This page shows what was measured, who it was measured in, and what that does not settle.
What Alteplase does in the body
Emergency clot-dissolving treatment for stroke, heart attack and major pulmonary embolism
Your blood carries an inactive enzyme called plasminogen everywhere, all the time. Something has to switch it on, and the natural switch is a protein released by the lining of blood vessels. Alteplase is a copy of that switch. Crucially, it only works properly when it is sitting on fibrin, the mesh that holds a clot together, so it activates dissolution mostly at the clot rather than everywhere in the bloodstream at once. That selectivity is partial, not absolute, which is why bleeding is the main risk.
What happened in people
NINDS: global odds ratio 1.7 for a favourable outcome at three months; symptomatic ICH 6.4% versus 0.6%
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That alteplase reduces death from stroke — pooled 90-day mortality was 17.9% versus 16.5%, hazard ratio 1.11
Where it acts
The fibrin surface of an occluding thrombus within the arterial circulation
Kind of result
The kind of result is not recorded
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 mixture.
FDA substance registry · 1RXS4UE564 · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 120 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.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 32 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer3 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
30 day mortality; hospital mortality; mortality rate
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
… Waiting for a reviewer
3 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
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.
Global outcome across four disability scales at three months
✓ The study showed what it set out to show
Who was studied
NINDS rt-PA Stroke Study (1995; predates ClinicalTrials.gov registration)
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
Global odds ratio 1.7 (95% CI 1.2-2.6)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Baseline stroke severity was imbalanced between arms, which a published graphical reanalysis argued weakens the result more than the original report conveyed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion after reconstitution of a lyophilised powder
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.4 registered measures of this kind. No reviewed result.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Alteplase
What a person takes: Intravenous infusion after reconstitution of a lyophilised powder.
The measurement behind this step
Supplied as 50 mg and 100 mg lyophilised vials, reconstituted with sterile water. The 100 mg vial contains 58 million International Units of biological potency and 3.5 g of L-arginine as solubiliser. A separate 2 mg presentation, Cathflo Activase, is used to clear blocked central venous catheters.
Getting in
Given intravenously, against the clock
A bolus followed by an hour-long infusion into a vein, started as soon as a brain scan has ruled out bleeding.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Plasma half-life is under five minutes because hepatic clearance through the mannose receptor and low-density lipoprotein receptor-related protein is rapid, which is why an infusion rather than a single injection is required.
Loop-shaped regions of the molecule recognise the fibrin mesh of the clot and stick to it, concentrating the drug where the clot is.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The finger domain and kringle 2 bind lysine residues exposed on the fibrin surface. This is the same interaction exploited in manufacturing, where lysine-Sepharose is the capture resin.
Fibrin acts as a template that switches the enzyme on
On its own the enzyme is sluggish. Sitting on fibrin next to its substrate, it becomes hundreds of times more active. That is what keeps most of the effect at the clot.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Fibrin forms a ternary template that co-localises alteplase and plasminogen and raises catalytic efficiency by two to three orders of magnitude. The selectivity is relative, not absolute: circulating plasminogen is still activated, producing a systemic lytic state that is the source of extracranial bleeding.
The enzyme makes a single cut that converts the inactive precursor into plasmin, the protein-cutting enzyme that actually dissolves clots.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The serine protease domain cleaves the Arg561-Val562 bond of plasminogen, generating the two-chain active plasmin. Alpha-2-antiplasmin neutralises free plasmin within seconds in the circulation but cannot reach plasmin bound within the fibrin network, which is a second layer of localisation.
Plasmin chews through the fibrin scaffold holding the clot together, and the clot breaks up.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Plasmin hydrolyses fibrin at multiple sites, releasing D-dimer and other degradation products and destabilising the thrombus until flow is restored. It also degrades fibrinogen, factor V and factor VIII, which is the systemic coagulopathy component.
