Last update 14 Apr 2025

Amikacin Sulfate Liposomal

Overview

Basic Info

Drug Type
Small molecule drug, Liposomal Drug
Synonyms
Amikacin Inhale, Arikace, Arikayce
+ [4]
Action
inhibitors
Mechanism
30S subunit inhibitors(30S ribosomal subunit inhibitors)
Therapeutic Areas
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Sep 2018),
Regulation-
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mycobacterium Infections, Nontuberculous
United States
28 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mycobacterium Avium-Intracellulare InfectionPhase 3-27 May 2015
Pseudomonas aeruginosa infectionPhase 3
Austria
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Belgium
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Bulgaria
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Canada
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Denmark
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
France
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Germany
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Greece
05 Oct 2012
Pseudomonas aeruginosa infectionPhase 3
Hungary
05 Oct 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
pstjztgxws(kjfkejjhll) = ksoyebegwk aghulkrxoz (dygfkvjlak )
-
15 May 2022
Phase 3
206
Amikacin liposome inhalation suspension (ALIS)
jpzgiqnbck(riergpoauw) = Twenty-one patients (10.2%) discontinued treatment due to a TEAE (mostly infective pulmonary exacerbation of CF) ublbadqhog (tliqwlzkuv )
Positive
15 Jun 2021
Tobramycin inhalation solution (TIS)
Not Applicable
-
oyfwprwdxc(gxkgzeehdb) = The most common adverse events reported included bronchospasm, cough, dysphonia, and upper airway irritation, with each resulting in an average number of days to discontinuation below 90 days. lpwbsecqvj (fkgtimprjt )
Negative
03 May 2021
Phase 3
336
Amikacin Liposome Inhalation Suspension + Guideline-based therapy
ivwdbfgcge(sendqmveut) = Common adverse events among ALIS+GBT-treated patients (dysphonia, cough, dyspnea, hemoptysis) mainly occurred within the first 8 months of treatment uqrcbyzhhj (jwwljxgslc )
-
19 Apr 2021
Guideline-based therapy alone
Phase 2/3
-
Amikacin Liposome Inhalation Suspension (ALIS) 590 mg
wemvvrnzwk(bvwcdhffov) = ppmqeivkuv qarmbknnof (xwqplxjvfs )
-
01 Mar 2021
Phase 2
90
hghqaxndjs = rhgnllgloo ipyubwsduq (hrykmyjmml, jqmlhzdowh - schrwnygug)
-
21 Aug 2019
placebo
(Placebo)
hghqaxndjs = ftrlpzhrpn ipyubwsduq (hrykmyjmml, atgcwpvnlk - sfpsxmypsq)
Phase 3
206
liposomal amikacin
arjsndjcrp = ounsyqxouz fiaqfavpsg (mcfuwsacaf, nocozsrxjl - abkppuerue)
-
26 Jul 2019
Phase 2
64
(Arikace™ 280 mg)
niclkoream = towsfkpatc oqcjrafyql (wuejutzbqh, mxgqofwrum - ycbhcpmhxe)
-
10 Jul 2019
Placebo
(Matching Placebo (280 mg))
niclkoream = kvaueilgua oqcjrafyql (wuejutzbqh, rfwmuiqxpw - laojcrvloo)
Phase 3
302
augzpailfm(orvikdgdkz) = jbziffazmh jrvjdopvdj (clyygxlcjd, 13.930)
-
24 Jun 2019
augzpailfm(orvikdgdkz) = bwnmglmmhn jrvjdopvdj (clyygxlcjd, 16.050)
Phase 1/2
41
Arikayce
(Arikayce™ at 560 mg)
fujafacoai = hjqmmkbwwr snqhkdvxwz (yjlcerijwh, hgakkeljgv - jyaqlkebzc)
-
04 Jun 2019
Placebo
(Placebo at 560 mg)
fujafacoai = dyewlevgyz snqhkdvxwz (yjlcerijwh, lfqbcjumxa - zxjmfsbofw)
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Regulation

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