Pluvicto

(Lutetium Lu 177 Vipivotide Tetraxetan)

Phase 3Radiopharmaceutical

Novartis

Pluvicto is one of 94 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Prostate AdenocarcinomaNot yet recruiting

Castration-Resistant Prostate CarcinomaRecruiting

Metastatic Castration-Resistant Prostate CarcinomaRecruiting

Metastatic Castration-Resistant Prostate NeoplasmsRecruiting

Prostatic NeoplasmsRecruiting

Prostate AdenocarcinomaPhase 2

Not yet recruiting

Castration-Resistant Prostate CarcinomaPhase 2

Recruiting

Metastatic Castration-Resistant Prostate CarcinomaPhase 3

Recruiting

Metastatic Castration-Resistant Prostate NeoplasmsPhase 1

Recruiting

Prostatic NeoplasmsPhase 1

Recruiting

Competition

Competitive Landscape

111 competitors in Prostate Adenocarcinoma

#DrugCompanyPhaseTrials

Zytiga

Johnson & Johnson

Phase 3

2 2

Estrace

Novo Nordisk

Phase 3

1 3

Depo-Provera

Eli Lilly

Phase 3

1 4

Eulexin

SSchering-Plough

Phase 3

5 5

Avastin

Tecentriq

Sutent

Keytruda

Zoladex

TTerSera Therapeutics LLC

Phase 3

4 10

Lupron

EEastern Cooperative Oncology Group

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Castration-Resistant Prostate Carcinoma

NCT06145633

Phase 2Recruiting

Metastatic Castration-Resistant Prostate Carcinoma

NCT06526299

Q2 2028

Phase 1Recruiting

Metastatic Castration-Resistant Prostate Neoplasms

NCT05818683

Phase 1Recruiting

Prostatic Neoplasms

NCT06095089

Q3 2029

Phase 2Recruiting

Prostate Adenocarcinoma

NCT07698535

Q3 2031

Phase 1Not yet recruiting

Metastatic Castration-Resistant Prostate Carcinoma

NCT07682649

Clinical

Trials by Indication[1]

Castration-Resistant Prostate Carcinoma3 trials

Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate Resistant Prostate Cancer

Suspended·MMayo Clinic·Phase 2·NCT06200103·236 enrolled

Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT06145633·15 enrolled

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT06632977·474 enrolled

Metastatic Castration-Resistant Prostate Carcinoma3 trials

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT07200830·1,524 enrolled

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics

Recruiting·UUniversity of Washington·Phase 2·NCT06526299·51 enrolled

A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

Not yet recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT07682649·20 enrolled

Prostate Adenocarcinoma1 trial

Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study

Recruiting·UUniversity of Washington·Phase 2·NCT07698535·64 enrolled

Prostatic Neoplasms1 trial

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT06095089·355 enrolled

Metastatic Castration-resistant Prostate Neoplasms1 trial

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05818683·300 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 22, 2022

PLUVICTO

NDA NDA215833

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Lutetium Lu 177 Vipivotide Tetraxetan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lutetium Lu 177 Vipivotide Tetraxetan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lutetium Lu 177 Vipivotide Tetraxetan. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215833). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Pluvicto. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Radiopharmaceutical[2]
Highest Phase: Phase 3[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

Aug 14, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11318121Aug 14, 2028

10406240Aug 14, 2028

11951190Nov 11, 2035

10398791Mar 22, 2036

12208102Sep 17, 2041

Pluvicto

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q3 2029

Q3 2031

Trials by Indication[1]

Castration-Resistant Prostate Carcinoma3 trials

Metastatic Castration-Resistant Prostate Carcinoma3 trials

Prostate Adenocarcinoma1 trial

Prostatic Neoplasms1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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