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Eculizumab

  • Antibody medicine
  • Given by a clinician
  • 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 Eculizumab does in the body

SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

From the FDA-approved label: Eculizumab-aagh, the active ingredient in EPYSQLI, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab products inhibit terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS. The precise mechanism by which eculizumab products exert their therapeutic effect in gMG patients is unknown, but is presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction.

Why people take it. SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

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

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · A3ULP0F556 · read 2026-08-29

Where each sentence above came from

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

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

No statement of the main limit is recorded.

The four opening statements run to 143 words.

Words this page uses

Four words worth knowing first

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

Biomarker

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

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

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

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

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

Placebo

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

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

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

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

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

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

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

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

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

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

Time to adjudicated safety or tolerability failure

The study did not show it

Who was studied
NCT07010302
How many people
540
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Iv (infusion)

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant

The study did not show it

Who was studied
NCT02145182
How many people
288
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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. Iv (infusion)

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels

The study did not show it

Who was studied
NCT02946463
How many people
272
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. Iv (infusion)

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

AUCinf

The study did not show it

Who was studied
NCT03722329
How many people
240
Study design
Phase 1
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. Iv (infusion)

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint

The study did not show it

Who was studied
NCT03955445
How many people
225
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. Iv (infusion)

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Percentage of Participants With Transfusion Avoidance (TA)

The study did not show it

Who was studied
NCT04434092
How many people
210
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. Iv (infusion)

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

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

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

Who was studied

People similar to this profile were included.

  • SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E.

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: “PNH and NMOSD Safety and effectiveness of SOLIRIS for the treatment of PNH, or NMOSD in pediatric patients have not been established. aHUS The safety and effectiveness of SOLIRIS for the treatment of aHUS have been established in pediatric patients.”

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-30

  • On older people, the label states: “Fifty-one patients 65 years of age or older (15 with PNH, 4 with aHUS, 26 with gMG, and 6 with NMOSD) were treated with SOLIRIS in clinical trials in the approved indications.”

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Limited data on outcomes of pregnancies that have occurred following SOLIRIS use in pregnant women have not identified a concern for specific adverse developmental outcomes ( see Data ).”

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk.”

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-30

Where the result stopped carrying

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

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

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

Why it might seem to do nothing

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

It was studied in different people

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

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

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

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

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

What taking it involves

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

How it is supplied

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

Iv (infusion)

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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

Quoted from a source

Where this came from

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

Suppression classes recorded: S1, S5, S6.

No source is stored against this line.

What is in the pack

Sold as injectable, injection, solution, concentrate, injection, solution, given by the iv (infusion), intravenous route.

Source-linked record

Where this came from

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

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

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

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

What can go wrong

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

Nothing found in the sources checked

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

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

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

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

Iv (infusion)

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

  • 6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.

    FDA National Drug Code directory · 68225-042 · read 2026-08-29

  • They are sold as injection, solution, injection, solution, concentrate and liquid, taken intravenous.

    FDA National Drug Code directory · 68225-042 · read 2026-08-29

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

    FDA National Drug Code directory · 68225-042 · read 2026-08-29

  • 3 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-29

  • SOLIRIS is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 300 mg/30 mL (10 mg/mL) as a clear, colorless solution in a single-dose vial., recorded as fda label in effect 2026-07-08 in the United States.

    US prescribing information · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · read 2026-08-30

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

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

What you could measure

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

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

Questions worth asking

  • Which of the trials of Eculizumab 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.

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 Eculizumab are recorded. Results from one form may not transfer to another.

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

What would answer it

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

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

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

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

What would answer it

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

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

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

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

Where else this substance is registered

FDA substance identifier (UNII)
A3ULP0F556
RxNorm concept
700384

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S5, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

  1. Withdrawn in United States, 2013, for "Presence of Particulate Matter: Failed the appearance test for the presence of visible particles." (openFDA drug enforcement Class I recall)

  2. Withdrawn in United States, 2014, for "Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition." (openFDA drug enforcement Class I recall)

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA125166, approved 20070316 to ALEXION PHARM.

    Drugs@FDA application register · BLA125166 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125166 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20070401.

    FDA National Drug Code directory · 68225-042 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

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

What is not here

9 questions this page could not answer

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

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

The record as stored

The full record, for auditing

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

Recorded evidence blocks (9)

On the Eculizumab label: indicated for what?


"SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.": indications and usage on Eculizumab's label. DailyMed label · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · 2026-07-08

104 registered trials of Eculizumab — at which phases?


Registered studies posting no result
54 of 104

104 registered studies of Eculizumab: 47 phase2, 41 phase3, 12 phase1, 9 na or unstated, 4 phase4, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

131 with a PubMed record

Show the evidence
  • phase2
    47
  • phase3
    41
  • phase1
    12
  • na or unstated
    9
  • phase4
    4
  • early phase1
    1
10 more recorded rows
  • completed
    66
  • terminated
    14
  • active not recruiting
    5
  • unknown
    5
  • withdrawn
    4
  • not yet recruiting
    3
  • recruiting
    3
  • no longer available
    2
  • approved for marketing
    1
  • available
    1

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

16 of Eculizumab's trials stopped: safety, futility/efficacy, accrual/recruitment, sponsor decision unspecified, other?


safety (1), futility/efficacy (2), accrual/recruitment (5), sponsor decision unspecified (2) and other (6): Eculizumab's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Poor enrollment"; 16 of 104 registered studies

