Amikacin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Arikayce liposomal | — | 2020-10-27 | europa.eu ↗ |
| Label expansion | US (FDA) | ARIKAYCE KIT | — | 2020-10-19 | fda.gov ↗ |
| Approved | US (FDA) | AMIKIN | — | 1981-01-22 | fda.gov ↗ |
Trials 61 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 31 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT05761405 Comparator | Jan 2024 → Oct 2025 | urinary tract infection | Centre Hospitalier Universitaire Vaudois | Unknown | No outcome recorded |
| Phase 0 | NCT06097767 Background | Oct 2023 → Apr 2024 | — | Al-Azhar University | Unknown | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 0 | NCT02277808 Comparator | Dec 2013 → Oct 2014 | — | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00558844 Comparator | Jan 2008 → Jun 2009 | cystic fibrosis | Insmed Incorporated | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04209192 Comparator | Jan 2020 → Apr 2023 | urinary bladder cancer, urinary tract infection | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 2 | NCT02365623 Background | Feb 2015 → Nov 2018 | multidrug-resistant tuberculosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00786305 Comparator | Oct 2004 → Sep 2008 | pneumonia caused by pseudomonas aeruginosa infection | Groupe Hospitalier Pitie-Salpetriere | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03622450 Comparator | Jan 2016 → Jan 2018 | — | Nourhan Hassan Osama Thuraya Mohamed | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07089186 Comparator | Apr 2025 → Dec 2026 expected | bacterial pneumonia, urinary tract infection | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04677543 Comparator | Dec 2020 → May 2023 | Mycobacterium avium complex disease | Insmed Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT03409679 Comparator | Mar 2018 → Jul 2019 | pneumonia | Polyphor Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT02975570 Comparator | Aug 2017 → Aug 2021 | multidrug-resistant tuberculosis | Boston University | Withdrawn | No outcome recorded |
| Phase 3 | NCT02120638 Comparator | Apr 2014 → Apr 2016 | multidrug-resistant tuberculosis | Huashan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01867138 Background | Mar 2007 → Aug 2010 | neonatal sepsis | Hospital Italiano de Buenos Aires | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07590648 Background | Jun 2026 → Jul 2028 expected | bacterial infectious disease, childhood malignant neoplasm, hematopoietic and lymphoid cell neoplasm, neutropenia | Hospital Universitari Vall d'Hebron Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07694700 Comparator | Dec 2025 → Aug 2026 overdue | primary bacterial infectious disease | Beni-Suef University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT05544565 Background | Mar 2023 → Jan 2028 expected | acute pyelonephritis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 4 | NCT05494957 Background | Aug 2022 → Aug 2024 | pulmonary non-tuberculous mycobacterial infection | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT04882085 Comparator | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04285320 Comparator | Mar 2021 → Apr 2023 | urinary tract infection | Atlantic Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03867136 Comparator | Jun 2020 → Aug 2024 | multidrug-resistant tuberculosis | Huashan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02365272 Comparator | Dec 2012 → Dec 2014 | infectious disease with sepsis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT01659866 Comparator | Aug 2012 → Aug 2015 | infectious disease | Northwestern University | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06051513 Background | Nov 2023 → Dec 2025 overdue | — | Southeast University, China | Recruiting | No outcome recorded |
| — | NCT04867993 Comparator | Aug 2018 → Aug 2022 | perinatal asphyxia | University of Sarajevo | Unknown | No outcome recorded |
| — | NCT03604848 Comparator | Aug 2018 → Aug 2024 | multidrug-resistant tuberculosis | Huashan Hospital | Unknown | No outcome recorded |
| — | NCT03169114 Comparator | Nov 2017 → Dec 2019 | appendicitis | Raja Isteri Pengiran Anak Saleha Hospital | Terminated | No outcome recorded |
| — | NCT02728518 Comparator | Aug 2014 → Aug 2015 | pneumonia | National Heart Institute, Egypt | Completed | No outcome recorded |
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 97 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amikacin | “The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to...” NCT07665788 ↗85“anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS],...” NCT02365623 ↗ “Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗ “590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium...” NCT02628600 ↗ “Drug stop within 24 hours after randomization:Piperacillin-tazobactam, amikacin, meropenem, cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacine and...” NCT07590648 ↗ “Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen” NCT03038178 ↗ “The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history” NCT05494957 ↗ “Amikacin liposome inhalation suspension in newly diagnosed Mycobacterium avium complex lung disease (ARISE): a 6-month double-blind, active comparator trial.” PMID 41915555 ↗ Apr 2026 “Ceftriaxone (50 mg/kg once a day by intravenous/intramuscular route) AND/OR Amikacin (20 mg/kg once a day by intravenous/intramuscular route) during 3 days.” NCT05544565 ↗ “Systematic aminoglycoside therapy using Amikacin at a dose of 25 to 30 mg/Kg per dose, at a rate of a maximum of 1 infusion per day will be delivered.” NCT05443854 ↗ “main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem” NCT04882085 ↗ “The abbreviation of the name of the 3 drugs in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）” NCT03830671 ↗ “Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery.” NCT06585020 ↗ “Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin” NCT03409679 ↗ “aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd” NCT03921645 ↗ “tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin” NCT03622450 ↗ “Amikacin (aminoglycoside) in a liposomal formulation.” NCT03905642 ↗ “5) aminoglycosides; amikacin, gentamicin, tobramycin” NCT07236944 ↗ “a parenteral agent (typically amikacin or kanamycin)” NCT02975570 ↗ “colistin combined with aminoglycosides (amikacin)” NCT06051513 ↗ “gatifloxacin, amikacin, capreomycin, kanamycin” NCT03237182 ↗ “Amikacin-30 mg in 60 ml of sterile water” NCT04285320 ↗ “Amikacin 600mg daily” NCT03867136 ↗ “Amikacin 600mg daily” NCT03604848 ↗ “Amikacin 600mg daily” NCT02120638 ↗ “Amikacin*” NCT02099240 ↗ |
| Known as | ALIS | “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI) and Amikacin Liposome Inhalation Suspension (ALIS) are all the same may be used interchangeably throughout the...” NCT00777296 ↗4“Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other...” NCT00775138 ↗ “Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗ “Does treatment with amikacin liposome inhalation suspension (ALIS) improve culture conversion in patients with M abscessus pulmonary disease who are treatment naive or who have...” PMID 37419144 ↗ Jun 2023 “RATIONALE: Guidelines recommend amikacin liposome inhalation suspension (ALIS) for refractory Mycobacterium avium complex lung disease (MACLD) treatment, alongside other antibiotics.” PMID 41915555 ↗ Apr 2026 |
| Known as | ALIS (Amikacin Liposome Inhalation Suspension) | “ALIS (Amikacin Liposome Inhalation Suspension)” NCT02344004 ↗ |
| Known as | Amikacin (as sulfate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Amikacin Liposome Inhalation Suspension | “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI) and Amikacin Liposome Inhalation Suspension (ALIS) are all the same may be used interchangeably throughout the...” NCT00777296 ↗2“Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗ “Does treatment with amikacin liposome inhalation suspension (ALIS) improve culture conversion in patients with M abscessus pulmonary disease who are treatment naive or who have...” PMID 37419144 ↗ Jun 2023 |
| Known as | Amikacin Liposome Inhalation Suspension (ALIS) | “Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other...” NCT00775138 ↗4“Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315678 ↗ “Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT00558844 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT03905642 ↗ “Amikacin Liposome Inhalation Suspension (ALIS)” NCT02628600 ↗ |
| Known as | AMIKACIN SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Amikacin Sulphate | “Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.” NCT00360607 ↗ |
| Known as | Amikacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | amikacine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02535130 ↗ |
| Known as | Amikacini sulfas | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Amikacinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Amikin | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | AMK | “We aim to strengthen the first week of treatment with the injectable drug amikacin (AMK).” PMID 39053960 ↗ Jul 20241“amikacin [AMK]” NCT02365623 ↗ |
| Known as | Amukin | “500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)” NCT02277808 ↗ |
| Known as | Arikace | “Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other...” NCT00775138 ↗7“Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT00558844 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315678 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315236 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT03905642 ↗ “Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗ “Liposomal amikacin for inhalation (Arikace™) was developed as a possible treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.” NCT01315691 ↗ |
| Known as | Arikayce | “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT03905642 ↗4“Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗ “Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.” NCT01315678 ↗ |
| Known as | Arikayce kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Arikayce liposomal | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | BAY41-6551 | “BAY41-6551 (NCT01004445), an investigational drug-device combination of amikacin” PMID 22147112 ↗ Dec 20112“Amikacin Inhalation Solution (BAY41-6551)” NCT01799993 ↗ “Amikacin inhalation solution (BAY41-6551)” NCT01021436 ↗ |
| Known as | BB-K8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | LAI | “Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other...” NCT00775138 ↗5“Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315678 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315236 ↗ “Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗ “Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen” NCT03038178 ↗ “LAI (Liposomal Amikacin for Inhalation) 590 mg” NCT02344004 ↗ |
| Known as | Likacin | “Amikacin (Likacin®; 500 mg/2mL vial; Lisapharma S.p.A., Erba, Italy) is given to the neonate, as an IV infusion via umbilical vein over 20 min by use of a syringe-pump” NCT04867993 ↗ |
| Known as | Liposomal amikacin for inhalation | “Arikace™, Arikayce™,Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01316276 ↗4“Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen” NCT03038178 ↗ “Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.” NCT01315678 ↗ “LAI (Liposomal Amikacin for Inhalation) 590 mg” NCT02344004 ↗ |
| Known as | Liposomal Amikacin for Inhalation (LAI) | “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT01315678 ↗2“Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT00558844 ↗ “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other...” NCT03905642 ↗ |
| Known as | Lukadin | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Mikacin | “Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.” NCT00360607 ↗ |
| Known as | NKTR-061 | “Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia” PMID 20003269 ↗ Dec 2009 |
| Known as | NSC-177001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | NSC-755846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Known as | Potentox | ChEMBL registry synonym — accepted as the source's own label CHEMBL177 ↗ |
| Modality | Small molecule | “aminoglycoside” NCT00360607 ↗ |
| Route | Intrathecal | “Amikacin administered intrathecally” NCT00362245 ↗ |