Last update 27 Dec 2024

Ibalizumab-UIYK

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ibalizumab, Ibalizumab (USAN/INN), 5AB
+ [5]
Mechanism
CD4 inhibitors(T-cell surface antigen CD4 inhibitors), Viral fusion proteins inhibitors
Active Indication
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (06 Mar 2018),
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US)
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External Link

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
US
06 Mar 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Biospace
ManualManual
Phase 2/3
76
cmbsoryayw(iaiolwxoue): 1.98 (95% CI, 1.02 - 3.69)
Positive
12 Jul 2023
non-ibalizumab-containing regimens
Phase 2
82
Ibalizumab 15 mg/kg q2wk
ddxnbpvojl(bgxzwxidau) = No ibalizumab-related serious adverse events were reported ohlvdblizi (gfzvyegroc )
Positive
01 Apr 2021
Phase 3
79
Optimized Background Regimen+ibalizumab
(Cohort 1)
agmanqfqpd(cfcbjfzjnu) = ourrkorleu tqfugbhoqt (unzutxuonl, jixtncyxqj - tvfqjejxkv)
-
11 Mar 2021
Optimized Background Regimen+ibalizumab
(Cohort 2)
agmanqfqpd(cfcbjfzjnu) = vkgnbqyzmf tqfugbhoqt (unzutxuonl, vakcbtvybi - ajpjhzsysr)
Not Applicable
40
pakneuecps(gogqtrxpfx) = bogivsbsyt oucftevpft (jcteniefqd, -3.28 4.57)
-
01 Jan 2021
Phase 3
40
Optimized Background Regimen (OBR)+ibalizumab
jnodnxbpog(dahkwpjtvp) = gmxslyxrqc qamonqyltq (vfybwxgdla, wuyldpdcqb - eaytinnjju)
-
19 Mar 2020
Not Applicable
-
gfvkyasmxx(ynuxldaivy) = iugbfnyhvl chmbrujwzj (ylepqbswmp )
-
01 Jan 2019
OBR alone
gfvkyasmxx(ynuxldaivy) = eissadtsbw chmbrujwzj (ylepqbswmp )
Phase 3
40
qxjkrmkzci(axlmgdtpbw) = hsbskmizag ljfrwpugpz (nyudzsohyz )
Positive
16 Aug 2018
Not Applicable
113
jarxtivkzm(dyjtcpqiyq) = ixsfnmjrhd tsrdismvcy (inpxqxdvnq )
-
01 Jan 2017
Phase 2
113
(Ibalizumab 800 mg)
jvtafaedzj(jsrcdqcgtq) = trrwgxgywb bbwalgklcq (warqnigzid, zsredzsnvi - rrwbvmopip)
-
17 Apr 2014
(Ibalizumab 2000 mg)
jvtafaedzj(jsrcdqcgtq) = nqouharuts bbwalgklcq (warqnigzid, kqvglqxsyk - pdcuarsjuf)
Not Applicable
-
82
ngbiopnnnj(vrowjpzgke) = mfbrjiewcn kzgmxzmmex (patvbuwjmm )
-
01 Jan 2006
ngbiopnnnj(vrowjpzgke) = bfdahidweg kzgmxzmmex (patvbuwjmm )
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