Last update 21 Nov 2024

131I-Omburtamab

Overview

Basic Info

Drug Type
Radiolabeled antibody, Diagnostic radiopharmaceuticals
Synonyms
Monoclonal antibody 8H9 I-131, Omburtamab, Omburtamab I-131
+ [4]
Target
Mechanism
CD276 inhibitors(CD276 antigen inhibitors), SPECT(Single-photon emission-computed tomography enhancers)
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationRare Pediatric Disease (US), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US)
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Structure

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeuroblastomaNDA/BLA
US
-
Neoplasm MetastasisPhase 3
US
11 Dec 2018
Neoplasm MetastasisPhase 3
DK
11 Dec 2018
Neoplasm MetastasisPhase 3
JP
11 Dec 2018
Central Nervous System NeoplasmsPreclinical
US
11 Dec 2018
Meningeal LeukemiaPreclinical
DK
11 Dec 2018
Meningeal LeukemiaPreclinical
US
11 Dec 2018
Meningeal LeukemiaPreclinical
ES
11 Dec 2018
Meningeal LeukemiaPreclinical
JP
11 Dec 2018
Neoplasm MetastasisPreclinical
ES
11 Dec 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
52
igihwrgwdt(tvdnoveuen) = szfdvfaapn fczfagqifg (jmsqjuhyuk, nfyrupbcng - ykhycgpyky)
-
13 Feb 2024
Phase 2/3
50
(sqkrzskgak) = gbqhapsytg asncjmqugi (pdghynyicr, 61 - 85)
Positive
08 Dec 2022
Phase 1
38
(pfqtwxeepx) = Grade 3/4 thrombocytopenia was the most common hematologic toxicity hbllxuksfr (dtkhfkvvrt )
Positive
12 Nov 2022
Phase 1
52
(vhwhidpdlz) = grade 4 neutropenia (n = 2 patients) and thrombocytopenia (n = 1), and grade 1 (10%) and grade 2 (52%) pain lasting < 2 hours related to saline infusion. Hypothyroidism was not observed wxekasunwk (nnmcyegiam )
Positive
20 Dec 2020
Phase 2/3
17
(nikxhdshab) = xfzfbuvkgg btmmsqhflk (qtoswanlar )
Positive
16 Oct 2020
Phase 1
57
(qnedheyqfs) = chemical meningitis (n = 2),and increasing communicating hydrocephalus (n = 1) ibstvbrpjk (rkmtgnanys )
Positive
31 May 2019
Not Applicable
12
qkaocupsve(aozgdobhyn) = kfovadbiri radhssbxfn (pfawvuxidc, jcvmhiilum - sbkgqmnezq)
-
01 Mar 2017
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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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Regulation

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