This page shows what was measured, who it was measured in, and what that does not settle.
What Idarucizumab does in the body
Infused into a vein, it mops the drug out of the bloodstream in minutes and holds it in a complex the kidneys then clear.
Dabigatran works by sitting in the pocket of thrombin, the enzyme that finishes a clot. Idarucizumab is a fragment of an antibody shaped like that same pocket, only better: it grips dabigatran roughly 350 times more tightly than thrombin can. Thrombin is left alone and clotting resumes.
Why people take it. Switching off the blood thinner dabigatran in an emergency — a serious bleed, or an operation that cannot wait
What happened in people
Median maximum reversal of dabigatran’s anticoagulant effect within 4 hours of 100% (95% CI 100 to 100) across 503 emergency patients
✎ 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 normalising the diluted thrombin time improves the outcome of the bleed — untestable in a trial design with no control arm, which the FDA label itself calls a single-cohort case series
Where it acts
Blood plasma, then the interstitial space where dabigatran is redistributing
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 97RWB5S1U6 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 110 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.
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.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
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.
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.
Maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours, by diluted thrombin time or ecarin clotting time
✓ The study showed what it set out to show
Who was studied
RE-VERSE AD (NCT02104947) — full cohort
How many people
503
Study design
Multicentre prospective open-label single-cohort case series, as described in the FDA label
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Median maximum reversal 100% (95% CI 100 to 100). No p-value is reported because there was no comparator arm
Repeated elsewhere
Unreplicated
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. 101 of 503 patients died, 19 within the first day of dosing. Thrombotic events occurred in 33 of 503. Neither figure can be attributed or exonerated, because no control group was enrolled.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or bolus, given once as two consecutive 2.5 g vials
Interval reported. 95% CI 100 to 100)
Written into the record, not signed off as a reviewed claim.
Maximum percentage reversal of dabigatran anticoagulant effect within 4 hours
✓ The study showed what it set out to show
Who was studied
RE-VERSE AD interim cohort — the accelerated approval basis
How many people
90
Study design
Prespecified interim analysis of the same single-arm cohort
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Complete normalisation of the diluted thrombin time or ecarin clotting time in 88% to 98% of patients depending on the assay
Repeated elsewhere
Unreplicated
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. Accelerated approval was granted on 90 patients with no control group and a laboratory endpoint, on 16 October 2015. Traditional approval followed on 12 April 2018 on the strength of the same trial, enlarged.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or bolus, given once as two consecutive 2.5 g vials
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Haemostatic effectiveness, all-cause mortality and thromboembolic events
✓ The study showed what it set out to show
Who was studied
Pooled real-world experience — 30 studies of idarucizumab in routine practice, to September 2022
How many people
3602
Study design
Systematic review and random-effects meta-analysis of observational studies
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Haemostatic effectiveness 77.7% (95% CI 66.7% to 87.2%); all-cause mortality 13.6% (95% CI 9.6% to 17.9%); thromboembolic events 2.0% (95% CI 0.8% to 3.4%)
Repeated elsewhere
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. Haemostatic effectiveness in practice is more than twenty percentage points below the near-universal laboratory reversal that the licence rests on. Between 2.0% and 27.3% of prescriptions across cohorts were for thrombolysis enablement, which is not a licensed indication.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or bolus, given once as two consecutive 2.5 g vials
Interval reported. 95% CI 66
Written into the record, not signed off as a reviewed claim.
Incidence of thrombotic events after specific anticoagulant reversal
✓ The study showed what it set out to show
Who was studied
Pooled thrombotic event rate across idarucizumab and andexanet alfa studies
How many people
1774
Study design
Systematic review and meta-analysis of 16 prospective and retrospective studies
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Pooled thrombotic events 5.5% (95% CI 2.0% to 10.1%) to 30-90 days; all-cause mortality 13.3% (95% CI 9.6% to 17.5%)
Repeated elsewhere
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. The authors state that causality of harm attributable to the antidotes cannot be established from these data, because none of the included studies had an untreated comparison group.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous infusion or bolus, given once as two consecutive 2.5 g vials
Interval reported. 95% CI 2
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 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 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
Idarucizumab
What a person takes: Intravenous infusion or bolus, given once as two consecutive 2.5 g vials.
