Drugs / 177Lu-PSMA-617
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177Lu-PSMA-617

Other / unclassified

Developed for
castration-resistant prostate carcinoma · prostate cancer · prostate carcinoma · metastatic prostate carcinoma · prostate adenocarcinoma · prostate neoplasm · clear cell renal carcinoma · adenoid cystic carcinoma
+11 more · anemia · diffuse astrocytoma · diffuse glioma, H3 G34 mutant · diffuse midline glioma, H3 K27-altered · diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype · hepatocellular carcinoma · IDH-wildtype glioblastoma · kidney cancer · prostate neuroendocrine neoplasm · thrombocytopenia · urinary system neoplasm
Investigated by
Novartis Pharmaceuticals · Novartis · Advanced Accelerator Applications · National Cancer Institute (NCI) · Endocyte · Australian and New Zealand Urogenital and Prostate Cancer Trials Group
+64 more · Jonsson Comprehensive Cancer Center · Peter MacCallum Cancer Centre, Australia · Prostate Cancer Foundation · University of California, San Francisco · Weill Medical College of Cornell University · Alliance for Clinical Trials in Oncology · Bristol-Myers Squibb · Dana-Farber Cancer Institute · Maria Sklodowska-Curie National Research Institute of Oncology · Mayo Clinic · Memorial Sloan Kettering Cancer Center · Movember Foundation · Prostate Cancer Research Alliance · Radboud University Medical Center · University of Washington · Alliance Foundation Trials, LLC. · Angela Y. Jia, MD PhD · Ankara University · Astellas Pharma Inc · Australasian Radiopharmaceutical Trials network (ARTnet) · Australia's Nuclear Science and Technology Organisation (ANSTO) · Bayer · Blue Earth Therapeutics Ltd · Canadian Cancer Trials Group · Cancer Research UK · Case Comprehensive Cancer Center · Centre for Biostatistics and Clinical Trials (BaCT) · City of Hope Medical Center · E.J. Whitten Foundation Prostate Cancer Research Centre · Ebrahim S Delpassand · Eli Lilly and Company · European Organisation for Research and Treatment of Cancer - EORTC · Hackensack Meridian Health · Hospices Civils de Lyon · Institute for Prostate Cancer Research (IPCR) · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Janssen Research & Development, LLC · Lombardi Comprehensive Cancer Center · M.D. Anderson Cancer Center · Medical Research Future Fund · Medpace, Inc. · Melissa Lumish · Merck Sharp & Dohme LLC · National Health and Medical Research Council, Clinical Trials Centre · OncoC4, Inc. · Prostaatkankerstichting · Prostate Cancer Canada · Prostate Cancer Clinical Trials Consortium · Prostate Cancer Foundation of Australia · RTOG Foundation, Inc. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Netherlands Cancer Institute · Thomas Hope · UMC Utrecht · UNICANCER · United States Department of Defense · University College, London · University Hospital, Essen · University of Michigan Rogel Cancer Center · University of Sydney · VA Office of Research and Development · Vadim S Koshkin

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) PLUVICTO 2025-03-28 – 2026-07-31 fda.gov
Approved EU (EMA) Pluvicto 2022-12-09 europa.eu
Approved US (FDA) PLUVICTO 2022-03-23 fda.gov

