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Pluvicto (TETRAXETAN)
Pluvicto works by binding to the PSMA protein on prostate cancer cells, delivering a radioactive payload to destroy the cancer cells.
Pluvicto (tetraxetan) is a radioligand therapeutic agent developed by Novartis for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is a small molecule with a half-life of 41.6 hours and has been FDA-approved since 2025. Pluvicto targets the PSMA protein, which is highly expressed in prostate cancer cells, allowing for targeted therapy. The commercial status of Pluvicto is patented, and it is not yet available as a generic product. Key safety considerations include its potential to cause bone marrow suppression and gastrointestinal toxicity.
At a glance
| Generic name | TETRAXETAN |
|---|---|
| Sponsor | Novartis |
| Drug class | Radioligand Therapeutic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
| Annual revenue | 386 |
Mechanism of action
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer, including mCRPC. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.
Approved indications
- metastatic castration-resistant prostate cancer (mCRPC)
- metastatic castration-resistant prostate cancer (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
- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE3)
- Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)
- 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)
- 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)
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PHASE3)
- PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pluvicto CI brief — competitive landscape report
- Pluvicto updates RSS · CI watch RSS
- Novartis portfolio CI