Perfusion restored, penumbra saved, and a real risk of bleeding
If the artery reopens in time, the at-risk brain tissue survives and the person has less disability. Around one in fifteen patients has a serious bleed into the brain instead.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Reperfusion of the penumbra before infarction completes is the mechanism of benefit. The mechanism of harm is bleeding into already ischaemic tissue with a disrupted blood-brain barrier: symptomatic intracranial haemorrhage 6.8% versus 1.3% and fatal intracranial haemorrhage 2.7% versus 0.4% in the pooled meta-analysis.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
30 day mortality
combined death and disability
hospital mortality
mortality rate
functional independence
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (27)
modified rankin scale 0 1
modified rankin scale 1 or return to mrs baseline
symptomatic intracranial hemorrhage
favorable clinical outcome
modified rankin scale
major bleeding
efficacy
safety
pulmonary hypertension
neurological outcome
adverse events
occurrence of symptomatic intracerebral hemorrhage
hrqol
rv to lv diameter
nt probnp
bleeding
mrs 0 1
catheter associated venous thrombosis
catheter associated bloodstream infection
right ventricle divided by left ventricular diameter
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Patients with disabling ischaemic stroke presenting within 4.5 hours of a known onset time, after haemorrhage has been excluded on imaging, and who meet a long exclusion list built around bleeding risk.
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 Activase in pediatric patients have not been established.”
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-30
On older people, the label states: “Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage.”
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of alteplase in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-30
Where the result stopped carrying
IST-3 did not meet its primary endpoint of alive and independent at six months
Earlier streptokinase stroke trials were stopped for excess harm, which is why streptokinase is not used in stroke
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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 (10)
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 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
Intravenous infusion after reconstitution of a lyophilised powder
✎ 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
Supplied as 50 mg and 100 mg lyophilised vials, reconstituted with sterile water. 5 g of L-arginine as solubiliser. A separate 2 mg presentation, Cathflo Activase, is used to clear blocked central venous catheters.
✎ 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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Bleeding is the dominant risk and is the reason for a long contraindication list: recent intracranial haemorrhage, recent intracranial or intraspinal surgery, severe uncontrolled hypertension, known bleeding diathesis, and in stroke any evidence of haemorrhage on imaging. Angioedema, particularly with concomitant ACE inhibitor use, is a labelled risk that can obstruct the airway.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Alteplase appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2518 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
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
Intravenous infusion after reconstitution of a lyophilised powder
✎ 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
5 g of L-arginine as solubiliser. A separate 2 mg presentation, Cathflo Activase, is used to clear blocked central venous catheters.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 68594-090 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, powder, powder, for solution and solution, taken intravenous.
FDA National Drug Code directory · 68594-090 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c669f77c-fa48-478b-a14b-80b20a0139c2 · read 2026-08-29
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 take◇Read 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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Alteplase 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 unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That alteplase reduces death from stroke — pooled 90-day mortality was 17.9% versus 16.5%, hazard ratio 1.11
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That benefit extends usefully beyond 4.5 hours; beyond that window the pooled odds ratio was 1.15 with a confidence interval crossing 1
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the NINDS effect size is secure; IST-3 missed its primary endpoint and a published reanalysis contested the baseline balance
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records 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 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 Alteplase 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 people◇Read 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.
Every line above can be traced to the study named beside it. Follow the link and read it.
NINDS: 30% more likely to have minimal or no disability at three months
In plain words
The trial that made this drug standard of care in stroke showed better function at three months, at the cost of a tenfold increase in dangerous brain bleeding, and with no change in the death rate.
What was measured
Global odds ratio 1.7 (95% CI 1.2-2.6) for favourable outcome; symptomatic ICH 6.4% versus 0.6%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two-part randomised, double-blind trial of intravenous t-PA within three hours of stroke onset, 291 patients in part 1 and 333 in part 2. In part 1 there was no significant difference in neurological improvement at 24 hours. In part 2 the global odds ratio for a favourable outcome at three months was 1.7 (95% CI 1.2-2.6); patients were at least 30% more likely to have minimal or no disability across four assessment scales. Symptomatic intracerebral haemorrhage within 36 hours occurred in 6.4% of t-PA patients versus 0.6% of placebo patients (p < 0.001). Mortality at three months was 17% versus 21% (p = 0.30).
Written into the record, not signed off as a reviewed claim
ECASS III extended the window to 4.5 hours, with a smaller effect
In plain words
Treating between three and four and a half hours still helped, but the margin was narrower: 52.4% versus 45.2% with little or no disability, and the confidence interval nearly touched no effect.
