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Amikacin

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Amikacin does in the body

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.

From the FDA-approved label: Amikacin, an aminoglycoside, binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria.

Why people take it. 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.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 84319SGC3C · read 2026-08-29

  • Its recorded molecular formula is C22H43N5O13∙2H2SO4, weighing 781.76.

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 149 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Number of days of broad-spectrum antibiotic therapy

The study did not show it

Who was studied
NCT05568654
How many people
28580
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Incidence of a first VAP episode from randomization to day 28

The study did not show it

Who was studied
NCT03149640
How many people
850
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of Participants Surviving Through LFU Visit

The study did not show it

Who was studied
NCT01799993
How many people
725
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms

The study did not show it

Who was studied
NCT01371656
How many people
624
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of Participants With Post-biopsy Infection.

The study did not show it

Who was studied
NCT01659866
How many people
563
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Clinical response (primary endpoint).

The study did not show it

Who was studied
NCT07236944
How many people
560
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Injection

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of ARIKAYCE in pediatric patients below 18 years of age have not been established.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

  • On older people, the label states: “In the NTM clinical trials, of the total number of patients receiving ARIKAYCE, 208 (51.5%) were ≥ 65 years and 59 (14.6%) were ≥ 75 years.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no data on ARIKAYCE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of ARIKAYCE in human milk, the effects on the breastfed infant, or the effects on milk production after administration of ARIKAYCE by inhalation.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

  • On people with reduced liver function, the label states: “ARIKAYCE has not been studied in patients with hepatic impairment.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

  • On people with reduced kidney function, the label states: “ARIKAYCE has not been studied in patients with renal impairment.”

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Injection

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S3.

No source is stored against this line.

What is in the pack

Sold as injectable, suspension, liposomal, injection, injection, solution, given by the injection, inhalation, intramuscular route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Injection

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 20 products list this as an active ingredient in the United States drug directory. 20 of them contain it and nothing else.

    FDA National Drug Code directory · 67184-0570 · read 2026-08-29

  • They are sold as injection, injection, solution, powder and suspension, taken intramuscular, intravenous and respiratory (inhalation).

    FDA National Drug Code directory · 67184-0570 · read 2026-08-29

  • The regulator's established pharmacologic class for it is aminoglycoside antibacterial [epc] and aminoglycosides [cs].

    FDA National Drug Code directory · 67184-0570 · read 2026-08-29

  • 8 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 20fa61ef-11e2-4d01-82ea-b5412cefaead · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 20fa61ef-11e2-4d01-82ea-b5412cefaead · read 2026-08-29

  • ARIKAYCE is respiratory (inhalation) at 3 DOSAGE FORMS AND STRENGTHS ARIKAYCE is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL (equivalent to amikacin sulfate…, recorded as fda label in effect 2026-08-04 in the United States.

    US prescribing information · 499ab990-2b21-474f-aaba-d86388965f40 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Amikacin studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Amikacin are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 8 documents were read for this substance.

    RNAWiki source record

  • 6 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
84319SGC3C
RxNorm concept
2059184

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn in United States, 2019, for "Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) ." (openFDA drug enforcement Class I recall)

What the approval register records

  • 26 approved applications cover products containing this substance. The earliest was ANDA062311, approved 19810122 to APOTHECON.

    Drugs@FDA application register · ANDA062311 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · ANDA062311 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20091209.

    FDA National Drug Code directory · 67184-0570 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (9)

On the Amikacin label: indicated for what?

"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…": indications and usage on Amikacin's label. DailyMed label · 499ab990-2b21-474f-aaba-d86388965f40 · 2026-08-04

46 registered trials of Amikacin — at which phases?

Registered studies posting no result
35 of 46

46 registered studies of Amikacin: 15 phase2, 8 na or unstated, 6 na, 6 phase3, 6 phase4, 5 phase1, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

566 with a PubMed record

Show the evidence
  • phase2
    15
  • na or unstated
    8
  • na
    6
  • phase3
    6
  • phase4
    6
  • phase1
    5
8 more recorded rows
  • early phase1
    3
  • completed
    26
  • unknown
    8
  • recruiting
    7
  • terminated
    2
  • enrolling by invitation
    1
  • not yet recruiting
    1
  • withdrawn
    1

recorded 2026-09-01 · last checked 2026-09-04

3 of Amikacin's trials stopped: safety, accrual/recruitment?

safety (1) and accrual/recruitment (2): Amikacin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern."; 3 of 46 registered studies

Show the evidence

Trial

  • NCT01528930
    withdrawn; "Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern."
  • NCT02099240
    terminated; "Not enough patient enrollment and lack of staffing"
  • NCT03169114
    terminated; "Poor recruitment and terminated during COVID-19 pandemic"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Amikacin used Arikayce™ 140 mg — over how long?

studies of Amikacin used the recorded amount. ClinicalTrials.gov · 2026-09-01

3 recorded entries; human; also "Arikayce™ 140 mg", "280 mg Arikayce™", "LAI (Liposomal Amikacin for Inhalation) 590 mg"

Show the evidence

human

  • NCT00558844
    Arikayce™ 140 mg
  • NCT00775138
    280 mg Arikayce™
  • NCT02344004
    LAI (Liposomal Amikacin for Inhalation) 590 mg

recorded 2026-09-01 · last checked 2026-09-04

Amikacin's half-life is 5.9 to 19.5 hrs — which schedules were studied?

