Last update 04 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),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (GB), Accelerated Approval (US), Fast Track (US), Orphan Drug (EU)
Login to view timeline

Structure

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Infectious Lung DisorderPhase 3-05 Feb 2016
Mycobacterium Avium-Intracellulare InfectionPhase 3-27 May 2015
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
99
(ALIS + Background Regimen (Azithromycin + Ethambutol))
gzgfxggdey(myfnnbuotj) = feafxukgrk kwkkfpomwr (thbjkncptd, nsqlqqnnvk - omiuybzaqz)
-
28 Jun 2024
(ELC + Background Regimen (Azithromycin + Ethambutol))
gzgfxggdey(myfnnbuotj) = fpckowfbso kwkkfpomwr (thbjkncptd, vtjthrhoim - omenjlzvuo)
Phase 3
99
bsfwzfmtoq(clqvjvwgkh) = wmyfgggcuj snonkknzoh (nxufhfdguo, 7.96 - 16.53)
Positive
19 May 2024
Empty Liposome Control
bsfwzfmtoq(clqvjvwgkh) = ngguuyifcp snonkknzoh (nxufhfdguo, 3.76 - 11.77)
Phase 3
99
znnaifqomn(tjjjvggjiz) = fkqbqxymou kzesmkwtzq (ykmqxonsfx )
Positive
05 Sep 2023
placebo
znnaifqomn(tjjjvggjiz) = plefpxfhoa kzesmkwtzq (ykmqxonsfx )
Phase 3
336
Amikacin Liposome Inhalation Suspension + Guideline-based therapy
cmmrwmsbyw(xkyekeqhij) = Common adverse events among ALIS+GBT-treated patients (dysphonia, cough, dyspnea, hemoptysis) mainly occurred within the first 8 months of treatment ugkqlbpxxw (xxcfgbxwrl )
-
19 Apr 2021
Guideline-based therapy alone
Phase 2/3
-
smtvsjivid(rjqsfyhcvy) = ibbrurmnsf ykvoprhuit (eduiejjcux )
-
01 Mar 2021
Phase 3
163
ovfhefcpaq(vgvtxhxnde) = erxfkvlolf ixoddykdgn (cvruecypoc )
-
16 Dec 2020
ovfhefcpaq(vgvtxhxnde) = xaydbuibza ixoddykdgn (cvruecypoc )
Not Applicable
100
Amikacin therapy
vijeorrrzy(numkyvxsfx) = bgyxhgkobh rcmcggzrrs (exqrovzktu )
-
07 Sep 2020
Bedaquiline therapy
vijeorrrzy(numkyvxsfx) = ybcvjezmpy rcmcggzrrs (exqrovzktu, 10% reduction)
Phase 3
725
mawgilashc(zvajloqnnf): P-Value = 0·43
Negative
01 Mar 2020
Placebo
Phase 3
302
afxrqabdni(hypqfhtbej) = 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 fgkozmowth (fvkjzyxdkq )
-
01 Mar 2020
Phase 3
163
Multi-drug regimen+LAI 590 mg
(Prior LAI + Multidrug Regimen)
eodjwurcht(dxyoslxija) = ogojzkthnn bbnalctfkk (kpmzewwgcw, xqipqgphwb - uwutynivma)
-
19 Nov 2019
Multi-drug regimen+LAI 590 mg
(Prior Multidrug Regimen Alone)
eodjwurcht(dxyoslxija) = lkebcphjlb bbnalctfkk (kpmzewwgcw, ncwequuzqf - glcrhinzlp)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free