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Natalizumab

  • 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 Natalizumab does in the body

Used as a monthly infusion for relapsing multiple sclerosis under strict monitoring.

Immune cells cannot enter tissue from the bloodstream unless they first grip the vessel wall using a surface protein. Natalizumab is an antibody that covers one part of that protein, so the cells cannot grip and cannot cross into the brain. That stops them attacking myelin. It also stops the immune cells that keep a common dormant virus, JC virus, suppressed in the brain, and in a small fraction of people that virus reactivates and destroys white matter.

What happened in people

Relapses fell by about two thirds, and lasting disability worsened less often over two years.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

A negative virus blood test means lower risk of a rare brain infection, not zero risk.

Where it acts
Blood-brain barrier endothelium and gut vascular endothelium; the toxicity site is oligodendrocytes in central nervous system white matter
Kind of result
The kind of result is not recorded
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 · 3JB47N2Q2P · 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.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 107 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.

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.

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.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in 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 35 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
EnduranceNothing 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.
Which registered measures put each goal on this table
Endurance
maximum walking distance
Fertility and sexual health
sexual dysfunction

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.
Waiting for a reviewer
1 registered performance measure of this kind.
Not recorded
Harms were not a registered measure for this goal.

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.

Rate of clinical relapse at one year and rate of sustained disability progression on the Expanded Disability Status Scale at two years

The study showed what it set out to show

Who was studied
NCT00027300
How many people
942
Study design
Phase 3 (AFFIRM)
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Relapse rate reduced 68 per cent at one year, P < 0.001; sustained disability progression hazard ratio 0.58 (95% CI 0.43 to 0.77), P < 0.001
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. Hypersensitivity reactions occurred in 4 per cent and serious hypersensitivity in 1 per cent. The trial was not long enough or large enough to observe PML, which emerged from post-marketing exposure.

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

Form and route. Intravenous infusion, 300 mg every four weeks, in a certified centre

Interval reported. 95% CI 0

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

Rate of clinical relapse at one year and cumulative probability of 12-week sustained disability progression at two years, added to interferon beta-1a

The study showed what it set out to show

Who was studied
NCT00030966
How many people
1171
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Sustained disability progression hazard ratio 0.76 (95% CI 0.61 to 0.96), P = 0.02; annualised relapse rate 0.34 versus 0.75, P < 0.001; new or enlarging T2 lesions 0.9 versus 5.4, P < 0.001
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. Two cases of progressive multifocal leukoencephalopathy, one fatal, were diagnosed in natalizumab-treated patients in this trial. Combination with other disease-modifying therapy is no longer used.

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

Form and route. Intravenous infusion, 300 mg every four weeks, in a certified centre

Interval reported. 95% CI 0

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

PML incidence per 1000 treated patients by anti-JCV serostatus, prior immunosuppressant use and treatment duration

The study showed what it set out to show

Who was studied
Pooled post-marketing and registry PML risk stratification (Bloomgren et al.)
How many people
99571
Study design
Post-marketing epidemiology across clinical studies, spontaneous reports and a Swedish registry
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
212 cases in 99,571 patients (2.1 per 1000); seronegative 0.09 or fewer per 1000 (95% CI 0 to 0.48); highest stratum 11.1 per 1000 (95% CI 8.3 to 14.5)
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. Post-marketing case ascertainment depends on reporting, and the seronegative interval does not exclude zero. Seroconversion during treatment means a stratum assignment is provisional.

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

Form and route. Intravenous infusion, 300 mg every four weeks, in a certified centre

Interval reported. 95% CI 0 to 0

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

What we know
RNAWiki holds 3 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.3 registered measures of this kind. No reviewed result.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.2 registered measures of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.2 registered measures 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.2 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 Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  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 changes in the bodyRead 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.

  1. Start

    Natalizumab

    What a person takes: Intravenous infusion, 300 mg every four weeks, in a certified centre.

    The measurement behind this step

    One-hour intravenous infusion every four weeks with post-infusion observation, given only through registered infusion centres under the monitoring programme. Extended-interval dosing at approximately six weeks is used in some settings, based on receptor saturation and PML risk considerations.

