Delving into the Latest Updates on 18F-Florbenguane with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Florbenguane (18F), Florbenguane F18(USAN), [18F]meta-fluorobenzylguanidine

+ [1]

Target-

Mechanism-

Therapeutic Areas

NeoplasmsOther DiseasesNervous System Diseases+ [2]

Active Indication

NeuroblastomaNeural Crest TumorPheochromocytoma+ [2]

Inactive Indication-

Originator Organization

Ground Fluor Pharmaceuticals, Inc.

Active Organization

Ground Fluor Pharmaceuticals, Inc.

Illumina Radiopharmaceuticals LLCStartup

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Structure

Molecular FormulaC8H10FN3

InChIKeyHNPHEZIYSZIWHH-RVRFMXCPSA-N

CAS Registry156021-12-4

This is a prospective Phase 2 study being performed to document the relationship between 18F-mIBG positron emission tomography (PET) findings in subjects, and expression of the norepinephrine transporter. In addition to collecting safety data for the imaging agent, the study aims to:
* compare the findings against other catacholamine transporters
* evaluate the imaging results at different time points and in different organs
* assess the quality of images with lower doses
* compare the ability to detect neuroblastoma lesions against other imaging agents, and in other tumors

Start Date01 Jan 2025

Sponsor / Collaborator

Illumina Radiopharmaceuticals LLCStartup

[+1]

CTIS2023-506508-18-00 / Recruiting

- S67620

Start Date19 Jan 2024

Sponsor / Collaborator

UZ Leuven

NCT04724369 / CompletedPhase 3

A Prospective Phase 3 Multi-center Study to Assess the Efficacy and Safety of 18F-mFBG PET Imaging in Subjects With Neuroblastoma

This is a Phase 3 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for confirming or excluding the presence of neuroblastoma

Start Date18 Nov 2021

Sponsor / Collaborator

Illumina Radiopharmaceuticals LLCStartup

[+1]

100 Clinical Results associated with 18F-Florbenguane

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100 Translational Medicine associated with 18F-Florbenguane

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100 Patents (Medical) associated with 18F-Florbenguane

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1

Literatures (Medical) associated with 18F-Florbenguane

01 Jan 2018·Journal of Nuclear MedicineQ1 · MEDICINE

Biodistribution and Dosimetry of ¹⁸F-Meta-Fluorobenzylguanidine: A First-in-Human PET/CT Imaging Study of Patients with Neuroendocrine Malignancies

Q1 · MEDICINE

Article

Author: Staton, Kevin D ; Modak, Shakeel ; Zhang, Hanwen ; Zanzonico, Pat ; Carrasquillo, Jorge A ; Lyashchenko, Serge ; Weber, Wolfgang A ; Pandit-Taskar, Neeta ; Burnazi, Eva ; Lewis, Jason S ; Reidy-Lagunes, Diane ; Larson, Steven M ; Blasberg, Ronald

¹²³I-meta-iodobenzylguanidine (¹²³I-MIBG) imaging is currently a mainstay in the evaluation of many neuroendocrine tumors, especially neuroblastoma. ¹²³I-MIBG imaging has several limitations that can be overcome by the use of a PET agent. ¹⁸F-meta-fluorobenzylguanidine (¹⁸F-MFBG) is a PET analog of MIBG that may allow for single-day, high-resolution quantitative imaging. We conducted a first-in-human study of ¹⁸F-MFBG PET imaging to evaluate the safety, feasibility, pharmacokinetics, and dosimetry of ¹⁸F-MFBG in neuroendocrine tumors (NETs). Methods: Ten patients (5 with neuroblastoma and 5 with paraganglioma/pheochromocytoma) received 148-444 MBq (4-12mCi) of ¹⁸F-MFBG intravenously followed by serial whole-body imaging at 0.5-1, 1-2, and 3-4 after injection. Serial blood samples (a total of 6) were also obtained starting at 5 min after injection to as late as 4 h after injection; whole-body distribution and blood clearance data, lesion uptake, and normal-tissue uptake were determined, and radiation-absorbed doses to normal organs were calculated using OLINDA. Results: No side effects were seen in any patient after ¹⁸F-MFBG injection. Tracer distribution showed prominent activity in the blood pool, liver, and salivary glands that decreased with time. Mild uptake was seen in the kidneys and spleen, which also decreased with time. Urinary excretion was prominent, with an average of 45% of the administered activity in the bladder by 1 h after injection; whole-body clearance was monoexponential, with a mean biologic half-life of 1.95 h, whereas blood clearance was biexponential, with a mean biologic half-life of 0.3 h (58%) for the rapid α phase and 6.1 h (42%) for the slower β phase. The urinary bladder received the highest radiation dose with a mean absorbed dose of 0.186 ± 0.195 mGy/MBq. The mean total-body dose was 0.011 ± 0.011 mGy/MBq, and the effective dose was 0.023 ± 0.012 mSv/MBq. Both skeletal and soft-tissue lesions were visualized with high contrast. The SUVmax (mean ± SD ) of lesions at 1-2 h after injection was 8.6 ± 9.6. Conclusion: Preliminary data show that ¹⁸F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. PET imaging with ¹⁸F-MFBG allows for same-day imaging of NETs. ¹⁸F-MFBG appears highly promising for imaging of patients with NETs, especially children with neuroblastoma.

100 Deals associated with 18F-Florbenguane

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroblastoma	Phase 3	US	Illumina Radiopharmaceuticals LLCStartup	18 Nov 2021
Neural Crest Tumor	Phase 2	US	Illumina Radiopharmaceuticals LLCStartup	01 Jan 2025
Pheochromocytoma	Phase 2	US	Illumina Radiopharmaceuticals LLCStartup	01 Jan 2025
Heart Diseases	Phase 2	US	Illumina Radiopharmaceuticals LLCStartup	05 Nov 2021
Cardiovascular Diseases	Phase 2	-	Illumina Radiopharmaceuticals LLCStartup	07 Feb 2021
Trauma, Nervous System	Phase 2	-	Ground Fluor Pharmaceuticals, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	Neuroblastoma	-	[18F]mFBG Long Axial Field Of View (LAFOV) PET/CT	ffljxpxrzz(qnlzoaeune) = wmwipgulkb txibfrbpqb (bxrnonvrpx, 2.6)	-	28 Aug 2023
				[123I]mIBG scintigraphy with single-photon emission computed tomography-CT (SPECT/CT)	ffljxpxrzz(qnlzoaeune) = bxkuslltvi txibfrbpqb (bxrnonvrpx, 16.3)
SNMMI2023	Not Applicable	Neuroblastoma	-	18F-MFBG (MFBG PET imaging)	asvyqwzcgw(fbneofdrpv) = No severe adverse events were noted in patients after MFBG injection vqnucqctif (feargxaaxe )	-	28 Aug 2023
				18F-MFBG (MIBG imaging)