Amikin, Arikayce liposomal(amikacin)
Amikacin, Arikayce (amikacin) is a small molecule pharmaceutical. Amikacin was first approved as Amikin on 1982-01-01. It is used to treat acinetobacter infections, bacterial infections, burns, central nervous system infections, and endocarditis amongst others in the USA. It has been approved in Europe to treat respiratory tract infections.
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Commercial
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Arikayce (generic drugs available since 1993-09-28, discontinued: Amikin)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amikacin sulfate | ANDA | 2023-05-31 |
| amikacin sulfate injection, 500 mg/2ml | Export only | 2021-01-03 |
| arikayce | New Drug Application | 2023-02-08 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMIKACIN SULFATE, ARIKAYCE KIT, INSMED INC | |||
| 2030-09-28 | GAIN | ||
| 2025-09-28 | ODE-214 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amikacin Sulfate, Arikayce Kit, Insmed Inc | |||
| 9895385 | 2035-05-15 | U-2417 | |
| 10251900 | 2035-05-15 | U-2414 | |
| 10751355 | 2035-05-15 | U-2414 | |
| 11446318 | 2035-05-15 | U-2414 | |
| 9566234 | 2034-01-18 | DP | U-2415 |
| 8226975 | 2028-08-15 | DP | |
| 8632804 | 2026-12-05 | U-2416 | |
| 8642075 | 2026-12-05 | DP | |
| 8679532 | 2026-12-05 | U-2415 | |
| 7718189 | 2025-06-06 | DP | U-2415 |
| 8802137 | 2024-04-08 | DP | U-2414 |
| 9827317 | 2024-04-08 | DP | U-2415 |
ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06A: Antibiotics for topical use
— D06AX: Other antibiotics for topical use in atc
— D06AX12: Amikacin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB06: Amikacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA06: Cefepime and amikacin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA21: Amikacin
HCPCS
Code | Description |
|---|---|
| J0278 | Injection, amikacin sulfate, 100 mg |
Clinical
Clinical Trials
120 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | — | 4 | 1 | 2 | 4 | 11 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | 3 | 2 | 5 | 10 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | 1 | — | 2 | 5 | 9 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 2 | 2 | 3 | 1 | 8 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 3 | 3 | 1 | 3 | 8 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | 3 | 1 | 5 |
| Febrile neutropenia | D064147 | — | — | — | — | 1 | 1 | 2 | 4 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | 1 | — | 2 | 1 | 4 |
| Bacterial infections | D001424 | — | A49 | — | 1 | — | 1 | 1 | 3 |
| Intraabdominal infections | D059413 | — | — | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | 3 | 2 | — | 7 | 13 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 5 | 1 | — | — | 6 |
| Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | 2 | 3 | — | — | 5 |
| Septic shock | D012772 | — | A48.3 | — | — | 1 | — | 3 | 4 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | 1 | — | 1 | 3 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 1 | 1 | — | 1 | 2 |
| Pseudomonas infections | D011552 | EFO_0001076 | A41.52 | — | — | 1 | — | — | 1 |
| Deafness | D003638 | EFO_0001063 | H91.9 | — | 1 | 1 | — | — | 1 |
| Disease progression | D018450 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 2 | 3 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Urologic surgical procedures | D013520 | — | — | — | 1 | — | — | — | 1 |
| Nontuberculous mycobacteria | D009170 | — | — | — | 1 | — | — | — | 1 |
| Ototoxicity | D000081015 | — | — | — | 1 | — | — | — | 1 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 2 | 5 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | 3 | 4 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 2 | 2 |
| Neutropenia | D009503 | — | D70 | — | — | — | — | 2 | 2 |
| Neonatal sepsis | D000071074 | HP_0040187 | — | — | — | — | — | 2 | 2 |
| Critical illness | D016638 | — | — | — | — | — | — | 2 | 2 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 2 | 2 |
| Chronic bronchitis | D029481 | — | J42 | — | — | — | — | 1 | 1 |
| Endophthalmitis | D009877 | — | — | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amikacin |
| INN | amikacin |
| Description | Amikacin is an amino cyclitol glycoside that is kanamycin A acylated at the N-1 position by a 4-amino-2-hydroxybutyryl group. It has a role as an antimicrobial agent, an antibacterial drug and a nephrotoxin. It is an alpha-D-glucoside, an aminoglycoside, a carboxamide and an amino cyclitol glycoside. It is functionally related to a kanamycin A. It is a conjugate base of an amikacin(4+). |
| Classification | Small molecule |
| Drug class | antibiotics obtained from Streptomyces kanamyceticus (related to kanamycin) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCC[C@H](O)C(=O)N[C@@H]1C[C@H](N)[C@@H](O[C@H]2O[C@H](CN)[C@@H](O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O[C@H]1O[C@H](CO)[C@@H](O)[C@H](N)[C@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 37517-28-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL177 |
| ChEBI ID | 2637 |
| PubChem CID | 37768 |
| DrugBank | DB00479 |
| UNII ID | 84319SGC3C (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Amikacin sulfate, Arikayce
Adverse Events
Top Adverse Reactions
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6,914 adverse events reported
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