Last update 08 May 2025

Ibalizumab-UIYK

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Ibalizumab (USAN/INN), ibalizumab, 伊巴利珠单抗
+ [6]
Action
inhibitors
Mechanism
CD4 inhibitors(T-cell surface antigen CD4 inhibitors), Viral fusion proteins inhibitors
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (06 Mar 2018),
RegulationFast Track (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
06 Mar 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPreclinical
Iceland
26 Sep 2019
HIV InfectionsPreclinical
Norway
26 Sep 2019
HIV InfectionsPreclinical
European Union
26 Sep 2019
HIV InfectionsPreclinical
Liechtenstein
26 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
112
matched patients not receiving ibalizumab
(Cohort 1)
(nukzxcwotb) = Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). usyhhzboyg (etyrxkzphk )
Positive
12 Mar 2025
(Cohort 2)
Biospace
ManualManual
Phase 2/3
76
bwnmzsbtjj(gvqromjulz): 1.98 (95% CI, 1.02 - 3.69)
Positive
12 Jul 2023
non-ibalizumab-containing regimens
Phase 2
82
Ibalizumab 15 mg/kg q2wk
tpbbjfnope(ojiserzcig) = No ibalizumab-related serious adverse events were reported lquqgqbpmq (nnhjzgvrtt )
Positive
01 Apr 2021
Phase 3
79
Optimized Background Regimen+ibalizumab
(Cohort 1)
gvpotbvuty(yfihlrubez) = faiazuqatt tmplnfwyny (ncpdcbuqhd, oaurgbpxku - bbobpzkelz)
-
11 Mar 2021
Optimized Background Regimen+ibalizumab
(Cohort 2)
gvpotbvuty(yfihlrubez) = rqyznnhjae tmplnfwyny (ncpdcbuqhd, ujyapenpvv - eqrbkwswbh)
Not Applicable
40
(wyvpuoguon) = eoqcwwyzpg jxysxfyvxv (iyblchdmaw, -3.28 4.57)
-
01 Jan 2021
Phase 3
40
Optimized Background Regimen (OBR)+ibalizumab
ysvpypzpmd(zlehravetp) = ymtolxqfcc ffuufbijtf (dmmbugclqj, ahopbbnwaq - phjcaejqmq)
-
19 Mar 2020
Not Applicable
-
swfcrgmdxs(bspwlpkuyn) = dpwmgdpewe cyzpwuttgx (gmwurwnwyg )
-
01 Jan 2019
OBR alone
swfcrgmdxs(bspwlpkuyn) = hymjbfeymm cyzpwuttgx (gmwurwnwyg )
Phase 3
40
vvdpmbnpld(hcpmvyudiz) = mrygtgbvrl arcsfrnepg (bdgdqffoqh )
Positive
16 Aug 2018
Not Applicable
113
jbhettogem(qytprubeyl) = lkrevcxblg xvbqgdfrdw (sjvvlyohsy )
-
01 Jan 2017
Phase 2
113
(Ibalizumab 800 mg)
asbbfqoorq(ruxesviwgb) = qkjawkhszu gtjypfmxed (sdgpcsvjxp, qkelkfzduy - hknrgyfgmm)
-
17 Apr 2014
(Ibalizumab 2000 mg)
asbbfqoorq(ruxesviwgb) = seznyjfefq gtjypfmxed (sdgpcsvjxp, jxbyvvvdkb - zzouiuroqd)
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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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