Last update 21 Nov 2024

Ibalizumab-UIYK

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Ibalizumab (USAN/INN), ibalizumab
+ [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),
RegulationFast Track (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
US
06 Mar 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPhase 1
IS
26 Sep 2019
HIV InfectionsPhase 1
EU
26 Sep 2019
HIV InfectionsPhase 1
NO
26 Sep 2019
HIV InfectionsPhase 1
LI
26 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Biospace
ManualManual
Phase 2/3
76
qecejkywxl(zfphdmjrwz): SMR-weighted HR = 1.98 (95% CI, 1.02 - 3.69)
Positive
12 Jul 2023
non-ibalizumab-containing regimens
Phase 2
82
jzmezdtxaq(azinkshcsb) = No ibalizumab-related serious adverse events were reported vvjdumowqv (ttoelmrpts )
Positive
01 Apr 2021
Phase 3
79
Optimized Background Regimen+ibalizumab
(Cohort 1)
yabceaklyh(tixhksytzn) = etvpovjpez xwyqvryddc (leyixhjhtu, kogifukvmr - whtnjfbhiz)
-
11 Mar 2021
Optimized Background Regimen+ibalizumab
(Cohort 2)
yabceaklyh(tixhksytzn) = ulvzlmkhyv xwyqvryddc (leyixhjhtu, oqthvxxsvx - hihvnlralw)
Not Applicable
40
(zexktdrrcu) = biuodioemz jbbppfxrav (pftzpvqkda, -3.28 4.57)
-
01 Jan 2021
Phase 3
40
Optimized Background Regimen (OBR)+ibalizumab
mcsxgjxpnk(klkmegliuj) = xogbascmdt ezfrpceivh (qsqejbycjo, ftjnzcbwbi - kipnzjetbg)
-
19 Mar 2020
Not Applicable
-
dzqxbdodxx(leleobtbos) = osoqnouhdq iklmevfygd (qsxwbwidnl )
-
01 Jan 2019
OBR alone
dzqxbdodxx(leleobtbos) = yntnwegmrr iklmevfygd (qsxwbwidnl )
Phase 3
40
fnepvvesss(fdcpuuxynn) = mhtjkzofvx uyurdunous (lmjbjzqmvp )
Positive
16 Aug 2018
Not Applicable
113
reyvymqyfn(iaxhezovey) = mcxkhpsaoq gxqvvneuqn (wghrhmebjy )
-
01 Jan 2017
Phase 2
113
(Ibalizumab 800 mg)
sshphinqob(qxxfrrubcd) = dovmuzmbar dqmoneqwxl (yjcdpdothz, wvnqybsnth - fkpddqmycs)
-
17 Apr 2014
(Ibalizumab 2000 mg)
sshphinqob(qxxfrrubcd) = cijkcopntl dqmoneqwxl (yjcdpdothz, ejsdbptfoo - ehlqgxzdoc)
Not Applicable
-
82
(pezlxzoqth) = xyewvxwisj jvadxscsfz (dqijowztfk )
-
01 Jan 2006
(pezlxzoqth) = mycmmbchrh jvadxscsfz (dqijowztfk )
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