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18F-mFBG for administration

Phase 1

Cardiovascular Diseases | Small molecule | Cardiovascular |Illumina, Inc.|Trials Updated: Jul 2, 2026

18F-mFBG for administration target and mechanism

ModalitySmall molecule

Also known as 18F-mFBG for intravenous administration

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

18F-mFBG for administration clinical trials

18F-mFBG for administration · 1 trial · 1 indication

Phase 1 1
NCT04535193Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic InnervationCardiovascular Diseases
ACTIVE NOT_RECRUITING10 Analytics
PHASE1ACTIVE NOT_RECRUITING
Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation
Cardiovascular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Chang in 18F-mFBG uptake
Up to 210 minutes after dosing

Change in 18F-mFBG uptake in the total body and the normal heart over time (based on serial PET images) to: * document the time course of global and regional myocardial activity reflecting specific uptake and clearance of the radiopharmaceutical; * estimate individual organ and whole-body radiation dosimetry.

Evaluation of 18F-mFBG for imaging myocardial sympathetic innervation
Up to 100 minutes after dosing

To demonstrate the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of HF subjects with significant LV dysfunction (LVEF≤35%).

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Low likelihood of coronary heart diseaseOTHERThorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation. PET imaging to 210 minutes post-administration.
Heart Failure + left ventricular function (LVEF ≤ 35%)OTHERThorax and total body imaging for quantification of myocardial sympathetic innervation. PET imaging to 100 minutes post-administration

Interventions

NameTypeDescription
18F-mFBG for intravenous administrationDRUGPositron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * ≥ 18 years of age at study entry * able and willing to comply with study procedures * signed and dated informed consent is obtained * male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation ...

Countries:United States
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Competitive Landscape -General Cardiovascular Diseases 67 trials (matched to "Cardiovascular Diseases")

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Frequently asked questions about 18F-mFBG for administration

What is 18F-mFBG for administration?

18F-mFBG for administration is an investigational small molecule imaging agent being studied in cardiovascular disease. It is a PET imaging agent designed to visualize myocardial sympathetic innervation, the nerve supply to the heart muscle. It is in Phase 1 clinical development and is not approved for commercial use.

What is 18F-mFBG for administration used for?

18F-mFBG for administration is being studied for imaging myocardial sympathetic innervation in patients with cardiovascular diseases. The single Phase 1 trial, NCT04535193, is an open-label study evaluating its use as a PET imaging agent to visualize the sympathetic nerve supply to the heart.

Who is developing 18F-mFBG for administration?

18F-mFBG for administration is being developed by Illumina, Inc., which trades under the ticker ILMN. The company is sponsoring the Phase 1 clinical program evaluating this imaging agent in cardiovascular disease.

What phase is 18F-mFBG for administration in?

18F-mFBG for administration is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes one active trial that is currently not recruiting participants.

What clinical trials is 18F-mFBG for administration in?

18F-mFBG for administration is being studied in one clinical trial, NCT04535193, titled "Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation." This Phase 1 trial is active but not recruiting, has enrolled 10 participants, and is being conducted in the United States.

Is 18F-mFBG for administration the same as 18F-mFBG for intravenous administration?

Yes, 18F-mFBG for intravenous administration is an alternative name for 18F-mFBG for administration. Both refer to the same investigational PET imaging agent being developed by Illumina, Inc. for imaging myocardial sympathetic innervation in cardiovascular disease.