Lutetium Lu-177 vipivotide tetraxetan (Pluvicto)

Also known as: Lu-PSMA-617 · 177Lu-PSMA-617 · lutetium Lu 177 vipivotide tetraxetan

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application
Randomized controlled trials 31 of 940 publications on PubMed
Registered clinical trials 106 79 active
Adverse event reports 13,350 3,408 classified as serious
  • Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) is an FDA-approved drug, marketed as Pluvicto (first approval: March 23, 2022).
  • PubMed lists 940 publications mentioning it, including 31 randomized controlled trials and 3 animal-only studies.
  • ClinicalTrials.gov lists 106 registered studies testing it (79 active).
  • FDA's adverse event system (FAERS) holds 13,350 reports mentioning it; 3,408 classified as serious. Reports do not prove causation.

Research topics

  • Radioisotopes 96
  • Dipeptides 91
  • Heterocyclic Compounds, 1-Ring 84
  • Prostate-Specific Antigen 81
  • Prostatic Neoplasms, Castration-Resistant 70
  • Radiopharmaceuticals 69
  • Prostatic Neoplasms 47
  • Antigens, Surface 33
  • Glutamate Carboxypeptidase II 30
  • Neoplasm Metastasis 27

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA215833 PLUVICTO Approved, marketed March 23, 2022 NOVARTIS

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 940
  • Human (MeSH) 667
  • Animal only 3
  • Clinical trials 59
  • Randomized controlled trials 31
  • Systematic reviews & meta-analyses 16
  • Case reports 75
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
106
Active
79
With posted results
7