Show the evidence

Trial

  • NCT01095887
    terminated; "Poor enrollment"
  • NCT01106027
    terminated; "Difficulty enrolling; competing industry-funded multi-center clinical trial"
  • NCT01275287
    withdrawn; "the study failed to enroll any patient and sponsor wished to stop."
  • NCT01399593
    terminated; "Did not achieve statistical significance for primary endpoint"
  • NCT01403389
    terminated; "After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy."
  • NCT01895127
    terminated; "Lack of efficacy"
10 further recorded trials
  • NCT01919346
    terminated; "Based on results from Alexion PROTECT DGF study"
  • NCT02113891
    withdrawn; "disengagement of the sponsor Alexion Pharmaceuticals"
  • NCT02614898
    terminated; "Terminated for administrative reasons before enrollment was complete."
  • NCT03468140
    withdrawn; "Unable to recruit due to COVID 19"
  • NCT04155424
    terminated; "Pediatric clinical study is not feasible."
  • NCT04702568
    terminated; "Sponsor decision"
  • NCT04725812
    terminated; "PI moved institutions"
  • NCT05116774
    terminated; "Sponsor decision"
  • NCT05131204
    terminated; "Sponsor decision not related to efficacy or safety."
  • NCT06673394
    withdrawn; "The study plan need to be modified after widely discussion with our consultation board, regarding the conscern about the efficiency may not be able to detect the expected differences. We would like to withdraw this study plan and startup a…"

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

Eculizumab's half-life is 141 h — which schedules were studied?


141 h, the half-life Eculizumab's label states: "Elimination The half life of eculizumab ranged between 141 h and 882 h." DailyMed label · ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 · 2026-07-08

Show the evidence
  • half life pharmacokinetics
    141 h; Elimination The half life of eculizumab ranged between 141 h and 882 h.

recorded 2026-07-08 · last checked 2026-09-04

Which running trial of Eculizumab could settle lifespan?


NCT07707687 measures 6-month overall survival rate after diagnosis of TA-TMA, reading out 2028-07-10.

1 open trial; n 24; "Safety and Efficacy of Eculizumab in High-risk TA-TMA"

Show the evidence
  • Trial NCT07707687
    "Safety and Efficacy of Eculizumab in High-risk TA-TMA"; n 24; "6-month overall survival rate after diagnosis of TA-TMA"; 2028-07-10

Which 24 trials of Eculizumab posted no result?


Posted no result
24 of 24 completed trials
Registrations
NCT00112983, NCT00122330, NCT00098280, NCT00122304, NCT00130000 and NCT00485576, and 18 more
Completion dates
oldest 2005-06; newest 2023-09-04
Show the evidence

Trial

  • NCT00112983
    2005-06
  • NCT00122330
    2006-01
  • NCT00098280
    2006-02
  • NCT00122304
    2006-11
  • NCT00130000
    2007-06-25
  • NCT00485576
    2008-11
14 further recorded trials
  • NCT01410916
    2012-06
  • NCT01757431
    2013-09-25
  • NCT01303952
    2015-06
  • NCT02493725
    2016-10
  • NCT02093533
    2017-12
  • NCT01756508
    2017-12-01
  • NCT02604420
    2018-03-28
  • NCT02205541
    2018-06
  • NCT02727608
    2018-06
  • NCT04463056
    2018-10-16
  • NCT03722329
    2019-04-08
  • NCT02574403
    2019-12-03
  • NCT04679103
    2020-04-20
  • NCT04060264
    2020-12-30

At the median, Eculizumab's trials enrolled 30 people — anything larger?


Median enrolment
30
Largest enrolment
540
Registered trials counted
99

What do 3738 spontaneous reports say about Eculizumab — 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.

Eculizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3738 reaction mentions were counted: fatigue 774; haemoglobin decreased 618; headache 469; haemolysis 357. FAERS via Open Targets · CHEMBL1201828 · 2026-06-24

Show the evidence
  • fatigue
    774
  • haemoglobin decreased
    618
  • headache
    469
  • haemolysis
    357
  • pyrexia
    333
  • platelet count decreased
    293
4 more recorded rows
  • blood lactate dehydrogenase increased
    279
  • abdominal pain
    254
  • nasopharyngitis
    185
  • renal impairment
    176

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

Which 10 reactions does Eculizumab's label not list?


abdominal pain, blood lactate dehydrogenase increased and fatigue and 7 more reported for Eculizumab, absent from its label. FAERS via Open Targets · CHEMBL1201828 · 2026-06-24

2 label terms; 10 reported and unlisted; ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722

Show the evidence
  • abdominal pain
    count not stated
  • blood lactate dehydrogenase increased
    count not stated
  • fatigue
    count not stated
  • haemoglobin decreased
    count not stated
  • haemolysis
    count not stated
  • headache
    count not stated
4 more recorded rows
  • nasopharyngitis
    count not stated
  • platelet count decreased
    count not stated
  • pyrexia
    count not stated
  • renal impairment
    count not stated

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

Where it is registered

Where it’s registered

Withdrawn in United States, 2013, for "Presence of Particulate Matter: Failed the appearance test for the presence of visible particles." (openFDA drug enforcement Class I recall)

Withdrawn in United States, 2014, for "Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition." (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201828
CAS number
2648435-91-8
RxCUI
591781
Development code
5G1.1, ABP-959, H5G1-1, H5G11, H5G1.1VHC+H5G1.1VLC
Also called
Alexion, Bekemv, Bkemv, Eculizumab-aagh, Eculizumab-aeeb, Eculizumab biosimilar (abp-959), Elizaria, Epysqli, h5g1.1-mab, sb12, ECULIZUMAB [EMA EPAR], ECULIZUMAB [JAN]
Trade name
Soliris, Soliris / Epysqli / Bkemv, Bekemv [EMA EPAR]
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 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.