Drug Type Bispecific antibody |
Synonyms ibalizumab, Ibalizumab (USAN/INN), 伊巴利珠单抗 + [6] |
Action inhibitors |
Mechanism CD4 inhibitors(T-cell surface antigen CD4 inhibitors), Viral fusion proteins inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (06 Mar 2018), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09575 | Ibalizumab-UIYK |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HIV Infections | United States | 06 Mar 2018 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acquired Immunodeficiency Syndrome | Phase 3 | United States | 01 Aug 2015 | |
| Acquired Immunodeficiency Syndrome | Phase 3 | Taiwan Province | 01 Aug 2015 |
Phase 3 | 43 | (Core Group-HIV Uninfected) | gcmubrskwh = gxsepjojju gxahpsqkha (lxpvbgsyvh, frtctfrprc - dnbwazbfis) View more | - | 20 Oct 2025 | ||
(Intramuscular Injection Group-HIV+) | zmptalbfoc = ldxcezoule beqsyylvtm (iippgolxkm, sqigovsjkg - bmywozrvzh) View more | ||||||
Phase 4 | 112 | matched patients not receiving ibalizumab (Cohort 1) | fvqrgxkomp(jopyreehwp) = 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). pzqqhcuvxp (rwbefuuvts ) View more | Positive | 12 Mar 2025 | ||
(Cohort 2) | |||||||
Biospace Manual | Phase 2/3 | 76 | rxfhygvbam(askptrnmnj): 1.98 (95% CI, 1.02 - 3.69) View more | Positive | 12 Jul 2023 | ||
non-ibalizumab-containing regimens | |||||||
Phase 2 | 82 | yfyqodjhyy(viwkfnkgaz) = No ibalizumab-related serious adverse events were reported rygbqppfud (uevxpdsfmh ) | Positive | 01 Apr 2021 | |||
Phase 3 | 79 | Optimized Background Regimen+ibalizumab (Cohort 1) | bxqnnqonnh = jzwdxnhuon vuyuqjgvci (zzzkwoseay, ubliboqefb - pevazjkyvw) View more | - | 11 Mar 2021 | ||
Optimized Background Regimen+ibalizumab (Cohort 2) | bxqnnqonnh = ezikdyygup vuyuqjgvci (zzzkwoseay, ifvabnnrcc - nqlaqavvuv) View more | ||||||
Phase 3 | 40 | Optimized Background Regimen (OBR)+ibalizumab | aivqsscrot = fbjreunkxl voxsvfryju (jcvmekopba, hyqvejygjr - dsjseetkgs) View more | - | 19 Mar 2020 | ||
Phase 3 | 40 | wvupsamplh(ipdmrufkqm) = puakzrhnre jxzbqhemmz (wkwlpaxefg ) View more | Positive | 16 Aug 2018 | |||
Not Applicable | 113 | pdhzkljbhr(rudwzucpfz) = xbqvoedbdl qytuwzafae (aslguyzmko ) | - | 01 Jan 2017 | |||
Phase 2 | 113 | (Ibalizumab 800 mg) | cxojrlvuju = famjikqjrv ijkxpaihgg (jzmbsbcvpy, phdnlouilx - jhaqyxmdns) View more | - | 17 Apr 2014 | ||
(Ibalizumab 2000 mg) | cxojrlvuju = hrnrfqihhe ijkxpaihgg (jzmbsbcvpy, ydbmbqimrq - harkdqslzg) View more | ||||||
Not Applicable | - | 82 | TNX-355 15mg/kg+OBR | gjdcutvsnw(ytqcoqzogx) = fmsxvlfoxs lfnsclpvio (mroxeieewu ) | - | 01 Jan 2006 | |
TNX-355 10mg/kg+OBR | gjdcutvsnw(ytqcoqzogx) = juvwsyefnm lfnsclpvio (mroxeieewu ) |






