AAA617

ApprovedSmall molecule

Novartis

AAA617 is one of 32 small molecule programs targeting Prostate Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Prostate CancerActive, not recruiting

Prostatic Cancer, Castration-ResistantActive, not recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcActive, not recruiting

Prostate CancerApproved

Active, not recruiting

Prostatic Cancer, Castration-ResistantPhase 2

Active, not recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcPhase 2

Active, not recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

AAA617

Novartis

Approved

2 2

Trexall

Alnylam Pharmaceuticals

Preclinical

—3

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 4

Viagra

VViatris Specialty LLC

Preclinical

1 5

Duragesic

CCephalon

Preclinical

1 6

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 7

Prednisone/prednisolone

Roche

Preclinical

3 8

Triptorelin Pamoate

Ipsen

Preclinical

2 9

Ifex

BBaxter Healthcare Corporation

Xylocaine

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Metastatic Castration-Resistant Prostate Cancer, Mcrpc

NCT06004661

Phase 2Active, not recruiting

PSMA PET

NCT05849298

Q2 2028

Phase 2Active, not recruiting

Prostatic Cancer, Castration-Resistant

NCT07047118

Q4 2028

Phase 1Recruiting

Prostate Cancer

NCT06531499

Q2 2029

Phase 2Active, not recruiting

First-Line

NCT06894511

Clinical

Trials by Indication[1]

Prostate Cancer2 trials

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

Recruiting· Novartis logo

Novartis·Phase 1·NCT06531499·106 enrolled

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Recruiting· Novartis logo

Novartis·Phase 4·NCT05803941·700 enrolled

First-line1 trial

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT06894511·7 enrolled

SMA1 trial

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Recruiting· Novartis logo

Novartis·Phase 3·NCT05939414·450 enrolled

PSMA PET1 trial

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05849298·49 enrolled

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT06004661·23 enrolled

1 more indication

Prostatic Cancer, Castration-Resistant1 trial

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT07047118·138 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for AAA617. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AAA617 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AAA617. 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: Approved[1]
Company: Novartis

AAA617

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Q4 2028

Q2 2029

Trials by Indication[1]

Prostate Cancer2 trials

First-line1 trial

SMA1 trial

PSMA PET1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

Prostatic Cancer, Castration-Resistant1 trial

References

Drug Info

Quick Facts

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