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Ecallantide

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

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

What Ecallantide does in the body

Treatment of acute attacks of hereditary angioedema

From the FDA-approved label: Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q and inherited as an autosomal dominant trait. HAE is characterized by low levels of C1-INH activity and low levels of C4. C1-INH functions to regulate the activation of the complement and intrinsic coagulation (contact system pathway) and is a major endogenous inhibitor of plasma kallikrein. The kallikrein-kinin system is a complex proteolytic cascade involved in the initiation of both inflammatory and coagulation pathways.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 5Q6TZN2HNM · 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.

No statement of the main limit is recorded.

The four opening statements run to 105 words.

Words this page uses

Four words worth knowing first

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

Biomarker

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

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

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

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

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

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead 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 38 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.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.Only a number moved6 registered test measure.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.
MuscleNothing in the sources checkedNo registered study lists a life outcome for this goal.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.Only a number moved7 registered test measure.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.
EnergyNothing in the sources checkedNo registered study lists a life outcome for this goal.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.
StrengthNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer1 registered performance measure of this kind.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.
Fertility and sexual healthNothing in the sources checkedNo registered study lists a life outcome for this goal.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.
Healthy ageingWaiting for a reviewer1 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
Body weight
body composition; body weight; obesity; fat mass; body mass index; body fat; fat mass index
Muscle
lean body mass; skeletal muscle mass; muscle thickness; lean mass; appendicular lean mass; lean mass index; appendicular lean mass index
Energy
energy intake
Strength
muscle strength
Fertility and sexual health
testosterone change
Healthy ageing
28 day mortality

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
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
6 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

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

Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery

The study did not show it

Who was studied
NCT00816023
How many people
276
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

Cumulative Volume of Packed Red Blood Cells Transfused

The study did not show it

Who was studied
NCT00888940
How many people
243
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing

The study did not show it

Who was studied
NCT00456508
How many people
147
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose

The study did not show it

Who was studied
NCT00457015
How many people
96
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

Treatment Outcome Score at 4 Hours Post-Dose

The study did not show it

Who was studied
NCT00262080
How many people
91
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

Safety and Efficacy of Ecallantide

The study did not show it

Who was studied
NCT01343823
How many people
79
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

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

What happened in peopleRead 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.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.16 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No 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 would be like to takeRead 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.

  • plasma inflammatory markers
  • body composition
  • muscle strength
  • lean body mass
  • skeletal muscle mass
  • body weight
  • fat mass
  • bone mineral density
  • 24 hour urine volume
  • muscle thickness

and 7 more.

Meaningful

Things that change how a life goes, not only a number.

  • 28 day mortality

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 (20)
  • gut hormone secretion
  • muscle protein synthesis
  • protein synthesis
  • energy intake
  • body lean tissue mass
  • 30 s chair stand performance
  • obesity
  • resting metabolic rate
  • circulating igf 1
  • marker of bone formation
  • marker of bone resorption
  • visceral adipose tissue mass
  • total fat free mass
  • distance walked in six minutes
  • testosterone change
  • length of hospital stay
  • systemic availability of diet derived amino acids
  • malnutrition
  • body mass
  • trunk fat

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

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

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 2.0 ± 0.5 hours hours

    Read from the label, which states: “Following administration, plasma concentration declined with a mean elimination half-life of 2.0 ± 0.5 hours.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

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

Who was studied

People similar to this profile were included.

  • KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. ( 1 )

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 KALBITOR in patients less than 12 years of age have not been established.”

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-30

  • On older people, the label states: “Clinical trials of KALBITOR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary The available data from the pharmacovigilance database for KALBITOR have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ecallantide in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-30

Where the result stopped carrying

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

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

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

Why it might seem to do nothing

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

It was studied 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 takeRead from sources, not yet reviewed

What taking it involves

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

How it is supplied

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Injection

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as injectable, injection, solution, given by the injection, subcutaneous route.

Source-linked record

Where this came from

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

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

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

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

What can go wrong

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

Nothing found in the sources checked

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

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

Reports sent to a regulator

  • 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.

