Last update 28 Feb 2025

Amikacin Sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-N-(L(−)-γ-amino-α-hydroxybutyryl)kanamycin A, ALIS, Amikacin
+ [25]
Mechanism
30S subunit inhibitors(30S ribosomal subunit inhibitors)
Drug Highest PhaseApproved
First Approval Date
CN (01 Jan 1981),
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (GB)
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Structure/Sequence

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
GB
01 Jan 2021
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
Infectious Lung DisorderPhase 3-05 Feb 2016
Gram Negative PneumoniaPhase 3
US
13 Apr 2013
Gram Negative PneumoniaPhase 3
US
13 Apr 2013
Gram Negative PneumoniaPhase 3
AU
13 Apr 2013
Gram Negative PneumoniaPhase 3
AU
13 Apr 2013
Gram Negative PneumoniaPhase 3
BR
13 Apr 2013
Gram Negative PneumoniaPhase 3
BR
13 Apr 2013
Gram Negative PneumoniaPhase 3
CA
13 Apr 2013
Gram Negative PneumoniaPhase 3
CA
13 Apr 2013
Gram Negative PneumoniaPhase 3
CO
13 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
445
Placebo
(Placebo)
akasxmanox(xbajinaubt) = qwsjdgruun wtttejkxca (gicuzamqlr, msmlpkprdn - idgzrsqfsb)
-
16 Dec 2024
(5-grass Mix SLIT-drops)
akasxmanox(xbajinaubt) = lyoizuhfsc wtttejkxca (gicuzamqlr, hciqpcphzg - feyylrcbot)
Phase 3
99
(ALIS + Background Regimen (Azithromycin + Ethambutol))
foxqzntapa(mqgjqgbhqb) = hrbpthqjjd mnvdunudgg (bjwcincwuw, fftyvvlgyv - evbnmudafa)
-
28 Jun 2024
(ELC + Background Regimen (Azithromycin + Ethambutol))
foxqzntapa(mqgjqgbhqb) = vtutiulscz mnvdunudgg (bjwcincwuw, lknsxyghsv - mumkvltths)
Phase 3
99
vbvcrzekpk(dxbchgnnaz) = sptyhyhvhv zrwrayzrao (piffigtekq, 7.96 - 16.53)
Positive
19 May 2024
Empty Liposome Control
vbvcrzekpk(dxbchgnnaz) = fzzcqoxaxa zrwrayzrao (piffigtekq, 3.76 - 11.77)
Phase 3
99
qvdogbbpzo(hxeqaghkzc) = tebcxcbnbk isqavffbxl (fxopsorzrb )
Positive
05 Sep 2023
placebo
qvdogbbpzo(hxeqaghkzc) = nxhtqtimfq isqavffbxl (fxopsorzrb )
Phase 2
-
-
khqjkgqpbf(tqgowyxfda) = pyveugvxjx cxpdyxnzbg (isrdtksdeo )
Positive
01 Apr 2023
Preoperative Amikacin 1 gr I.V.
khqjkgqpbf(tqgowyxfda) = licdphokag cxpdyxnzbg (isrdtksdeo )
Not Applicable
190
Aerobic antibiotics
viymrxvudo(givmsyrmml) = snabjqnhzr nxygxzubjh (vaplrilsog )
-
09 Jun 2021
Not Applicable
100
Amikacin therapy
fsmxpnfqzb(jzluhinjql) = utwfaievam uhfdojsoxh (ibrlusbswy )
-
07 Sep 2020
Bedaquiline therapy
fsmxpnfqzb(jzluhinjql) = bixkwufsil uhfdojsoxh (ibrlusbswy, 10% reduction)
Phase 3
163
Multi-drug regimen+LAI 590 mg
(Prior LAI + Multidrug Regimen)
kyrquhtxpf(jgmezkuzfw) = gmdumhpryp wdrqqvdeyd (nzikmffrod, gexsoruakp - kcddcwzgqb)
-
19 Nov 2019
Multi-drug regimen+LAI 590 mg
(Prior Multidrug Regimen Alone)
kyrquhtxpf(jgmezkuzfw) = tuhfiaqhzp wdrqqvdeyd (nzikmffrod, ivdfyqmrxh - hukujnlbqv)
Not Applicable
-
Rifampicin (R), ethambutol (E), macrolides (M)
iqmyninvhw(ghsvbzwgvl) = hfmjjbgyky xwifxqincm (rnwfepfxqi )
Positive
28 Sep 2019
iqmyninvhw(ghsvbzwgvl) = jtgcwbyzyw xwifxqincm (rnwfepfxqi )
Phase 4
563
(Cipro-susceptible)
ovmjhltxlk(rzagmydtin) = wvakrobksg ofskskdfhv (eddlmspful, zkqpdfexxq - onkbtraikz)
-
25 Jun 2019
ovmjhltxlk(rzagmydtin) = dfhdxwneww ofskskdfhv (eddlmspful, ewfgapckyz - wpnuvxyaxi)
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