5.9 to 19.5 hrs, the half-life Amikacin's label states: "Elimination Following inhalation of ARIKAYCE in MAC patients, the apparent serum half-life of amikacin ranged from approximately 5.9 to 19.5 hrs." DailyMed label · 499ab990-2b21-474f-aaba-d86388965f40 · 2026-08-04

Show the evidence
  • half life pharmacokinetics
    5.9 to 19.5 hrs; Elimination Following inhalation of ARIKAYCE in MAC patients, the apparent serum half-life of amikacin ranged from approximately 5.9 to 19.5 hrs.
  • metabolism pharmacokinetics
    Metabolism Amikacin does not undergo appreciable metabolism.

recorded 2026-08-04 · last checked 2026-09-04

Which 12 trials of Amikacin posted no result?

Posted no result
12 of 12 completed trials
Registrations
NCT00000641, NCT00000796, NCT05999942, NCT01004445, NCT01867138 and NCT02365272, and 6 more
Completion dates
oldest 1994-12; newest 2023-04-01
Show the evidence

Trial

  • NCT00000641
    1994-12
  • NCT00000796
    1998-10
  • NCT05999942
    2004-06-29
  • NCT01004445
    2006-06
  • NCT01867138
    2011-01
  • NCT02365272
    2014-12
6 further recorded trials
  • NCT02897869
    2016-12
  • NCT02574130
    2018-04
  • NCT01431326
    2019-11
  • NCT03038178
    2019-12-31
  • NCT04867135
    2021-09-03
  • NCT04209192
    2023-04-01

At the median, Amikacin's trials enrolled 90 people — anything larger?

Median enrolment
90
Largest enrolment
3520
Registered trials counted
45

What do 915 spontaneous reports say about Amikacin — and not say?

These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Amikacin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 915 reaction mentions were counted: acute kidney injury 151; drug resistance 126; cough 120; deafness 104. FAERS via Open Targets · CHEMBL177 · 2026-06-24

Show the evidence
  • acute kidney injury
    151
  • drug resistance
    126
  • cough
    120
  • deafness
    104
  • drug reaction with eosinophilia and systemic symptoms
    74
  • dysphonia
    74
4 more recorded rows
  • thrombocytopenia
    74
  • ototoxicity
    68
  • tinnitus
    66
  • electrocardiogram qt prolonged
    58

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Amikacin's label not list?

acute kidney injury, cough and deafness and 7 more reported for Amikacin, absent from its label. FAERS via Open Targets · CHEMBL177 · 2026-06-24

2 label terms; 10 reported and unlisted; 499ab990-2b21-474f-aaba-d86388965f40

Show the evidence
  • acute kidney injury
    count not stated
  • cough
    count not stated
  • deafness
    count not stated
  • drug reaction with eosinophilia and systemic symptoms
    count not stated
  • drug resistance
    count not stated
  • dysphonia
    count not stated
4 more recorded rows
  • electrocardiogram qt prolonged
    count not stated
  • ototoxicity
    count not stated
  • thrombocytopenia
    count not stated
  • tinnitus
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered

Where it’s registered

Withdrawn in United States, 2019, for "Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) ." (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL177
PubChem CID
37768
CAS number
37517-28-5
RxCUI
641
InChIKey
LKCWBDHBTVXHDL-RMDFUYIESA-N
Also called
Amikacina, Amikacine, Amikacinum, Lukadin, Potentox, alis, am, arikace, bay41-6551, lai, liposomal amikacin for inhalation, AMIKACIN SULFATE
Development code
BAY 41-6551, NSC-177001, BB-K8, NSC-755846
Salt form
amikacin liposome inhalation suspension, Amikacin sulphate, Amikin in Sodium Chloride 0.9% in Plastic Container, Amikacin Sulfate in Sodium Chloride 0.9% in Plastic Container, Amikin / Amikin in Sodium Chloride 0.9% in Plastic Container / Arikayce Kit / Amikacin Sulfate in Sodium Chloride 0.9% in Plastic Container / Arikayce
Trade name
Amikin, Arikayce kit, Arikayce liposomal
Sources (7)

Sources

1 more source

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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