Drugs / Amikacin
Amikacin
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed mixed dust pneumoconiosis 1 milestone | |||||
| Filed | US (FDA) | — | mixed dust pneumoconiosis | 2018-03-29 | “today announced that it has submitted its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. Food and Drug Administration (FDA)” insmed.com ↗ |
| Filed Mycobacterium avium complex disease 3 milestones | |||||
| Filed | US (FDA) | ARIKAYCE | Mycobacterium avium complex disease | 2026-09-21 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Supplemental New Drug Application (sNDA) for review of ARIKAYCE®” insmed.com ↗ “In July 2026, Insmed submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE” insmed.com ↗ |
| Filed | Japan (PMDA) | ARIKAYCE | Mycobacterium avium complex disease | 2020-03-16 | “Insmed has also submitted a new drug application for ARIKAYCE in Japan for the treatment of patients with NTM lung disease caused by MAC” insmed.com ↗ “Insmed filed a Japanese New Drug Application (JNDA) with the Japanese Ministry of Health, Labour and Welfare in March of this year.” insmed.com ↗ “Insmed has also submitted a new drug application for ARIKAYCE to Japan's Ministry of Health, Labour and Welfare” insmed.com ↗ “submitted a new drug application (JNDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for ARIKAYCE” insmed.com ↗ |
| Filed | EU (EMA) | ARIKAYCE | Mycobacterium avium complex disease | — | “In July, Insmed submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ARIKAYCE for the treatment of persistent MAC lung infection” insmed.com ↗ “filing for regulatory approval of ARIKAYCE in the EU last quarter” insmed.com ↗ |
| Filed pulmonary non-tuberculous mycobacterial infection 1 milestone | |||||
| Filed | Japan (PMDA) | ARIKAYCE | pulmonary non-tuberculous mycobacterial infection | 2020-10-28 | “Insmed has submitted a new drug application for ARIKAYCE in Japan for the treatment of patients with NTM lung disease caused by MAC” insmed.com ↗ |
| Clinical hold cystic fibrosis 1 milestone | |||||
| Clinical hold | US (FDA) | ARIKACE | cystic fibrosis | 2011-10-10 | “FDA that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF)” insmed.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 59
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03449459 | Dec 2018 → Dec 2020 | chronic obstructive pulmonary disease | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT04249531 | Jun 2020 → Apr 2022 | tuberculosis | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 1 | NCT02897869 | Apr → Aug 2016 | — | Polyphor Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02709265 | Apr → Jul 2016 | — | Cardeas Pharma | Completed | No outcome recorded |
| Phase 1 | NCT05999942 | Jun 2004 | — | Insmed Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06238856 | May 2004 → Feb 2005 | cystic fibrosis | Insmed Incorporated | Completed | No outcome recorded |
| Phase 214 trials · 1 missed | ||||||
| Phase 2 | NCT07485010 | Apr 2027 → Apr 2031 expected | pulmonary non-tuberculous mycobacterial infection | The University of Queensland | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06602557 | Nov 2026 → May 2028 expected | bacterial pneumonia | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06585020 | Oct 2024 → Aug 2026 overdue | Mycobacterium xenopi infection, lung disorder | Centre Hospitalier Universitaire, Amiens | Recruiting | No outcome recorded |
| Phase 2 | NCT05555303 | Mar 2023 → Mar 2024 | multidrug-resistant tuberculosis | Rwanda Biomedical Centre | Unknown | No outcome recorded |
| Phase 2 | NCT03038178 | Oct 2016 → Oct 2019 | pulmonary non-tuberculous mycobacterial infection | Kevin Winthrop | Completed | No outcome recorded |
| Phase 2 | NCT02218359 | Oct 2014 → Dec 2015 | bacterial pneumonia | Cardeas Pharma | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01969799 | Dec 2013 → Mar 2016 | bacterial pneumonia | Cardeas Pharma | Completed | Missed primary |
