NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
PLUVICTO (lutetium lu 177 vipivotide tetraxetan) by Novartis is radioligand activity [moa]. Approved for radioligand therapeutic agent [epc]. First approved in 2022.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLUVICTO is a radioligand therapeutic agent combining lutetium-177 with vipivotide tetraxetan, designed to target prostate-specific membrane antigen (PSMA) in prostate cancer cells. It delivers targeted radiation directly to PSMA-expressing tumors, enabling precision oncology treatment. The drug represents a shift toward radiopharmaceutical precision medicine in advanced prostate cancer.
Peak15.0 years to LOE
PLUVICTO is in peak commercial phase post-launch with strong oncology positioning; the Novartis team is likely expanding to capture market share in the high-value mCRPC segment.
Mechanism of Action
Radioligand Activity
Pharmacologic Class:
Radioligand Therapeutic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Started Oct 2026
1,085 enrolled
Prostatic Neoplasms, Castration-ResistantNeoplasm Metastasis
Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer
Started Sep 2026
30 enrolled
mCRPC (Metastatic Castration-resistant Prostate Cancer)
Post Marketing Study on Pluvicto in Korea
Started Apr 2025
278 enrolled
Metastatic Castration-resistant Prostate Cancer
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Started Oct 2024
17 enrolled
Metastatic Prostate Cancer
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
Started Dec 2023
148 enrolled
Metastatic Castration-resistant Prostate Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.