Lutetium Lu-177 vipivotide tetraxetan clinical trials
Lutetium Lu-177 vipivotide tetraxetan is named as an intervention in 3 current clinical trials in our USA, Australia, Spain, China, France, Japan and Mexico registers. 2 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is Janssen Research & Development, LLC (2). The most-studied condition is Metastatic Castration-resistant Prostate Neoplasms.
Where Lutetium Lu-177 vipivotide tetraxetan is approved
All regulators →Of the three regulators tracked here, the first to approve Lutetium Lu-177 vipivotide tetraxetan was the US, on 23 Mar 2022.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Lutetium Lu-177 vipivotide tetraxetan patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lutetium Lu-177 vipivotide tetraxetan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 18 Sep 2041 (US 12208102).
- Latest patent on the drug substance itself: 23 Mar 2036 (US 10398791).
- Exclusivity I-996: New indication: in combination with androgen receptor pathway inhibitor (arpi) therapy for the treatment of adult patients with prostate-sp…, until 31 Jul 2029.
- Exclusivity I-965: New indication: treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostat…, until 28 Mar 2028.
- Exclusivity NCE: New chemical entity, until 23 Mar 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Lutetium Lu-177 vipivotide tetraxetan works
All drug targets →- Glutamate carboxypeptidase II binding agent Binding agentTarget: FOLH1 folate hydrolase 1ChEMBL only
- Clear cell renal carcinomaPhase 3
- Digestive system neuroendocrine tumor, grade 1/2Phase 3
- Neuroendocrine neoplasmPhase 3
- Renal cell carcinomaPhase 3
- Adenoid cystic carcinomaPhase 2
- CancerPhase 2
- Neuroendocrine carcinomaPhase 2
- Prostate adenocarcinomaPhase 2
- Salivary duct carcinomaPhase 2
- Cervical cancerPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594406, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Lutetium Lu-177 vipivotide tetraxetan
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Lutetium Lu-177 vipivotide tetraxetan
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
NCT05818683 · Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
|
Phase 1 | Recruiting | Janssen Research & Development, LLC | USA, Spain, Australia |
|
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
NCT06095089 · Prostatic Neoplasms
|
Phase 1 | Recruiting | Janssen Research & Development, LLC | USA, China, France, Japan, Australia |
|
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
NCT05682443 · Metastatic Castration-resistant Prostate Cancer
|
Phase 1/2 | Active, closed | OncoC4, Inc | USA, Mexico |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Lutetium Lu-177 vipivotide tetraxetan
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Janssen Research & Development, LLC | 2 |
| OncoC4, Inc | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 3 | 2 |
| Clinical trials in Australia | 2 | 2 |
| Clinical trials in Spain | 1 | 1 |
| Clinical trials in China | 1 | 1 |
| Clinical trials in France | 1 | 1 |
| Clinical trials in Japan | 1 | 1 |
| Clinical trials in Mexico | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Lutetium Lu-177 vipivotide tetraxetan trials
How many clinical trials are testing Lutetium Lu-177 vipivotide tetraxetan?
3 current trials in our USA, Australia, Spain, China, France, Japan and Mexico registers name Lutetium Lu-177 vipivotide tetraxetan as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Lutetium Lu-177 vipivotide tetraxetan trials recruiting patients?
Yes. 2 of the 3 trials are recruiting: 2 with sites in USA, 2 with sites in Australia, 1 with sites in Spain, 1 with sites in China, 1 with sites in France and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lutetium Lu-177 vipivotide tetraxetan clinical trials?
Janssen Research & Development, LLC (2) and OncoC4, Inc (1). The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lutetium Lu-177 vipivotide tetraxetan works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Lutetium Lu-177 vipivotide tetraxetan works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lutetium Lu-177 vipivotide tetraxetan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.