Sexual & reproductive PSMA-targeted radioligand
Lutetium Lu-177 vipivotide tetraxetan
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- Pluvicto
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Lutetium Lu-177 vipivotide tetraxetan (sold as Pluvicto) is a targeted radiation therapy that homes in on a protein found on prostate cancer cells and delivers radiation directly to them. It is used for PSMA-positive metastatic prostate cancer, either after other treatments have stopped working or earlier alongside hormone therapy. It has been FDA-approved in the U.S. since 2022 and is given as a series of intravenous infusions.
At a glance
- What it is
- A PSMA-targeted radioligand therapy labeled with lutetium-177
- Approved for
- PSMA-positive metastatic prostate cancer, both castration-resistant disease and, with a hormone-blocking drug, disease that still responds to hormone therapy
- Key fact
- In the VISION trial it improved both progression-free and overall survival when added to standard care
- Route
- Intravenous infusion, up to six cycles six weeks apart
- Evidence strength
- FDA approved
Summary
Lu-177 vipivotide tetraxetan (Pluvicto) is an FDA-approved radiation therapy for PSMA-positive prostate cancer. See how it works and side effects.
What is lutetium Lu-177 vipivotide tetraxetan?
Lutetium Lu-177 vipivotide tetraxetan, sold under the brand Pluvicto, is a radioligand therapy that links a molecule targeting prostate-specific membrane antigen (PSMA) to the radioactive isotope lutetium-177. It is used for advanced prostate cancer whose cells carry PSMA. It is also known in the literature as 177Lu-PSMA-617, and it was approved in the United States in 2022.
How does lutetium Lu-177 vipivotide tetraxetan work?
Prostate cancer cells typically display large amounts of PSMA, a protein on their surface. The targeting part of this drug binds PSMA, and the attached lutetium-177 emits beta-particle radiation over a short range. Because the drug accumulates on PSMA-bearing cells, it delivers a concentrated dose of radiation to the cancer and its immediate surroundings while limiting exposure to more distant healthy tissue, causing lethal DNA damage in the targeted cells.
Patients are selected using a PSMA PET scan to confirm the target is present before treatment. In the VISION trial, adding this radioligand therapy to standard care improved both imaging-based progression-free survival and overall survival compared with standard care alone, in men whose disease had progressed after hormonal and chemotherapy treatment.
Is it FDA-approved?
Editor’s note
Status: Yes. Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) is FDA-approved, and its indication has widened in steps: Year | FDA action 2022 | Approved for PSMA-positive metastatic castration-resistant prostate cancer, initially after hormonal and taxane chemotherapy 2025 | Indication broadened to patients who have not yet had chemotherapy 2026 | Added use alongside a hormone-blocking drug for metastatic prostate cancer that still responds to hormone therapy It is given as an intravenous infusion, up to six cycles about six weeks apart.
Category: FDA-approved · Primary body area: Sexual & reproductive
Yes. Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) is FDA-approved, and its indication has widened in steps:
| Year | FDA action |
|---|---|
| 2022 | Approved for PSMA-positive metastatic castration-resistant prostate cancer, initially after hormonal and taxane chemotherapy |
| 2025 | Indication broadened to patients who have not yet had chemotherapy |
| 2026 | Added use alongside a hormone-blocking drug for metastatic prostate cancer that still responds to hormone therapy |
It is given as an intravenous infusion, up to six cycles about six weeks apart.
What is lutetium Lu-177 vipivotide tetraxetan prescribed for?
It is prescribed for PSMA-positive metastatic prostate cancer, confirmed by a PSMA PET scan. That includes castration-resistant cancer that has progressed on hormone-blocking therapy and, in combination with a hormone-blocking drug, cancer that still responds to hormone therapy. It is administered in specialized centers equipped to handle radiopharmaceuticals.
What are the side effects?
According to the prescribing information, common side effects include:
- Fatigue
- Dry mouth
- Nausea and decreased appetite
- Anemia and constipation
More serious considerations include:
- Bone-marrow suppression
- Kidney toxicity
- Radiation exposure and precautions to protect others
- Effects on fertility
Sources: FDA prescribing information for Pluvicto; the VISION trial (Sartor et al., New England Journal of Medicine, 2021, DOI: 10.1056/NEJMoa2107322), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
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