Piflufolastat

Phase 3Small molecule

Piflufolastat is one of 12 small molecule programs targeting Castration-resistant Prostate Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Castration-Resistant Prostate CancerRecruiting

Castration-Resistant Prostate CancerPhase 3

Recruiting

Competition

Competitive Landscape

11 competitors in Castration-Resistant Prostate Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 2

1 2

Erleada

Johnson & Johnson

Phase 2

1 3

Xtandi

Astellas

Phase 2

1 4

Delatestryl

AAntares Pharma Inc.

Phase 2

1 5

Depo-Testosterone

AAzurity Pharmaceuticals

Phase 2

1 6

Piflufolastat

Novartis

Phase 3

1 7

Evofosfamide

Merck & Co.

Phase 2

1 8

Zytiga

Johnson & Johnson

Preclinical

1 9

Lynparza

AstraZeneca

Preclinical

1 10

Ptvg-HP

UUniversity of Wisconsin, Madison

Phase 2

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

Timeline

Expected Milestones

Q3 2030

ApprovedRecruiting

Castration-Resistant Prostate Cancer

NCT05919329

Q4 2031

Phase 3Recruiting

Oligometastatic Prostate Cancer (OMPC)

NCT05939414

Clinical

Trials by Indication[1]

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Withdrawn· Novartis logo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

Castration-resistant Prostate Cancer1 trial

Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy

Recruiting·OOHSU Knight Cancer Institute·Approved·NCT05919329·80 enrolled

Prostate Cancer1 trial

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

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]

ART1 trial

Oligometastatic Prostate Cancer (OMPC)1 trial

Castration-resistant Prostate Cancer1 trial

Prostate Cancer1 trial

References

Drug Info

Quick Facts

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