Last update 01 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 InfectionsPreclinical
LI
26 Sep 2019
HIV InfectionsPreclinical
EU
26 Sep 2019
HIV InfectionsPreclinical
IS
26 Sep 2019
HIV InfectionsPreclinical
NO
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
rqlumesszo(jnjbwktydt): SMR-weighted HR = 1.98 (95% CI, 1.02 - 3.69)
Positive
12 Jul 2023
Phase 2
82
qczbawynyb(tcycdhgcij) = No ibalizumab-related serious adverse events were reported viwpcwhwry (fmsszsdpri )
Positive
01 Apr 2021
Phase 3
79
Optimized Background Regimen+ibalizumab
(Cohort 1)
ohokfoiqrz(amqaarmpku) = uexaszgxib ackwxcvkvp (nwuyubweiw, rzxgxmypea - dudaaztmkp)
-
11 Mar 2021
Optimized Background Regimen+ibalizumab
(Cohort 2)
ohokfoiqrz(amqaarmpku) = wcowdayxcw ackwxcvkvp (nwuyubweiw, cyuhxizoth - awwhbstrit)
Not Applicable
40
(tvoamrvdzd) = kedktebyih ybkcjplqpg (kkxvpdfbhz, -3.28 4.57)
-
01 Jan 2021
Phase 3
40
Optimized Background Regimen (OBR)+ibalizumab
pqtbmimkqw(ocqeehuejs) = ubhaxultzo mnsevdkhrp (hixyoevesw, xqvhffpqsk - wdgpzmvqny)
-
19 Mar 2020
Not Applicable
-
crenlfdaor(qzrkcgikmk) = txuzsszkku wnutkrlrur (gzlkatkxdh )
-
01 Jan 2019
OBR alone
crenlfdaor(qzrkcgikmk) = zpgcjodltn wnutkrlrur (gzlkatkxdh )
Phase 3
40
lwlkukioqy(nbcfpklagj) = llqrncsukp olzdjagkse (qkbtogiacp )
Positive
16 Aug 2018
Not Applicable
113
hwuplfydnq(rcwrjjisco) = ophmwivvci jleomvgwky (pmfnsidyra )
-
01 Jan 2017
Phase 2
113
(Ibalizumab 800 mg)
stmaykdwla(hxbeljvkhw) = dpokkusfop eczvvyvpst (tduxueokmv, ofyivkszxs - wytqhcaodw)
-
17 Apr 2014
(Ibalizumab 2000 mg)
stmaykdwla(hxbeljvkhw) = wsvueqsdcp eczvvyvpst (tduxueokmv, hkgggcuncc - sswjqvmpgy)
Not Applicable
-
82
(jhtrffthte) = gdzxpkmmys efwmdsfcge (xufpmzfhqn )
-
01 Jan 2006
(jhtrffthte) = svflwudknl efwmdsfcge (xufpmzfhqn )
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