NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
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 3d ago
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 (3)
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
Company
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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.