Lu-PSMA-617

Phase 2Small molecule

Novartis

Lu-PSMA-617 is one of 110 small molecule programs targeting Metastatic Prostate Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

109

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Prostate CancerRecruiting

Metastatic Neuroendocrine Prostate CancerActive, not recruiting

Prostate CancerRecruiting

Hepatocellular CarcinomaNot yet recruiting

Metastatic Prostate CancerPhase 2

Recruiting

Metastatic Neuroendocrine Prostate CancerPhase 1

Active, not recruiting

Prostate CancerPhase 2

Recruiting

Hepatocellular CarcinomaPhase 2

Not yet recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

22 2

Antibiotic

Pfizer

Phase 3

1 3

Triptorelin Embonate

Ipsen

Phase 3

3 4

Lhrha

Johnson & Johnson

Phase 3

2 5

Aglatimagene Besadenovec

CCandel Therapeutics, Inc.

Phase 3

2 6

Lu-PSMA-617

Novartis

Phase 2

3 7

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 8

INR101

YYunhe Pharmaceutical (Tianjin) Co., Ltd

Phase 3

3 9

Trexall

Jazz Pharmaceuticals

Preclinical

—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 2026

Phase 2Recruiting

Metastatic Prostate Cancer

NCT06738303

Q1 2027

Phase 2Active, not recruiting

Prostate Cancer

NCT05658003

Phase 1/2Recruiting

Prostate Cancer

NCT06574880

Q2 2027

Phase 2Not yet recruiting

Hepatocellular Carcinoma

NCT06852820

Q2 2030

Phase 2Recruiting

Prostate Cancer

NCT06866938

Clinical

Trials by Indication[1]

Prostate Cancer3 trials

A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05658003·63 enrolled

Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer

Recruiting·HHospices Civils de Lyon·Phase 2·NCT06866938·58 enrolled

STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

Recruiting·—·Phase 1/2·NCT06574880·45 enrolled

Hepatocellular Carcinoma1 trial

68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)

Not yet recruiting·MMelissa Lumish·Phase 2·NCT06852820·10 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Completed· Novartis logo

Novartis·Phase 2·NCT05670106·62 enrolled

Metastatic Prostate Cancer1 trial

Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)

Recruiting·CCase Comprehensive Cancer Center·Phase 2·NCT06738303·44 enrolled

Metastatic Neuroendocrine Prostate Cancer1 trial

A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT06379217·31 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Lu-PSMA-617. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lu-PSMA-617 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lu-PSMA-617. 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 2[1]
Company: Novartis

Lu-PSMA-617

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q2 2030

Trials by Indication[1]

Prostate Cancer3 trials

Hepatocellular Carcinoma1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Metastatic Prostate Cancer1 trial

Metastatic Neuroendocrine Prostate Cancer1 trial

References

Drug Info

Quick Facts

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