Last update 25 Mar 2025

Daclizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
DAC HYP, Dacliximab, Daclizumab (USAN/INN)
+ [14]
Target
Action
inhibitors
Mechanism
IL2RA inhibitors(Interleukin-2 receptor alpha chain inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Dec 1997),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03639Daclizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-Remitting
Canada
08 Dec 2016
Multiple Sclerosis
United States
27 May 2016
Renal transplant rejection
European Union
26 Feb 1999
Renal transplant rejection
Iceland
26 Feb 1999
Renal transplant rejection
Liechtenstein
26 Feb 1999
Renal transplant rejection
Norway
26 Feb 1999
Graft Rejection
United States
10 Dec 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Allograft RejectionPhase 2
United States
01 Oct 2003
Cardiac transplant rejectionPhase 2
United States
01 Oct 2003
Colitis, UlcerativePhase 2
United States
01 Apr 2003
Colitis, UlcerativePhase 2
Belgium
01 Apr 2003
Colitis, UlcerativePhase 2
Canada
01 Apr 2003
Persistent asthmaPhase 2
United States
01 Sep 2001
Diabetes Mellitus, Type 1Phase 2
United States
01 Jul 2000
Diabetes Mellitus, Type 1Phase 2
United States
01 Jul 2000
Psoriasis vulgarisPhase 2
United States
01 Oct 1997
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ASH2024
ManualManual
Not Applicable
169
Daclizumab + standard GvHD prophylaxis
jvnlpnvhjz(vjnwliufzi) = mjtfxbkaov tzujzugphx (hpuqwfjkxz )
Positive
07 Dec 2024
Standard GvHD prophylaxis
jvnlpnvhjz(vjnwliufzi) = zdvuxtldbd tzujzugphx (hpuqwfjkxz )
Phase 3
1,203
aslftdntgf(ockqnnoove) = wxlmlgujrq wihupvvvle (spwzftnsiv )
Negative
26 Feb 2021
Phase 2
455
ejfavgpojo(lfppynarap) = evxvfighva xtkeauuecv (qmyapmsnrz )
Positive
01 Oct 2020
Phase 3
1,501
IFN β-1a+DAC HYP
(IFN β-1a 30 µg (301)/DAC HYP 150 mg (303))
tpmlwigref = vynfzxhowh xtsdcnckfl (vhjqetomkw, efswerkgbv - crmnckzzat)
-
04 Dec 2019
(DAC HYP 150 mg (301) /DAC HYP 150 mg (303))
tpmlwigref = gljrgivgrr xtsdcnckfl (vhjqetomkw, zxepuhcwab - jebbypwurb)
Phase 3
41
wvgswsnwoa = vgagunbsjt zftkhyyfov (ozmanhjipi, mokpsghlqi - uwrtrdguzb)
-
24 Sep 2019
Phase 3
24
ahwodxbtwq(toyknoswau): HR = 0.73 (95% CI, 0.55 - 0.98)
Similar
01 Dec 2018
interferon beta-1a
Phase 2
410
trivalent seasonal influenza vaccine+BIIB019 (Daclizumab)
xjvxweqzss = wjwktxogbl umnekxsxjd (gujpxevpsz, bkcathophg - onrcvrnypk)
-
09 Nov 2018
Not Applicable
-
ptazsukvbg(krjfdthuqp) = 7 patients who developed meningitis/meningoencephalitis after undergoing daclizumab therapy tztwycqirj (bfimxibsqu )
-
09 Oct 2018
Phase 3
1,841
oldmydiwmh(xkxtytvijc): P-Value = 0.0274
Positive
01 May 2018
IM IFN beta-1a
Not Applicable
-
522
hbcxamiwgj(zialpuwomr) = efnutjuovk vbzloowkjs (ghkgfwweee )
Positive
10 Apr 2018
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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