  2. Getting in

    An intravenous infusion every four weeks

    Given as a drip in a registered infusion centre, once a month, with the patient enrolled in a monitoring programme.

    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

    Natalizumab 300 mg by intravenous infusion every four weeks. Extended-interval dosing at six weeks is used in some settings on the basis of receptor saturation data. Administration is restricted to certified infusion centres.

  3. What it acts on

    Binds alpha-4 integrin on circulating lymphocytes

    It coats a docking protein on the surface of circulating immune cells, and pulls some of it off the surface.

    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
  4. Reaching the cell

    Lymphocytes can no longer cross the blood-brain barrier

    Those cells can no longer stick to inflamed brain blood vessels, so they stop entering the brain.

    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

    Blocked alpha4beta1 cannot engage VCAM-1 on cytokine-activated brain endothelium, so firm adhesion under shear and subsequent diapedesis fail. The same blockade at alpha4beta7 and MAdCAM-1 reduces lymphocyte entry to gut mucosa.

  5. The change it makes

    Demyelination stops — and so does viral surveillance

    The immune attack on myelin stops, so relapses and new lesions fall sharply. The same block removes the immune patrol that keeps a dormant virus suppressed in brain tissue.

    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

    Reduced central nervous system lymphocyte trafficking cuts new inflammatory demyelinating lesions by 83 to 92 per cent on MRI. It also removes CD4 and CD8 surveillance of JC polyomavirus, permitting reactivation and lytic infection of oligodendrocytes in susceptible patients.

  6. What that does for a person

    Two thirds fewer relapses; PML in 2.1 per 1000, stratified more than a hundredfold

    Relapses fall by about two thirds and disability progression by 42 per cent. Two patients per thousand develop PML, but who those two are is largely predictable in advance.

    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

    Measured: 68 per cent relapse rate reduction at one year, 42 per cent reduction in sustained disability progression (HR 0.58, 95% CI 0.43 to 0.77). Measured: 212 PML cases in 99,571 patients (2.1 per 1000), ranging from under 0.09 per 1000 seronegative to 11.1 per 1000 in the highest stratum.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to 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.

  • maximum plasma concentration
  • time to maximum plasma concentration

Meaningful

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

  • maximum walking distance
  • expanded disability status scale
  • gvhd free survival rate
  • confirmed disease progression in edss 2 5 at baseline
  • multiple sclerosis relapse free survival

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 (28)
  • american college of rheumatology 20
  • treatment emergent adverse events and serious aes
  • serious adverse events
  • dose limiting toxicities
  • objective response rate
  • adverse events
  • incidence of treatment emergent serious adverse events
  • cost effectiveness
  • treatment emergent adverse events and serious adverse events
  • part a number of adverse events
  • sexual dysfunction
  • apparent clearance
  • volume of distribution
  • elimination half life
  • experiencing serious adverse events
  • infarct volume from baseline to day 5
  • complete response
  • incidence of all serious adverse events
  • disease related impact on daily life physical
  • disease related impact on daily life psychological

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. 11 ± 4 days

    Read from the label, which states: “The mean ± SD half-life, volume of distribution, and clearance of natalizumab were 11 ± 4 days, 5.7 ± 1.9 L, and 16 ± 5 mL/hour, respectively.”

  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.

  • Patients with relapsing multiple sclerosis, generally those with inadequate response to or intolerance of other disease-modifying therapies, enrolled in the mandatory monitoring programme. Anti-JC virus antibody status is checked before and during treatment.

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 in pediatric patients with multiple sclerosis or Crohn's disease below the age of 18 years have not been established.”

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-30

  • On older people, the label states: “Clinical studies of natalizumab did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients.”

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of natalizumab products in pregnant women.”

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Natalizumab products have been detected in human milk.”