| Phase 2 | NCT01528930 | Feb 2012 → Dec 2015 | pulmonary non-tuberculous mycobacterial infection | Samsung Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT01570192 | Sep 2010 → Apr 2015 | bacterial pneumonia | University of Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03905642 | Jan 2009 → Nov 2010 | cystic fibrosis | Insmed Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT00775138 | Jun 2008 → May 2009 | bronchiectasis | Insmed Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01021436 | Mar → Aug 2007 | pneumonia | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01004445 | May 2005 → Jun 2006 | pneumonia | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00000641 | ? → Dec 1994 | HIV infectious disease, Mycobacterium avium complex disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04310930 | Mar 2020 → Jun 2029 expected | pulmonary non-tuberculous mycobacterial infection | The University of Queensland | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00861315 | Jan 2009 → Jan 2011 | — | Association Pour La Promotion A Tours De La Reanimation Medicale | Unknown | No outcome recorded |
| Phase 311 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT07665788 | Jun 2026 → Jul 2029 expected | tracheobronchitis | University Hospital, Tours | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05443854 | Sep 2022 → Jun 2024 | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm, infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT05213507 | Mar 2022 → Dec 2023 | chronic obstructive pulmonary disease | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT06739382 | Jan → Dec 2021 | ventilation pneumonitis | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT03149640 | Jul 2017 → Mar 2021 | — | University Hospital, Tours | Completed | Met primary |
| Phase 3 | NCT02628600 | Feb 2016 → Oct 2018 | Mycobacterium avium complex disease | Insmed Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT02344004 | May 2015 → Jul 2018 | pulmonary non-tuberculous mycobacterial infection | Insmed Incorporated | Completed | Met primary |
| Phase 3 | NCT01799993 | Apr 2013 → Apr 2017 | bacterial pneumonia | Bayer | Completed | Missed primary |
| Phase 3 | NCT01316276 | Oct 2012 → Jul 2015 | cystic fibrosis | Insmed Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01315678 | Feb 2012 → Jun 2013 | Pseudomonas aeruginosa infectious disease | Insmed Incorporated | Completed | Met primary |
| Phase 3 | NCT01315691 | — | cystic fibrosis | Insmed Incorporated | Withdrawn | No outcome recorded |
| Phase 414 trials · 1 met primary | ||||||
| Phase 4 | NCT06808074 | Feb 2025 → Feb 2026 overdue | cirrhosis of liver, hepatic encephalopathy | Asian Institute of Gastroenterology, India | Recruiting | No outcome recorded |
| Phase 4 | NCT07369336 | Jan → Nov 2024 | pneumonia | Postgraduate Medical Institute, Lahore | Completed | No outcome recorded |
| Phase 4 | NCT05862402 | May 2023 → May 2024 | Klebsiella pneumonia | Phramongkutklao College of Medicine and Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04948463 | Nov 2021 → Dec 2025 | neutropenia | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02872272 | Jan 2020 → Jul 2021 | — | Assistance Publique Hopitaux De Marseille | Terminated | No outcome recorded |
| Phase 4 | NCT04197739 | Dec 2019 → Dec 2021 | primary bacterial infectious disease, urinary tract infection | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03830671 | Mar 2019 → Jun 2022 | multidrug-resistant tuberculosis | Beijing Chest Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03237182 | Jun 2017 → Dec 2022 | multidrug-resistant tuberculosis | Centre for the AIDS Programme of Research in South Africa | Terminated | No outcome recorded |
| Phase 4 | NCT02509091 | Dec 2014 → Mar 2019 | bronchiectasis | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT02898961 | Oct 2014 → Dec 2016 | infectious disease with sepsis | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02081963 | Mar 2014 → Mar 2016 | bronchiectasis | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT00445094 | Nov 2006 → Jan 2007 | pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00362245 | Sep 2006 → Nov 2008 | bacterial meningitis caused by gram-negative bacteria | Rambam Health Care Campus | Withdrawn | No outcome recorded |
| Phase 4 | NCT00360607 | Jul 2004 → Apr 2005 | infectious disease | Pfizer | Completed | Met primary |
| Phase not applicable12 trials · 1 missed | ||||||
| — | NCT03921645 | Jan 2018 → Dec 2019 | — | Shanghai 10th People's Hospital | Unknown | No outcome recorded |
| — | NCT02535130 | Aug 2015 → Aug 2016 | cystic fibrosis | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| — | NCT02574130 | Jul 2015 → Apr 2018 | — | Thammasat University | Completed | No outcome recorded |