What was measured
Modified Rankin 0-1 at 90 days: 52.4% versus 45.2%, odds ratio 1.34 (95% CI 1.02-1.76), p = 0.04
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind trial in 821 patients treated between 3 and 4.5 hours after onset, median administration time 3 hours 59 minutes. Favourable outcome, modified Rankin 0 or 1 at 90 days, in 52.4% versus 45.2%; odds ratio 1.34 (95% CI 1.02-1.76), p = 0.04. Global outcome analysis odds ratio 1.28 (95% CI 1.00-1.65), p < 0.05. Any intracranial haemorrhage 27.0% versus 17.6% (p = 0.001), symptomatic 2.4% versus 0.2% (p = 0.008). Mortality 7.7% versus 8.4% (p = 0.68).
Written into the record, not signed off as a reviewed claim
It improves function, and it does not save lives
In plain words
Pooling 6,756 patients from nine randomised trials, alteplase increased disability-free survival by about 10 percentage points and increased fatal brain haemorrhage sevenfold. Overall death at 90 days was slightly higher, not lower.
What was measured
That a treatment which improves function in stroke also reduces death from stroke
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Prespecified individual-patient-data meta-analysis of nine completed randomised phase 3 trials. Good outcome, modified Rankin 0 or 1, with treatment within 3 hours: 32.9% versus 23.1% (odds ratio 1.75, 95% CI 1.35-2.27); 3 to 4.5 hours: 35.3% versus 30.1% (odds ratio 1.26); beyond 4.5 hours: 32.6% versus 30.6% (odds ratio 1.15, 95% CI 0.95-1.40). Symptomatic intracranial haemorrhage 6.8% versus 1.3% (odds ratio 5.55) and fatal intracranial haemorrhage within seven days 2.7% versus 0.4% (odds ratio 7.14, p < 0.0001). Mortality at 90 days was 17.9% versus 16.5%, hazard ratio 1.11 (95% CI 0.99-1.25), p = 0.07.
Written into the record, not signed off as a reviewed claim
IST-3 missed its primary endpoint and the debate never fully closed
In plain words
The largest single stroke thrombolysis trial ever run enrolled 3,035 patients, over half of them older than 80. Its primary endpoint was not met, though a secondary analysis of the same data was positive.
What was measured
Primary endpoint adjusted odds ratio 1.13 (95% CI 0.95-1.35), p = 0.181
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
International, multicentre, randomised, open-treatment trial of rt-PA within 6 hours. At six months 554 of 1,515 (37%) in the rt-PA group versus 534 of 1,520 (35%) in the control group were alive and independent, adjusted odds ratio 1.13 (95% CI 0.95-1.35), p = 0.181, a non-significant absolute increase of 14 per 1,000. A prespecified ordinal analysis of the same outcome scale was positive, common odds ratio 1.27 (95% CI 1.10-1.47, p = 0.001). Fatal or non-fatal symptomatic intracranial haemorrhage within seven days occurred in 7% versus 1%, adjusted odds ratio 6.94, an absolute excess of 58 per 1,000. Deaths within seven days were higher with rt-PA (11% versus 7%, p = 0.001), and by six months total deaths were equal. A published graphical reanalysis of the earlier NINDS data had already argued that baseline stroke severity imbalance made that trial result less secure than usually presented.
Written into the record, not signed off as a reviewed claim
In heart attack, the benefit over streptokinase was one life per hundred treated
In plain words
The 41,021-patient trial that established alteplase in myocardial infarction found 30-day mortality of 6.3% against 7.2% and 7.4% for streptokinase, alongside a small excess of bleeding strokes.
What was measured
30-day mortality 6.3% versus 7.2-7.4%; absolute benefit approximately 1 per 100 treated
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GUSTO-I randomised 41,021 patients across 1,081 hospitals in 15 countries to four thrombolytic strategies. 30-day mortality was 7.2% for streptokinase plus subcutaneous heparin, 7.4% for streptokinase plus intravenous heparin, 6.3% for accelerated t-PA plus intravenous heparin, and 7.0% for the combination. Accelerated t-PA gave a 14% relative mortality reduction versus streptokinase alone (95% CI 5.9-21.3, p = 0.001). Haemorrhagic stroke rates were 0.49%, 0.54%, 0.72% and 0.94%, a significant excess for accelerated t-PA (p = 0.03). The composite of death or disabling stroke was 6.9% versus 7.8% (p = 0.006).