Ecallantide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 341 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • hereditary angioedema — 199 reaction mentions
  • anaphylactic reaction — 38 reaction mentions
  • hypersensitivity — 29 reaction mentions
  • therapeutic response decreased — 21 reaction mentions
  • pharyngeal oedema — 14 reaction mentions
  • swelling — 13 reaction mentions
  • migraine — 11 reaction mentions
  • extra dose administered — 7 reaction mentions
  • swollen tongue — 7 reaction mentions
  • infusion site urticaria — 2 reaction mentions
  • 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 unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

Injection

Source-linked record

Where this came from

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

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.

    FDA National Drug Code directory · 47783-101 · read 2026-08-29

  • They are sold as injection, solution, taken subcutaneous.

    FDA National Drug Code directory · 47783-101 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kallikrein inhibitors [moa] and plasma kallikrein inhibitor [epc].

    FDA National Drug Code directory · 47783-101 · 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 · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-29

  • Kalbitor is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS KALBITOR is a clear, colorless liquid free of preservatives., recorded as fda label in effect 2025-07-01 in the United States.

    US prescribing information · f56aec67-c662-477c-b866-bfc23e8809cf · read 2026-08-30

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

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

What you could measure

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

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

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

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

Missing populations

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

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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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.

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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 Ecallantide 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.

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No reviewed mechanism story exists for this substance.

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

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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.

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Check any of this yourself

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Where else this substance is registered

FDA substance identifier (UNII)
5Q6TZN2HNM
RxNorm concept
884698

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA125277, approved 20091201 to DYAX CORP..

    Drugs@FDA application register · BLA125277 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125277 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20100202.

    FDA National Drug Code directory · 47783-101 · read 2026-08-29

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5 questions this page could not answer

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Recorded evidence blocks (11)

What did Ecallantide's largest trial (276 people) and its longest (11 years) measure?


276 people in Ecallantide's largest registered study, 11 years in its longest registered window, measuring Change of Sarcopenia Z-Score. ClinicalTrials.gov · 2026-09-01

48 na, 7 phase2, 5 phase3, 2 na or unstated, 1 phase4; NCT02347995; 2026-08-31. Last human test completed 2025, NCT06078345.

Interpretation These counts include studies where Ecallantide 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
  • na
    48
  • phase2
    7
  • phase3
    5
  • na or unstated
    2
  • phase4
    1
  • Last recorded human test NCT06078345
    2025-08-15

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

Ecallantide was tested only in human — what did it show?


human: healthspan (62): the rungs where Ecallantide has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Change of Sarcopenia Z-Score — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human healthspan
Show the evidence
  • human NCT02857660
    healthspan; Change of Sarcopenia Z-Score; 62

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

7 of Ecallantide's trials stopped: futility/efficacy, funding/business, other?


futility/efficacy (1), funding/business (3) and other (3): Ecallantide's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Experience gained from this study is sufficient to design and facilitate the follow-on study."; 7 of 62 registered studies

Show the evidence

Trial

  • NCT00448864
    terminated; "Experience gained from this study is sufficient to design and facilitate the follow-on study."
  • NCT01343823
    terminated; "Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature."
  • NCT02078375
    terminated; "Funding ended"
  • NCT03410823
    terminated; "Due to the extended COVID-19 shutdown, the study was terminated early with a smaller sample size of 12 included in the analyses"
  • NCT03614351
    withdrawn; "lack of funding to pay for a coordinator and interventionist,"
  • NCT03867006
    terminated; "Stop funding by Regional Council of Auvergne-Rhône-Alpes, France"
  • 1 further recorded trial NCT03895853
    terminated; "At the request of the PI"

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

Human studies of Ecallantide used ecallantide 60 mg — over how long?


