Fludeoxyglucose F18

(Fludeoxyglucose F-18)

Phase 2Small molecule

WWeill Medical College of Cornell University

Fludeoxyglucose F18 is one of 2 small molecule programs targeting Estrogen Receptor Positive. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Estrogen Receptor PositiveActive, not recruiting

Estrogen Receptor PositivePhase 2

Active, not recruiting

Competition

Competitive Landscape

1 competitor in Estrogen Receptor Positive

#DrugCompanyPhaseTrials

F-18 16 Alpha-Fluoroestradiol

UUniversity of Washington

Phase 2

1 2

Fludeoxyglucose F18

WWeill Medical College of Cornell University

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2041

Phase 2Active, not recruiting

Estrogen Receptor Positive

NCT04692103

Clinical

Trials by Indication[1]

Breast Cancer2 trials

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Terminated·MMayo Clinic·Phase 1·NCT03432741·17 enrolled

F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy

Terminated·UUniversity of Washington·N/A·NCT02149173·29 enrolled

Lung Cancer2 trials

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

Completed·EEmory University·Phase 1·NCT03493789·19 enrolled

18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

Completed·AAndrei Iagaru·Phase 2·NCT03824535·15 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Tumor-Specific Clonotype, Metabolic Profile, and PET/CT in Predicting Chemotherapy Response in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02405078·35 enrolled

Diagnosis1 trial

FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Completed·MM.D. Anderson Cancer Center·N/A·NCT04219969·11 enrolled

Non-Small Cell Lung Cancer1 trial

Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer

Unknown status·NNational Cancer Institute (NCI)·Phase 2·NCT01507428·138 enrolled

5 more indications

Prostate Cancer1 trial

NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

Terminated·SStanford University·Phase 1·NCT02429804·4 enrolled

Ovarian Cancer1 trial

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

Terminated·SStanford University·Phase 1·NCT01494012·1 enrolled

Melanoma1 trial

18F-FLT PET Imaging in Patients With Advanced Melanoma

Terminated·WWashington University School of Medicine·Phase 1·NCT02891616·4 enrolled

Diabetes Mellitus1 trial

Inflammatory Characterization of Known or Possible Cardiovascular Diseases

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)··NCT01934660·150 enrolled

Estrogen Receptor Positive1 trial

Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy

Active, not recruiting·UUniversity of Washington·Phase 2·NCT04692103·2 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 19, 1994

FLUDEOXYGLUCOSE F18

NDA NDA020306

Aug 5, 2004

FLUDEOXYGLUCOSE F18

NDA NDA021768

Aug 19, 2005

FLUDEOXYGLUCOSE F18

NDA NDA021870

Aug 19, 2005

FLUDEOXYGLUCOSE F18

NDA NDA021870

Aug 18, 2010

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jan 5, 2011

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jan 18, 2012

FLUDEOXYGLUCOSE F18

NDA NDA021870

Nov 28, 2012

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jan 13, 2014

FLUDEOXYGLUCOSE F18

NDA ANDA203246

May 9, 2014

FLUDEOXYGLUCOSE F18

NDA ANDA203902

Dec 15, 2014

FLUDEOXYGLUCOSE F18

NDA NDA021870

Apr 23, 2015

FLUDEOXYGLUCOSE F18

NDA ANDA203904

May 1, 2015

FLUDEOXYGLUCOSE F18

NDA ANDA203837

Jul 8, 2015

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jul 17, 2015

FLUDEOXYGLUCOSE F18

NDA ANDA204531

Sep 10, 2015

FLUDEOXYGLUCOSE F18

NDA NDA021870

Sep 11, 2015

FLUDEOXYGLUCOSE F18

NDA ANDA204472

Oct 30, 2015

FLUDEOXYGLUCOSE F18

NDA ANDA203778

Apr 11, 2016

FLUDEOXYGLUCOSE F18

NDA ANDA203942

Aug 1, 2016

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jun 27, 2019

FLUDEOXYGLUCOSE F18

NDA NDA021870

Jun 24, 2020

FLUDEOXYGLUCOSE F18

NDA ANDA203778

Mar 4, 2021

FLUDEOXYGLUCOSE F18

NDA ANDA203902

Jun 9, 2021

FLUDEOXYGLUCOSE F18

NDA ANDA203246

Nov 9, 2023

FLUDEOXYGLUCOSE F18

NDA NDA021870

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Fludeoxyglucose F-18. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fludeoxyglucose F-18 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fludeoxyglucose F-18. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021870). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Weill Medical College of Cornell University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: WWeill Medical College of Cornell University

Fludeoxyglucose F18

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2041

Trials by Indication[1]

Breast Cancer2 trials

Lung Cancer2 trials

Diffuse Large B-Cell Lymphoma1 trial

Diagnosis1 trial

Non-Small Cell Lung Cancer1 trial

Prostate Cancer1 trial

Ovarian Cancer1 trial

Melanoma1 trial

Diabetes Mellitus1 trial

Estrogen Receptor Positive1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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