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-30

Where the result stopped carrying

  • Accelerated approval November 2004, voluntary suspension February 2005 after three PML cases, four months on the market
  • Two of the three index cases came from the combination trial, which is why combination with other disease-modifying therapy is no longer used
  • 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

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, 300 mg every four weeks, in a certified centre

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

One-hour intravenous infusion every four weeks with post-infusion observation, given only through registered infusion centres under the monitoring programme. Extended-interval dosing at approximately six weeks is used in some settings, based on receptor saturation and PML risk considerations.

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 takeRead 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

Progressive multifocal leukoencephalopathy is the defining risk: 212 confirmed cases in 99,571 patients as of February 2012, stratified from 0.09 or fewer per 1000 in anti-JCV antibody negative patients to 11.1 per 1000 in patients who are seropositive, previously immunosuppressed and 25 to 48 months into treatment. Anti-JCV antibody status is checked before and during treatment and MRI is used for surveillance. Other effects include infusion hypersensitivity reactions in about 4 per cent with serious reactions in about 1 per cent, anti-natalizumab antibodies causing loss of efficacy, hepatotoxicity, herpes infections, and immune reconstitution inflammatory syndrome after the drug is removed by plasma exchange.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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.

Natalizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 17756 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • multiple sclerosis relapse — 4723 reaction mentions
  • malaise — 2714 reaction mentions
  • urinary tract infection — 2210 reaction mentions
  • multiple sclerosis — 2067 reaction mentions
  • progressive multifocal leukoencephalopathy — 1410 reaction mentions
  • gait disturbance — 1270 reaction mentions
  • memory impairment — 944 reaction mentions
  • balance disorder — 896 reaction mentions
  • immune reconstitution inflammatory syndrome — 792 reaction mentions
  • abortion spontaneous — 730 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

Intravenous infusion, 300 mg every four weeks, in a certified centre

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

Extended-interval dosing at approximately six weeks is used in some settings, based on receptor saturation and PML risk considerations.

Source-linked record

Where this came from

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

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.

    FDA National Drug Code directory · 64406-120 · read 2026-08-29

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

    FDA National Drug Code directory · 64406-120 · read 2026-08-29

  • The regulator's established pharmacologic class for it is integrin receptor antagonist [epc] and integrin receptor antagonists [moa].

    FDA National Drug Code directory · 64406-120 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · read 2026-08-29

  • TYRUKO is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 300 mg/15 mL (20 mg/mL) colorless and clear to slightly opalescent solution in a single-dose vial for dilution prior to infusion., recorded as fda label in effect 2025-10-31 in the United States.

    US prescribing information · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · 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 Natalizumab 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

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 anti-JCV antibody negative status confers immunity — the estimate is 0.09 or fewer per 1000 with an interval to 0.48, and seroconversion occurs during treatment

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 2.1 per 1000 average describes any individual patient; the stratified estimates differ by more than a hundredfold

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 2005 cases reflected combination with interferon — the Crohn's disease case, on natalizumab alone, removed that explanation

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 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 Natalizumab 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.

Every line above can be traced to the study named beside it. Follow the link and read it.