The measurement behind this step
Supplied as two single-dose 50 mL vials, each containing 2.5 g. Given as two consecutive infusions of no more than five to ten minutes each, or as a bolus injection. There is no other route: it is a 48 kDa protein and would not survive the gut or reach plasma from a subcutaneous depot fast enough to matter in the situations it is used in.
Getting in
Five grams of antibody fragment, infused over about five minutes
Given as two vials into a vein, one after the other. It is a large dose by the standards of antibody drugs, because it has to outnumber every molecule of dabigatran in the body.
──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
Each vial contains 2.5 g of idarucizumab in 50 mL. The dose is stoichiometric rather than pharmacological: the Fab binds dabigatran one-to-one, so the amount required is set by the amount of drug present rather than by a receptor occupancy curve. The formulation contains 2004.20 mg of sorbitol per vial, which is why the label carries a specific warning for patients with hereditary fructose intolerance.
Its target is a drug circulating in the plasma, so the antibody fragment never needs to cross into a cell. It works entirely in the bloodstream.
╌╌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
Idarucizumab is a Fab with no Fc region. That removes neonatal Fc receptor recycling and gives it a short half-life, which is appropriate for a molecule intended to act once and leave. It also removes complement and Fc receptor engagement, so the bound complex is cleared renally rather than by immune effector mechanisms.
It grips dabigatran about 350 times harder than thrombin can
The fragment was engineered to copy the shape of the pocket in thrombin that dabigatran normally sits in, and then to hold on far more tightly. Dabigatran leaves thrombin and goes to the antidote.
╌╌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 X-ray crystal structure of dabigatran bound to the humanised Fab shows structural similarities to how thrombin recognises the drug, but a tighter network of interactions that yields an affinity roughly 350-fold greater than dabigatran’s affinity for thrombin. The Fab does not bind known thrombin substrates and shows no activity in coagulation assays or platelet aggregation on its own.
Thrombin is released and starts making fibrin again
With the blocker pulled off, thrombin returns to normal and can convert fibrinogen into the mesh that holds a clot together. The clotting tests fall back to baseline within minutes.
──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
Unbound dabigatran plasma concentration fell below the limit of quantification immediately after infusion in healthy subjects. In 14 dabigatran-exposed volunteers the thrombin time went from 127 s to 12.5 s, the ecarin clotting time from 122 s to 34.7 s, and the activated clotting time from 236 s to 116 s by the end of the infusion. Idarucizumab alone showed no procoagulant effect on endogenous thrombin potential.
The complex is cleared, and the patient is no longer anticoagulated
The antidote and the drug leave together through the kidneys. From that moment the patient has none of the protection the anticoagulant was giving them, which is its own risk.
──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
The label states plainly that reversing dabigatran exposes patients to the thrombotic risk of their underlying disease and directs that anticoagulation be resumed as soon as medically appropriate. Thirty-three of 503 patients in RE-VERSE AD had a thrombotic event, most of them not back on antithrombotic therapy at the time.
Dabigatran is not only in the blood. In some patients enough seeps back from the tissues over the next twelve to twenty-four hours to push the clotting tests up again.
──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
Redistribution of dabigatran from the peripheral compartment produced re-elevation of diluted thrombin time, ecarin clotting time, aPTT and thrombin time between 12 and 24 hours in a limited number of patients. A further 5 g dose may be considered, and the label states that the safety and effectiveness of repeat treatment have not been established.
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 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.
Given once, in an emergency department, operating theatre or intensive care unit, by the team looking after a bleeding or pre-operative patient known to be taking dabigatran.
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 have not been established in pediatric patients.”
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-30
On older people, the label states: “A total of 454 (90%) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 318 (63%) were 75 years of age and older.”
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.”
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the effects of PRAXBIND on the breastfed child or on milk production.”
