Drugs / Daclizumab
Daclizumab
also known as
Zenapax · BIIB019 · anti-TAC · DAC HYP · Daclizumab High Yield Process · daclizumab, zenapax · Daclizumub · DZB · +2 more
Monoclonal antibody targets IL2RA via depletion
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Zinbryta | — | 2018-03-27 | europa.eu ↗ |
| Label expansion | US (FDA) | ZINBRYTA | — | 2017-05-26 | fda.gov ↗ |
| Approved | US (FDA) | ZINBRYTA | — | 2016-05-27 | fda.gov ↗ |
| Approved | EU (EMA) | Zenapax | — | 1999-02-26 | europa.eu ↗ |
Trials 51 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01143441 | May 2010 → Aug 2017 | relapsing-remitting multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT00626015 | Mar 2007 → Feb 2013 | brain cancer | John Sampson | Completed | No outcome recorded |
| Phase 1 | NCT00080431 | Mar 2004 → Dec 2007 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00078689 | Mar 2004 → Jul 2008 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1 | NCT00001526 | Jun 1996 → Sep 2007 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT00847106 | Mar 2004 → Oct 2005 | melanoma | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00141037 | Mar 2004 → Sep 2006 | kidney disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00284531 | Oct 2003 → May 2007 | — | Baylor College of Medicine | Terminated | No outcome recorded |
| Phase 1/2 | NCT00001941 | Dec 1999 → Feb 2011 | T-cell leukemia, human T-lymphotropic virus 1 infectious disease | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00050661 | Oct 1997 → Apr 2004 | psoriasis | Rockefeller University | Completed | No outcome recorded |
| Phase 1/2 | NCT00002681 | Jul 1995 → Sep 2003 | leukemia, lymphoma | Roger Williams Medical Center | Completed | No outcome recorded |
| Phase 221 trials | ||||||
| Phase 2 | NCT01051349 | Mar 2010 → Aug 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00390221 | Feb 2008 → May 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00326508 | May → Dec 2006 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00130637 | Aug 2005 → May 2008 | anterior uveitis, iritis, juvenile idiopathic arthritis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00109161 | Apr 2005 → Oct 2006 | multiple sclerosis | PDL BioPharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00100178 | May 2004 → Apr 2008 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00072969 | Nov 2003 → Aug 2005 | myelodysplastic syndrome | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00071838 | Oct 2003 → Oct 2007 | relapsing-remitting multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00070759 | Oct 2003 → Oct 2006 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00064714 | Jul 2003 → Mar 2008 | diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00073047 | Apr 2003 → Jul 2006 | ulcerative colitis | Facet Biotech | Completed | No outcome recorded |
| Phase 2 | NCT00049725 | Nov 2002 → Dec 2004 | thrombocytopenia | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 2 | NCT00693524 | Nov 2002 → Mar 2004 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00043667 | Aug 2002 → Oct 2004 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00040248 | Jun 2002 → May 2005 | granulomatosis with polyangiitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00028288 | Sep 2001 → Dec 2003 | asthma | Facet Biotech | Completed | No outcome recorded |
| Phase 2 | NCT00198146 | Jul 2000 → Feb 2007 | — | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT00006350 | Jan 2000 → Nov 2001 | leukemia, myelodysplastic syndrome, plasma cell neoplasm | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 2 | NCT00001962 | Nov 1999 → Aug 2009 | Diamond-Blackfan anemia | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | No outcome recorded |
| Phase 2 | NCT00001934 | Sep 1999 → Aug 2005 | multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00001865 | Jul 1999 → Jun 2004 | Behcet disease, retinal disorder, uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00181142 | Oct 1999 → Dec 2004 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07689630 | May 2026 → May 2028 expected | acute graft versus host disease, hematopoietic and lymphoid cell neoplasm | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 3 | NCT02881567 | Apr 2017 → Sep 2018 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00275509 | Jan 2007 → Jun 2010 | chronic renal failure syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 3 | NCT00296348 | Nov 2005 → Feb 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00195273 | Nov 2004 → Jul 2008 | graft versus host disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00053976 | Jan 2001 → Nov 2003 | acute graft versus host disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT00048152 | Dec 2000 → Mar 2006 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT00574470 | Jan 2006 → Nov 2007 | graft versus host disease | University of Iowa | Completed | No outcome recorded |
| Phase 4 | NCT00246129 | Oct 2005 → Jun 2011 | kidney failure | EMagnusson | Completed | No outcome recorded |
| Phase 4 | NCT02554955 | Feb 2004 → Dec 2007 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02576145 | Apr 2003 → Jan 2006 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00231764 | Nov 2002 → May 2006 | — | Ekberg, Henrik, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00685061 | Nov 2002 → Sep 2004 | — | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT00681343 | Sep 2002 → Oct 2006 | — | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT00138970 | Jan 2002 → Feb 2005 | disease related to solid organ transplantation | University of Oslo School of Pharmacy | Completed | No outcome recorded |