Human studies of Ecallantide used "ecallantide 60 mg". ClinicalTrials.gov · 2026-09-01

6 recorded entries; human; also "ecallantide 30 mg", "ecallantide 10 mg", "placebo match for 30 mg ecallantide arm"

Show the evidence

human

  • NCT01343823
    ecallantide 60 mg
  • NCT01343823
    ecallantide 30 mg
  • NCT01343823
    ecallantide 10 mg
  • NCT01343823
    placebo match for 30 mg ecallantide arm
  • NCT01343823
    placebo match for 10 mg ecallantide arm
  • NCT03384719
    35 g protein (100% milk)

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

Ecallantide's half-life is 2.0 ± 0.5 hours — which schedules were studied?


2.0 ± 0.5 hours, the half-life Ecallantide's label states. openfda-label · f56aec67-c662-477c-b866-bfc23e8809cf · 2026-08-30

Show the evidence
  • half life
    2.0 ± 0.5 hours hours; Following administration, plasma concentration declined with a mean elimination half-life of 2.0 ± 0.5 hours.

recorded 2026-08-30 · last checked 2026-09-04

Could one person measure Ecallantide's effect on gut hormone secretion?


Gut hormone secretion: measured in Ecallantide's trials.

Interpretation gut hormone secretion is the recorded endpoint.

Show the evidence

biomarkers

  • gut hormone secretion; 2026-09-01
  • plasma inflammatory markers; 2026-09-01
  • muscle protein synthesis; 2026-09-01
  • protein synthesis; 2026-09-01
  • energy intake; 2026-09-01
  • body composition; 2026-09-01
14 more recorded rows
  • biomarkers
    muscle strength; 2026-09-01
  • biomarkers
    lean body mass; 2026-09-01
  • biomarkers
    skeletal muscle mass; 2026-09-01
  • biomarkers
    body weight; 2026-09-01
  • biomarkers
    body lean tissue mass; 2026-09-01
  • biomarkers
    30 s chair stand performance; 2026-09-01
  • biomarkers
    obesity; 2026-09-01
  • biomarkers
    resting metabolic rate; 2026-09-01
  • biomarkers
    circulating igf 1; 2026-09-01
  • biomarkers
    marker of bone formation; 2026-09-01
  • biomarkers
    marker of bone resorption; 2026-09-01
  • biomarkers
    fat mass; 2026-09-01
  • biomarkers
    visceral adipose tissue mass; 2026-09-01
  • biomarkers
    total fat free mass; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 2.0 ± 0.5 hours; 2026-08-30
  • human trials at or under30
    25
  • smallest human trial
    0; NCT01253382; PHASE2/PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 24 hour urine volume, 28 day mortality and 30 s chair stand performance did Ecallantide's trials measure?


24 hour urine volume, 28 day mortality and 30 s chair stand performance lead 38 outcome terms across Ecallantide's trials. ClinicalTrials.gov · 2026-09-01

Interpretation protein synthesis, energy intake, body composition, muscle strength, lean body mass and skeletal muscle mass follow.

Show the evidence
  • gut hormone secretion
    1
  • plasma inflammatory markers
    1
  • muscle protein synthesis
    1
  • protein synthesis
    1
  • energy intake
    1
  • body composition
    1
14 more recorded rows
  • muscle strength
    1
  • lean body mass
    1
  • skeletal muscle mass
    1
  • body weight
    1
  • body lean tissue mass
    1
  • 30 s chair stand performance
    1
  • obesity
    1
  • resting metabolic rate
    1
  • circulating igf 1
    1
  • marker of bone formation
    1
  • marker of bone resorption
    1
  • fat mass
    1
  • visceral adipose tissue mass
    1
  • total fat free mass
    1

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

Which of Ecallantide's 6 ongoing trials reports first?