| — | NCT02489955 | Feb 2015 → Feb 2017 | cystic fibrosis | The Leeds Teaching Hospitals NHS Trust | Unknown | No outcome recorded |
| — | NCT02652169 | Jun 2014 → Dec 2025 overdue | chronic ulcer of skin | Medical University of Vienna | Recruiting | No outcome recorded |
| — | NCT02084043 | Mar 2014 → Jun 2015 | asthma, chronic obstructive pulmonary disease, cystic fibrosis | University Hospital St Luc, Brussels | Completed | No outcome recorded |
| — | NCT02201082 | Sep 2012 → Jul 2013 | cystic fibrosis | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Completed | No outcome recorded |
| — | NCT01290003 | Jun 2010 → Jan 2011 | neonatal sepsis | Lady Hardinge Medical College | Completed | Missed primary |
| — | NCT00950222 | Jun 2009 → Sep 2011 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| — | NCT00153634 | Mar 2004 → Nov 2007 | chronic bronchitis, cystic fibrosis | Seattle Children's Hospital | Completed | No outcome recorded |
| — | NCT00129688 | Apr 2002 → Jun 2004 | cancer, neutropenia | Khon Kaen University | Completed | No outcome recorded |
| — | NCT00000796 | ? → Oct 1998 | HIV infectious disease, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Comparator or background therapy31 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 Stop: Enrollment |
| Phase 0 | NCT02277808 Comparator | Dec 2013 → Oct 2014 | — | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT00558844 Comparator | Jan 2008 → Jun 2009 | cystic fibrosis | Insmed Incorporated | Completed | No outcome recorded |
| 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 2/3 | NCT03622450 Comparator | Jan 2016 → Jan 2018 | — | Nourhan Hassan Osama Thuraya Mohamed | Completed | No outcome recorded |
| 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 Stop: Business |
| 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 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 |
| — | 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 Stop: Enrollment |
| — | NCT02728518 Comparator | Aug 2014 → Aug 2015 | pneumonia | National Heart Institute, Egypt | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Insmed Incorporated | Regulatory FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027 insmed.com ↗
In its communication to Insmed, the FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA). |
| 2026-05-07 | Insmed Incorporated | Results Insmed Reports First-Quarter 2026 Financial Results and Provides Business Update insmed.com ↗
Phase 3b ENCORE Study of ARIKAYCE in Patients with MAC Lung Disease Met Primary and All Multiplicity-Controlled Secondary Culture Conversion Endpoints |
| 2026-03-23 | Insmed Incorporated | Results Insmed Announces Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in Patients with MAC Lung Disease insmed.com ↗ |
| 2024-05-20 | Insmed Incorporated | Results Insmed Presents Positive Patient-Reported Outcomes and Microbiologic Data from Phase 3 ARISE Study Of ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in Patients with NTM Lung Disease Caused by MAC at American Thoracic Society 2024 International Conference Plenary Session insmed.com ↗
Patients Treated with ARIKAYCE Plus Macrolide-Based Background Regimen Had Meaningfully Greater Improvements in Respiratory Symptoms vs. Macrolide-Based Background Regimen Alone, As Measured By the QOL-B Respiratory Domain Instrument |
| 2023-09-05 | Insmed Incorporated | Results INSMED ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 3 ARISE STUDY OF ARIKAYCE® (AMIKACIN LIPOSOME INHALATION SUSPENSION) IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC insmed.com ↗
The study met its primary objective of demonstrating that the Quality of Life – Bronchiectasis (QOL-B) respiratory domain works effectively as a patient-reported outcome (PRO) instrument in patients with MAC lung disease. |
| 2023-05-22 | Insmed Incorporated | Results Insmed Presents Range of New Study Findings at American Thoracic Society 2023 International Conference insmed.com ↗
This real-world study of adults in the United States with a self-reported, clinician-confirmed diagnosis of refractory Mycobacterium avium complex (MAC) lung disease provided insights on patient perspectives and practices used to mitigate adverse events (AEs) associated with ARIKAYCE (referred to as ALIS in this poster). |
| 2023-01-06 | Insmed Incorporated | Results Insmed Provides Business Updates and Near-Term Strategic Outlook at 41st Annual J.P. Morgan Healthcare Conference insmed.com ↗
