piflufolastat F 18

Phase 3Small molecule

Novartis

piflufolastat F 18 is one of 31 small molecule programs targeting Prostate Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Prostate CancerActive, not recruiting

Prostate CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Radium-223

Bayer

Phase 3

6 2

Triptorelin Embonate

Ipsen

Phase 3

3 3

Lhrha

Johnson & Johnson

Phase 3

2 4

Docetaxel /m²

AstraZeneca

Phase 3

2 5

Gallium Ga 68 Gozetotide

MMayo Clinic

Phase 3

3 6

Luteinizing Hormone Releasing Hormone

UUS Department of Veterans Affairs

Phase 3

2 7

Lupron Depot

RRepros Therapeutics Inc.

Phase 3

2 8

piflufolastat F 18

Novartis

Phase 3

1 9

Trexall

Duragesic

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Prostatic Neoplasm

NCT05849298

Clinical

Trials by Indication[1]

Metastatic1 trial

Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

Withdrawn·LLantheus Medical Imaging·Phase 2/3·NCT07084909

Prostate Cancer1 trial

PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Active, not recruiting·LLantheus Medical Imaging·Phase 4·NCT06074510·274 enrolled

Prostatic Neoplasm1 trial

An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05849298·49 enrolled

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for piflufolastat F 18. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — piflufolastat F 18 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for piflufolastat F 18. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

piflufolastat F 18

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Metastatic1 trial

Prostate Cancer1 trial

Prostatic Neoplasm1 trial

References

Drug Info

Quick Facts

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