Relapse rate down 68 per cent at one year, disability progression down 42 per cent
In plain words
In a two-year trial of 942 patients, relapses fell by about two thirds in the first year and the chance of lasting disability worsening fell from 29 per cent to 17 per cent.
What was measured
Annualised relapse rate at one year and sustained disability progression at two years, natalizumab versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
AFFIRM (NCT00027300): 942 patients with relapsing multiple sclerosis randomised 2:1 to natalizumab 300 mg or placebo by intravenous infusion every four weeks for more than two years. Natalizumab reduced the rate of clinical relapse at one year by 68 per cent (P < 0.001) and reduced the risk of sustained disability progression over two years by 42 per cent (hazard ratio 0.58, 95% CI 0.43 to 0.77, P < 0.001); cumulative probability of progression was 17 per cent against 29 per cent. New or enlarging T2 hyperintense lesions fell by 83 per cent over two years — mean 1.9 lesions against 11.0 (P < 0.001) — and gadolinium-enhancing lesions by 92 per cent at both one and two years (P < 0.001).
Source
Polman CH et al., AFFIRM Investigators. N Engl J Med 2006;354:899-910
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
Three PML cases, one of them in Crohn's disease, and the drug came off the market
In plain words
Within months of approval, three patients on natalizumab developed a rare fatal brain infection. Two had multiple sclerosis; one had Crohn's disease. The drug was suspended.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Three cases of progressive multifocal leukoencephalopathy were reported in early 2005 and published together in the New England Journal of Medicine: two in patients receiving natalizumab with interferon beta-1a in the multiple sclerosis programme, and one in a patient treated for Crohn's disease. Natalizumab was voluntarily suspended from marketing and from all clinical trials in February 2005, four months after its accelerated approval in November 2004. The third case, in Crohn's disease, is the one that established this as a property of the drug rather than of combination therapy with interferon.
Source
Kleinschmidt-DeMasters BK, Tyler KL. N Engl J Med 2005;353:369-374; Langer-Gould A et al. N Engl J Med 2005;353:375-381; Van Assche G et al. N Engl J Med 2005;353:362-368
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
It returned in 2006 — the risk unchanged, the information about it transformed
In plain words
The drug came back sixteen months later under a programme that requires prescribers, pharmacies and patients to register and be monitored. The infection risk did not go away.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Natalizumab returned to the United States market in June 2006 under a restricted distribution and monitoring programme, now operated as a risk evaluation and mitigation strategy, requiring enrolment of prescribers, infusion centres and patients, with mandatory reporting and periodic reassessment. Nothing about the molecule changed. What changed was that the drug could only be given inside a system that counts the exposures, checks for the risk factors, and images the brain when symptoms appear. This is the clearest example in this file of a withdrawal reversed by building an information system around a drug rather than by re-analysing its data — which is the opposite of what happened with tegaserod.
Source
Drugs@FDA BLA 125104 (TYSABRI, Biogen); Bloomgren G et al. N Engl J Med 2012;366:1870-1880
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
2.1 PML cases per 1000 overall — and a 120-fold spread once stratified
In plain words
By 2012 there were 212 confirmed cases among 99,571 patients treated. But the risk is not one number: it ranges from under 0.09 per 1000 to 11.1 per 1000 depending on three things known before treatment.
What was measured
PML incidence per 1000 natalizumab-treated patients, stratified by anti-JCV serostatus, prior immunosuppressant use and treatment duration
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
As of 29 February 2012 there were 212 confirmed PML cases among 99,571 natalizumab-treated patients, 2.1 per 1000. Stratifying by three factors — anti-JC virus antibody status, prior immunosuppressant use, and treatment duration of 1 to 24 versus 25 to 48 months — separates that average into groups that differ by more than a hundredfold. Anti-JCV antibody negative patients had an estimated incidence of 0.09 cases or fewer per 1000 (95% CI 0 to 0.48). Patients who were antibody positive, had prior immunosuppressant exposure, and had received 25 to 48 months of treatment had an estimated 11.1 cases per 1000 (95% CI 8.3 to 14.5). All 54 PML patients for whom a pre-diagnosis sample existed were anti-JCV antibody positive, without exception.
Source
Bloomgren G et al. N Engl J Med 2012;366:1870-1880
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
Seronegative does not mean immune, and the confidence interval says so
In plain words
A negative antibody test puts a patient in the lowest risk group, but the interval around that estimate does not reach zero, and antibody status can change.
What was measured
That an anti-JC virus antibody negative result confers immunity to natalizumab-associated PML
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The seronegative estimate is 0.09 cases or fewer per 1000 with a 95% confidence interval of 0 to 0.48. The upper bound is not zero, the test has a false-negative rate, and seroconversion occurs during treatment at a measurable annual rate, which is why the programme repeats the serology rather than testing once. A negative result is a statement about the current stratum, not a permanent exemption. Reading "anti-JCV negative" as "cannot develop PML" is the single most consequential inference error available on this drug, and the stratified table exists precisely to prevent one number from standing in for a distribution.
Source
Bloomgren G et al. N Engl J Med 2012;366:1870-1880
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
The combination trial was the one that produced two of the three first cases
In plain words
The second pivotal trial added natalizumab to an existing interferon treatment. Two of the first three brain infections came out of that trial.
What was measured
Relapse rate and disability progression with natalizumab added to interferon beta-1a versus interferon alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SENTINEL (NCT00030966) randomised 1,171 patients who had relapsed despite interferon beta-1a to continue interferon with added natalizumab 300 mg (589 patients) or placebo (582) every four weeks for up to 116 weeks. Combination therapy reduced the relative risk of sustained disability progression by 24 per cent (hazard ratio 0.76, 95% CI 0.61 to 0.96, P = 0.02), with cumulative progression at two years of 23 per cent against 29 per cent, and lowered the annualised relapse rate from 0.75 to 0.34 (P < 0.001) with 0.9 against 5.4 new or enlarging T2 lesions (P < 0.001). Two cases of progressive multifocal leukoencephalopathy, one fatal, were diagnosed in natalizumab-treated patients in this trial. That initially suggested the harm might belong to the combination rather than to natalizumab itself; the Crohn's disease case, in a patient not receiving interferon, removed that explanation. Natalizumab is not used in combination with other disease-modifying therapies today, and the reason is this trial.
Source
Rudick RA et al., SENTINEL Investigators. N Engl J Med 2006;354:911-923; Kleinschmidt-DeMasters BK, Tyler KL. N Engl J Med 2005;353:369-374
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
A biosimilar was approved in 2023 for a drug that was withdrawn in 2005
In plain words
A second manufacturer's version of natalizumab was approved in 2023, on the basis that it is the same molecule rather than by repeating the trials.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Natalizumab-sztn (Tyruko, BLA 761322, Sandoz) is listed in Drugs@FDA with prescription marketing status. A biosimilar approval is a statement that the molecule and its clinical behaviour are established well enough that similarity can substitute for a repeat efficacy programme. That a drug suspended for a fatal infection eighteen years earlier reached that point is a measure of how completely the monitoring programme converted an unmanageable risk into a quantified one. The biosimilar carries the identical PML risk and the identical programme obligations.
Source
Drugs@FDA BLA 761322 (TYRUKO, natalizumab-sztn, Sandoz Inc) — Prescription
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

