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Drug ReportsAmikacin
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
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5D
1M
3M
6M
YTD
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2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
respiratory tract diseasesD012140
nervous system diseasesD009422
urogenital diseasesD000091642
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
Trade Name
FDA
EMA
Amikacin, Arikayce (discontinued: Amikacin, Amikin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amikacin sulfate
Tradename
Company
Number
Date
Products
ARIKAYCE KITInsmedN-207356 RX2018-09-28
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amikacin sulfateANDA2024-06-14
amikacin sulfate injection, 500 mg/2mlExport only2021-01-03
arikayceNew Drug Application2025-03-17
Agency Specific
FDA
EMA
Expiration
Code
AMIKACIN SULFATE, ARIKAYCE KIT, INSMED INC
2030-09-28GAIN
2025-09-28ODE-214
Patent Expiration
Patent
Expires
Flag
FDA Information
Amikacin Sulfate, Arikayce Kit, Insmed Inc
98953852035-05-15U-2417
102519002035-05-15U-2414
107513552035-05-15U-2414
114463182035-05-15U-2414
95662342034-01-18DPU-2415
82269752028-08-15DP
86328042026-12-05U-2416
86420752026-12-05DP
86795322026-12-05U-2415
77181892025-06-06DPU-2415
88021372024-04-08DPU-2414
98273172024-04-08DPU-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
127 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_00005442596828
PneumoniaD011014EFO_0003106J181165727
Communicable diseasesD0031411353819
SepsisD018805EFO_0001420A41.9133713
TuberculosisD014376EFO_0000774A15-A191223412
FibrosisD0053553322311
Ventilator-associated pneumoniaD053717EFO_1001865J95.851433311
Urinary tract infectionsD014552EFO_0003103N39.011259
Lung diseasesD008171EFO_0003818J98.4142118
Multidrug-resistant tuberculosisD018088EFO_000738122318
Show 19 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20123
Respiratory aspirationD053120EFO_1001839213
Urinary bladder neoplasmsD001749C6711
Urologic surgical proceduresD01352011
Nontuberculous mycobacteriaD00917011
Abdominal abscessD018784EFO_100175311
Extracorporeal membrane oxygenationD01519911
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059933
AppendicitisD001064EFO_0007149K3733
HemorrhageD006470MP_0001914R5822
EnterococcusD01698322
Respiratory tract infectionsD012141J06.922
KeratitisD007634H1622
Chronic bronchitisD029481J4211
BronchitisD001991J4011
Disease susceptibilityD00419811
EndophthalmitisD00987711
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmikacin
INNamikacin
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 classantibiotics obtained from Streptomyces kanamyceticus (related to kanamycin)
Image (chem structure or protein)Loading
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-ID37517-28-5
RxCUI
ChEMBL IDCHEMBL177
ChEBI ID2637
PubChem CID37768
DrugBankDB00479
UNII ID84319SGC3C (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 40,647 documents
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Safety
Black-box Warning
Black-box warning for: Amikacin sulfate, Arikayce
Adverse Events
Top Adverse Reactions
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11,251 adverse events reported
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