AAA617

Phase 3Small molecule

AAA617 is one of 50 small molecule programs targeting Metastatic Castration-resistant Prostate Cancer, mCRPC. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Castration-Resistant Prostate Cancer, McrpcActive, not recruiting

Oligometastatic Prostate Cancer (OMPC)Recruiting

First-LineActive, not recruiting

Prostate CancerRecruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcPhase 2

Active, not recruiting

Oligometastatic Prostate Cancer (OMPC)Phase 3

Recruiting

First-LinePhase 2

Active, not recruiting

Prostate CancerPhase 3

Recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Androgen Deprivation Therapy

Johnson & Johnson

Phase 3

48 2

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

7 3

Antiandrogen Therapy

UUniversity of Washington

Phase 3

10 4

Xaluritamig

Amgen

Phase 3

4 5

Radium-223

Bayer

Phase 3

6 6

AAA617

Novartis

Phase 3

2 7

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase 3

1 8

Gallium Ga 68 Gozetotide

MMayo Clinic

Phase 3

3 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

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

Prostatic Neoplasm

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

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

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

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

1 more indication

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

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: Phase 3[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

Prostatic Cancer, Castration-Resistant1 trial

Prostatic Neoplasm1 trial

Oligometastatic Prostate Cancer (OMPC)1 trial

Metastatic Castration-resistant Prostate Cancer, mCRPC1 trial

References

Drug Info

Quick Facts

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