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lutetium lu-177 vipivotide tetraxetan

Generic: LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN·Brand: PLUVICTO

lutetium lu-177 vipivotide tetraxetan: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.

lutetium lu-177 vipivotide tetraxetan evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect lutetium lu-177 vipivotide tetraxetan to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could lutetium lu-177 vipivotide tetraxetan → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 1 study sponsors

Related indications

Prostate CancerMetastatic Neuroendocrine Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer (mCRPC)Prostatic Neoplasms
Development Pipeline (3)
CompanyPhase
Novartis AG (NVS)
Prostate Cancer
Phase 4
Novartis AG (NVS)
Metastatic Neuroendocrine Prostate Cancer; Metastatic Castra…
Phase 4
Novartis AG (NVS)
Metastatic Neuroendocrine Prostate Cancer; Metastatic Castra…
Phase 4
Clinical Trials (4)

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

NCT06095089·Phase 1
Recruiting

Primary endpoint: Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)

Interventionalopen355 targetStarted 2023-11Completion 2028-0615 sites · France, Japan, United StatesJanssen Research & Development, LLC

A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT05670106·Phase 2·NVS
Completed

Primary endpoint: Main part: Confirmed Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)

Interventionalopen62 enrolledStarted 2023-05Completion 2026-0417 sites · ChinaNovartis Pharmaceuticals

An Open-label, Multi-center, Randomized, Phase II Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

NCT05658003·Phase 2·NVS
Active, not recruiting

Primary endpoint: Radiographic progression free survival (rPFS)

InterventionalRandomizedsingle63 targetStarted 2023-05Completion 2027-0115 sites · ChinaNovartis Pharmaceuticals

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

NCT05818683·Phase 1·GHRS
Recruiting

Primary endpoint: Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Interventionalopen300 targetStarted 2023-04Completion 2028-0515 sites · Australia, Spain, United StatesJanssen Research & Development, LLC
FDA Decisions1 records
Approval(NVS)FDA ↗
NDA215833Type 1 - New Molecular EntityPriorityIntravenousSolution

Frequently asked questions

Who is developing lutetium lu-177 vipivotide tetraxetan?

lutetium lu-177 vipivotide tetraxetan is being developed by Novartis AG.

How many clinical trials involve lutetium lu-177 vipivotide tetraxetan?

BioSniper tracks 4 clinical trials involving lutetium lu-177 vipivotide tetraxetan.

What is lutetium lu-177 vipivotide tetraxetan's latest FDA decision?

The most recent tracked FDA decision for lutetium lu-177 vipivotide tetraxetan is Approval, dated March 23, 2022.