Where else this substance is registered

FDA substance identifier (UNII)
3JB47N2Q2P
RxNorm concept
477484

Checks this page had to pass

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  • Not passed

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    Suppression classes recorded: S1, S5, S6.

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    Canonical metadata present

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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 BLA125104, approved 20041123 to BIOGEN IDEC.

    Drugs@FDA application register · BLA125104 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125104 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20041123.

    FDA National Drug Code directory · 64406-120 · 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.

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What is not here

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The full record, for auditing

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

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

An anti-alpha-4-integrin antibody that cut the relapse rate by 68 per cent at one year and sustained disability progression by 42 per cent over two years, withdrawn in 2005 after three PML cases and returned in 2006 under monitoring that now stratifies PML risk from under 0.09 cases per 1000 patients in the seronegative to 11.1 per 1000 in patients who are seropositive, previously immunosuppressed, and 25 to 48 months into treatment.

Recorded evidence blocks (10)

What did Natalizumab's largest trial (80327 people) and its longest (18 years) measure?


80327 people in Natalizumab's largest registered study, 18 years in its longest registered window, measuring Maximum observed concentration (Cmax) of natalizumab. ClinicalTrials.gov · 2026-09-01

27 na or unstated, 20 phase2, 17 phase4, 14 phase3, 7 phase1, 3 na; NCT06705608; 2020-12-31; no ageing endpoint recorded. Last human test completed 2025, NCT04565431.

