Lutetium oxodotreotide
As of the edition of 20 October 2026, Lutetium oxodotreotide is a protein: marketed, first approved in 2017 (EU); acts on SSTR1, SSTR2 and SSTR3 and 2 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Lutathera
- First approved
- 26 September 2017 (EU)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- FUJIFILM Toyama Chemical; 3 holders in all
- Registered trials
- 67, 7 stopped early
- Disease areas
- Cancer; Hormones; Nervous system; Digestive system; Blood and lymph; Chemically induced
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Advanced Accelerator Applications.
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 product4 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
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Lutetium oxodotreotide.
See the 10 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 2 | 2 | 0 |
| Phase 1 | 13 | 2 | 10 | 0 |
| Phase 2 | 38 | 6 | 20 | 7 |
| Phase 3 | 9 | 3 | 6 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2017 to now |
| Advanced Accelerator Applications | Applicant and Lead sponsor of trials | 2018 to now |
| FUJIFILM Toyama Chemical | Applicant | 2021 to now |