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-30
Where the result stopped carrying
Coagulation parameters re-elevated between 12 and 24 hours in a limited number of patients as dabigatran redistributed from the tissues, and the label concedes that repeat dosing has not been shown to be safe or effective
Real-world haemostatic effectiveness of 77.7% sits far below the near-total laboratory reversal, which is the gap between a surrogate and an outcome made visible
Post-hoc review found 2.8% (95% CI 0.5% to 6.2%) of real-world prescriptions inappropriate for the indication given
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.
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 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 or bolus, given once as two consecutive 2.5 g vials
✎ 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. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as Monoclonal Antibody (mAb).
No source is stored against this line.
What is in the pack
5 g. Given as two consecutive infusions of no more than five to ten minutes each, or as a bolus 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.
Recorded notes on how this is sold. The rest of the recorded wording: There is no other route: it is a 48 kDa protein and would not survive the gut or reach plasma from a subcutaneous depot fast enough to matter in the situations it is used in.
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
No boxed warning. The principal risk is the one the drug is designed to create: removing anticoagulation returns the patient to the thrombotic risk of the disease that put them on dabigatran, and the label directs resumption of anticoagulation as soon as medically appropriate. Coagulation parameters can re-elevate between 12 and 24 hours from redistribution. Hypersensitivity reactions have been reported and clinical experience is described in the label as insufficient to quantify the risk. Each vial contains 2004.20 mg of sorbitol, which is a specific hazard in hereditary fructose intolerance. The commonest reported reactions in patients were constipation (7%) and nausea (5%).
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 or bolus, given once as two consecutive 2.5 g vials
✎ 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. Given as two consecutive infusions of no more than five to ten minutes each, or as a bolus 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.
Recorded notes on which forms are sold. The rest of the recorded wording: There is no other route: it is a 48 kDa protein and would not survive the gut or reach plasma from a subcutaneous depot fast enough to matter in the situations it is used in.
No source is stored against this line.
What is recorded as being sold
3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 12714-196 · read 2026-08-29
They are sold as injection and liquid, taken intravenous.
FDA National Drug Code directory · 12714-196 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, humanized monoclonal antibody fragment [epc] and humanized [cs].
FDA National Drug Code directory · 12714-196 · 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 · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · read 2026-08-29
Praxbind is intravenous at 3 DOSAGE FORMS AND STRENGTHS PRAXBIND is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution available as: Injection: 2.5 g/50 mL solution in a single-dose vial., recorded as fda label in effect 2024-01-23 in the United States.
US prescribing information · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · 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 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.
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 Idarucizumab 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 normalising the diluted thrombin time improves the outcome of the bleed — untestable in a trial design with no control arm, which the FDA label itself calls a single-cohort case series
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 101 deaths among 503 patients were all attributable to the index event and comorbidity; that attribution is the sponsor’s, made without a comparator
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 33 thrombotic events reflect the underlying disease rather than any effect of the antidote — the pooled meta-analysis says causality remains to be established
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 reversal followed by thrombolysis in acute stroke is safe because reversal is complete; that is an off-label pathway resting on the same laboratory surrogate
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 much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
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 Idarucizumab 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.
The clotting test went back to normal in essentially every patient
In plain words
Across 503 emergency patients, the median reversal of dabigatran’s effect on the clotting test within four hours was 100%, with a confidence interval of 100 to 100. As laboratory results go, that is about as clean as medicine gets.
What was measured
Maximum percentage reversal of dabigatran anticoagulant effect within 4 hours, by diluted thrombin time or ecarin clotting time
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
RE-VERSE AD was a multicentre, prospective, open-label study of a single 5 g intravenous dose in patients with uncontrolled bleeding (group A, n=301) or requiring an urgent procedure (group B, n=202). The primary endpoint was the maximum percentage reversal of dabigatran’s anticoagulant effect within 4 hours, measured by diluted thrombin time or ecarin clotting time; the median was 100% (95% CI 100 to 100). In healthy volunteers given dabigatran 220 mg twice daily, a 5 g infusion took the diluted thrombin time from 66.6 s to 32.1 s and the ecarin clotting time from 122 s to 34.7 s by the end of the infusion, with unbound dabigatran below the limit of quantification for at least 24 hours.