Trials 68 · started per year

today
US approved 2022
EU approved 2022
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201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06516510 Oct 2024 → Aug 2025 metastatic prostate carcinoma Blue Earth Therapeutics Ltd Terminated No outcome recorded
Phase 113 trials
Phase 1 NCT07682649 Aug 2026 → Aug 2027 expected castration-resistant prostate carcinoma University of Michigan Rogel Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07145177 Mar 2026 → Oct 2028 expected metastatic prostate carcinoma University of California, San Francisco Recruiting No outcome recorded
Phase 1 NCT07219147 Mar 2026 → Jul 2028 expected prostate adenocarcinoma City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT07223034 Oct 2025 → Oct 2027 expected IDH-wildtype glioblastoma, diffuse astrocytoma, diffuse glioma, H3 G34 mutant, diffuse midline glioma, H3 K27-altered +1 Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT07054346 Jul 2025 → Apr 2027 expected prostate carcinoma Thomas Hope Recruiting No outcome recorded
Phase 1 NCT06531499 Nov 2024 → Nov 2028 expected prostate carcinoma Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT06379217 Jul 2024 → Aug 2026 overdue prostate neuroendocrine neoplasm Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT06303713 May 2024 → Oct 2026 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1 NCT05818683 Apr 2023 → Aug 2027 expected prostate carcinoma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT05162573 Dec 2021 → Sep 2025 prostate neoplasm The Netherlands Cancer Institute Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT06388369 Aug 2025 → Mar 2026 prostate cancer University Hospital, Essen Terminated No outcome recorded
Phase 1/2 NCT06574880 May 2025 → Sep 2026 expected prostate cancer Angela Y. Jia, MD PhD Recruiting No outcome recorded
Phase 1/2 NCT05682443 Dec 2023 → Nov 2026 expected prostate carcinoma OncoC4, Inc. Active not recruiting No outcome recorded
Phase 1/2 NCT05340374 Jul 2022 → Jun 2026 overdue castration-resistant prostate carcinoma Peter MacCallum Cancer Centre, Australia Active not recruiting No outcome recorded
Phase 1/2 NCT05113537 Jul 2022 → May 2026 overdue castration-resistant prostate carcinoma, prostate adenocarcinoma Vadim S Koshkin Recruiting No outcome recorded
Phase 1/2 NCT04430192 Aug 2020 → Dec 2022 overdue prostate neoplasm Peter MacCallum Cancer Centre, Australia Active not recruiting No outcome recorded
Phase 1/2 NCT03828838 Jul 2018 → Nov 2019 prostate neoplasm Radboud University Medical Center Completed No outcome recorded
Phase 1/2 NCT03545165 Apr 2018 → Jul 2020 prostate cancer Weill Medical College of Cornell University Terminated No outcome recorded
Phase 1/2 NCT03042468 Dec 2016 → Sep 2021 overdue prostate cancer Weill Medical College of Cornell University Active not recruiting No outcome recorded
Phase 234 trials
Phase 2 NCT07698535 Dec 2026 → Jul 2029 expected prostate adenocarcinoma University of Washington Not yet recruiting No outcome recorded
Phase 2 NCT07650240 Jul 2026 → Dec 2030 expected metastatic prostate carcinoma, prostate adenocarcinoma Mayo Clinic Not yet recruiting No outcome recorded
Phase 2 NCT07550517 Jul 2026 → Jul 2032 expected Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Not yet recruiting No outcome recorded
Phase 2 NCT06852820 Jun → Dec 2026 expected hepatocellular carcinoma Melissa Lumish Recruiting No outcome recorded
Phase 2 NCT06783348 Apr 2026 → Jan 2028 expected clear cell renal carcinoma European Organisation for Research and Treatment of Cancer - EORTC Recruiting No outcome recorded
Phase 2 NCT07150715 Dec 2025 → Oct 2030 expected prostate adenocarcinoma Jonsson Comprehensive Cancer Center Recruiting No outcome recorded
Phase 2 NCT06894511 Sep 2025 → Oct 2026 expected prostate carcinoma Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 2 NCT07025512 Aug 2025 → May 2026 anemia, castration-resistant prostate carcinoma, thrombocytopenia M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT06964958 Jul 2025 → Dec 2026 expected clear cell renal carcinoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 2 NCT06738303 Jul 2025 → Dec 2026 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma Case Comprehensive Cancer Center Recruiting No outcome recorded
Phase 38 trials
Phase 3 NCT06959433 May 2026 → Feb 2028 expected kidney cancer Ankara University Not yet recruiting No outcome recorded
Phase 3 NCT07200830 Mar 2026 → Sep 2034 expected castration-resistant prostate carcinoma, prostate adenocarcinoma Alliance for Clinical Trials in Oncology Recruiting No outcome recorded
Phase 3 NCT06496581 Sep 2024 → Feb 2033 expected metastatic prostate carcinoma UNICANCER Recruiting No outcome recorded
Phase 3 NCT06320067 Jun 2024 → Apr 2031 expected metastatic prostate carcinoma University College, London Recruiting No outcome recorded
Phase 3 NCT05939414 Mar 2024 → Apr 2028 expected prostate carcinoma Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT04689828 Jun 2021 → Oct 2022 overdue prostate neoplasm Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 3 NCT04720157 Jun 2021 → Jan 2025 overdue prostate neoplasm Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 3 NCT03511664 May 2018 → Jan 2021 prostate cancer Endocyte Completed No outcome recorded
Phase 42 trials
Phase 4 NCT07677566 Jul 2026 → Jul 2027 expected prostate cancer The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Not yet recruiting No outcome recorded
Phase 4 NCT05803941 Aug 2023 → Jul 2033 expected prostate cancer Novartis Pharmaceuticals Recruiting No outcome recorded
Phase not stated1 trial
NCT04825652 castration-resistant prostate carcinoma Advanced Accelerator Applications No longer available No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT06943495 Comparator Aug 2025 → Mar 2029 expected castration-resistant prostate carcinoma Jean-Mathieu Beauregard Recruiting No outcome recorded
Phase 1 NCT06095089 Background Nov 2023 → Jun 2027 expected prostate neoplasm Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT05613894 Background Jul 2023 → Dec 2026 prostate carcinoma University of Utah Suspended No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT07206056 Comparator Oct 2025 → Nov 2029 expected castration-resistant prostate carcinoma Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1/2 NCT06329830 Background Oct 2024 → Oct 2026 castration-resistant prostate carcinoma, metastatic prostate carcinoma Baptist Health South Florida Withdrawn No outcome recorded
Phase 21 trial
Phase 2 NCT06145633 Background Sep 2024 → Dec 2026 expected castration-resistant prostate carcinoma, prostate adenocarcinoma Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT06855277 Comparator Jul 2025 → Sep 2028 expected prostate cancer Novartis Pharmaceuticals Recruiting No outcome recorded