Written into the record, not signed off as a reviewed claim
Tenecteplase is displacing it, on a non-inferiority result
In plain words
A pragmatic Canadian trial in 1,600 patients showed a single-push alternative works as well. Practice has moved, and the reason is workflow rather than a better outcome.
What was measured
Risk difference 2.1% (95% CI -2.6 to 6.9), non-inferiority threshold -5% met
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The AcT trial randomised 1,600 patients across 22 Canadian stroke centres to tenecteplase 0.25 mg/kg as a single bolus or alteplase 0.9 mg/kg as bolus plus 60-minute infusion. Modified Rankin 0-1 at 90-120 days occurred in 296 of 802 (36.9%) versus 266 of 765 (34.8%); unadjusted risk difference 2.1% (95% CI -2.6 to 6.9), meeting the prespecified non-inferiority threshold of -5%. Symptomatic intracerebral haemorrhage at 24 hours was 3.4% versus 3.2% and 90-day mortality 15.3% versus 15.4%. The practical advantage is that a bolus can be given before or during transfer for thrombectomy, where a 60-minute infusion cannot.
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What is not here
4 questions this page could not answer
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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.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A recombinant copy of the human enzyme that activates clot dissolution only where fibrin is present; in the trial that made it standard of care it raised the odds of minimal or no disability at three months by 70%, while increasing symptomatic intracerebral haemorrhage from 0.6% to 6.4% and leaving mortality unchanged.
Recorded evidence blocks (13)
Q1
What did Alteplase's largest trial (113035 people) and its longest (17 years) measure?
113035 people in Alteplase's largest registered study, 17 years in its longest registered window, measuring Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol. ClinicalTrials.gov · 2026-09-01
50 phase3, 31 phase2, 28 na or unstated, 23 phase4, 10 na, 7 phase1, 1 early phase1; NCT01451320; 2009-12. Last human test completed 2025, NCT07360717.
Interpretation These counts include studies where Alteplase was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
50
phase2
31
na or unstated
28
phase4
23
na
10
phase1
7
2 more recorded rows
early phase1
1
Last recorded human testNCT07360717
2025-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Alteplase shown lifespan?
Interpretation Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol — the recorded outcome words.
Show the evidence
mouse
lifespan
rat
mechanism-only
humanNCT01670474
lifespan; Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol; 142
recorded 2026-09-01 · last checked 2026-09-04
Q3
18 of Alteplase's trials stopped: safety, accrual/recruitment, funding/business, other?
safety (3), accrual/recruitment (5), funding/business (1) and other (9): Alteplase's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"difficulty in recruiting subjects"; 18 of 142 registered studies
Show the evidence
Trial
NCT00265005
terminated; "difficulty in recruiting subjects"
NCT00303420
terminated; "Unable to enrol enough people to achieve the full sample size"
NCT01464788
terminated; "The study was halted prematurely at 90 of 105 planned patients due to the beneficial results of embolectomy clinical trials."
NCT01745692
terminated; "IDMC decision - recommended on basis of results from other relevant clinical trials, there were not safety concerns"
NCT01870492
terminated; "Principle Investigator relocated to a new institution"
NCT01878136
withdrawn; "Time constraints"
12 further recorded trials
NCT02072226
terminated; "The study was terminated due to slow enrollment."
NCT02338466
withdrawn; "Departure of the principal investigator and lack of succession"
NCT02492477
terminated; "poor recruitment"
NCT02767232
withdrawn; "Did not receive NIH Funding"
NCT02893280
withdrawn; "Due to an incompatibility with the local procedures"
NCT03357133
terminated; "The number and speed of enrollment were significantly less than expected."
NCT03506009
terminated; "it is very difficult to recruit qualified patients"
NCT03594175
terminated; "Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational…"
NCT03854500
terminated; "Per protocol safety analysis 200 patients showed a significant difference in bleeding rates between the two drug groups."
NCT03988842
terminated; "COVID-19 pandemic"
NCT03997292
withdrawn; "The study has been terminated due to key change of protocol"
NCT04453371
withdrawn; "Our local committee has denied the approval request"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Alteplase used rt-PA (2mg/2mL) actilysis — over how long?
2 recorded entries; human; also "Alteplase (0.9mg/kg)"
Show the evidence
human
NCT01670474
rt-PA (2mg/2mL) actilysis
NCT05635786
Alteplase (0.9mg/kg)
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Alteplase's effect on 30 day mortality?
