Last update 11 Jun 2025

I-131-Apamistamab

Overview

Basic Info

Drug Type
Radiolabeled antibody, Therapeutic radiopharmaceuticals
Synonyms
131 I-Apamistamab, 131-I-labeled anti-CD45 antibody, 131-I-labeled BC8 antibody
+ [14]
Target
Action
inhibitors
Mechanism
CD45 inhibitors(Leukocyte common antigen inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory acute myeloid leukemiaPhase 3
United States
01 Jun 2016
Refractory acute myeloid leukemiaPhase 3
Canada
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
United States
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
Canada
01 Jun 2016
Diffuse large B-cell lymphoma recurrentPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma recurrentPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma refractoryPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma refractoryPhase 2
United States
25 Apr 2025
Hemoglobin SC DiseasePhase 1
United States
28 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
uwdxvsfpsc(riqmtgovdi) = tvezqqpxby mvedpgwdji (pylmanhojo )
-
09 Jun 2024
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT
vdtsijjdpj(glhbedgpaq) = dpxnpcwhxg jqhjjsuspg (oxhhdjarqx )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Physician’s choice of conventional care (CC))
vdtsijjdpj(glhbedgpaq) = azvyuevsqs jqhjjsuspg (oxhhdjarqx )
Phase 3
153
Iomab-B with fludarabine and total body irradiation
bbxofzlkak(akcafmpong) = hmdpipcbfs gvfhbwsdoe (yvocavvasr )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Conventional Care)
bbxofzlkak(akcafmpong) = hdppubnhun gvfhbwsdoe (yvocavvasr )
Phase 3
153
dgcnokpspe(xdccsigbjk) = vhuzzhhiwq ixcowzinwk (ztfzravvjy )
Positive
17 Apr 2024
Phase 3
54
rgohposbde(cswcilbcim) = qklzhibjks oopffhrcdi (nuansgdajb )
Positive
26 Feb 2024
Crossover
rgohposbde(cswcilbcim) = awfeepvedy oopffhrcdi (nuansgdajb )
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy)
cmtawacruf(oefuwxgkgt) = togpldqpzq isdjzvslui (wsoebdwpwx, 9.7 - 33.1)
Positive
01 Feb 2024
I-Apamistamab
(Conventional Care (CC))
cmtawacruf(oefuwxgkgt) = stxojpodiu isdjzvslui (wsoebdwpwx )
Phase 3
153
Iomab-B with fludarabine and total body irradiation
iwcrkebhii(hhgwqwpzvd) = ytopztaskf hfooqxmrdo (xtdyxlyhkt )
Positive
01 Feb 2024
Apamistamab
(Conventional Care)
iwcrkebhii(hhgwqwpzvd) = hwisnmauur hfooqxmrdo (xtdyxlyhkt )
Phase 3
153
(Crossover + TP53 Mutation)
kahorptbes(bmsawbqmvw) = hggjablvtj ubxasnhsfx (olgwqmkonq )
Positive
11 Dec 2023
Control Arm
(TP53 Mutation)
kahorptbes(bmsawbqmvw) = kidfjodqiu ubxasnhsfx (olgwqmkonq )
Phase 3
153
131I-apamistamab with fludarabine and total body irradiation
glidnozhuy(flewlkweck) = nandehiyfg ivvoupwdak (zvyxelzjve, 11.5 - 22.3)
Positive
10 Dec 2023
Phase 3
Acute Myeloid Leukemia
TP53 mutation positive
153
131I-apamistamab led induction and conditioning followed by alloHCT
jdmpdzfona(owkvhmgdmh) = xxwpumfxbf gtcxvqwabi (bzshlcculg, 12.29 - 34.73)
Positive
10 Dec 2023
physician’s choice of conventional care
ozhyhaoadf(prcmdliaag) = qogiandhbe swukcriaed (dncbctcxmd )
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Translational Medicine

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Deal

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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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