Press releases naming this drug 18 releases

DateIssuerRelease
2026-07-31 Novartis Pharmaceuticals FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease novartis.com
2026-05-31 Novartis Pharmaceuticals Pluvicto™ demonstrated consistent efficacy across key patient subgroups in metastatic hormone-sensitive prostate cancer novartis.com
2026-05-17 Novartis Pharmaceuticals New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer novartis.com
2026-02-24 Novartis Pharmaceuticals New real‑world data reinforce earlier use of Pluvicto™ before chemotherapy in metastatic castration-resistant prostate cancer novartis.com
2025-10-19 Novartis Pharmaceuticals PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer novartis.com
2025-06-02 Novartis Pharmaceuticals Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer novartis.com
2025-03-28 Novartis Pharmaceuticals FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer novartis.com
2024-01-05 Novartis Pharmaceuticals Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis novartis.com
2023-10-26 Novartis Pharmaceuticals Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers novartis.com
2023-10-23 Novartis Pharmaceuticals Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting novartis.com
2022-12-13 Novartis Pharmaceuticals Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer novartis.com
2022-12-05 Novartis Pharmaceuticals Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer novartis.com

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 87 sources stand behind the page.

FieldValueCited text
Known as 177Lu PSMA 617 “PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when...” NCT06496581
36

“Five participants will receive a single dose of 177Lu-PSMA-617 radioligand therapy intravenously (IV), five participants will receive a single dose of 177Lu-PSMA-617...” NCT07054346

“The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate...” NCT06852820

“(177)Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer...” PMID 39293462 Sep 2024

“Background Lutetium 177 (177Lu) prostate-specific membrane antigen (PSMA)-617 SPECT/CT has demonstrated promise as a response biomarker for 177Lu-PSMA-617 therapy.” PMID 42048586 Apr 2026

177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body.” NCT04663997

“BACKGROUND: 177Lu-PSMA-617 is a radioligand therapy targeting cells expressing prostate-specific membrane antigen (PSMA).” PMID 41764712 Mar 2026

“injection of 3.7-5.5 GBq of 177Lu-PSMA-617 repeated four times at interval of 8 weeks.” PMID 32430583 May 2020

“(177Lu)-PSMA-617 will be administered every 6 weeks for up to 6 cycles per SOC.” NCT05613894

“177Lu-PSMA-617 is a nuclear medicine therapy.” NCT06320067

NCT04443062

NCT04825652

NCT04343885

NCT07550517

NCT07223034

NCT04689828

NCT05079698

NCT03545165

NCT04886986

NCT04720157

NCT03511664

NCT06303713

NCT07025512

NCT05162573

NCT04663997

NCT07145177

NCT03042312

NCT06783348

NCT05766371

NCT06943495

NCT07677566

NCT05150236

NCT06964958

NCT06329830

NCT04430192

NCT03042468

NCT05340374

Known as 177Lu-DOTA-PSMA-617 177Lu-DOTA-PSMA-617 (177Lu-PSMA-617) is a PSMA-targeted small molecule with favorable properties and is the most extensively investigated PSMA radioligand for radionuclide...” PMID 31595044 Oct 2019
Known as 177Lu-PSMA-617 also referred to as 177Lu-PSMA 177Lu-PSMA-617 also referred to as 177Lu-PSMANCT04343885
Known as 177Lutetium -PSMA 617 also referred to as 177Lu-PSMA 177Lutetium -PSMA 617 also referred to as 177Lu-PSMANCT04419402
1