Interpretation These counts include studies where Natalizumab 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 or unstated
    27
  • phase2
    20
  • phase4
    17
  • phase3
    14
  • phase1
    7
  • na
    3
1 more recorded row
  • Last recorded human test NCT04565431
    2025-12-15

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

From mouse to human: where has Natalizumab shown lifespan?


mouse: lifespan and human: biomarker (85): the rungs where Natalizumab has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Maximum observed concentration (Cmax) of natalizumab — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat Dog Non-human primate Human biomarker
Show the evidence
  • mouse
    lifespan
  • human NCT00559702
    biomarker; Maximum observed concentration (Cmax) of natalizumab; 85

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

14 of Natalizumab's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (2), accrual/recruitment (4), funding/business (2), sponsor decision unspecified (3) and other (3): Natalizumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"The biological effect seen with natalizumab was not sufficient to warrant further development in RA."; 14 of 85 registered studies

Show the evidence

Trial

  • NCT00083759
    terminated; "The biological effect seen with natalizumab was not sufficient to warrant further development in RA."
  • NCT00675428
    terminated; "Sponsor decision due to low enrollment and not safety concerns."
  • NCT00707512
    terminated; "Sponsor's decision."
  • NCT00801125
    withdrawn; "Study sponsor decided to withdraw the current study prior to enrollment of first participant."
  • NCT00831649
    terminated; "The biological effect seen with natalizumab was not sufficient to warrant further development in RA."
  • NCT01058005
    terminated; "Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study."
8 further recorded trials
  • NCT01416181
    terminated; "The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints."
  • NCT02142192
    terminated; "Sponsor's decision."
  • NCT02241785
    terminated; "Business Decision"
  • NCT02342704
    terminated; "Business Decision"
  • NCT03811886
    withdrawn; "No accruals"
  • NCT05265728
    terminated; "Due to sponsor decision, not for efficacy or safety reasons."
  • NCT05532163
    terminated; "Sponsor's decision"
  • NCT05701423
    terminated; "Due to low enrolment the sponsor decided to terminate the study"

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

Natalizumab's half-life is 11 ± 4 days — which schedules were studied?


11 ± 4 days, the half-life Natalizumab's label states. openfda-label · ef653c36-dd4b-4e71-9d2d-40b8fea24b67 · 2026-08-30

Show the evidence
  • half life
    11 ± 4 days; The mean ± SD half-life, volume of distribution, and clearance of natalizumab were 11 ± 4 days, 5.7 ± 1.9 L, and 16 ± 5 mL/hour, respectively.

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

Which of adverse events, american college of rheumatology 20 and apparent clearance did Natalizumab's trials measure?


adverse events, american college of rheumatology 20 and apparent clearance lead 35 outcome terms across Natalizumab's trials. ClinicalTrials.gov · 2026-09-01

Interpretation dose limiting toxicities, objective response rate, adverse events, maximum walking distance, expanded disability status scale and incidence of treatment emergent serious adverse events follow.

Show the evidence
  • american college of rheumatology 20
    1
  • treatment emergent adverse events and serious aes
    1
  • serious adverse events
    1
  • dose limiting toxicities
    1
  • objective response rate
    1
  • adverse events
    1
14 more recorded rows
  • maximum walking distance
    1
  • expanded disability status scale
    1
  • incidence of treatment emergent serious adverse events
    1
  • cost effectiveness
    1
  • treatment emergent adverse events and serious adverse events
    1
  • part a number of adverse events
    1
  • sexual dysfunction
    1
  • maximum plasma concentration
    1
  • time to maximum plasma concentration
    1
  • apparent clearance
    1
  • volume of distribution
    1
  • elimination half life
    1
  • experiencing serious adverse events
    1
  • infarct volume from baseline to day 5
    1

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

Which of Natalizumab's 7 ongoing trials reports first?


