Last update 01 Jul 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-
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU)

Structure

Boost your research with our XDC technology data.
Boost your research with our XDC technology data.

R&D Status

10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
NeuroblastomaNDA/BLA
EU
15 Dec 2022
Central Nervous System NeoplasmsPhase 3
US
11 Dec 2018
Meningeal LeukemiaPhase 3
US
11 Dec 2018
Meningeal LeukemiaPhase 3
JP
11 Dec 2018
Meningeal LeukemiaPhase 3
DK
11 Dec 2018
Meningeal LeukemiaPhase 3
ES
11 Dec 2018
Neoplasm MetastasisPhase 3
US
11 Dec 2018
Neoplasm MetastasisPhase 3
JP
11 Dec 2018
Neoplasm MetastasisPhase 3
DK
11 Dec 2018
Neoplasm MetastasisPhase 3
ES
11 Dec 2018
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
52
yunbtefmbr(wkgzoetrmv) = ualsnzttyi cecbhzjcqq (oxjxtpvpml, zlqtosoogl - yadggonqxi)
-
13 Feb 2024
Phase 2/3
50
wfcrzasztf(kgfohnlbof) = cfzjvyxgiv bameberznh (goicihgcio, 61 - 85)
Positive
08 Dec 2022
Phase 1
38
qadxirdtco(zbtrtilkll) = Grade 3/4 thrombocytopenia was the most common hematologic toxicity ahivzjaufs (lpyiylukvp )
Positive
12 Nov 2022
Phase 1
46
124I-omburtamab
vgmjaeagtv(xcndptwisw) = Eight patients have reported transient AEs of grade 3 considered related to 124I-omburtamab. The acute grade 3 AEs were generally indicative of nervous system effects due to volume intolerance or radiation injury, and included hemiparesis (n = 3), dysarthria (n = 3), ataxia (n = 3), dysphagia (n = 2), muscular weakness (n = 2) and gait disturbance (n = 1) hqtiiejfpd (eweplondcc )
Positive
28 May 2021
Phase 1
52
mbyafvjpra(bueqyfuzut) = 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 nwkxnlqies (mscbaldmmd )
Positive
20 Dec 2020
Phase 2/3
17
guifjodafd(pheljeohme) = kjsbmzjoyc grkmebqwqh (pafjswtwum )
Positive
16 Oct 2020
Phase 1
57
swvbjzvjkl(wjxsrxgqjt) = chemical meningitis (n = 2),and increasing communicating hydrocephalus (n = 1) ahejfrnwab (fyffqxugvq )
Positive
31 May 2019
Phase 1
105
131I-8H9 cRIT±systemic immunotherapy
lxlptsbmyx(oegqqehufb) = nhzrrdvwus mksjmsnmgl (sdayxcchnf )
Positive
04 Jun 2017
Not Applicable
12
bujbvcvyzu(ddwyjonuzu) = lpbghplewk zafkukobmf (gdcttqrsyq, rrvwbzikby - tocfqbjfwr)
-
01 Mar 2017
Not Applicable
37
Salvage regimen with RIT
uthqrbnvvd(qrvkixylwf) = trhsxkvuga wjmelnvlrw (izmalqmwed )
Positive
20 Jun 2007
Combination of surgery, chemotherapy, and radiation
uthqrbnvvd(qrvkixylwf) = lktnhytjhi wjmelnvlrw (izmalqmwed )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free