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Pluvicto (Lutetium (177Lu) vipivotide tetraxetan)
Pluvicto works by binding to prostate-specific antigen (PSMA) on cancer cells, delivering a radioactive payload that kills the cells.
Pluvicto (Lutetium (177Lu) vipivotide tetraxetan) is a radiopharmaceutical developed by Novartis, targeting prostate-specific antigen (PSMA) in PSMA-positive metastatic castration-resistant prostate cancer. It is a small molecule modality approved by the FDA in 2022. Pluvicto is used to treat patients with PSMA-positive metastatic castration-resistant prostate cancer. The commercial status of Pluvicto is patented, and key safety considerations include radiation exposure and potential side effects. Novartis remains the current owner of Pluvicto.
At a glance
| Generic name | Lutetium (177Lu) vipivotide tetraxetan |
|---|---|
| Also known as | Pluvicto, Pluvicto 1 000 MBq/mL |
| Sponsor | Aaa Usa Novartis |
| Drug class | Radioligand Therapeutic Agent [EPC] |
| Target | Prostate-specific antigen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 386 |
Mechanism of action
Imagine a key that fits perfectly into a lock. Pluvicto is like that key, designed to bind to a specific protein called PSMA on the surface of prostate cancer cells. Once bound, it releases a small amount of radiation that kills the cancer cells, helping to slow down the growth of the disease.
Approved indications
- PSMA-positive mCRPC
Common side effects
- Ill-defined disorder
- Laboratory test abnormal
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
| 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
- Aaa Usa Novartis portfolio CI