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Obinutuzumab

  • 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 Obinutuzumab does in the body

Previously untreated chronic lymphocytic leukemia

From the FDA-approved label: Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysis through (1) engagement of immune effector cells, (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis. As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines.

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 · O43472U9X8 · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 111 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.

Median Time to Progression-Free Survival (PFS), Investigator-Assessed

The study did not show it

Who was studied
NCT01287741
How many people
1418
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed

The study did not show it

Who was studied
NCT01332968
How many people
1401
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

The study did not show it

Who was studied
NCT06191744
How many people
1095
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS

The study did not show it

Who was studied
NCT03836261
How many people
984
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Number of Participants With Adverse Events (AEs)

The study did not show it

Who was studied
NCT01905943
How many people
979
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)

The study did not show it

Who was studied
NCT03075696
How many people
940
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • 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.

  • GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1, 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen.

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: “The safety and effectiveness of GAZYVA in pediatric patients have not been established.”

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · read 2026-08-30

  • On older people, the label states: “Lupus Nephritis Clinical studies of GAZYVA in patients with active LN did not include sufficient numbers of patients aged 65 years and older (1 patient) to determine whether they respond differently from younger adult patients.”

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and its mechanism of action, GAZYVA can cause fetal B-cell depletion [see Clinical Pharmacology (12.1) ] .”

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of GAZYVA in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · 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

Injection

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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, S3, S4, S6.

No source is stored against this line.

What is in the pack

Sold as injectable, injection, solution, concentrate, given by the injection, 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

Injection

Source-linked record

Where this came from

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

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.

    FDA National Drug Code directory · 50242-070 · read 2026-08-29

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

    FDA National Drug Code directory · 50242-070 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cd20-directed antibody interactions [moa] and cd20-directed cytolytic antibody [epc].

    FDA National Drug Code directory · 50242-070 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · read 2026-08-29

  • Gazyva is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg/40 mL (25 mg/mL) clear, colorless to slightly brown solution in a single-dose vial., recorded as fda label in effect 2025-12-19 in the United States.

    US prescribing information · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · 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 Obinutuzumab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

Missing populations

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

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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 Obinutuzumab 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)
O43472U9X8
RxNorm concept
1442693

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: Written into the record, not signed off.

  • 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, S3, S4, 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.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA125486, approved 20131101 to GENENTECH.

    Drugs@FDA application register · BLA125486 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125486 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20131101.

    FDA National Drug Code directory · 50242-070 · 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 (10)

On the Obinutuzumab label: indicated for what?


"GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma…": indications and usage on Obinutuzumab's label. DailyMed label · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · 2025-12-19

291 registered trials of Obinutuzumab — at which phases?


Registered studies posting no result
212 of 291

291 registered studies of Obinutuzumab: 172 phase2, 100 phase1, 44 phase3, 9 na or unstated, 2 na, 2 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

169 with a PubMed record

Show the evidence
  • phase2
    172
  • phase1
    100
  • phase3
    44
  • na or unstated
    9
  • na
    2
  • phase4
    2
8 more recorded rows
  • completed
    93
  • recruiting
    65
  • active not recruiting
    57
  • terminated
    35
  • not yet recruiting
    22
  • unknown
    11
  • withdrawn
    7
  • suspended
    1

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

42 of Obinutuzumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (5), futility/efficacy (1), accrual/recruitment (7), funding/business (14), sponsor decision unspecified (4) and other (11): Obinutuzumab's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years."; 42 of 291 registered studies