Treatment Discontinuation Rate of 15% Reported in Postmarketing ARISE Trial of ARIKAYCE® (amikacin liposome inhalation suspension) in Frontline Patients with MAC Lung Disease—Less than Half that of Pivotal Trial in Refractory Patients |
| 2022-05-17 | Insmed Incorporated | Results Insmed Presents New Data Across Three Pillars at American Thoracic Society 2022 International Conference insmed.com ↗
In particular, we were excited to share the first real-world data for ARIKAYCE, which showed significant reductions in hospitalizations in the 12 months after ARIKAYCE was initiated. |
| 2021-05-19 | Insmed Incorporated | Results Insmed Presents Broad Range of Data Across Its Three Programs at the American Thoracic Society 2021 International Conference insmed.com ↗
Findings were presented from a post-hoc analysis of clinical trial data to assess the NNT and NNH for ARIKAYCE. |
| 2021-03-23 | Insmed Incorporated | Regulatory ARIKAYCE® (amikacin liposome inhalation suspension) Approved by Japan's Ministry of Health, Labour and Welfare for the Treatment of Patients with NTM Lung Disease Caused by MAC Who Did Not Sufficiently Respond to Prior Treatment with MDR insmed.com ↗
Today's approval of ARIKAYCE is a significant milestone for patients with refractory MAC lung disease in Japan, who currently have no approved treatments available specifically for this serious and chronic pulmonary disease. |
| 2020-10-28 | Insmed Incorporated | Regulatory European Commission Grants Marketing Authorization for ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Adult Non-CF Patients with Limited Treatment Options insmed.com ↗
Today's approval underscores our commitment to serving the MAC lung disease community around the world, and we look forward to bringing ARIKAYCE to appropriate patients in the EU. |
| 2020-07-24 | Insmed Incorporated | Regulatory Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options insmed.com ↗
Today's positive opinion from the CHMP marks an important step in our journey to transform the way MAC lung disease is managed for patients around the world. |
| 2020-03-16 | Insmed Incorporated | Regulatory Insmed Provides Business Update insmed.com ↗
The submission of our JNDA filing for ARIKAYCE marks an important step in our journey to transform the way NTM lung disease caused by MAC is managed for patients in Japan. |
| 2020-03-04 | Insmed Incorporated | Results Insmed Announces Publication Discussing the Clinical Management of Common Respiratory Events Associated with ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in the Journal Open Forum Infectious Disease insmed.com ↗
The study shows that the application of management techniques communicated by treating physicians and subsequently practiced by patients were generally effective in improving common respiratory events, such as dysphonia, increased sputum production, increased cough and dyspnea. |
| 2019-05-20 | Insmed Incorporated | Results New Phase 3 Data Show Sustainability and Durability of Culture Conversion with ARIKAYCE® (amikacin liposome inhalation suspension) in Patients with Refractory MAC Lung Disease insmed.com ↗
These data were presented during a late-breaking session at the American Thoracic Society (ATS) International Conference in Dallas. |
| 2018-10-11 | Insmed Incorporated | Results Insmed Presents New Data at IDWeek 2018 and CHEST Annual Meeting Enhancing the Understanding of MAC Lung Disease and Treatment with ARIKAYCE® (amikacin liposome inhalation suspension) insmed.com ↗
In a poster presentation on October 4, researchers reported the results of a post-hoc analysis of the Phase 3 CONVERT (INS-212) study to evaluate the impact of amikacin susceptibility on culture conversion outcomes in the study. |
| 2018-09-28 | Insmed Incorporated | Regulatory Insmed Announces FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), the First and Only Therapy Specifically Indicated for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease in Adult Patients with Limited or No Alternative Treatment Options insmed.com ↗
ARIKAYCE is the first and only therapy approved in the U.S. specifically for patients with MAC lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality. |
| 2018-09-17 | Insmed Incorporated | Results Pivotal Phase 3 Data from CONVERT Study of ALIS in Patients with Treatment-Refractory NTM Lung Disease Caused by MAC Published in American Journal of Respiratory and Critical Care Medicine insmed.com ↗ |
