ARIKAYCE KIT (amikacin sulfate) · INSMED INC
Amikacin sulfate injection is indicated for the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, including *Pseudomonas* spp., *Escherichia coli*, and *Klebsiella-Enterobacter-Serratia* spp. It is clinically effective for bacterial septicemia (including neonatal sepsis) and serious infections of the respiratory tract, bones, joints,
How ARIKAYCE KIT Works
This medication works by binding to the ribosomes within bacteria, which prevents them from producing the proteins necessary to function. By disrupting this protein synthesis, the drug acts as a bactericidal agent that directly kills the susceptible bacteria.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-28
- Patent Cliff
- 2035
- Routes
- INHALATION
- Dosage Forms
- SUSPENSION, LIPOSOMAL
ARIKAYCE KIT Approval History
What ARIKAYCE KIT Treats
9 indicationsARIKAYCE KIT is approved for 9 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Septicemia
- Respiratory Tract Infection
- Meningitis
- Skin and Soft Tissue Infection
- Intra-Abdominal Infection
- Peritonitis
- Burn
- Post-Operative Infection
- Urinary Tract Infection
ARIKAYCE KIT Boxed Warning
RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] . WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS See full prescribing information for complete boxed warning. ARIKAYCE has been associated wi...
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] . WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS See full prescribing information for complete boxed warning. ARIKAYCE has been associated with a risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. ( 5.1 , 5.2 , 5.3 , 5.4 )
ARIKAYCE KIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARIKAYCE KIT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
INSMED INC's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT06602557 NAVAP-ECMO | NAVAP-ECMO | Ph 2 | recruiting | " 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 " |
| NCT04209192 | URO-2995-19-20-1 | Ph 2 | completed | Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB) |
| NCT01659866 results posted | STU00059558 EAM-237 | Ph 4 | completed | Antibiotic Prophylaxis for Transrectal Prostate Biopsy |
| NCT02081963 results posted | NCFB-AMK-01 | Ph 4 | completed | Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis |
| NCT02897869 | POL7080-009 | Ph 1 | completed | DDI Study to Investigate Interaction Between Amikacin and POL7080 |
| NCT02365272 | University Hospitals Leuven | Ph 4 | completed | Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department |
| NCT01528930 | 2011-10-104-001 | Ph 2 | withdrawn | Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARIKAYCE KIT FDA Label Details
Indications & Usage
FDA Label (PDF)LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options . This drug is indicated for use in a limited and s...
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some case...
ARIKAYCE KIT Patents & Exclusivity
Patents (13 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ARIKAYCE KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 13 active patents
Trial Analysis
- • 10 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment