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Amikin

(Amikacin)

ApprovedSmall molecule

IInsmed Incorporated

Amikacin is an antibiotic used to treat serious bacterial infections, particularly those caused by gram-negative bacteria and some gram-positive bacteria. It's often used for infections that don't respond to other antibiotics.[2] Amikin is currently approved and in use across 21 indications[4].[1]

Amikin is one of 309 small molecule programs targeting Asphyxia Neonatorum. It is currently in Approved.

21

Indications

29

Total Trials

6

Active Trials

308

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

14

Patents

Pipeline

Status by Indication[4][1]

Indication

Asphyxia NeonatorumActive, not recruiting

Urinary Tract InfectionActive, not recruiting

Recurrent Urinary Tract InfectionsActive, not recruiting

Neonatal SepsisActive, not recruiting

Eye InfectionActive, not recruiting

Bacterial DiseaseActive, not recruiting

Ventilator-Associated PneumoniaApproved

TuberculosisApproved

Bacterial PneumoniaApproved

BronchiectasisApproved

Asphyxia NeonatorumPreclinical

Active, not recruiting

Urinary Tract InfectionPreclinical

Active, not recruiting

Recurrent Urinary Tract InfectionsPreclinical

Active, not recruiting

Neonatal SepsisPreclinical

Active, not recruiting

Eye InfectionApproved

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Ventilator-Associated PneumoniaApproved

Approved

TuberculosisApproved

Approved

Bacterial PneumoniaApproved

Approved

BronchiectasisApproved

Approved

Showing 10 of 21 indications

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Amikin

IInsmed Incorporated

Jakafi

Primaquine

Acanya

Prevacid

Avlosulfon

AAlmirall, S.A.

Virazole

CConrado Roberto Hoffmann Filho

Advil

Retrovir

BBp Consulting, Inc

Primsol

CConrado Roberto Hoffmann Filho

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Urinary Tract Infections

NCT05227937

Q1 2029

Phase 2Recruiting

Pneumonia, Bacterial

NCT06602557

Q2 2030

Phase 2/3Recruiting

Abscess

NCT04310930

Q3 2031

Phase 2Not yet recruiting

Cystic Fibrosis

NCT07485010

Clinical

Trials by Indication[1]

Pneumonia3 trials

Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

Completed·NNational Heart Institute, Egypt·N/A·NCT02728518·133 enrolled

Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Unknown status·AAssociation Pour La Promotion A Tours De La Reanimation Medicale·Phase 2/3·NCT00861315·24 enrolled

Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia

Completed·PPostgraduate Medical Institute, Lahore·Phase 4·NCT07369336·90 enrolled

Cystic Fibrosis3 trials

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

Completed·QQilu Hospital of Shandong University·Phase 4·NCT02081963·178 enrolled

Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

Unknown status·TThe Leeds Teaching Hospitals NHS Trust·N/A·NCT02489955

Abscess2 trials

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

Enrolling by invitation·VVancouver Coastal Health·Phase 1·NCT07228702·1 enrolled

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Critically Ill Patients2 trials

Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT02365272·100 enrolled

Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Unknown status·RRadboud University Medical Center··NCT04470973·40 enrolled

Elderly1 trial

Fixed-dose Amikacin for Elderly UTI

Unknown status·RRabin Medical Center·Phase 4·NCT04197739·200 enrolled

18 more indications

Sepsis1 trial

Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Completed·HHospital Italiano de Buenos Aires·Phase 3·NCT01867138·109 enrolled

Antibiotic Prophylaxis1 trial

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Completed·NNorthwestern University·Phase 4·NCT01659866·563 enrolled

Liver1 trial

A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)

Completed· Bayer logo

Bayer·Phase 2·NCT01004445·69 enrolled

Neutropenia1 trial

Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

Completed·MMurdoch Childrens Research Institute·Phase 4·NCT04948463·55 enrolled

Local1 trial

Pharmacokinetic Evaluation and Local Tolerability of Dry Powder Amikacin Via the Cyclops™

Unknown status·UUniversity Medical Center Groningen·Phase 1·NCT04249531·8 enrolled

Appendicitis1 trial

Raja Isteri Pengiran Anak Saleha Appendicitis Treatment Without Operation

Terminated·RRaja Isteri Pengiran Anak Saleha Hospital·N/A·NCT03169114·81 enrolled

Antibiotic Therapy1 trial

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Unknown status·AAzienda Sanitaria-Universitaria Integrata di Udine··NCT04132115·104 enrolled

Transurethral Resection1 trial

Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 2·NCT04209192·75 enrolled

Interaction1 trial

DDI Study to Investigate Interaction Between Amikacin and POL7080

Completed·PPolyphor Ltd.·Phase 1·NCT02897869·14 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Urinary Tract Infection1 trial

Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis

Recruiting·—·Phase 1·NCT05761405·90 enrolled

Multidrug-Resistant Tuberculosis1 trial

Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

Unknown status·—·Phase 2·NCT05555303·20 enrolled

Necrotizing Enterocolitis1 trial

the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

Unknown status·—·Phase 1·NCT06097767·50 enrolled

Hypothermia1 trial

Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia

Unknown status·UUniversity of Sarajevo·N/A·NCT04867993·80 enrolled

Ventilator-Associated Pneumonia1 trial

Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria

Completed·TThammasat University·N/A·NCT02574130·60 enrolled

Lung Disease1 trial

Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Withdrawn·SSamsung Medical Center·Phase 2·NCT01528930

Urinary Tract Infections1 trial

Single Dose Amikacin for Uncomplicated Cystitis in the Emergency Department (ED): A Feasibility Study

Recruiting·AAntonios Likourezos··NCT05227937·75 enrolled

Pneumonia, Bacterial1 trial

" Study of the Benefit of Nebulized Amikacin in the Treatment of Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-arterial Oxygenation "

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06602557·26 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

AMIKIN

NDA NDA050495

Nov 30, 1987

AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA NDA050618

Sep 28, 2018

ARIKAYCE KIT

NDA NDA207356

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Amikacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Amikin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amikacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amikacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207356). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Amikin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Insmed Incorporated company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IInsmed Incorporated

Patent Landscape[6]

Patent Cliff

Dec 5, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8632804Dec 5, 2026

8642075Dec 5, 2026

8679532Dec 5, 2026

8226975Aug 15, 2028

9566234Jan 18, 2034

9 more patents

10751355May 15, 2035

11446318May 15, 2035

12168022May 15, 2035

12168021May 15, 2035

12616708May 15, 2035

10251900May 15, 2035

12377114May 15, 2035

9895385May 15, 2035

12016873May 15, 2035

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