Friday, July 10, 2026

Drug profile · INN

amikacin sulfate

amikacin sulfate (ARIKAYCE) is a bacterial 70s ribosome inhibitor. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn Antiinfectives for systemic use (J01) J01GB06
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — amikacin sulfate
US status
approved
Class
Antiinfectives for systemic use (J01)
Route
INJECTION
Patents
0
Programs
1
Data quality
0.84

Quick answer

amikacin sulfate (ARIKAYCE) is a bacterial 70s ribosome inhibitor. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN amikacin sulfate
Brand ARIKAYCE
Mechanism Bacterial 70S ribosome inhibitor
Target Bacterial 70S ribosome
Therapeutic class Antiinfectives for systemic use (J01)
Route INJECTION
Formulation SUSPENSION, LIPOSOMAL
ATC code J01GB06

Mechanism of action

Bacterial 70S ribosome inhibitor

Primary target: Bacterial 70S ribosome

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. INS-416 Phase 3 · Insmed Incorporated · "Adult Subjects with Newly Diagnosed Nontuberculous Mycobact

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. azithromycin Bacterial 70S ribosome inhibitor
  3. chloramphenicol Bacterial 70S ribosome inhibitor
  4. clarithromycin Bacterial 70S ribosome inhibitor
  5. clindamycin hydrochloride Bacterial 70S ribosome inhibitor
  6. clindamycin palmitate hydrochloride Bacterial 70S ribosome inhibitor

Frequently asked questions

What is amikacin sulfate?

amikacin sulfate (ARIKAYCE) is a bacterial 70s ribosome inhibitor. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for amikacin sulfate?

ARIKAYCE is a marketed brand name for amikacin sulfate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of amikacin sulfate?

amikacin sulfate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.