Vipivotide tetraxetan lutetium
As of the edition of 20 October 2026, Vipivotide tetraxetan lutetium is a protein: marketed, first approved in 2022 (US); acts on FOLH1; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Pluvicto
- First approved
- 23 March 2022 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 62, 6 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Blood and lymph; Digestive system
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product10 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Vipivotide tetraxetan lutetium.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FOLH1 | Glutamate carboxypeptidase 2 | Q04609 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 15 | 2 | 12 | 1 |
| Phase 2 | 37 | 3 | 27 | 5 |
| Phase 3 | 6 | 1 | 5 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 62 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant, Acquired holder and Lead sponsor of trials | 2017 to now |