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Drug

lutetium Lu 177 vipivotide tetraxetan

Approved medicine
ClassGlutamate carboxypeptidase II binding agentResearchActive indication expansion
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.

RxNorm2597053ChEMBLCHEMBL4594406ATCV10XX05UNIIG6UF363ECX
1
Research papers
41
Active clinical trials
Glutamate carboxypeptidase 2
Primary target
5
Regulatory events
Latest activity
beta

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

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

Clinical trial2026-09-11Results expected Q4 2026 · ClinicalTrials.gov

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Clinical trial2026-09-02Results expected Q2 2030 · 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 trial2026-08-18Results 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 trial2026-08-18Results expected Q3 2028 · 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 trial2026-08-07Results posted · ClinicalTrials.gov

Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

Clinical trial2026-08-06Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-08-05Results expected Q3 2034 · ClinicalTrials.gov

Indication expansion: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)

Regulatory2026-07-31FDA

Label change: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)

Regulatory2026-04-07FDA

Indication expansion: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)

Regulatory2025-03-28FDA

Label change: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)

Regulatory2025-03-28FDA

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
ChEMBL ID
CHEMBL4594406
ATC codes
V10XX05
UNII
G6UF363ECX
Primary mechanism
Glutamate carboxypeptidase II binding agent
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Glutamate carboxypeptidase 2
FOLH1 · Q04609
BINDING AGENTGlutamate carboxypeptidase II binding agent

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-03-23
Latest approval
2026-07-31
Authorities
FDA
Total events
5
fdaU.S. Food and Drug Administration· 5 events
2026-07-31Indication expansion
Indication expansion: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)
Evidence ↗
2026-04-07Label change
Label change: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)
Evidence ↗
2025-03-28Label change
Label change: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (NDA215833)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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
51
registered trials across all phases
LATEST COMPLETION 2026
41
Active studies
26
Recruiting
7
Late-stage (III+)
4
Completed
6
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
Recent papers

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

The New England journal of medicine · 2021 · 1,942 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
Leading researchers
  • Armour A1
  • Beer TM1
  • Chi KN1
  • de Bono J1
  • DeSilvio M1
  • El-Haddad G1
  • Fizazi K1
  • Gericke G1
Leading institutions
free-text, unnormalised
  • From the School of Medicine1

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
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.