6 registered trials of Ecallantide are open; earliest completion 2026-03-01. ClinicalTrials.gov · 2026-09-01

Change in thigh muscle area; Postprandial muscle protein synthesis; latest 2027-12-31

Show the evidence

Trial

  • NCT02347995
    "Resistive Training Combined With Nutritional Therapy After Stroke"; n 93; "Change in thigh muscle area"; 2026-08-31
  • NCT06852547
    "The Effect of Ingesting a Novel Algae Protein Source on Rested and Exercised Muscle Protein Synthesis Rates in Older Adults."; n 15; "Postprandial muscle protein synthesis"; 2026-03-01
  • NCT07113405
    "Influence of Tea Extract on Maximal Voluntary Knee Contraction Following Downhill Jogging"; n 60; "Change in maximum knee extension force immediately after training-induced muscle damage and 24, 48, 72, and 96 hours thereafter compared to baseline."; 2026-12-30
  • NCT07526909
    "Effect of Different Meal Types Given Before Exercise on Plasma Amino Acid Levels and Metabolic Control Parameters in Classical Phenylketonuria Patients Undergoing Aerobic and Resistance Exercises"; n 10; "Change in Plasma Phenylalanine Levels"; 2026-07-15
  • NCT07709611
    "A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU"; n 250; "Branched-chain amino acid concentration"; 2027-12-31
  • NCT07772908
    "Efficacy of Protein Supplementation in Preventing Muscle Mass Loss During the Weight Loss Process."; n 76; "Change in fat-free mass relative"; 2027-02

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

Which 33 trials of Ecallantide posted no result?


Posted no result
33 of 33 completed trials
Registrations
NCT01826916, NCT00051350, NCT00621231, NCT00917878, NCT00869453 and NCT00991523, and 27 more
Completion dates
oldest 2006-01-01; newest 2024-04-20
Show the evidence

Trial

  • NCT01826916
    2006-01-01
  • NCT00051350
    2008-03
  • NCT00621231
    2008-04
  • NCT00917878
    2009-07
  • NCT00869453
    2009-12
  • NCT00991523
    2010-12
14 further recorded trials
  • NCT01317511
    2011-02
  • NCT01239277
    2011-07
  • NCT01576848
    2012-03
  • NCT01640145
    2014-10
  • NCT02327208
    2015-02
  • NCT02128698
    2015-11
  • NCT03412136
    2016-04-10
  • NCT02529124
    2016-05
  • NCT03352583
    2016-11-18
  • NCT02251301
    2017-01
  • NCT02857660
    2017-04
  • NCT02217579
    2017-08
  • NCT03462381
    2018-06-01
  • NCT02717819
    2018-06-20

At the median, Ecallantide's trials enrolled 44 people — anything larger?


Median enrolment
44
Largest enrolment
276
Registered trials counted
61

What do 341 spontaneous reports say about Ecallantide — 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.

Ecallantide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 341 reaction mentions were counted: hereditary angioedema 199; anaphylactic reaction 38; hypersensitivity 29; therapeutic response decreased 21. open-targets-adr · CHEMBL1201837 · 2026-06-24

Show the evidence
  • hereditary angioedema
    199
  • anaphylactic reaction
    38
  • hypersensitivity
    29
  • therapeutic response decreased
    21
  • pharyngeal oedema
    14
  • swelling
    13
4 more recorded rows
  • migraine
    11
  • extra dose administered
    7
  • swollen tongue
    7
  • infusion site urticaria
    2

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201837
PubChem CID
118984459
CAS number
460738-38-9
RxCUI
658708
Development code
DX-88
Also called
Ecalantida, Escallantide, Protein, (GLU(SUP 20),ALA(SUP 21),ARG(SUP 36),ALA(SUP 38),HIS(SUP 39),PRO(SUP 40),TRP(SUP 42))TISSUE FACTOR PATHWAY INHIBITOR (HUMAN)-(20 79)-PEPTIDE (MODIFIED ON REACTIVE BOND REGION KUNITZ INHIBITOR 1 DOMAIN CONTAINING FRAGMENT), ECALLANTIDE [JAN], ECALLANTIDE [MART.], ECALLANTIDE [MI], ECALLANTIDE [PURPLE BOOK CDER], ECALLANTIDE [USAN], ECALLANTIDE [VANDF], Ecallantide [WHO-DD]
Trade name
Kalbitor
Sources (8)

Sources

2 more sources
  • openfda-label f56aec67-c662-477c-b866-bfc23e8809cf ·
  • national registers US ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 8 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.