Lutetium Lu-177 Vipivotide Tetraxetan
Also referenced as: Pluvicto
A PSMA-targeted radioligand for a defined metastatic prostate-cancer population.
- Evidence grade
- AStrong Clinical Evidence
Strong Clinical Evidence
- Regulatory status
- FDA Approved for Specific Indication
Pluvicto is FDA-approved for PSMA-positive metastatic castration-resistant prostate cancer after ARPI therapy when appropriate to delay taxane chemotherapy or after prior taxane therapy.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A PSMA-targeted radioligand for a defined metastatic prostate-cancer population.
Pluvicto is FDA-approved for PSMA-positive metastatic castration-resistant prostate cancer after ARPI therapy when appropriate to delay taxane chemotherapy or after prior taxane therapy.
Placement in the reproductive-system atlas reflects prostate-cancer targeting, not improvement in sexual function.
Why It's Being Studied
- PSMA-positive metastatic prostate cancer
- Targeted radioligand therapy
Mechanism of Action
The targeting ligand delivers lutetium-177 beta radiation to PSMA-expressing cells.
The targeting ligand delivers lutetium-177 beta radiation to PSMA-expressing cells. Placement in the reproductive-system atlas reflects prostate-cancer targeting, not improvement in sexual function.
From molecular target to clinical evidence
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Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- PSMA-positive metastatic prostate cancer
- Targeted radioligand therapy
- Intravenous therapeutic radiopharmaceutical
Evidence Summary
Randomized cancer studies support the approved indication; an earlier-line expansion improved radiographic progression-free survival, not a significant survival result in that analysis.
Higher tiers carry more weight. Filled tiers have evidence for Lutetium Lu-177 Vipivotide Tetraxetan; tap to read it.
- Randomized cancer studies support the approved indication; an earlier-line expansion improved radiographic progression-free survival, not a significant survival result in that analysis.
1 cited sources.
- Regulatory document1
Human clinical evidence
- Randomized cancer studies support the approved indication; an earlier-line expansion improved radiographic progression-free survival, not a significant survival result in that analysis.
Reported Adverse Events in Research
- Radiation exposure, marrow suppression, kidney toxicity and infertility risks require specialist precautions.
Limitations of Current Evidence
- Placement in the reproductive-system atlas reflects prostate-cancer targeting, not improvement in sexual function.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Lutetium Lu-177 Vipivotide Tetraxetan | Trofinetide | |
|---|---|---|
| Evidence grade | A — Strong Clinical Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Intravenous therapeutic radiopharmaceutical | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Regulatory document
Lutetium Lu-177 Vipivotide Tetraxetan — regulatory document