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Drug

Daclizumab

Regulatory activity · MHRA
Emerging researchLate-stage development

Also known as Daclizumab beta, Zenapax, Zinbryta, Dacliximab.

RxNorm190353UNIICUJ2MVI71Y
1
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®

Clinical trial2023-09-28Results posted · ClinicalTrials.gov

Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950

Clinical trial2022-03-25Results posted · ClinicalTrials.gov

A Randomised Controlled Comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate Mofetil in Kidney Transplantation

Clinical trial2021-09-29Results posted · ClinicalTrials.gov

New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial (Preservation of Pancreatic Production of Insulin Through Immunosuppression-POPPII #1)

Clinical trial2020-05-05Results posted · ClinicalTrials.gov

A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)

Clinical trial2018-09-12Terminated · ClinicalTrials.gov

Drug Safety Update: Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy

Regulatory2018-03-08MHRA

Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Clinical trial2018-01-18Results posted · ClinicalTrials.gov

Islet Transplantation for Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression (ITN005CT)

Clinical trial2017-03-15Results posted · ClinicalTrials.gov

Treatment of Active Anterior Uveitis Associated With JIA, Using Humanized Anti-Tac (HAT, Daclizumab)

Clinical trial2017-01-30Results posted · ClinicalTrials.gov

Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation

Clinical trial2016-11-29Results posted · ClinicalTrials.gov

Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response

Clinical trial2016-11-29Results posted · ClinicalTrials.gov

High-dose daclizumab for the treatment of juvenile idiopathic arthritis-associated active anterior uveitis.

Research2009-08-06American journal of ophthalmology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Daclizumab
Aliases & brands
Daclizumab betaZenapaxZinbrytaDacliximab
RxNorm CUI
190353
UNII
CUJ2MVI71Y
Regulatory jurisdictions
mhra

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2018-03-08Safety communicationSafety
Drug Safety Update: Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

55 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
55
registered trials across all phases
LATEST COMPLETION 2017
21
Late-stage (III+)
49
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 55
Phase 14Phase 1 / 28Phase 222Phase 2 / 31Phase 38Phase 410Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomised Controlled Comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate Mofetil in Kidney Transplantation

CompletedPH IVEMagnussonn=1232011

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®

CompletedPH IVUniversity of Miamin=2002010

Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx

CompletedPH IVKey trialEkberg, Henrik, M.D.n=1,7602008

Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function

CompletedPH IVHoffmann-La Rochen=362007

Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy

CompletedPH IVUniversity of Miamin=382007

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950

CompletedPH I/IISumitomo Pharma Switzerland GmbHn=142017

Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.

CompletedN/AMedical University of South Carolinan=2002014

Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]

CompletedPH IJohn Sampsonn=162013

Zenapax (Daclizumab) Admin to Pts With Multiple Sclerosis (ZAP MS): Effect of Intravenously Admin Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (Daclizumab) on Inflammatory Activity in the Central Nervous System

CompletedPH IINational Institute of Neurological Disorders and Stroke (NINDS)n=162011

A Randomised Controlled Comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate Mofetil in Kidney Transplantation

CompletedPH IVEMagnussonn=1232011

A Phase I/II Study of the Efficacy and Toxicity of Humanized Anti-Tac (Zenapax(Trademark)) in the Therapy of Tac-Expressing Adult T-Cell Leukemia

CompletedPH I/IINational Cancer Institute (NCI)n=342011

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • American journal of ophthalmology1
Leading researchers
  • Barron KS1
  • Faia LJ1
  • Hammel K1
  • Levy-Clarke G1
  • Li Z1
  • Nussenblatt RB1
  • Ryan JG1
  • Sen HN1
Leading institutions
free-text, unnormalised
  • National Eye Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.