Show the evidence

Trial

  • NCT01287741
    terminated; "The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years."
  • NCT01644253
    terminated; "Business decision"
  • NCT01659099
    terminated; "experimental treatment not Superior to standard - no need to continue the follow-up"
  • NCT01889797
    terminated; "Closed due prolonged enrollment timelines"
  • NCT02225275
    terminated; "Due to slow accrual"
  • NCT02292225
    terminated; "The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib."
14 further recorded trials
  • NCT02336048
    terminated; "This study was terminated early because premedication with tocilizumab was unlikely to reduce the risk of IRR."
  • NCT02371590
    withdrawn; "Study Not Activated Due to Contract Issues"
  • NCT02391545
    terminated; "Sponsor is focusing on studies which can enable registration of duvelisib."
  • NCT02420210
    terminated; "Trials was stopped early due to lack of funding."
  • NCT02457598
    terminated; "The goal of the study was to improve tolerability while maintaining or increasing efficacy. The results of this study showed no efficacy advantage although the combinations were well tolerated."
  • NCT02495454
    terminated; "Primary objective not obtained after interim analysis"
  • NCT02611908
    withdrawn; "No participants enrolled"
  • NCT02612311
    terminated; "Strategic/Business decision"
  • NCT02624986
    terminated; "Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2."
  • NCT02670317
    terminated; "GA101-CHOP not advantage from rituximab-CHOP"
  • NCT03086395
    withdrawn; "Funding Unavailable"
  • NCT03135262
    terminated; "Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2."
  • NCT03145480
    terminated; "Investigator decision to close study"
  • NCT03153514
    terminated; "Prematurely terminated due to poor accrual"

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

Human studies of Obinutuzumab used TRU-016 20 mg/kg + Obinutuzumab — over how long?


studies of Obinutuzumab used the recorded amount. ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; also "TRU-016 20 mg/kg + Obinutuzumab", "Obinutuzumab 25 MG/ML", "Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]"

Show the evidence

human

  • NCT01644253
    TRU-016 20 mg/kg + Obinutuzumab
  • NCT03679455
    Obinutuzumab 25 MG/ML
  • NCT04787042
    Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]
  • NCT04962126
    Obinutuzumab 25 MG/1 ML Intravenous Solution

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

Obinutuzumab's half-life is 22.4 days — which schedules were studied?


22.4 days, the half-life Obinutuzumab's label states: "Distribution Volume of Distribution At steady state. , L 4.1 (20) 4.3 (21) Elimination Terminal Half-life, days 25.5 (48) 35.3 (35) Clearance, L/day 0.11 (53) 0.08 (41) LN The steady state clearance of obinutuzumab was approximately 0.13 L/day with a median elimination t 1/2 of 22.4 days." DailyMed label · df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda · 2025-12-19

Show the evidence
  • half life pharmacokinetics
    22.4 days; Distribution Volume of Distribution At steady state. , L 4.1 (20) 4.3 (21) Elimination Terminal Half-life, days 25.5 (48) 35.3 (35) Clearance, L/day 0.11 (53) 0.08 (41) LN The steady state clearance of obinutuzumab was approximately 0.13 L/day with a median elimination t 1/2 of 22.4 days.

recorded 2025-12-19 · last checked 2026-09-04

Which running trial of Obinutuzumab could settle lifespan?


NCT02475681 measures Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B, reading out 2026-09-15.

25 open trials; n 535; "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL"

Show the evidence

Trial

  • NCT02475681
    "Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL"; n 535; "Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B"; 2026-09-15
  • NCT05950997
    "A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL"; n 89; "Progression-free survival rate at 24 months"; 2026-09-30
  • NCT03737981
    "Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia"; n 465; "Progression-free Survival (PFS)"; 2026-12-29
  • NCT04722172
    "A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL"; n 55; "progression-free survival (PFS)"; 2027-02
  • NCT05861050
    "Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma"; n 50; "Progression free survival (PFS)"; 2027-02-01
  • NCT04447768
    "The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)"; n 100; "progression-free survival (PFS)"; 2027-07
14 further recorded trials
  • NCT04608318
    "Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)"; n 897; "Investigator-assessed progression-free survival (PFS)"; 2027-09
  • NCT05798156
    "Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP"; n 125; "1 year progression-free survival (PFS) rate of the first 80 patients"; 2028-02-28
  • NCT04408638
    "A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"; n 270; "Overall survival (OS), defined as the time from randomization to date of death from any cause"; 2028-03-31
  • NCT06084936
    "A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma"; n 182; "Progression-free survival (PFS)"; 2028-03-31
  • NCT05197192
    "A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL"; n 202; "Progression-free survival (PFS)"; 2028-05
  • NCT03701282
    "Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia"; n 720; "Progression-free survival"; 2028-05-07
  • NCT06656234
    "The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study"; n 200; "Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma"; 2028-09-15
  • NCT04269902
    "Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study"; n 247; "Overall survival (OS)"; 2028-10-01
  • NCT03462719
    "A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)"; n 211; "Progression Free Survival (PFS)"; 2029-04-05
  • NCT05057494
    "A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 607; "Progression-free Survival (PFS)"; 2029-04-10
  • NCT06970743
    "A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors"; n 153; "Progression-Free Survival (PFS) by IRC"; 2029-11-30
  • NCT05100862
    "A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma"; n 799; "Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)"; 2030-06
  • NCT06961500
    "Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A"; n 133; "Progression-Free Survival (PFS)"; 2030-11-01
  • NCT07599423
    "A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"; n 96; "Event-Free Survival (EFS)"; 2030-12-31

