Drugs / Daclizumab
last change May 2026 re-read 9 days ago

Daclizumab

Monoclonal antibody targets IL2RA via depletion

Developed for
uveitis · relapsing-remitting multiple sclerosis · acute graft versus host disease · graft versus host disease · leukemia · myelodysplastic syndrome · adult T-cell leukemia/lymphoma · anterior uveitis
+22 more · asthma · Behcet disease · brain cancer · diabetes mellitus · Diamond-Blackfan anemia · end stage renal failure · granulomatosis with polyangiitis · HIV infectious disease · kidney disorder · lymphoma · melanoma · multiple sclerosis · plasma cell neoplasm · psoriasis · retinal disorder · T-cell leukemia · thrombocytopenia · type 1 diabetes mellitus · ulcerative colitis · acute transplant rejection · age-related macular degeneration · choroidal neovascularization
Investigated by
National Eye Institute (NEI) · Hoffmann-La Roche · National Institute of Allergy and Infectious Diseases (NIAID) · National Cancer Institute (NCI) · AbbVie · Astellas Pharma Inc
+37 more · Biogen · Facet Biotech · Johns Hopkins University · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Neurological Disorders and Stroke (NINDS) · University of Miami · AstraZeneca · Baylor College of Medicine · Beth Israel Deaconess Medical Center · Dana-Farber Cancer Institute · Dutch Cancer Society · EMagnusson · Ekberg, Henrik, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · John Sampson · Juvenile Diabetes Research Foundation · King's College Hospital NHS Trust · National Center for Research Resources (NCRR) · National Institutes of Health Clinical Center (CC) · PDL BioPharma, Inc. · Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member) · Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member) · Prof. Philip Halloran, Edmonton, Canada (sponsor) · Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member) · Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member) · Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member) · Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member) · Radboud University Medical Center · Roche Pharma AG · Rockefeller University · Roger Williams Medical Center · The Emmes Company, LLC · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University of Iowa · University of Maryland, Baltimore · Wyeth is now a wholly owned subsidiary of Pfizer

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed relapsing-remitting multiple sclerosis 2 milestones
Filed US (FDA) ZINBRYTA relapsing-remitting multiple sclerosis 2015-04-29

“FDA has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA™” biogen.com ↗

Filed EU (EMA) ZINBRYTA relapsing-remitting multiple sclerosis 2015-03-27

“validated the companies’ Marketing Authorisation Application (MAA) for ZINBRYTA™ (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS)” biogen.com ↗

Withdrawn Indication not stated 4 milestones
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 47

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 · 1 missed
Phase 1/2 NCT00141037 Mar 2004 → Sep 2006 kidney disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 1/2 NCT00847106 Mar 2004 → Oct 2005 melanoma Radboud University Medical Center Completed No outcome recorded
Phase 1/2 NCT00284531 Oct 2003 → May 2007 — Baylor College of Medicine Terminated No outcome recorded Stop: Enrollment
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 219 trials · 1 met primary · 2 missed
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 Met primary
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 Mixed
Phase 2 NCT00100178 May 2004 → Apr 2008 type 1 diabetes mellitus National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Missed primary
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 Missed primary
Phase 2/31 trial
Phase 2/3 NCT00181142 Oct 1999 → Dec 2004 — Johns Hopkins University Completed No outcome recorded
Phase 36 trials · 1 missed
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 Missed primary
Phase 3 NCT00053976 Jan 2001 → Nov 2003 acute graft versus host disease Dana-Farber Cancer Institute Completed No outcome recorded
Phase 49 trials · 1 met primary · 1 missed
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 Missed primary
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 NCT00048165 Aug 1999 → Aug 2002 — Hoffmann-La Roche Completed Met primary
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
Comparator or background therapy20 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 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 Stop: Business

News releases announcing trial results or a regulatory action · 19

DateIssuerRelease
2018-03-02 Biogen Regulatory Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis biogen.com ↗
Biogen (Nasdaq:BIIB) and AbbVie (NYSE:ABBV) today announced the voluntary worldwide withdrawal of ZINBRYTA for relapsing multiple sclerosis.
2016-09-15 Biogen Results New Data Presented at ECTRIMS Reinforce Efficacy of ZINBRYTA™ (Daclizumab) and Support Long-Term Safety Profile biogen.com ↗
A new post-hoc analysis from the pivotal DECIDE study shows that a significantly greater number of people treated with ZINBRYTA TM (daclizumab) achieved no evidence of disease activity (NEDA) compared to those taking AVONEX ® (interferon beta-1a) intramuscular injection.
2016-09-08 Biogen Results Biogen Demonstrates Commitment to Improving Patient Outcomes with Study on Burden of MS and New Clinical Data from Its Leading MS Portfolio biogen.com ↗
A new analysis from the pivotal DECIDE study that further supports the positive impact of ZINBRYTA on no evidence of disease activity (NEDA), and the first interim results from the ongoing EXTEND study, providing up to five years of efficacy and safety data.
2016-07-05 Biogen Regulatory Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (Daclizumab) Approved in European Union for Treatment of Multiple Sclerosis biogen.com ↗
The European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today.
2016-05-27 AbbVie Regulatory Biogen and AbbVie Receive FDA Approval of Once-Monthly ZINBRYTA™ (daclizumab) for Multiple Sclerosis abbvie.com ↗
The U.S. Food and Drug Administration (FDA) approved ZINBRYTA™ (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today.
2016-05-27 Biogen Regulatory Biogen and AbbVie Receive FDA Approval of Once-Monthly ZINBRYTA™ (Daclizumab) for Multiple Sclerosis biogen.com ↗
The U.S. Food and Drug Administration (FDA) approved ZINBRYTA TM (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today.
2016-04-29 Biogen Regulatory Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis biogen.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today.
2016-04-20 Biogen Results Data Presented at AAN Highlight Impact of ZINBRYTA™ (Daclizumab HYP) on Cognitive Outcomes and the Reversibility of Its Targeted Mechanism of Action biogen.com ↗
New data presented today show that investigational therapy ZINBRYTA TM (daclizumab HYP) provided improvements on cognitive outcome measures in people living with relapsing forms of multiple sclerosis (RMS).
2016-04-12 Biogen Results Biogen Data at 2016 AAN Annual Meeting Highlight Its Expansive Portfolio of MS Therapies That Meets Diverse Needs of Patients biogen.com ↗
ZINBRYTA Improved Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis with Daclizumab HYP in the Phase 3 DECIDE Study
2015-10-08 Biogen Results Results from ZINBRYTA™ (Daclizumab High-Yield Process) Phase 3 DECIDE Study Highlighting Efficacy Compared to Interferon Beta-1a Published in the New England Journal of Medicine and Presented at ECTRIMS biogen.com ↗
Lead investigators on behalf of Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) presented these new findings today at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain (7-10 October).
2015-04-29 Biogen Regulatory FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment of MS biogen.com ↗
Today Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA™ (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS).
2015-03-27 Biogen Regulatory European Medicines Agency Validates Marketing Authorisation Application for ZINBRYTA™ (Daclizumab High-Yield Process) for Treatment of MS biogen.com ↗
Today Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for ZINBRYTA™ (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS) in the European Union (EU).

All press releases naming this drug 21 releases

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 68 sources stand behind the page.

FieldValueCited 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 ↗
67

“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 ↗

“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 ↗

NCT00080431 ↗

Show 57 more sources

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 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 ↗
3

“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 “targeting the high affinity interleukin-2 (IL-2) receptor (IL-2Rα/CD25)” PMID 22383993 ↗ Feb 2012