| Phase 4 | NCT00048165 | Aug 1999 → Aug 2002 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01418430 | — | adult T-cell leukemia/lymphoma | King's College Hospital NHS Trust | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00023231 | Feb 2001 → Aug 2004 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 21 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT00579527 Background | Dec 2005 → Dec 2011 | DiGeorge syndrome | Sumitomo Pharma Switzerland GmbH | Completed | 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 1/2 | NCT00050648 Comparator | Oct 1997 → Sep 2004 | psoriasis | Rockefeller University | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT02694770 Comparator | Jul 2016 → Sep 2017 | acute graft versus host disease | AbGenomics B.V Taiwan Branch | Withdrawn | 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 | NCT00468442 Background | Nov 2006 → Sep 2011 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | 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 | NCT00304954 Comparator | Feb 2006 → Jan 2010 | age-related macular degeneration, choroidal neovascularization | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00295607 Comparator | Jun 2005 → Jun 2008 | hepatitis C virus infection | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00446264 Background | May 2003 → Oct 2007 | hypoglycemia, type 1 diabetes mellitus | University Hospital, Lille | Completed | No outcome recorded |
| Phase 2 | NCT00014911 Background | Apr 2001 → Jun 2005 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| 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 | NCT02686619 Background | Nov 2004 → Jan 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00682292 Comparator | May 2001 → Nov 2006 | — | University Hospital, Lille | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT01172418 Comparator | Feb 2006 → May 2010 | — | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT01046955 Comparator | Nov 2005 → Apr 2007 | end stage renal failure | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT00132691 Comparator | Sep 2005 → Dec 2010 | uveitis | JHSPH Center for Clinical Trials | Completed | No outcome recorded |
| Phase 4 | NCT00493194 Background | May 2005 → Jul 2007 | chronic renal failure syndrome, disease related to solid organ transplantation, renal fibrosis | University Hospital, Antwerp | Unknown | No outcome recorded |
| Phase 4 | NCT00163657 Comparator | Jul 2002 → Apr 2006 | hepatitis C virus infection, liver failure | Baylor Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT00363116 Comparator | Apr 1999 → Dec 2004 | acute transplant rejection | University of Cincinnati | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00859131 Comparator | Mar 2009 → Jul 2012 | end stage renal failure | Medical University of South Carolina | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-03-02 | AbbVie | Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis abbvie.com ↗ |
| 2016-05-27 | AbbVie | Biogen and AbbVie Receive FDA Approval of Once-Monthly ZINBRYTA™ (daclizumab) for Multiple Sclerosis abbvie.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 72 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daclizumab | “Anti-CD25 monoclonal antibody, also described as daclizumab in the protocol, will be administered intravenously at 1 mg/kg on Day 0 and Day +4 after haploidentical...” NCT07689630 ↗68“A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding...” NCT00295607 ↗ “combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen” NCT00693524 ↗ “A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients” NCT00048152 ↗ “Daclizumab is an interleukin 2 receptor (IL-2) antagonist which is FDA approved as an immunosuppressive agent.” NCT00181142 ↗ “methotrexate, basiliximab, daclizumab, inolimomab, denileukin diftitox, alemtuzumab, ATG+ etanercept” NCT02694770 ↗ “150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC)” NCT01143441 ↗ “using daclizumab 1 mg/kg IV immediately pre-transplant” NCT00566813 ↗ “Biological: Daclizumab” NCT00468442 ↗ “daclizumab” NCT00132691 ↗ “daclizumab” NCT00132691 ↗ |
| Known as | anti-TAC | “This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris.” NCT00050648 ↗ |
| Known as | BIIB019 | “BIIB019 (Daclizumab High Yield Process)” NCT00390221 ↗1“BIIB019 (Daclizumab)” NCT01051349 ↗ |
| Known as | DAC HYP | “150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC)” NCT01143441 ↗ |
| Known as | Daclizumab High Yield Process | “BIIB019 (Daclizumab High Yield Process)” NCT00390221 ↗ |
| Known as | daclizumab, zenapax | “daclizumab, zenapax” NCT00859131 ↗ |
| Known as | Daclizumub | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00163657 ↗ |
| Known as | DZB | “Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it...” NCT00100178 ↗ |
| Known as | Zenapax | “Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it...” NCT00100178 ↗7“This study will examine the safety and effectiveness of daclizumab (also called Zenapax or anti-CD25) in patients with Wegener's granulomatosis, a type of vasculitis (blood...” NCT00040248 ↗ “This study will examine the safety and effectiveness of daclizumab (also called Zenapax or anti-CD25) in reducing viral replication in patients with HIV infection.” NCT00080431 ↗ “Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax)” NCT00001526 ↗ |
| Known as | Zenapax (Daclizumab) | “Zenapax (Daclizumab)” NCT01172418 ↗ |
| Known as | Zenapax(R) | “This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation.” NCT00284531 ↗ |
| Action | Inhibit | “Zenapax is a monoclonal antibody that binds to certain proteins (receptors) on white blood cells, preventing them from interacting with a chemical called interleukin-2.” NCT00001865 ↗ |
| Modality | Monoclonal antibody | “humanized anti-Tac monoclonal antibody” NCT00001526 ↗ |
| Route | Intravenous | “intravenous (IV) daclizumab treatments” NCT00001526 ↗ |
| Target | IL2RA | “a humanized antibody against the IL-2Ra subunit (Zenapax(Registered Trademark))” NCT00001934 ↗ |