Fluciclovine

Phase 3Small molecule

UUniversity of Utah

Fluciclovine is one of 128 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

127

Competitors

Pipeline

Status by Indication[3][1]

Indication

Prostate AdenocarcinomaActive, not recruiting

Prostate CancerRecruiting

GlioblastomaRecruiting

Prostate AdenocarcinomaPhase 2

Active, not recruiting

Prostate CancerPhase 3

Recruiting

GlioblastomaPhase 1

Recruiting

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

21 2

Lupron

EEastern Cooperative Oncology Group

Phase 3

53 3

Zoladex

TTerSera Therapeutics LLC

Phase 3

35 4

Tecentriq

Roche

Phase 3

6 5

Truqap

AstraZeneca

Phase 3

2 6

Fluciclovine

UUniversity of Utah

Phase 3

3 7

Piflufolastat F 18

Novartis

Phase 3

1 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 1Recruiting

Glioblastoma

NCT06613841

Q2 2030

Phase 2Active, not recruiting

Prostate Adenocarcinoma

NCT03762759

Q4 2032

ApprovedRecruiting

Prostate Cancer

NCT07569926

Clinical

Trials by Indication[1]

Prostate Cancer3 trials

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT03515577·50 enrolled

Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

Completed·UUniversity of Utah·Phase 2·NCT03707184·17 enrolled

The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence

Recruiting·BBlue Earth Diagnostics·Approved·NCT07569926·142 enrolled

Breast Cancer1 trial

Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer

Completed·EEmory University·Phase 1·NCT04750473·20 enrolled

Brain Tumors1 trial

[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors

Terminated·UUniversity of Utah·Phase 1/2·NCT03276676·10 enrolled

Metastatic Prostate Cancer1 trial

An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT04134208·2 enrolled

Endometrial Cancer1 trial

Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

Unknown status·BBital Savir-Baruch·Phase 4·NCT03349463·30 enrolled

2 more indications

Glioblastoma1 trial

Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma

Recruiting·AAbramson Cancer Center at Penn Medicine·Phase 1·NCT06613841·15 enrolled

Prostate Adenocarcinoma1 trial

Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

Active, not recruiting·EEmory University·Phase 2·NCT03762759·140 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Fluciclovine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fluciclovine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fluciclovine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — University of Utah company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: UUniversity of Utah

Fluciclovine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2030

Q4 2032

Trials by Indication[1]

Prostate Cancer3 trials

Breast Cancer1 trial

Brain Tumors1 trial

Metastatic Prostate Cancer1 trial

Endometrial Cancer1 trial

Glioblastoma1 trial

Prostate Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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