Gadopiclenol
As of the edition of 20 October 2026, Gadopiclenol is a small molecule: marketed, first approved in 2022 (US); US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Elucirem
- First approved
- 21 September 2022 (US)
- Approvals on record
- 11 in 3 regions
- Holder of the most recent approval
- Guerbet; 2 holders in all
- Registered trials
- 21, 1 stopped early
- Disease areas
- Cancer; Nervous system; Urinary and reproductive; Digestive system; Heart and blood vessels; Inherited and neonatal
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Guerbet.
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 product28 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 28 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 6 | 5 | 1 | 0 |
| Phase 3 | 6 | 4 | 1 | 0 |
| Phase 4 | 4 | 0 | 3 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Guerbet | Originator and Lead sponsor of trials | 2013 to now |
| Bracco Imaging | Applicant | 2023 to now |