PLUVICTO (lutetium lu-177 vipivotide tetraxetan)
Pluvicto is a radioligand therapy used for adults with a specific type of advanced prostate cancer that has spread and no longer responds to hormone-lowering treatments. It helps patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have already tried androgen receptor pathway inhibitor therapy. This medication is used for patients who have either already received taxane-based chemotherapy or for those where delaying that type of chemotherapy is considered appropriate.
How PLUVICTO Works
This medication works by targeting PSMA, a protein found on the surface of prostate cancer cells. Once the drug binds to these cells, the radioactive component, lutetium-177, releases beta-minus emissions that deliver radiation directly to the tumor and nearby cells. This process causes DNA damage within the cells, which ultimately leads to cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-03-23
- Patent Cliff
- 2041
- Revenue
- $605M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PLUVICTO Approval History
What PLUVICTO Treats
1 indicationsPLUVICTO is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Castration-Resistant Prostate Cancer
PLUVICTO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PLUVICTO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PLUVICTO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PLUVICTO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05818683 | CR109321 78278343PCR1003, 2022-503132-14-00 | Ph 1 | recruiting | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer |
| NCT06095089 | CR109330 87189401PCR1001, 2023-504063-17-00 | Ph 1 | recruiting | A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer |
| NCT06084338 | SPLP-002-23M 1I01CX002775 | Ph 2 | recruiting | Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PLUVICTO FDA Label Details
Indications & Usage
FDA Label (PDF)PLUVICTO is indicated for the treatment of Metastatic Castration-Resistant Prostate Cancer.
PLUVICTO Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PLUVICTO
Revenue Insights
- • Q4-2025: $605M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 5 active patents
Trial Analysis
- • 12 total trials
- • Stage: Growth
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment