → Mar 2015 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01239563 Comparator | Jan 2011 → May 2012 | ischemic disease | University of Oxford | Unknown | No outcome recorded |
| Phase 3 | NCT01079143 Background | Sep 2009 → Jun 2012 | renal fibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00933231 Background | Aug 2009 → May 2015 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01028092 Comparator | Mar 2009 → Mar 2014 | — | University Hospital, Brest | Completed | No outcome recorded |
| Phase 3 | NCT00658320 Background | Feb 2008 → Aug 2010 | — | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00679042 Background | Sep 2007 → Jul 2017 overdue | type 1 diabetes mellitus | CellTrans Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00514514 Comparator | Jul 2007 → Jun 2015 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00468117 Background | Jan 2007 → Jul 2015 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00434811 Background | Oct 2006 → Sep 2012 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00378014 Background | Aug 2006 → Jan 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00251004 Background | Oct 2005 → Aug 2009 | transplant rejection | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00154284 Background | Jul 2005 → Jul 2008 | disease related to solid organ transplantation | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00149890 Background | Mar 2004 → Mar 2009 | infectious disease | Novartis | Completed | No outcome recorded |
| Phase 422 trials | ||||||
| Phase 4 | NCT04773392 Comparator | Nov 2021 → Feb 2024 | transplant rejection | University of Southern California | Terminated | No outcome recorded |
| Phase 4 | NCT04104438 Comparator | Jan 2021 → Sep 2024 | — | Fady M Kaldas, M.D., F.A.C.S. | Completed | No outcome recorded |
| Phase 4 | NCT04404127 Comparator | Sep 2020 → May 2023 | — | King Faisal Specialist Hospital & Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT03794492 Background | Mar 2018 → Jul 2022 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT03789006 Comparator | Mar 2018 → Mar 2022 | transplant rejection | University of Khartoum | Unknown | No outcome recorded |
| Phase 4 | NCT03171831 Background | Apr 2017 → Dec 2021 | beta-thalassemia major | First Affiliated Hospital of Guangxi Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03006419 Comparator | Dec 2016 → Jul 2019 | transplant rejection | Coordinación de Investigación en Salud, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT02056938 Comparator | Jun 2014 → Feb 2017 | — | Nantes University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02683291 Background | Jan 2014 → Jan 2015 | cytomegalovirus infection, disease related to solid organ transplantation | Associação Médico Espírita de Botucatu | Completed | No outcome recorded |
| Phase 4 | NCT01950819 Background | Dec 2013 → Feb 2017 | end stage renal failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01435291 Background | Oct 2011 → May 2013 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 4 | NCT01817322 Background | Jun 2011 → Aug 2013 | chronic kidney disease | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01304836 Background | Jan 2011 → May 2013 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02523768 Comparator | Jan 2011 → Jan 2020 | IgA glomerulonephritis | University Hospital of Saint-Etienne | Terminated | No outcome recorded |
| Phase 4 | NCT01002339 Background | Feb 2010 → Feb 2014 | type 2 diabetes mellitus | Armando Torres Ramírez | Terminated | No outcome recorded |
| Phase 4 | NCT00965094 Background | Dec 2009 → Jun 2013 | chronic renal failure syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00717470 Comparator | May 2008 → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00634920 Background | Mar 2008 → May 2013 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00369161 Comparator | Jun 2006 → Dec 2008 | — | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00296244 Background | Feb 2006 → May 2008 | cirrhosis of liver | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00113269 Comparator | May 2005 → Mar 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00149994 Background | Dec 2002 → Dec 2007 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02095418 Comparator | Feb 2014 → Feb 2018 | diabetes mellitus | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT02459977 Comparator | Apr 2012 → Jun 2015 | — | Asan Medical Center | Unknown | No outcome recorded |
| — | NCT01137084 Comparator | Jan 2005 → Jan 2008 | hepatocellular carcinoma, immunodeficiency disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01049633 Background | — | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | No longer available | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Basiliximab | “Basiliximab 20mg dose for adults and 10mg for children, 1 time a week or every 3 days if worsens the stage of GVHD until reaching Very Good Partial Response (VGPR) or for a...” NCT02770430 ↗100“Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3,...” PMID 35255929 ↗ Mar 2022 “The anti CD25 (basiliximab, Simulect®) is administered intravenously before surgery of renal transplantation (Day 0 and Day + 4 (1 ampoule of 20 mg x 2 times).” NCT02523768 ↗ “receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.” NCT01137084 ↗ “clinical trials and an overall understanding of the molecular mechanisms of MSCs combined with basiliximab for SR-aGVHD are limited” PMID 38413930 ↗ Feb 2024 “Ruxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease.” NCT05021276 ↗ “All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.” NCT01950819 ↗ “methotrexate, basiliximab, daclizumab, inolimomab, denileukin diftitox, alemtuzumab, ATG+ etanercept” NCT02694770 ↗ “Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant” NCT00679042 ↗ “anti-CD25-mAB (basiliximab 20 mg on day 0 and day 4 after the procedure)” NCT00604357 ↗ “Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.” NCT00626015 ↗ “Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks)” NCT02095418 ↗ “including ruxolitinib, basiliximab, or methotrexate” NCT07572669 ↗ “Drug: Basiliximab IV infusion Other Name: Simulect” NCT01435291 ↗ “Basiliximab induction (4 mg i.v., days 0 and 4).” NCT01002339 ↗ “Basiliximab, Tacrolimus, Prednisolone” NCT07572071 ↗ “two doses of basiliximab 20 mg iv.” NCT00566813 ↗ “Simulect (basiliximab)” NCT00235300 ↗ “Basiliximab” NCT04738981 ↗ “Basiliximab” NCT03789006 ↗ |
| Known as | Basiliximab (Simulect) | “Basiliximab (Simulect®)” NCT00679042 ↗1“Basiliximab: Simulect” NCT00890253 ↗ |
| Known as | Basiliximabe | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01354301 ↗ |
| Known as | CHI-621 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201439 ↗ |
| Known as | SDZ-CHI-621 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201439 ↗ |
| Known as | Simulect | “REGULATory T-Cell Inhibition With Basiliximab (Simulect®) During Recovery From Therapeutic Temozolomide-induced Lymphopenia During Antitumor Immunotherapy Targeted Against...” NCT00626483 ↗17“The anti CD25 (basiliximab, Simulect®) is administered intravenously before surgery of renal transplantation (Day 0 and Day + 4 (1 ampoule of 20 mg x 2 times).” NCT02523768 ↗ “The infusion of Basiliximab (Simulect® (20mg)) starts before the surgery on peripheral vein for 15 minutes and the second infusion at day 4.” NCT05385432 ↗ “Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients” NCT00409656 ↗ “Basilixumab(Simulect®) will be given just prior to transplant” NCT01817322 ↗ “Simulect® (Basiliximab) - at 2nd or 3rd transplant” NCT00789308 ↗ “anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)” NCT01028092 ↗ “Basiliximab 20 milligram [Simulect]” NCT04404127 ↗ |
| Known as | Simulect (basiliximab) | “Simulect (basiliximab)” NCT00928811 ↗ |
| Action | Inhibit | “IL-2 Receptor Antagonist” NCT00369161 ↗ |
| Modality | Monoclonal antibody | “Anti-CD25 monoclonal antibody, chimeric” NCT00023244 ↗ |
| Route | Intravenous | “Administered as a bolus intravenous injection.” NCT00023244 ↗ |