Lutetium Lu 177 vipivotide tetraxetan
FDA approved · RxPSMA-targeted radioligand therapy
Also known as: Pluvicto, PSMA-617
Strong, human-grade evidence
- Regulatory standing. FDA-approved prescription medicine
- Human trials. Backed by controlled human studies
- Registered human trials. 21 registered studies on ClinicalTrials.gov, most advanced Phase 3
- 1 cited source. Includes primary / regulatory sources
Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.
What it is
Lutetium Lu 177 vipivotide tetraxetan, sold as Pluvicto and also known as PSMA-617, is a small peptide-like molecule that binds prostate-specific membrane antigen (PSMA) and carries the radioactive isotope lutetium-177. It attaches to cells that express PSMA, a protein found at high levels on many prostate cancer cells, and the attached radiation damages those cells and nearby tissue.
What the evidence shows
It is FDA approved for adults with PSMA-positive metastatic castration-resistant prostate cancer who meet specific prior-treatment criteria, based on Phase 3 trial evidence. Registered human trials (19 listed) continue to study other settings, and use outside the approved indication is not established.
Key facts
Registered human trials
Live from ClinicalTrials.gov, refreshed daily.
Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
177LuPSMA in Renal Cell Carcinoma
Published literature
Live from Europe PMC. This is how much has been published, not how much is proven in humans.
FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.
Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.
PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.
Cost-Effectiveness Analysis of 177Lu-PSMA-617 Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer.
Sources
Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.