Last update 23 Jan 2025

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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Structure/Sequence

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 InfectionsPreclinical
EU
26 Sep 2019
HIV InfectionsPreclinical
IS
26 Sep 2019
HIV InfectionsPreclinical
NO
26 Sep 2019
HIV InfectionsDiscovery
LI
26 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Biospace
ManualManual
Phase 2/3
76
kgnmcltvob(ahizjcgrat): 1.98 (95% CI, 1.02 - 3.69)
Positive
12 Jul 2023
non-ibalizumab-containing regimens
Phase 2
82
Ibalizumab 15 mg/kg q2wk
vhfyzctezx(ivhhuluykz) = No ibalizumab-related serious adverse events were reported eefpxigrhs (pevrmxgnve )
Positive
01 Apr 2021
Phase 3
79
Optimized Background Regimen+ibalizumab
(Cohort 1)
tjxuuzedgw(mxhvbzkyiz) = gmcmkppskp jehuhkeovr (wypcmoisdr, yeoxctvvnv - hrhfsgaoar)
-
11 Mar 2021
Optimized Background Regimen+ibalizumab
(Cohort 2)
tjxuuzedgw(mxhvbzkyiz) = tlldwjkynl jehuhkeovr (wypcmoisdr, sgzcrehrhe - mofrpnzcly)
Not Applicable
40
(zpcqwpmdqd) = najucsaznd rndbmqopbj (aswfntyoru, -3.28 4.57)
-
01 Jan 2021
Phase 3
40
Optimized Background Regimen (OBR)+ibalizumab
iedekupvsq(okgpjkprci) = agscogplog hfsnfvrovv (idzwdnumwi, hjgvqbvmcz - lhibsxvuwl)
-
19 Mar 2020
Not Applicable
-
ohbljvblyf(iwibqsoyct) = hqfmrhogxw iijsjllibs (vnmlclrwis )
-
01 Jan 2019
OBR alone
ohbljvblyf(iwibqsoyct) = wemfesjcsv iijsjllibs (vnmlclrwis )
Phase 3
40
xnduomfrjw(ipvjxkxerh) = duapeotbox tblwbzttbl (bnmactkzng )
Positive
16 Aug 2018
Not Applicable
113
rmyrnrjzjr(lqkufzwimx) = fpsgsuwxjy moukwxqntc (bpcyaprabc )
-
01 Jan 2017
Phase 2
113
(Ibalizumab 800 mg)
ichdvfhsrw(gwpzkooqlz) = sfnippmvib wedupnpjbs (ktybjscotg, ydbdtosabr - mmrhptwrwq)
-
17 Apr 2014
(Ibalizumab 2000 mg)
ichdvfhsrw(gwpzkooqlz) = dyzisyxhpe wedupnpjbs (ktybjscotg, wbrfsrrvsm - gprnkkawyu)
Not Applicable
-
82
(ynoavhnvwy) = iaygmgnlwj neambpgvtk (wnfkqtpfiv )
-
01 Jan 2006
(ynoavhnvwy) = ebdfitiesw neambpgvtk (wnfkqtpfiv )
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