--- title: "Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) | PepTracker Pro" url: https://peptrackerpro.com/peptides/pluvicto description: "An FDA-approved PSMA-targeted radioligand therapy (brand name Pluvicto) for advanced prostate cancer. It pairs a small PSMA-binding ligand with the radioactive isotope lutetium-177 to deliver radiation directly to cancer cells. In 2026 it gained major traction after the Phase 3 PSMAddition trial showed benefit in earlier, hormone-sensitive disease." lang: en --- Skip to main content **Educational information only.** This site does not provide medical advice. Read full disclaimer (https://peptrackerpro.com/disclaimer) **Research-only content.** This page is for educational purposes and does not constitute medical advice. Read full disclaimer → (https://peptrackerpro.com/research-disclaimer) # Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) High Evidence An FDA-approved PSMA-targeted radioligand therapy (brand name Pluvicto) for advanced prostate cancer. It pairs a small PSMA-binding ligand with the radioactive isotope lutetium-177 to deliver radiation directly to cancer cells. In 2026 it gained major traction after the Phase 3 PSMAddition trial showed benefit in earlier, hormone-sensitive disease. Aliases Pluvicto +9 more Evidence High Evidence Last Updated 2026-06-19 Reading Time 5 min ## What It Is Lutetium Lu 177 vipivotide tetraxetan, sold as Pluvicto and known in research as 177Lu-PSMA-617, is a radioligand therapy made by Novartis for men with advanced prostate cancer. It is built from two parts joined together: a small targeting ligand (vipivotide / PSMA-617) that locks onto prostate-specific membrane antigen (PSMA) — a protein found at high levels on most prostate-cancer cells — and the beta-emitting radioactive isotope lutetium-177, attached through a chemical 'cage' (a DOTA-type chelator, the 'tetraxetan' part). When the drug is infused into a vein, the ligand carries the radiation directly to PSMA-positive tumor cells throughout the body, where the lutetium-177 delivers a short-range dose that damages the cancer DNA while largely sparing surrounding tissue. This 'find it, treat it' design is the classic example of a theranostic, because the same PSMA target is first imaged with a companion PSMA-PET scan to confirm a patient is eligible. The U.S. FDA first approved Pluvicto in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in men already treated with an androgen-receptor pathway inhibitor (ARPI) and taxane chemotherapy, based on the Phase 3 VISION trial, which showed improved overall survival. In March 2025 the FDA expanded the label to allow use earlier — in PSMA-positive mCRPC after an ARPI but before chemotherapy — supported by the PSMAfore trial. The biggest 2026 development is the Phase 3 PSMAddition trial, which moved Pluvicto into even earlier, hormone-sensitive metastatic disease (mHSPC): adding Pluvicto to standard hormone therapy significantly improved radiographic progression-free survival, with data presented at major 2026 oncology meetings. An important nuance for this site: Pluvicto is technically a radiopharmaceutical, not a classic polypeptide drug — its targeting portion is a small peptide-like (peptidomimetic) molecule rather than a long chain of amino acids. It is included here because it is one of the most prominent 'peptide-targeted' medicines in oncology and a useful illustration of how the word 'peptide' is often stretched in headlines. It is a hospital-administered prescription radiation therapy, not an over-the-counter or research-use peptide. Also known as: Pluvicto, lutetium Lu 177 vipivotide tetraxetan, 177Lu-PSMA-617, Lu-177-PSMA-617, lutetium-177 PSMA-617, PSMA-617, vipivotide tetraxetan, LuPSMA, PSMA-targeted radioligand therapy, PSMA radioligand ## Regulatory Status FDA-approved prescription drug (radioligand therapy) Pluvicto (lutetium Lu 177 vipivotide tetraxetan) was first approved by the U.S. FDA in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with an androgen-receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, based on the Phase 3 VISION trial. In March 2025 the FDA expanded the indication to PSMA-positive mCRPC after an ARPI and before chemotherapy (supported by the PSMAfore trial). In 2026 the Phase 3 PSMAddition trial reported benefit in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), supporting further indication expansion. Eligibility requires a positive PSMA-PET scan. It is a prescription radiopharmaceutical administered in specialized centers. Effective: March 2022 (first approval); expanded March 2025 View FDA Source (https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer) ## Why Researchers Study It Pluvicto is studied because it demonstrated that targeted radioligand therapy — delivering radiation directly to cancer cells using a homing molecule — can extend survival in advanced prostate cancer, a disease where options run out quickly once standard