Written into the record, not signed off as a reviewed claim
The FDA label calls the pivotal trial a case series, because that is what it was
In plain words
RE-VERSE AD had no control group. Everyone enrolled got the drug. There is therefore no measurement anywhere of what would have happened to the same patients without it.
What was measured
That normalising the diluted thrombin time is the same thing as improving the outcome of the bleed or the operation — an inference the trial design makes untestable rather than merely untested
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Clinical Studies section of the PRAXBIND label describes RE-VERSE AD (NCT02104947) as "a single cohort case series trial". The FDA granted accelerated approval under BLA 761025 on 16 October 2015 on the basis of the interim cohort, converting to traditional approval on 12 April 2018 after the full cohort was published. A surrogate endpoint of 100% reversal in an uncontrolled cohort establishes that the antidote does what the chemistry says it does. It does not establish that giving it changes the outcome of a brain haemorrhage, because the counterfactual was never observed. No randomised trial of idarucizumab against usual care has been performed, and given that dabigatran now has an antidote and the comparator would be no antidote, none is likely.
Source
PRAXBIND (idarucizumab) FDA-approved prescribing information, section 14 Clinical Studies; Drugs@FDA BLA 761025, original approval 16 October 2015, supplement 2 approved 12 April 2018
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
One in five patients died, and the drug was not designed to stop that
In plain words
Of the 503 patients given idarucizumab, 101 died. Nineteen died within a day of the infusion. The mortality rate at 90 days was about 19% in both groups.
What was measured
Pooled all-cause mortality and haemostatic effectiveness across 30 real-world studies and 3,602 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The PRAXBIND label states that of the 503 dabigatran-treated patients across the entire study period, 101 died, 19 of them within the first day after dosing, and attributes each death either to a complication of the index event or to comorbidity. The published full-cohort analysis reports 90-day mortality of 18.8% in the bleeding group and 18.9% in the procedure group. This is a population presenting with intracranial haemorrhage or major gastrointestinal bleeding on an anticoagulant, so a high death rate is expected; the point of the audit is that the trial cannot separate deaths the drug failed to prevent from deaths it had no bearing on, because there was no comparison arm. A subsequent meta-analysis of 30 studies and 3,602 real-world patients found pooled all-cause mortality of 13.6% (95% CI 9.6% to 17.9%) and haemostatic effectiveness of 77.7% (95% CI 66.7% to 87.2%) — appreciably lower than the near-universal laboratory reversal.
Written into the record, not signed off as a reviewed claim
Clotting comes back hours later in some patients as the drug redistributes
In plain words
The antidote clears the bloodstream, but dabigatran is also sitting in the tissues. In some patients it seeps back in over the next twelve to twenty-four hours and the clotting tests drift up again.
What was measured
Reappearance of elevated aPTT and ecarin clotting time between 12 and 24 hours after a single 5 g dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports that in a limited number of patients in the clinical programme, elevated coagulation parameters — activated partial thromboplastin time or ecarin clotting time — reappeared between 12 and 24 hours after the 5 g dose, and attributes this to redistribution of dabigatran from the periphery into plasma. The stated response is that an additional 5 g dose may be considered, with the explicit caveat that the safety and effectiveness of repeat treatment have not been established. This is a mechanistic consequence of an antidote that binds a drug in one compartment while the drug is distributed across two, and it is one of the few places where the label states a limitation of its own recommendation.
Source
PRAXBIND (idarucizumab) FDA-approved prescribing information, sections 5.2 Re-elevation of Coagulation Parameters and 12.2 Pharmacodynamics
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Thrombosis after reversal: 33 events in 503 patients, cause unresolved
In plain words
Taking away someone’s anticoagulant returns them to the clotting risk it was preventing. Thirty-three of the 503 patients had a clot; eleven of those within five days. Whether the antidote contributed, or simply the loss of anticoagulation, has never been separated.
