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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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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 sulfateANDA2025-06-18
amikacin sulfate injection, 500 mg/2mlExport only2021-01-03
arikayceNew Drug Application2025-07-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract infections—D012141J06.9
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
intraabdominal infections—D059413—
pseudomonas infectionsEFO_0001076D011552A41.52
infectious skin diseases—D012874—
escherichia coli infectionsEFO_1001318D004927B96.20
soft tissue infections—D018461—
surgical wound infection—D013530—
staphylococcal infections—D013203A49.01
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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
128 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805EFO_0001420A41.9——1——1
Urinary tract infectionsD014552EFO_0003103N39.0——1——1
Intraabdominal infectionsD059413————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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 43,607 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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13,079 adverse events reported
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