Amikacin
As of the edition of 20 October 2026, Amikacin is a small molecule: marketed, first approved in 1976 (CH); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Amikin
- First approved
- 25 May 1976 (CH)
- Approvals on record
- 11 in 6 regions
- Holder of the most recent approval
- Insmed GK; 7 holders in all
- Registered trials
- 58, 4 stopped early
- Disease areas
- Infections; Lungs and airways; Inherited and neonatal; Digestive system; Urinary and reproductive; Immune system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Insmed holds a later exclusivity on its own new formulation or combination product, ending 2030; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 10 | 2 | 0 |
| Phase 1 | 7 | 4 | 1 | 0 |
| Phase 2 | 16 | 10 | 3 | 2 |
| Phase 3 | 12 | 8 | 1 | 1 |
| Phase 4 | 8 | 5 | 1 | 1 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Acquired holder | 2003 to now |
| Insmed | Applicant, Later holder and Lead sponsor of trials | 2004 to now |