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LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN is a Radioligand Therapeutic Agent [EPC] drug. It is currently FDA-approved (first approved 2022) for PSMA-positive mCRPC.
Lutetium Lu 177 vipivotide tetraxetan binds to PSMA on prostate cancer cells, delivering radiation that causes DNA damage and cell death.
Lutetium Lu-177 vipivotide tetraxetan is a marketed radiopharmaceutical targeting PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Its key strength lies in its mechanism of action, which delivers targeted radiation to cancer cells, causing DNA damage and cell death. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition.
At a glance
| Generic name | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN |
|---|---|
| Drug class | Radioligand Therapeutic Agent [EPC] |
| Target | PSMA |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapy that targets PSMA, a protein found on prostate cancer cells. When it binds to these cells, the radiation from lutetium-177 damages the DNA, leading to cell death.
Approved indications
- PSMA-positive mCRPC
Common side effects
- decreased lymphocytes
- decreased hemoglobin
- fatigue
- dry mouth
- decreased platelets
- decreased estimated glomerular filtration rate
- nausea
- decreased neutrophils
- decreased calcium
- decreased sodium
- increased aspartate aminotransferase
- increased alkaline phosphatase
Key clinical trials
- Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease (PHASE2)
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PHASE3)
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
- Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN CI brief — competitive landscape report
- LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN updates RSS · CI watch RSS
Frequently asked questions about LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
What is LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN?
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What drug class is LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN in?
When was LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN approved?
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What does LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN target?
Related
- Drug class: All Radioligand Therapeutic Agent [EPC] drugs
- Target: All drugs targeting PSMA
- Indication: Drugs for PSMA-positive mCRPC
- Compare: LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN vs similar drugs
- Pricing: LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN cost, discount & access