177Lutetium -PSMA 617 also referred to as 177Lu-PSMANCT05150236

Known as 177Lutetium-PSMA-617 “The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient...” NCT06783348
Known as [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 is a standard treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated...” PMID 39978808 Apr 2025
1

[177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 (177Lu-PSMA-617) is a novel treatment for metastatic castration-resistant prostate cancer.” PMID 41926960 Apr 2026

Known as [177Lu]Lu-PSMA-617 “BACKGROUND: Dosimetry in [177Lu]Lu-PSMA therapy is a valuable tool to assess treatment efficacy and toxicity. This study aims to develop a clinically implementable protocol to...” PMID 36692682 Jan 2023
9

“Overall survival and quality of life with [(177)Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p):...” PMID 39956124 Feb 2025

“In HCC, a recent preclinical study demonstrated that radioligand therapy using \[177Lu\]Lu-PSMA-617 and \[177Lu\]Lu-EB-PSMA-617 effectively suppressed tumor growth and...” NCT06852820

“lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI)” PMID 40441170 May 2025

[177Lu]Lu-PSMA-617 radiopharmaceutical therapy has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC)” PMID 40876952 Oct 2025

“2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617 at 6 weeks intervals” NCT06388369

NCT06866938

NCT06379217

NCT05670106

NCT05658003

Known as [177Lu]Lu-PSMA-617 (AAA617) [177Lu]Lu-PSMA-617 (AAA617)NCT06855277
Known as AAA617 “The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or \[177Lu\]Lu-PSMA-617 (AAA617).” NCT06855277
7

NCT05939414

NCT07047118

NCT06004661

NCT06531499

NCT05849298

NCT05803941

NCT06894511

Known as Lu-177 PSMA “Two cycles of Lu-177 PSMA (3GBq and 3-6 GBq)” NCT03828838
Known as Lu-177 PSMA-617 “2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy in patients with high risk localized prostate cancer.” NCT06798558
2

NCT03828838

NCT06959433

Known as Lu-177 vipivotide tetraxetan “The VISION study was a phase 3 trial investigating the efficacy and safety of 177Lu-PSMA-617 (Lu-177 vipivotide tetraxetan) with standard of care in patients with previously...” NCT06852820
Known as Lu-PSMA ClinicalTrials.gov intervention name — accepted as the source's own label NCT04419402
Known as Lu-PSMA-617 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06852820
2

NCT06738303

NCT06574880

Known as lutetium (177Lu) vipivotide tetraxetan “This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of...” NCT06004661
3

lutetium (177Lu) vipivotide tetraxetan (Pluvicto®)” NCT06516510

NCT06199453

NCT06449781

Known as Lutetium Lu 177 vipivotide tetraxetan “The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in...” NCT06943495
15

NCT06632977

NCT05818683

NCT05682443

NCT06145633

NCT07200830

NCT06095089

NCT06200103

NCT07150715

NCT06526299

NCT07219147

NCT07698535

NCT06288113

NCT07650240

NCT06216249

NCT07682649

Known as Lutetium Lu 177-PSMA-617 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03805594
1

NCT05113537

Known as Lutetium-177-PSMA-617 Lutetium-177-PSMA-617 in Low-Volume Hormone-Sensitive Metastatic Prostate Cancer: A Prospective Pilot Study.” PMID 33883176 Apr 2021
1

NCT06972628

Known as Pluvicto “The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer...” NCT06972628
5

“The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in...” NCT06943495

“Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator” NCT07206056

“lutetium (177Lu) vipivotide tetraxetan (Pluvicto®)” NCT06516510

“[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)” NCT06866938

NCT06084338

Known as PluvictoⓇ “2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy in patients with high risk localized prostate cancer.” NCT06798558
Known as vipivotide tetraxetan “In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic...” PMID 37269841 Jun 2023
1

“lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI)” PMID 40441170 May 2025

Action Inhibit “which is an inhibitor capable of binding to the domain of PSMA.” NCT03042312
Modality Other / unclassified “Radioligand therapy (RLT) with 177Lu-PSMA-617 is a promising option” PMID 32430583 May 2020
Route Intravenous “repeated intravenous (i.v.) injection” NCT03042312