Pluvicto

(Lutetium Lu 177 Vipivotide Tetraxetan)

Radiopharmaceutical

Novartis

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

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

Q4 2028

Phase 2Not yet recruiting

Prostate Adenocarcinoma

NCT07860554

Q3 2029

Phase 2Recruiting

Prostate Adenocarcinoma

NCT07698535

Clinical

Trials by Indication[1]

Prostate Adenocarcinoma4 trials

A Phase II Study to Validate the Efficacy and Safety of Pluvicto in African American Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Not yet recruiting·EEmory University·Phase 2·NCT07860554·88 enrolled

A Randomized Phase II/III Trial Evaluating Bipolar Androgen Therapy Followed by Darolutamide vs. Standard of Care in Patients With Metastatic Castration Resistant Prostate Cancer

Not yet recruiting·EECOG-ACRIN Cancer Research Group·Preclinical·NCT07852195·432 enrolled

Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07150715·107 enrolled

Show 1 more 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

Castration-Resistant Prostate Carcinoma3 trials

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

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

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

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

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

1 more indication

Recurrent Prostate Adenocarcinoma1 trial

A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer

Recruiting·MMayo Clinic·Phase 2·NCT07650240·202 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 22, 2022

PLUVICTO

NDA NDA215833

Sources

References

[1]
ClinicalTrials.gov — 13 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]
OpenFDA — FDA approval records (NDA NDA215833). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Pluvicto. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Radiopharmaceutical[2]
Company: Novartis

Patent Landscape[4]

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

Expected Milestones

Q4 2027

Q2 2028

Q4 2028

Q3 2029

Trials by Indication[1]

Prostate Adenocarcinoma4 trials

Castration-Resistant Prostate Carcinoma3 trials

Metastatic Castration-Resistant Prostate Carcinoma3 trials

Prostatic Neoplasms1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

Recurrent Prostate Adenocarcinoma1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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