Gallium
As of the edition of 20 October 2026, Gallium is a small molecule: marketed, first approved in 1991 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Ganite
- First approved
- 17 January 1991 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Eckert & Ziegler Radiopharma; 3 holders in all
- Registered trials
- 4, 0 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Lungs and airways; Pregnancy and women's health
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 1 | 0 | 0 | 0 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Earlier holder | 1991 to now |
| Chapter 7 Trustee Of Genta | Acquired holder | 2020 to now |
| Eckert & Ziegler Radiopharma | Applicant | 2025 to now |