This page shows what was measured, who it was measured in, and what that does not settle.
What Histidine does in the body
Menkes disease
From the FDA-approved label: Menkes disease is an X-linked recessive disorder caused by pathogenic variants in the copper transport ATPase encoded by ATP7A . Patients with Menkes disease have impaired absorption of copper from their diet, impaired transport of copper across the blood-brain barrier, and dysregulation of many copper-dependent enzymes. ZYCUBO is a bioavailable copper replacement therapy that is administered as a subcutaneous injection to bypass the impaired gastrointestinal absorption observed in patients with Menkes disease.
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
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 9078K3MO9U · read 2026-08-29
The supplement label database classes it as mineral, under the name Copper.
Its recorded molecular formula is C12H16CuN6O4, weighing 371.84 g/mol.
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 90 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.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What happened in people◇Read 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.
Incidence of SAEs
✗ The study did not show it
Who was studied
NCT07398508
How many people
6
Study design
Phase 1/Phase 2
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. Subcutaneous
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 1 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 unclear◇Read 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.
ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.
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: “The safety and effectiveness of ZYCUBO for the treatment of Menkes disease have been established in pediatric patients, and the information on this use is discussed throughout the labeling.”
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-30
On older people, the label states: “Clinical trials of ZYCUBO did not include patients 65 years of age and older.”
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no available data on ZYCUBO use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of copper histidinate and its metabolites in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · 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 take◇Read 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.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (10)
It was studied for a different goal
The studies measured something else entirely. 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 take◇Read 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
Given by a clinician
❝ 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
Subcutaneous
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as powder, injection, powder, lyophilized, for solution, given by the subcutaneous 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 take∅Nothing 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 unclear◇Read 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
Subcutaneous
✎ 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
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 42358-329 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, taken subcutaneous.
FDA National Drug Code directory · 42358-329 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · read 2026-08-29
3448 marketed supplement labels list this ingredient, classed as mineral and single vitamin and mineral.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Zycubo is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS For Injection: 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper) as a blue lyophilized powder or cake in a single-dose vial for reconstitution., recorded as fda label in effect 2026-01-12 in the United States.
US prescribing information · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · 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.
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)
Q1
On the Histidine label: indicated for what?
"ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients.": indications and usage on Histidine's label. DailyMed label · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · 2026-01-12
Q2
5 registered trials of Histidine — at which phases?
Histidine's half-life is 75 hours — which schedules were studied?
75 hours, the half-life Histidine's label states: "Elimination The mean (SD) serum clearance (CL/F) of copper histidinate was 10.3 (1.6) L/hr, and the mean terminal half-life was 75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult…" DailyMed label · e3aeefc2-f44d-4337-9c2e-3dba44a89e48 · 2026-01-12
tmax 0.75 hours.
Show the evidence
half lifepharmacokinetics
75 hours; Elimination The mean (SD) serum clearance (CL/F) of copper histidinate was 10.3 (1.6) L/hr, and the mean terminal half-life was 75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.
tmaxpharmacokinetics
0.75 hours; The median time to reach maximum serum concentrations of copper histidinate (T max ) was 0.75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.
metabolismpharmacokinetics
Metabolism The metabolism of copper histidinate has not been well characterized.
recorded 2026-01-12 · last checked 2026-09-04
Q4
Which running trial of Histidine could settle lifespan?
NCT04337684 measures Long Term Follow-Up on Survival, reading out 2026-08-31.
1 open trial; n 50; "Long Term Follow-up on Menkes Disease Patients"
Show the evidence
TrialNCT04337684
"Long Term Follow-up on Menkes Disease Patients"; n 50; "Long Term Follow-Up on Survival"; 2026-08-31
Q5
Which one trial of Histidine posted no result?
Posted no result
1 of 1 completed trials
Registrations
NCT04142294
Completion dates
oldest 2019-08-31
Show the evidence
TrialNCT04142294
2019-08-31
Q6
At the median, Histidine's trials enrolled 45 people — anything larger?
Median enrolment
45
Largest enrolment
60
Registered trials counted
4
Q7
What do 120 spontaneous reports say about Histidine — 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.
Histidine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 120 reaction mentions were counted: parenteral nutrition associated liver disease 50; foetal growth restriction 15; cerebral haemorrhage 12; extravasation 11. FAERS via Open Targets · CHEMBL17962 · 2026-06-24
Show the evidence
parenteral nutrition associated liver disease
50
foetal growth restriction
15
cerebral haemorrhage
12
extravasation
11
apnoea neonatal
8
feeding disorder neonatal
8
4 more recorded rows
hyperpyrexia
5
caesarean section
4
maternal exposure timing unspecified
4
anaphylactoid reaction
3
recorded 2026-06-24 · last checked 2026-09-04
Q8
Which 10 reactions does Histidine's label not list?
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
✗ 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: 5 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.