Piflufolastat

Phase 3Small molecule

Piflufolastat is one of 32 small molecule programs targeting Oligometastatic Prostate Cancer (OMPC). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Oligometastatic Prostate Cancer (OMPC)Recruiting

Prostate CancerCompleted

Oligometastatic Prostate Cancer (OMPC)Phase 3

Recruiting

Prostate CancerPhase 3

Completed

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

Piflufolastat

Novartis

Phase 3

2 7

Luteinizing Hormone Releasing Hormone

UUS Department of Veterans Affairs

Phase 3

2 8

Lupron Depot

RRepros Therapeutics Inc.

Phase 3

2 9

Trexall

Duragesic

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

Timeline

Expected Milestones

Q3 2030

Post-ApprovalRecruiting

Prostate Cancer

NCT05919329

Q4 2031

Phase 3Recruiting

Oligometastatic Prostate Cancer (OMPC)

NCT05939414

Clinical

Trials by Indication[1]

Prostate Cancer2 trials

Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

Recruiting·OOHSU Knight Cancer Institute·Phase 4·NCT05919329·80 enrolled

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Completed·BBlue Earth Diagnostics·Approved·NCT06604442·62 enrolled

ART1 trial

Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC

Withdrawn· Novartis logo

Novartis·Phase 1/2·NCT06881823

Oligometastatic Prostate Cancer (OMPC)1 trial

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

Recruiting· Novartis logo

Novartis·Phase 3·NCT05939414·450 enrolled

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Piflufolastat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Piflufolastat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Piflufolastat. 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

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2030

Q4 2031

Trials by Indication[1]

Prostate Cancer2 trials

ART1 trial

Oligometastatic Prostate Cancer (OMPC)1 trial

References

Drug Info

Quick Facts

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