Last update 08 May 2025

131I-Omburtamab

Overview

Basic Info

Drug Type
Radiolabeled antibody, Diagnostic radiopharmaceuticals
Synonyms
Monoclonal antibody 8H9 I-131, Omburtamab, Omburtamab I-131
+ [4]
Target
Action
inhibitors
Mechanism
CD276 inhibitors(CD276 antigen inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationRare Pediatric Disease (United States), Orphan Drug (European Union), Breakthrough Therapy (United States), Priority Review (United States)
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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
NeuroblastomaNDA/BLA
United States
-
Peritoneal NeoplasmsPhase 2
United States
15 Jul 2019
Meningeal LeukemiaPhase 1
Japan
11 Dec 2018
Meningeal LeukemiaPhase 1
United States
11 Dec 2018
Meningeal LeukemiaPhase 1
Denmark
11 Dec 2018
Meningeal LeukemiaPhase 1
Spain
11 Dec 2018
Neoplasm MetastasisPhase 1
Japan
11 Dec 2018
Neoplasm MetastasisPhase 1
Denmark
11 Dec 2018
Neoplasm MetastasisPhase 1
Spain
11 Dec 2018
Neoplasm MetastasisPhase 1
United States
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
(dvtkbkrrks) = ebevuegqla ylupgbmeuz (btfxfqeeps, mwbohhdjto - xvwnkqrvxx)
-
13 Feb 2024
Phase 2/3
50
(qagjfpxfmy) = fkylxxeqjx umonfqflof (pidamlrsor, 61 - 85)
Positive
08 Dec 2022
Phase 1
38
(mvadrwqyiz) = Grade 3/4 thrombocytopenia was the most common hematologic toxicity latfylmaeq (cebadncjep )
Positive
12 Nov 2022
Phase 1
52
(whzkfvpqva) = 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 lmbzemzuzp (luzrfzyien )
Positive
20 Dec 2020
Phase 2/3
17
(rhzqlpezja) = hzogelpnpk jsfjhfsfki (hrbmaqhtxb )
Positive
16 Oct 2020
Phase 1
57
(pskkzyyrgu) = chemical meningitis (n = 2),and increasing communicating hydrocephalus (n = 1) klzybvkzch (dqirwukuol )
Positive
31 May 2019
Not Applicable
12
MAB 131-I LABELED 8H9+131I-8H9
ashmmofwuy(vfbpedheli) = celtxgbzio hequimjmla (tlqsrpwlkh, ukqyvpwbox - xczkwmebdv)
-
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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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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