What was measured
Pooled incidence of thrombotic events to 30-90 days across 16 studies and 1,774 patients receiving a specific reversal agent
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports 33 of 503 patients with thrombotic events, 11 within 5 days of treatment and 22 at 6 days or more, and notes that most of these patients were not back on antithrombotic therapy. The full-cohort publication reports thrombotic events in 6.3% of the bleeding group and 7.4% of the procedure group at 90 days. A systematic review pooling 13 idarucizumab studies (1,384 patients) with 3 andexanet alfa studies (390 patients) found a combined thrombotic event rate of 5.5% (95% CI 2.0% to 10.1%) to 30-90 days and all-cause mortality of 13.3% (95% CI 9.6% to 17.5%), and concluded explicitly that causality of harm attributable to the antidotes remains to be established. The label’s own framing is that reversing dabigatran exposes the patient to the thrombotic risk of their underlying disease.
Written into the record, not signed off as a reviewed claim
It became a stroke drug, which is not what it was licensed for
In plain words
Idarucizumab was approved for bleeding and emergency surgery. A large share of real-world use is now something else entirely: clearing dabigatran out of the way so a stroke patient can be given a clot-busting drug.
What was measured
That reversal-then-thrombolysis is safe and effective because reversal is complete — an off-label pathway built on the same surrogate the licence was built on
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The pooled real-world analysis of 30 studies found that between 2.0% and 27.3% of idarucizumab prescriptions across cohorts were given to enable thrombolysis, an indication that appears nowhere in the label, alongside 63.1% for bleeding and 30.5% for invasive procedures. Registry-based work has since compared thrombolysis after dabigatran reversal against alternative strategies in patients with recent direct oral anticoagulant intake. The shift is a reasonable one on mechanism, and it is also a demonstration that the licensed indication stopped describing the drug’s use within a few years of approval. The same review found that 2.8% (95% CI 0.5% to 6.2%) of prescriptions were judged inappropriate on post-hoc review.
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What is not here
7 questions this page could not answer
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How close this is to real life — 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.
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The record as stored
The full record, for auditing
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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.
An antibody fragment engineered to bind dabigatran about 350 times more tightly than thrombin does, and which strips it out of the plasma so completely that the median reversal of the clotting test was 100% with a confidence interval of 100 to 100 — measured, as the FDA label itself describes it, in a single-cohort case series with no control group, in which 101 of the 503 patients died.
Recorded evidence blocks (7)
Q1
On the Idarucizumab label: indicated for what?
"PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when…": indications and usage on Idarucizumab's label. DailyMed label · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · 2024-01-23
Q2
10 registered trials of Idarucizumab — at which phases?
Idarucizumab's half-life is 47 minutes — which schedules were studied?
47 minutes, the half-life Idarucizumab's label states: "Elimination Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4%), an initial half-life of 47 minutes (gCV 11.4%), and a terminal half-life of 10.3 h (gCV 18.9%)." DailyMed label · c7400f8a-dcf4-a6df-6d07-983081b1bf34 · 2024-01-23
Show the evidence
half lifepharmacokinetics
47 minutes; Elimination Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4%), an initial half-life of 47 minutes (gCV 11.4%), and a terminal half-life of 10.3 h (gCV 18.9%).
metabolismpharmacokinetics
Metabolism Several pathways have been described that may contribute to the metabolism of antibodies.
recorded 2024-01-23 · last checked 2026-09-04
Q5
At the median, Idarucizumab's trials enrolled 32.5 people — anything larger?
Median enrolment
32.5
Largest enrolment
1402
Registered trials counted
10
Q6
What do 185 spontaneous reports say about Idarucizumab — 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.
Idarucizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 185 reaction mentions were counted: haemorrhage 36; ischaemic stroke 25; acute kidney injury 18; cerebrovascular accident 18. FAERS via Open Targets · CHEMBL3544996 · 2026-06-24
Show the evidence
haemorrhage
36
ischaemic stroke
25
acute kidney injury
18
cerebrovascular accident
18
cerebral haemorrhage
17
aphasia
16
4 more recorded rows
haemorrhagic transformation stroke
16
haemorrhage intracranial
14
gastrointestinal haemorrhage
13
cerebral infarction
12
recorded 2026-06-24 · last checked 2026-09-04
Q7
Which 10 reactions does Idarucizumab's label not list?
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
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