AAA617

Phase 2Small molecule

AAA617 is one of 7 small molecule programs targeting Metastatic Castration-resistant Prostate Cancer, mCRPC. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Castration-Resistant Prostate Cancer, McrpcActive, not recruiting

Metastatic Castration-Resistant Prostate Cancer, McrpcPhase 2

Active, not recruiting

Competition

Competitive Landscape

10 competitors in Metastatic Castration-Resistant Prostate Cancer, Mcrpc

#DrugCompanyPhaseTrials

Libtayo

Regeneron

Preclinical

1 2

Xaluritamig

Amgen

Phase 1

1 3

Fludara

AAA617

2 5

Cytoxan

BBaxter Healthcare Corporation

REGN5678

1 7

Adi-212

AAdicet Therapeutics

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

Q2 2029

Phase 1Active, not recruiting

Metastatic Castration-Resistant Prostate Cancer

NCT06531499

Q4 2031

Phase 3Recruiting

Oligometastatic Prostate Cancer (OMPC)

NCT05939414

Clinical

Trials by Indication[1]

Metastatic Castration-resistant Prostate Cancer, mCRPC2 trials

A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT06894511·7 enrolled

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

Prostate Cancer1 trial

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

Recruiting· Novartis logo

Novartis·Phase 4·NCT05803941·700 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

Metastatic Castration-Resistant Prostate Cancer1 trial

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT06531499·110 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: Phase 2[1]
Company: Novartis

AAA617

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Q2 2029

Q4 2031

Trials by Indication[1]

Metastatic Castration-resistant Prostate Cancer, mCRPC2 trials

Prostate Cancer1 trial

Prostatic Neoplasm1 trial

Oligometastatic Prostate Cancer (OMPC)1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

Prostatic Cancer, Castration-Resistant1 trial

References

Drug Info

Quick Facts

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