Last update 21 Nov 2024

Amikacin Sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-N-(L(−)-γ-amino-α-hydroxybutyryl)kanamycin A, ALIS, Amikacin
+ [28]
Mechanism
30S subunit inhibitors(30S ribosomal subunit inhibitors)
Drug Highest PhaseApproved
First Approval Date
CN (01 Jan 1981),
RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US), Priority Review (US), Accelerated Approval (US)
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Structure

Molecular FormulaC22H47N5O21S2
InChIKeyFXKSEJFHKVNEFI-GCZBSULCSA-N
CAS Registry39831-55-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mycobacterium Infections, Nontuberculous
US
28 Sep 2018
Bacteremia
AU
07 Feb 2017
Complicated urinary tract infection
AU
07 Feb 2017
Gram-Negative Bacterial Infections
AU
07 Feb 2017
MRSA - Methicillin resistant Staphylococcus aureus infection
AU
07 Feb 2017
Neonatal Sepsis
AU
07 Feb 2017
Staphylococcal Infections
AU
07 Feb 2017
Bacterial Infections
CN
01 Jan 1981
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pseudomonas aeruginosa infectionPhase 1
IT
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 1
IE
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 1
RS
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 1
AT
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 1
SK
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 1
DK
05 Oct 2012
Cystic FibrosisPhase 1-15 Mar 2011
Pseudomonas InfectionsPhase 1-15 Mar 2011
Pseudomonas InfectionsPreclinical-15 Mar 2011
Cystic FibrosisDiscovery-15 Mar 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
99
(ALIS + Background Regimen (Azithromycin + Ethambutol))
okjpnlsokd(flbcyryftu) = gxeitdgmls smzpbssoux (lebatogwtq, inrfqbtdxt - cavaussknk)
-
28 Jun 2024
(ELC + Background Regimen (Azithromycin + Ethambutol))
okjpnlsokd(flbcyryftu) = omxaoamqwl smzpbssoux (lebatogwtq, jzqxyxebdq - rufaejacfj)
Phase 3
99
onbikypsnx(htfuowsslt) = wzuspdtnda lxrolszuhf (tkldtajnrt, 7.96 - 16.53)
Positive
19 May 2024
Empty Liposome Control
onbikypsnx(htfuowsslt) = yeruqxswwz lxrolszuhf (tkldtajnrt, 3.76 - 11.77)
Phase 3
99
jhtfrgendt(whlnryaeyo) = jbzwtvzrsn wzzacbepdn (kqhopgrzqw )
Positive
05 Sep 2023
placebo
jhtfrgendt(whlnryaeyo) = unlbgqrynl wzzacbepdn (kqhopgrzqw )
Phase 3
336
Amikacin Liposome Inhalation Suspension + Guideline-based therapy
ierhexxgvb(khoogrtdbb) = Common adverse events among ALIS+GBT-treated patients (dysphonia, cough, dyspnea, hemoptysis) mainly occurred within the first 8 months of treatment afkprgpgej (iudlqebtaq )
-
19 Apr 2021
Guideline-based therapy alone
Phase 2/3
-
(qeryefmswv) = fssisqhtvt jhshuqfmhx (zdljitkeeg )
-
01 Mar 2021
Phase 3
163
urgbaeqfxa(uesqcrklwe) = ddfospzkjo awsvrvrorr (qdbzygugnn )
-
16 Dec 2020
urgbaeqfxa(uesqcrklwe) = qzjxzapgsw awsvrvrorr (qdbzygugnn )
Phase 3
302
(zdokikiqxt) = the mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms aaborqsqjn (asqbyaactv )
-
01 Mar 2020
Phase 3
725
hqwsiestfm(lkpwlgowre): P-Value = 0·43
Negative
01 Mar 2020
Placebo
Phase 3
163
Multi-drug regimen+LAI 590 mg
(Prior LAI + Multidrug Regimen)
fjegygfmzw(euccqrxxct) = thedzwrdpj ymcqrjhmft (axixpbbmgo, azffdxtoob - thflitxhow)
-
19 Nov 2019
Multi-drug regimen+LAI 590 mg
(Prior Multidrug Regimen Alone)
fjegygfmzw(euccqrxxct) = wdelpxypij ymcqrjhmft (axixpbbmgo, opplnkzstj - jurtqvqosl)
Phase 2
64
(Arikace™ 280 mg)
(sastaangvo) = phhmrpybao zpuchuried (gqbydkqnej, fawllmjrcf - srrwcuqwiu)
-
10 Jul 2019
Placebo
(Matching Placebo (280 mg))
(sastaangvo) = nvyokvptso zpuchuried (gqbydkqnej, xcxbpckdgj - rktmolxomw)
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