30 day mortality: measured in Alteplase's trials.
30 day mortality is the recorded endpoint.
Show the evidence
biomarkers
30 day mortality; 2026-09-01
modified rankin scale 0 1; 2026-09-01
modified rankin scale 1 or return to mrs baseline; 2026-09-01
symptomatic intracranial hemorrhage; 2026-09-01
favorable clinical outcome; 2026-09-01
combined death and disability; 2026-09-01
14 more recorded rows
biomarkers
hospital mortality; 2026-09-01
biomarkers
modified rankin scale; 2026-09-01
biomarkers
major bleeding; 2026-09-01
biomarkers
efficacy; 2026-09-01
biomarkers
safety; 2026-09-01
biomarkers
pulmonary hypertension; 2026-09-01
biomarkers
neurological outcome; 2026-09-01
biomarkers
adverse events; 2026-09-01
biomarkers
occurrence of symptomatic intracerebral hemorrhage; 2026-09-01
biomarkers
mortality rate; 2026-09-01
biomarkers
hrqol; 2026-09-01
biomarkers
rv to lv diameter; 2026-09-01
biomarkers
nt probnp; 2026-09-01
biomarkers
bleeding; 2026-09-01
human trials at or under30
26
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT01150266; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of 30 day mortality, adverse events and bleeding did Alteplase's trials measure?
30 day mortality, adverse events and bleeding lead 32 outcome terms across Alteplase's trials. ClinicalTrials.gov · 2026-09-01
Interpretation symptomatic intracranial hemorrhage, favorable clinical outcome, combined death and disability, hospital mortality, modified rankin scale and major bleeding follow.
Show the evidence
30 day mortality
1
modified rankin scale 0 1
1
modified rankin scale 1 or return to mrs baseline
1
symptomatic intracranial hemorrhage
1
favorable clinical outcome
1
combined death and disability
1
14 more recorded rows
hospital mortality
1
modified rankin scale
1
major bleeding
1
efficacy
1
safety
1
pulmonary hypertension
1
neurological outcome
1
adverse events
1
occurrence of symptomatic intracerebral hemorrhage
1
mortality rate
1
hrqol
1
rv to lv diameter
1
nt probnp
1
bleeding
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Alteplase's 20 ongoing trials reports first?
Right ventricle (RV) to Left ventricle (LV) ratio; Composite of (1) death from any cause or (2) hemodynamic decompensation or (3) objectively confirmed recurrent PE.; latest 2037-12-31
Show the evidence
Trial
NCT03581877
"Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE"; n 31; "Right ventricle (RV) to Left ventricle (LV) ratio"; 2025-03-19
NCT04430569
"Pulmonary Embolism International THrOmbolysis Study-3"; n 800; "Composite of (1) death from any cause or (2) hemodynamic decompensation or (3) objectively confirmed recurrent PE."; 2028-03
NCT04663750
"Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER)."; n 210; "assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the study eye."; 2028-12
NCT05540834
"Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure"; n 70; "Change in clot lysis time on viscoelastic testing from baseline and up to 72 hours"; 2026-12-01
NCT05728333
"Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke"; n 800; "Functional independence"; 2026-07-31
NCT05766124
"Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)"; n 30; "Study feasibility"; 2028-06-30
14 further recorded trials
NCT05910125
"Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke"; n 472; "The modified Rankin Scale score (mRS) 0-1"; 2027-07
NCT06184321
"Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion"; n 30; "Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events"; 2027-02-02
NCT06194968
"Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study"; n 1800; "modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90"; 2026-12-01
NCT06583889
"Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus Thrombosis(ESCORT)"; n 224; "Efficacy endpoint"; 2029-08
NCT06621121
"A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke"; n 6000; "mRS"; 2026-10-01
NCT06653946
"the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients"; n 716; "the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group"; 2024-11-01
NCT06658197
"Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke"; n 850; "mRS ≤ 2 at 90 days or no change from baseline"; 2027-06-01
NCT06663631
"Study on Hibernation-like Therapy Based on Mechanical Thrombectomy"; n 32; "The incidence and severity of all adverse events (AEs) and severe adverse events (SAEs)"; 2025-02
NCT06878066
"Thrombolysis in Factor Xa-inhibitors Trial"; n 300; "Early neurological improvement (ENI)"; 2037-12-31
NCT07003646
"Reperfusion Treatment in Acute Pulmonary Embolism"; n 220; "Composite of severe bleeding or mortality at 30 days"; 2029-05-01
NCT07111559
"Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial"; n 500; "Excellent outcome"; 2029-03-31
NCT07519889
"Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke"; n 4500; "Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment"; 2027-04-10
NCT07592520
"Flush, Lyse, Operate"; n 30; "Time to chest tube removal"; 2027-04
NCT07727395
"INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy"; n 416; "Modified Rankin Scale at day 90"; 2028-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Alteplase could settle lifespan?
