Drug

lutetium Lu 177 vipivotide tetraxetan

In clinical development

Emerging researchLate-stage development

Also known as 177Lu-PSMA-617, 177Lu-labeled PSMA-617, 177Lutetium -PSMA 617, 177Lutetium-PSMA-617+8 more

177Lu-PSMA-617, 177Lu-labeled PSMA-617, 177Lutetium -PSMA 617, 177Lutetium-PSMA-617, AAA617, Lu-177-PSMA-617, Lu177-PSMA-617, Pluvicto, lutetium Lu 177-PSMA-617, lutetium-177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium (177Lu) vipivotide tetraxetan.

RxNorm2597053UNIIG6UF363ECX

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase I/II Study of CDK4/6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy

Clinical trial2026-07-24Results expected Q2 2027 · ClinicalTrials.gov

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.

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

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)

Clinical trial2026-07-09Results expected Q3 2027 · ClinicalTrials.gov

PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-Directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Clinical trial2026-07-08Results posted · ClinicalTrials.gov

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Clinical trial2026-07-02Results expected Q3 2028 · ClinicalTrials.gov

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Clinical trial2026-07-02Results expected Q3 2034 · ClinicalTrials.gov

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

Clinical trial2026-06-25Results expected Q4 2027 · ClinicalTrials.gov

Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer.

Research2021-06-23The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

lutetium Lu 177 vipivotide tetraxetan

Aliases & brands

177Lu-PSMA-617177Lu-labeled PSMA-617177Lutetium -PSMA 617177Lutetium-PSMA-617AAA617Lu-177-PSMA-617Lu177-PSMA-617Pluvictolutetium Lu 177-PSMA-617lutetium-177-PSMA-617LUTETIUM LU-177 VIPIVOTIDE TETRAXETANLutetium (177Lu) vipivotide tetraxetan

RxNorm CUI

2597053

UNII

G6UF363ECX

Clinical trials

51 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 51

Phase 113Phase 1 / 28Phase 223Phase 36Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

RecruitingPH IVNovartis Pharmaceuticalsn=7002033

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

RecruitingPH IIIKey trialAlliance for Clinical Trials in Oncologyn=1,5242034

Studying Treatments in Patients Receiving Androgen Deprivation Therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy: A 2nd Multi-arm Multi-stage Randomised Controlled Trial (STAMPEDE2).

RecruitingPH IIIKey trialUniversity College, Londonn=3,3602032

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)

RecruitingPH IIINovartis Pharmaceuticalsn=4502031

An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Active, not recruitingPH IIIKey trialNovartis Pharmaceuticalsn=1,1402027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Lutetium-177-PSMA-617 Radioligand Therapy in Oligo-metastatic Hormone Sensitive Prostate Cancer.

CompletedPH IIRadboud University Medical Centern=582026

Tolerability of Concurrent EBRT + Lu-PSMA for Node-positive Prostate Cancer (PROQURE-1)

CompletedPH IThe Netherlands Cancer Instituten=142025

Immunogenic Priming With PSMA-Targeted Radioligand Therapy in Advanced Prostate Cancer: A Phase 1b Study of 177Lu-PSMA-617 in Combination With Pembrolizumab

CompletedPH IUniversity of California, San Franciscon=432024

VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

CompletedPH IIIEndocyten=8612023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer.

The New England journal of medicine · 2021 · 1,942 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Lutetium

Studied across the same disease area as lutetium Lu 177 vipivotide tetraxetan in the shared literature.

1 shared disease1 shared paper

Lutetium-177

Studied across the same disease area as lutetium Lu 177 vipivotide tetraxetan in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
Europe PMC — research literature
ClinicalTrials.gov — clinical trials