Conditions studied

  • Prostate Cancer 30
  • Stage IVB Prostate Cancer AJCC v8 15
  • Metastatic Castration-resistant Prostate Cancer 12
  • Prostatic Neoplasms 8
  • Castration-Resistant Prostate Carcinoma 8
  • Metastatic Prostate Cancer 7
  • Prostatic Neoplasms, Castration-Resistant 5
  • Metastatic Castration-Resistant Prostate Adenocarcinoma 4
  • Metastatic Castration-Resistant Prostate Carcinoma 4
  • Metastatic Prostate Adenocarcinoma 4
  • Prostate Cancer Metastatic 4
  • Prostate Adenocarcinoma 3
Study Status Phase Start
Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate Cancer
NCT07852195 ECOG-ACRIN Cancer Research Group
Not yet recruiting Phase 2, Phase 3 January 6, 2027
Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer
NCT07682649 University of Michigan Rogel Cancer Center
Not yet recruiting Phase 1 December 1, 2026
Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial
NCT07698535 University of Washington
Recruiting Phase 2 November 15, 2026
Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer
NCT07860554 Emory University
Not yet recruiting Phase 2 November 2, 2026
Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy
NCT07609225 University of Wisconsin, Madison
Recruiting Early phase 1 October 16, 2026
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
NCT07697989 Novartis Pharmaceuticals
Recruiting — October 1, 2026
Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer
NCT07623460 Stuthi Perimbeti
Not yet recruiting Phase 2 Sep 2026
Impact of Body Composition on Dosimetry of 177Lu-PSMA Radioligand Therapy
NCT07587814 Centre Henri Becquerel
Not yet recruiting N/A Sep 2026
PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT
NCT07550517 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 August 17, 2026
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
NCT07650240 Mayo Clinic
Recruiting Phase 2 August 4, 2026
Show 40 more studies
Study Status Phase Start
Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT07863986 Lithuanian University of Health Sciences
Recruiting — August 4, 2026
177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial
NCT07677566 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Not yet recruiting Phase 4 July 1, 2026
A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
NCT07677267 Novartis Pharmaceuticals
Recruiting — June 30, 2026
68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
NCT06852820 Melissa Lumish
Recruiting Phase 2 Jun 2026
Lu-177 PSMA Treatment in Cell Renal Carcinoma
NCT06959433 Ankara University
Not yet recruiting Phase 3 May 1, 2026
Radiopharmaceutical Treatment of Advanced Kidney Cancer
NCT06783348 European Organisation for Research and Treatment of Cancer - EORTC
Recruiting Phase 2 April 7, 2026
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
NCT07200830 Alliance for Clinical Trials in Oncology
Recruiting Phase 3 March 31, 2026
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
NCT07145177 University of California, San Francisco
Recruiting Phase 1 March 16, 2026
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT07219147 City of Hope Medical Center
Recruiting Phase 1 March 6, 2026
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
NCT07150715 Jonsson Comprehensive Cancer Center
Recruiting Phase 2 December 12, 2025
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
NCT07226986 Novartis Pharmaceuticals
Recruiting Phase 1, Phase 2 December 5, 2025
Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
NCT06917781 Institut Claudius Regaud
Recruiting N/A October 28, 2025
A Study of 177Lu-PSMA-617 in People With Gliomas
NCT07223034 Memorial Sloan Kettering Cancer Center
Recruiting Phase 1 October 27, 2025
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
NCT07206056 Novartis Pharmaceuticals
Recruiting Phase 1, Phase 2 October 15, 2025
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
NCT06894511 Novartis Pharmaceuticals
Active, not recruiting Phase 2 September 11, 2025
Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)
NCT06943495 Jean-Mathieu Beauregard
Recruiting Phase 1 August 15, 2025
177LuPSMA in Renal Cell Carcinoma
NCT06964958 Dana-Farber Cancer Institute
Active, not recruiting Phase 2 July 31, 2025
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
NCT06738303 Case Comprehensive Cancer Center
Recruiting Phase 2 July 14, 2025
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
NCT07054346 Thomas Hope
Recruiting Phase 1 July 8, 2025
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT07047118 Novartis Pharmaceuticals
Active, not recruiting Phase 2 July 3, 2025
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
NCT06855277 Novartis Pharmaceuticals
Recruiting Phase 3 July 1, 2025
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
NCT06972628 Ebrahim S Delpassand
Recruiting Phase 2 May 23, 2025
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
NCT06574880 Angela Y. Jia, MD PhD
Recruiting Phase 1, Phase 2 May 13, 2025
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease
NCT06526299 University of Washington
Recruiting Phase 2 April 29, 2025
Post Marketing Study on Pluvicto in Korea
NCT06514521 Novartis Pharmaceuticals
Recruiting — April 18, 2025
Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
NCT06866938 Hospices Civils de Lyon
Recruiting Phase 2 April 11, 2025
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
NCT06798558 Hackensack Meridian Health
Recruiting Phase 2 March 5, 2025
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
NCT06632977 Alliance for Clinical Trials in Oncology
Recruiting Phase 2 February 6, 2025
SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
NCT06389097 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting — February 3, 2025
SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
NCT07096999 University of Michigan Rogel Cancer Center
Recruiting — January 23, 2025
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
NCT06449781 Maria Sklodowska-Curie National Research Institute of Oncology
Recruiting Phase 2 January 9, 2025
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
NCT06706921 VA Greater Los Angeles Healthcare System
Recruiting Phase 4 December 15, 2024
XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06568562 University of Utah
Recruiting Phase 2 December 9, 2024
Comprehensive Assessment of Cancer Theranostic Response
NCT06815354 AIQ Solutions
Active, not recruiting N/A December 2, 2024
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
NCT06531499 Novartis Pharmaceuticals
Active, not recruiting Phase 1 November 11, 2024
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
NCT06145633 Fred Hutchinson Cancer Center
Recruiting Phase 2 September 18, 2024
Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
NCT06496581 UNICANCER
Recruiting Phase 3 September 12, 2024
Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer(mCRPC)
NCT06546527 Peking University First Hospital
Not yet recruiting Early phase 1 August 1, 2024
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
NCT06288113 Jonsson Comprehensive Cancer Center
Recruiting Phase 2 August 1, 2024
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
NCT06216249 Jonsson Comprehensive Cancer Center
Recruiting Phase 2 August 1, 2024

All 106 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
13,350
Serious
3,408
With death outcome
1,698

Most reported reactions

  • General physical health deterioration 6,143
  • Ill-defined disorder 3,640
  • Death 1,328
  • Disease progression 351
  • Malignant neoplasm progression 346
  • Prostatic specific antigen increased 278
  • Laboratory test abnormal 261
  • Fatigue 245
  • Anaemia 208
  • Hormone-refractory prostate cancer 172
  • Platelet count decreased 162
  • Illness 156

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • PLUVICTO HUMAN PRESCRIPTION DRUG Novartis Pharmaceuticals Corporation August 12, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.