NCT07003646 measures Composite of severe bleeding or mortality at 30 days, reading out 2029-05-01.
1 open trial; n 220; "Reperfusion Treatment in Acute Pulmonary Embolism"
Show the evidence
TrialNCT07003646
"Reperfusion Treatment in Acute Pulmonary Embolism"; n 220; "Composite of severe bleeding or mortality at 30 days"; 2029-05-01
Q9
Which 40 trials of Alteplase posted no result?
Posted no result
40 of 40 completed trials
Registrations
NCT00307580, NCT00148460, NCT00781378, NCT00250991, NCT01451320 and NCT00975962, and 34 more
Completion dates
oldest 2003-05; newest 2024-08-15
Show the evidence
Trial
NCT00307580
2003-05
NCT00148460
2006-02
NCT00781378
2006-02
NCT00250991
2007-07
NCT01451320
2009-12
NCT00975962
2011-03
14 further recorded trials
NCT01472926
2013-12-10
NCT02474810
2015-09
NCT02132689
2015-12
NCT01930682
2016-09-12
NCT01949948
2016-12-31
NCT07146360
2017-12-11
NCT02388061
2018-02
NCT03451903
2018-02-01
NCT01422616
2018-08
NCT01580839
2018-08-22
NCT00887328
2018-08-27
NCT01525290
2018-10
NCT03677466
2019-03-20
NCT02257294
2019-05-08
Q10
At the median, Alteplase's trials enrolled 180 people — anything larger?
Median enrolment
180
Largest enrolment
113035
Registered trials counted
142
Q11
What do 2518 spontaneous reports say about Alteplase — 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.
Alteplase appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2518 reaction mentions were counted: angioedema 486; cerebral haemorrhage 355; haemorrhage intracranial 345; haemorrhagic transformation stroke 272. open-targets-adr · CHEMBL1201593 · 2026-06-24
Show the evidence
angioedema
486
cerebral haemorrhage
355
haemorrhage intracranial
345
haemorrhagic transformation stroke
272
haemorrhage
269
chest pain
222
4 more recorded rows
hypotension
204
cerebral infarction
125
haematoma
124
ventricular extrasystoles
116
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Alteplase studied with exercise?
exercise is named in Alteplase's label sentences: "In this single-center, randomized controlled study, we selected 60 patients with acute ischemic stroke with mild non-disabling neurological deficit admitted to our hospital from January 2021 to January 2022, and randomly divided them into the study group (n = 30) and the control group (n = 30), the…" openfda-label+europepmc · 2024-05-01
1 recorded statement; exercise
Show the evidence
exercise
In this single-center, randomized controlled study, we selected 60 patients with acute ischemic stroke with mild non-disabling neurological deficit admitted to our hospital from January 2021 to January 2022, and randomly divided them into the study group (n = 30) and the control group (n = 30), the control group was given the Aspirin treatment, the study group was given the Alteplase treatment,…
recorded 2024-05-01 · last checked 2026-09-04
Q13
What is recorded about Alteplase and mTOR?
"The patients taking ACE inhibitors and mTOR inhibitors, DPP4 inhibitors, alteplase, or sacubitril/valsartan concurrently may be at increased risk of developing angioedema." — where Alteplase and mTOR appear together. Europe PMC · pathway abstract search · 2022-01-01
mTOR; PMID 35546745
Show the evidence
mTORPMID 35546745
"The patients taking ACE inhibitors and mTOR inhibitors, DPP4 inhibitors, alteplase, or sacubitril/valsartan concurrently may be at increased risk of developing angioedema."
recorded 2022-01-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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