hormonal and chemotherapy treatments stop working. Researchers are interested in three questions. First, how early in the disease it should be used: trials have steadily moved it from late-line mCRPC (VISION) to pre-chemotherapy mCRPC (PSMAfore) and now to hormone-sensitive disease (PSMAddition, 2026). Second, how to optimize patient selection and dosing using companion PSMA-PET imaging, the 'theranostic' pairing of a diagnostic scan with a matched therapy. Third, whether the same find-and-treat approach can be applied to other PSMA-positive or antigen-positive cancers and combined with other agents. For this site, it is also a clear teaching example of how the language of 'peptides' overlaps with radiopharmaceuticals: the PSMA-binding ligand behaves like a small targeting peptide, but the finished medicine is a precisely engineered radiation drug, not a wellness or metabolic peptide. ## Proposed Mechanisms - The vipivotide (PSMA-617) ligand binds with high affinity to prostate-specific membrane antigen (PSMA), a protein over-expressed on most prostate-cancer cells - Once bound, the molecule is internalized by the tumor cell, concentrating the radioactive payload inside the cancer - The attached lutetium-177 emits short-range beta radiation that breaks tumor-cell DNA, causing cell death while limiting damage to nearby healthy tissue - Companion PSMA-PET imaging is used first to confirm the tumor is PSMA-positive, matching the diagnostic and therapeutic targets (a theranostic pair) - By acting throughout the body wherever PSMA-positive cells are found, it provides a systemic, target-directed form of radiation rather than localized external-beam radiation ## Evidence Snapshot High Evidence Low Medium High | Study Type | Model | Outcome | Link | | --- | --- | --- | --- | | Human (Phase 3, pivotal) | VISION trial (NCT03511664): 831 men with PSMA-positive mCRPC previously treated with an ARPI and taxane chemotherapy, randomized to Pluvicto + standard care vs standard care alone | Improved overall survival (median ~15.3 vs 11.3 months; HR ~0.62) and radiographic progression-free survival; basis for the first FDA approval in March 2022 | Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9608311/ | | Human (Phase 3) | PSMAfore trial: PSMA-positive mCRPC after an ARPI but before taxane chemotherapy, comparing Pluvicto with a change in ARPI | Improved radiographic progression-free survival, supporting the March 2025 FDA expansion to earlier, pre-chemotherapy use | Source: https://www.onclive.com/view/fda-expands-indication-for-lutetium-lu-177-vipivotide-tetraxetan-in-mcrpc | | Human (Phase 3, primary results) | PSMAddition trial: PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), Pluvicto added to standard of care (ADT + ARPI) vs standard of care alone | Statistically significant improvement in radiographic progression-free survival (HR ~0.72, a 28% reduction in risk of progression or death); presented at ASCO 2026 | Source: https://www.targetedonc.com/view/psmaddition-177lu-psma-617-benefits-mhspc-across-disease-burdens | | Human (Phase 3, secondary endpoint) | PSMAddition trial PSA analysis (mHSPC), Pluvicto + standard of care vs standard of care alone | 58% lower risk of PSA progression with Pluvicto added to standard care (HR 0.42; 95% CI 0.30–0.59); presented at AUA 2026 | Source: https://www.novartis.com/news/media-releases/pluvictotm-demonstrated-consistent-efficacy-across-key-patient-subgroups-metastatic-hormone-sensitive-prostate-cancer | ## Commonly Discussed Benefits Oncology: https://peptrackerpro.com/benefits/oncology Researching Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)? Track it, set reminders, and keep notes in the free app. Track in App (https://app.peptrackerpro.com/?add=pluvicto) ## Safety & Cautions - Pluvicto is a prescription radioligand (radioactive) cancer therapy given by intravenous infusion in specialized centers — it is NOT an over-the-counter or research-use 'peptide' - It is technically a radiopharmaceutical: its PSMA-targeting part is a small peptide-like molecule, but the finished drug is a radiation medicine, not a classic polypeptide or wellness peptide - Eligibility requires a positive PSMA-PET scan; it is only for PSMA-positive metastatic prostate cancer and is not a general anti-cancer or anti-aging compound - Because it is radioactive, treatment requires radiation-safety precautions for the patient, caregivers, and household contacts for a period after each dose - Common side effects include fatigue, dry mouth, nausea, and low blood counts; the label warns of bone-marrow suppression and kidney effects - It can cause serious reproductive and embryo-fetal harm and infertility; it is not used in women and is intended only for the approved prostate-cancer setting - Its 2026 hormone-sensitive (mHSPC) data come from the PSMAddition trial and reflect an expanding role; clinicians determine the right line of therapy for each patient ## Comparisons See how Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) compares to related peptides: Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) vs Icotrokinra (ICOTYDE): https://peptrackerpro.com/compare/pluvicto-vs-icotrokinra Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) vs Motixafortide (Aphexda): https://peptrackerpro.com/compare/pluvicto-vs-motixafortide Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) vs SS-31: https://peptrackerpro.com/compare/pluvicto-vs-ss-31 Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) vs Thymosin Alpha-1: https://peptrackerpro.com/compare/pluvicto-vs-thymosin-alpha-1 ## Calculator Tools Use our research tools to explore dosing and reconstitution data: Reconstitution Calculator: https://peptrackerpro.com/calculators ## Citations 1. [1] FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive mCRPC — Novartis PubMed (https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer) 2. [2] PSMAddition: 177Lu-PSMA-617 Benefits mHSPC Across Disease Burdens (ASCO 2026) — Targeted Oncology PubMed (https://www.targetedonc.com/view/psmaddition-177lu-psma-617-benefits-mhspc-across-disease-burdens) 3. [3] Pluvicto demonstrated consistent efficacy across key patient subgroups in mHSPC (PSMAddition, 2026) — Novartis PubMed (https://www.novartis.com/news/media-releases/pluvictotm-demonstrated-consistent-efficacy-across-key-patient-subgroups-metastatic-hormone-sensitive-prostate-cancer) ### Keep researching in the app - Log Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) to your private tracker - Set a dosing reminder - Compare it side-by-side with your stack Open PepTracker Pro Free: https://app.peptrackerpro.com/?add=pluvicto Browse more peptides: https://peptrackerpro.com/peptides ## Related Peptides ### Icotrokinra (ICOTYDE) High Evidence The first FDA-approved targeted oral macrocyclic peptide — an IL-23 receptor antagonist for moderate-to-severe plaque psoriasis, marking a new era for oral peptide therapeutics. Skin: https://peptrackerpro.com/benefits/skin Inflammation: https://peptrackerpro.com/benefits/inflammation Immune Support: https://peptrackerpro.com/benefits/immune-support View Details: https://peptrackerpro.com/peptides/icotrokinra \+ Compare: https://peptrackerpro.com/compare?select=icotrokinra Track in App: https://app.peptrackerpro.com/?add=icotrokinra ### Motixafortide (Aphexda) High Evidence An FDA-approved synthetic cyclic peptide and CXCR4 antagonist (brand name Aphexda; research name BL-8040) used together with G-CSF to mobilize blood-forming stem cells for autologous transplant in multiple myeloma. In 2026 it is being actively studied as part of combination immunotherapy for pancreatic cancer. Hematology: https://peptrackerpro.com/benefits/hematology Oncology: https://peptrackerpro.com/benefits/oncology Immune Modulation: https://peptrackerpro.com/benefits/immune-modulation View Details: https://peptrackerpro.com/peptides/motixafortide \+ Compare: https://peptrackerpro.com/compare?select=motixafortide Track in App: https://app.peptrackerpro.com/?add=motixafortide ### SS-31 High Evidence A mitochondria-targeted peptide FDA-approved as FORZINITY (elamipretide) for Barth syndrome in September 2025 — the first FDA-approved mitochondrial-targeted therapeutic. Longevity: https://peptrackerpro.com/benefits/longevity Anti-Aging: https://peptrackerpro.com/benefits/anti-aging Recovery: https://peptrackerpro.com/benefits/recovery Neuroprotection: https://peptrackerpro.com/benefits/neuroprotection View Details: https://peptrackerpro.com/peptides/ss-31 \+ Compare: https://peptrackerpro.com/compare?select=ss-31 Track in App: https://app.peptrackerpro.com/?add=ss-31 ### Thymosin Alpha-1 High Evidence A thymic peptide approved in some countries for immune modulation, studied for viral infections and cancer adjunct therapy. Immune Support: https://peptrackerpro.com/benefits/immune-support Longevity: https://peptrackerpro.com/benefits/longevity Inflammation: https://peptrackerpro.com/benefits/inflammation View Details: https://peptrackerpro.com/peptides/thymosin-alpha-1 \+ Compare: https://peptrackerpro.com/compare?select=thymosin-alpha-1 Track in App: https://app.peptrackerpro.com/?add=thymosin-alpha-1 ## Structured data ```json [ { "@context": "https://schema.org", "@type": "Organization", "name": "PepTracker Pro", "url": "https://peptrackerpro.com", "logo": "https://peptrackerpro.com/favicon.png", "description": "Evidence-based educational resource dedicated to improving peptide research literacy.", "contactPoint": { "@type": "ContactPoint", "email": "hello@peptrackerpro.com", "contactType": "customer support" }, "sameAs": [] }, { "@context": "https://schema.org", "@type": "MedicalWebPage", "name": "Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto)", "description": "An FDA-approved PSMA-targeted radioligand therapy (brand name Pluvicto) for advanced prostate cancer. 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