Gentamicin
As of the edition of 20 October 2026, Gentamicin is a small molecule: marketed, first approved in 1966 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1984
- Kind
- Small molecule
- Brand name
- Garamycin
- First approved
- 1 February 1966 (ES)
- Approvals on record
- 17 in 6 regions
- Holder of the most recent approval
- Baxter Healthcare; 8 holders in all
- Registered trials
- 90, 18 stopped early
- Disease areas
- Infections; Inherited and neonatal; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health; Digestive system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 13 | 1 | 1 |
| Phase 1 | 7 | 6 | 1 | 0 |
| Phase 2 | 20 | 5 | 5 | 8 |
| Phase 3 | 19 | 9 | 5 | 3 |
| Phase 4 | 24 | 9 | 5 | 6 |
| All trials | 90 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1970 to now |
| Organon | Applicant and Lead sponsor of trials | 1974 to now |
| Baxter Healthcare | Later holder | 1995 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2009 to now |