Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, 177Lu-PSMA-617): what the evidence says

Name: Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, 177Lu-PSMA-617)
Published: 2026-10-27

At a glance

What it is: Caution Not a classic peptide (urea-based peptidomimetic radioligand). Vipivotide tetraxetan (PSMA-617) is a small PSMA-binding molecule built from amino-acid building blocks linked via a urea bond (Glu-urea-Lys) rather than a normal ribosomal amide peptide backbone, attached to a chelator carrying lutetium-177 to deliver targeted radiation to prostate cancer cells. Approved as Pluvicto in Mar 2022 after taxane chemotherapy; openFDA lists efficacy supplements approved Mar 28, 2025 and Jul 31, 2026, and the current label also covers patients before chemotherapy and hormone-sensitive disease combined with hormone therapy. ^{R1, R2}

What the evidence says: Human in VISION (831 men), adding Pluvicto to standard care lengthened survival (median 15.3 vs 11.3 months). ^R3 PSMAfore and PSMAddition showed longer time without scan-detected progression in earlier disease. ^{R4, R5}

Biggest risks: label warnings: radiation exposure, bone marrow suppression, kidney toxicity, harm to an unborn baby and possible infertility. Dry mouth is very common. ^{R2, R5}

Rating


Human Human evidence	Strong: three phase 3 RCTs (n = 831; 468; 1,144) ^{R3, R4, R5}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved ^R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · not named by WADA ^R9
Established human dose	Yes, label dose (see Study details)

Evidence verdict: PSMA-positive metastatic prostate cancer after hormone therapy: Strong (phase 3 RCTs) · Hormone-sensitive metastatic prostate cancer with hormone therapy: Strong (phase 3 RCT) · Other uses: No human data reviewed

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: large sponsor RCTs; PSMAfore and PSMAddition are open-label with progression endpoints, and overall survival results there are less mature.

What is it?

Does it work?

Human VISION: overall survival 15.3 vs 11.3 months; scan-based progression-free survival 8.7 vs 3.4 months. ^{R3, R10}
Human PSMAfore (before chemotherapy): progression-free survival 9.30 vs 5.55 months vs switching hormone drug. ^{R4, R11}
Human PSMAddition (hormone-sensitive disease): 28% lower relative risk of progression or death. ^R5

Is it safe?

Warnings: radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, infertility. ^R2
Human Grade 3 or worse adverse events 52.7% vs 38.0% in VISION. ^R3
Human Dry mouth 46% vs 4% in PSMAddition. ^R5

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, prescription (Pluvicto), given only in licensed nuclear medicine settings. ^{R1, R2}
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
VISION 2021	831 men, PSMA+ mCRPC after ARPI and taxane	IV	7.4 GBq every 6 weeks, up to 6 cycles	Median 20.9 months	OS 15.3 vs 11.3 months	PMID 34161051
PSMAfore 2024	468 taxane-naive men with mCRPC	IV	7.4 GBq every 6 weeks, up to 6 cycles	Median 7.3 months (primary)	rPFS 9.30 vs 5.55 months	PMID 39293462
PSMAddition 2026	1,144 men with PSMA+ hormone-sensitive mPC	IV, with ADT + ARPI	7.4 GBq every 6 weeks, up to 6 cycles	Median 23.6 months	rPFS HR 0.72	PMID 42561994

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Drugs@FDA, Pluvicto (lutetium Lu 177 vipivotide tetraxetan), application NDA215833 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA215833
^R2 Pluvicto prescribing information, label published Aug 13, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a
^R3 Sartor O, et al. N Engl J Med. 2021. PMID 34161051
^R4 Morris MJ, et al. Lancet. 2024. PMID 39293462
^R5 Tagawa ST, et al. Lancet. 2026. PMID 42561994
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R10 ClinicalTrials.gov NCT03511664, VISION, phase 3, completed, 861 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT03511664
^R11 ClinicalTrials.gov NCT04689828, PSMAfore, phase 3, active not recruiting, 469 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT04689828

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, 177Lu-PSMA-617). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).