7 registered trials of Natalizumab are open; earliest completion 2026-10-31. ClinicalTrials.gov · 2026-09-01

Brain volume loss, baseline to month 36; Multiple Sclerosis (MS) Relapse-Free Survival; latest 2032-07-06

Show the evidence

Trial

  • NCT03535298
    "Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS"; n 800; "Brain volume loss, baseline to month 36"; 2027-07-30
  • NCT04047628
    "Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"; n 156; "Multiple Sclerosis (MS) Relapse-Free Survival"; 2029-10
  • NCT04106830
    "Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)"; n 1000; "The brain structural change over time between the baseline MRI and the follow-up MRIs"; 2028-12-31
  • NCT05418010
    "Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)"; n 40; "To establish whether there is efficacy superiority of Natalizumab (Tyruko®) over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR)."; 2027-10-31
  • NCT05658497
    "Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)"; n 908; "Number of Major Congenital Malformations (MCMs)"; 2032-07-06
  • NCT05688436
    "A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies"; n 1178; "Number of Major Congenital Malformations (MCMs)"; 2031-01-17
  • 1 further recorded trial NCT05925049
    "A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)"; n 400; "Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)"; 2026-10-31

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

Which running trial of Natalizumab could settle lifespan?


NCT04047628 measures Multiple Sclerosis (MS) Relapse-Free Survival, reading out 2029-10.

1 open trial; n 156; "Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"

Show the evidence
  • Trial NCT04047628
    "Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)"; n 156; "Multiple Sclerosis (MS) Relapse-Free Survival"; 2029-10

Which 37 trials of Natalizumab posted no result?


Posted no result
37 of 37 completed trials
Registrations
NCT00055536, NCT00032799, NCT00032786, NCT00097760, NCT00055367 and NCT00280956, and 31 more
Completion dates
oldest 2003-07; newest 2024-04-30
Show the evidence

Trial

  • NCT00055536
    2003-07
  • NCT00032799
    2003-09
  • NCT00032786
    2004-03
  • NCT00097760
    2004-03
  • NCT00055367
    2004-05
  • NCT00280956
    2004-09
14 further recorded trials
  • NCT00027300
    2005-01
  • NCT00078611
    2005-03
  • NCT00030966
    2005-12
  • NCT00276172
    2006-01
  • NCT00744679
    2008-12
  • NCT00937677
    2010-11
  • NCT00818038
    2011-03
  • NCT00942214
    2011-03
  • NCT00884481
    2011-06-30
  • NCT00559702
    2011-11
  • NCT01077466
    2012-01
  • NCT01070823
    2012-06
  • NCT01591551
    2013-08
  • NCT02142205
    2013-12

At the median, Natalizumab's trials enrolled 106 people — anything larger?


Median enrolment
106
Largest enrolment
80327
Registered trials counted
83

What do 17756 spontaneous reports say about Natalizumab — 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.

Natalizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 17756 reaction mentions were counted: multiple sclerosis relapse 4723; malaise 2714; urinary tract infection 2210; multiple sclerosis 2067. open-targets-adr · CHEMBL1201607 · 2026-06-24

Show the evidence
  • multiple sclerosis relapse
    4723
  • malaise
    2714
  • urinary tract infection
    2210
  • multiple sclerosis
    2067
  • progressive multifocal leukoencephalopathy
    1410
  • gait disturbance
    1270
4 more recorded rows
  • memory impairment
    944
  • balance disorder
    896
  • immune reconstitution inflammatory syndrome
    792
  • abortion spontaneous
    730

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201607
CAS number
189261-10-7
RxCUI
354770
Development code
AN100226M, ANTEGRAN
Also called
Antegren, bg00002, ntz, IMMUNOGLOBULIN G4 (HUMAN-MOUSE MONOCLONAL AN100226 4-CHAIN ANTI-HUMAN INTEGRIN 4), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL AN100226 LIGHT CHAIN, DIMER, IMMUNOGLOBULIN G4 (HUMAN-MOUSE MONOCLONAL AN100226 4-CHAIN ANTI-HUMAN INTEGRIN 4), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL AN100226 LIGHT CHAIN, DIMER, NATALIZUMAB [EMA EPAR], NATALIZUMAB [JAN], NATALIZUMAB [MART.], NATALIZUMAB [MI], NATALIZUMAB [PURPLE BOOK CDER]
Trade name
Natalizumab elan pharma, Tyruko, Tysabri
Salt form
NATALIZUMAB-SZTN
Sources (7)

Sources

1 more source

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: 7 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.