NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
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 16h ago · AI intelligence enriched 1mo 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.
Peak14.9 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 (6)
Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer
Started Nov 2026
88 enrolled
Metastatic Castration-Resistant Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
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
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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.