| 2018-08-27 | Insmed Incorporated | Regulatory FDA Advisory Committee Votes 12-2 in Favor of the Safety and Effectiveness of Insmed’s ALIS for the Treatment of NTM Lung Disease Caused by MAC for Adult Patients with Limited or No Treatment Options insmed.com ↗
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have limited or no treatment options. |
| 2018-06-15 | Insmed Incorporated | Regulatory Insmed Announces FDA Advisory Committee Meeting to Review ALIS as a treatment for NTM Lung Disease Caused by MAC insmed.com ↗
The tentative date for the meeting is set for August 7, 2018. |
| 2018-05-22 | Insmed Incorporated | Results Insmed Announces Presentations at the American Thoracic Society 2018 International Conference insmed.com ↗
The global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical significance (p < 0.0001). |
| 2018-05-16 | Insmed Incorporated | Regulatory Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC insmed.com ↗
The FDA granted Insmed's request for Priority Review and has set an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA). |
| 2018-03-29 | Insmed Incorporated | Regulatory Insmed Submits New Drug Application to FDA for ALIS in NTM Lung Disease Caused by MAC insmed.com ↗
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that it has submitted its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. Food and Drug Administration (FDA) for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). |
| 2018-01-03 | Insmed Incorporated | Results Insmed Announces Additional Data from ALIS (Amikacin Liposome Inhalation Suspension) Phase 3 Clinical Program for Adult Patients with Treatment Refractory NTM Lung Disease Caused by MAC and Reports Progress with Commercial Preparations insmed.com ↗
The interim results announced today from our ongoing INS-212 and INS-312 studies provide confirmation of the initial positive clinical data released in September 2017. |
| 2017-11-24 | Bayer | Results Phase III study with Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia does not meet primary endpoint of superiority bayer.com ↗
Bayer today announced that INHALE, a global Phase III clinical study program investigating Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia, did not demonstrate superiority versus standard of care and aerosolized placebo. |
| 2017-09-05 | Insmed Incorporated | Results Insmed Announces Positive Top-Line Results from Phase 3 CONVERT Study of ALIS (Amikacin Liposome Inhalation Suspension) in Adult Patients with Treatment-Refractory Nontuberculous Mycobacterial (NTM) Lung Disease Caused by Mycobacterium Avium Complex (MAC) insmed.com ↗
The study demonstrated that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone (p < 0.0001). |
| 2016-10-18 | Insmed Incorporated | Results Insmed Announces Publication of Phase 2 Study of ARIKAYCE in Treatment-Refractory Nontuberculous Mycobacterial Lung Disease insmed.com ↗
Although the primary endpoint was not reached, data from the study suggest that the addition of ARIKAYCE to the guideline-based multi-drug regimen can achieve early and sustained negative sputum cultures. |
| 2016-06-08 | Insmed Incorporated | Regulatory Insmed Announces Withdrawal of Marketing Authorization Application for ARIKAYCE™ in Europe insmed.com ↗
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that it has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for ARIKAYCE™ for the treatment of nontuberculous mycobacteria (NTM) lung disease. |
| 2015-08-06 | Insmed Incorporated | Results Insmed Reports Second Quarter 2015 Financial Results and Provides Business Update insmed.com ↗
Twelve of the 14 patients remained culture negative for NTM at their one-year follow-up visit. |
| 2014-12-15 | Insmed Incorporated | Regulatory Insmed Provides End of Year Regulatory and Clinical Update insmed.com ↗
Insmed has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and is awaiting its validation. |
| 2014-05-20 | Insmed Incorporated | Results Insmed Announces Positive Open Label Data from Phase 2 Clinical Trial of ARIKAYCE for Treatment Resistant Nontuberculous Mycobacterial Lung Infections insmed.com ↗
These results collected from the open label phase show that 21 of these patients were culture negative for NTM at Day 168. |