Which 32 trials of Obinutuzumab posted no result?


Posted no result
32 of 32 completed trials
Registrations
NCT00825149, NCT02586051, NCT02345863, NCT03059251, NCT02453087 and NCT01685892, and 26 more
Completion dates
oldest 2015-11; newest 2024-05-21
Show the evidence

Trial

  • NCT00825149
    2015-11
  • NCT02586051
    2018-11-26
  • NCT02345863
    2019-03-29
  • NCT03059251
    2019-03-30
  • NCT02453087
    2019-07-12
  • NCT01685892
    2019-08-23
14 further recorded trials
  • NCT02324257
    2019-09-03
  • NCT02174172
    2019-11-25
  • NCT02220842
    2020-01-21
  • NCT01671904
    2020-08-11
  • NCT03755947
    2021-02-01
  • NCT02750670
    2021-02-09
  • NCT03039114
    2021-03-30
  • NCT02915224
    2021-06-08
  • NCT02987400
    2021-10-19
  • NCT02758665
    2022-03
  • NCT02445131
    2022-03-09
  • NCT03113695
    2022-05-02
  • NCT02877550
    2022-05-04
  • NCT01582776
    2022-05-20

At the median, Obinutuzumab's trials enrolled 55 people — anything larger?


Median enrolment
55
Largest enrolment
1418
Registered trials counted
291

What do 3173 spontaneous reports say about Obinutuzumab — 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.

Obinutuzumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3173 reaction mentions were counted: infusion related reaction 535; neutropenia 524; pyrexia 416; febrile neutropenia 399. FAERS via Open Targets · CHEMBL1743048 · 2026-06-24

Show the evidence
  • infusion related reaction
    535
  • neutropenia
    524
  • pyrexia
    416
  • febrile neutropenia
    399
  • thrombocytopenia
    296
  • chills
    264
4 more recorded rows
  • covid-19
    257
  • myelosuppression
    173
  • tumour lysis syndrome
    158
  • platelet count decreased
    151

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

Which 10 reactions does Obinutuzumab's label not list?


chills, covid-19 and febrile neutropenia and 7 more reported for Obinutuzumab, absent from its label. FAERS via Open Targets · CHEMBL1743048 · 2026-06-24

2 label terms; 10 reported and unlisted; df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda

Show the evidence
  • chills
    count not stated
  • covid-19
    count not stated
  • febrile neutropenia
    count not stated
  • infusion related reaction
    count not stated
  • myelosuppression
    count not stated
  • neutropenia
    count not stated
4 more recorded rows
  • platelet count decreased
    count not stated
  • pyrexia
    count not stated
  • thrombocytopenia
    count not stated
  • tumour lysis syndrome
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1743048
CAS number
949142-50-1
RxCUI
974779
Development code
AFUTUZUMAB, GA-101, GA101, HUMAB CD20, HUMABCD20, R-7159, RG-7159, RO 5072759, RO 5072759 HUMAB<CD20>
Also called
Gazyva, Ro5072759, gpt, obi, IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL GA101 HEAVY CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL GA101 .KAPPA.-CHAIN, DIMER, IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL GA101 HEAVY CHAIN), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL GA101 .KAPPA.-CHAIN, DIMER, OBINUTUZUMAB [JAN], OBINUTUZUMAB [MART.]
Trade name
Gazyvaro
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

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

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