| 2014-03-26 | Insmed Incorporated | Results Insmed Announces Results from Phase 2 Clinical Trial for Treatment Resistant Nontuberculous Mycobacterial Lung Infections insmed.com ↗
ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend (p=0.148) in favor of ARIKAYCE. |
| 2014-02-19 | Insmed Incorporated | Results Insmed Provides Interim Update from Two-Year, Open-Label Extension Study of ARIKACE to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients insmed.com ↗
The data showed that ARIKACE was well tolerated, and there was a sustained improvement from baseline level in Forced Expiratory Volume in One Second (FEV1). |
| 2013-07-01 | Insmed Incorporated | Results ARIKACE Meets Primary Endpoint of Non-Inferiority to TOBI in Phase 3 Clinical Trial in Europe and Canada to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients insmed.com ↗ |
| 2012-05-07 | Insmed Incorporated | Regulatory Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections insmed.com ↗
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections. |
| 2012-01-20 | Insmed Incorporated | Regulatory Insmed Incorporated Provides Corporate Update insmed.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease. |
| 2011-10-24 | Insmed Incorporated | Regulatory Insmed Incorporated Provides Regulatory Update on ARIKACE® in Non-Tuberculous Mycobacteria Indication insmed.com ↗
FDA is requiring that Insmed conduct a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for ARIKACE in NTM before the Company can proceed with a phase 3 clinical trial. |
| 2011-10-10 | Insmed Incorporated | Regulatory Insmed Incorporated Provides Regulatory Update insmed.com ↗ |
| 2011-08-01 | Insmed Incorporated | Regulatory Insmed Incorporated Announces Clinical Hold on ARIKACE® Phase 3 Clinical Trials insmed.com ↗
As a result of the clinical hold, the Company has suspended initiation of the ARIKACE phase 3 clinical trial programs, including the recruitment and enrollment of patients. |
| 2011-06-10 | Insmed Incorporated | Results Insmed's ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections insmed.com ↗
The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. |
| 2011-03-21 | Insmed Incorporated | Regulatory Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE™ in Nontuberculous Mycobacteria Indication insmed.com ↗
the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA). |
| 2011-03-03 | Insmed Incorporated | Regulatory Insmed Announces European Medicines Agency Acceptance of Its Pediatric Investigation Plan for ARIKACE™ in the Cystic Fibrosis Pseudomonas Indication insmed.com ↗ |
| 2008-05-19 | Nektar Therapeutics | Results Amikacin Inhale Shows Promising Results in Phase II Study nektar.com ↗
Bayer HealthCare together with Nektar Therapeutics (Nasdaq: NKTR), today presented positive preliminary Phase II data on their unique drug-device combination Amikacin Inhale at the American Thoracic Society (ATS) annual meeting. |
| 2007-05-21 | Nektar Therapeutics | Results Nektar Threraputics Announces Phase 2a Clinical Results Regarding the use of NKTR-061 (Inhaled Amikacin) to Treat Gram-Negative Hospital-Acquired Pneumonia Presented at the Annual American Thoracic Society International Conference nektar.com ↗ |
| 2007-05-09 | Nektar Therapeutics | Results Clinical Trial Data (Phase 2a) Regarding Inhaled Amikacin Will Be Presented at American Thoracic Society International Conference nektar.com ↗
Data will be presented and discussed at this ATS session to show a reduction in the use of IV antibiotics in mechanically ventilated patients during treatment of gram-negative pneumonia with NKTR-061. |
All press releases naming this drug 68 releases
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 95 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 ↗ |
| Known as | 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 ↗3“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) may be used interchangeably throughout this study and other...” NCT01316276 ↗1“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 NCT02277808 ↗ |
| 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 ↗5“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 ↗ “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...” 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 ↗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...” 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 ↗3“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 ↗ |