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Venetoclax

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

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

What Venetoclax does in the body

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma

From the FDA-approved label: Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL and AML cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.

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 chemical.

    FDA substance registry · N54AIC43PW · read 2026-08-29

  • Its recorded molecular formula is C45H50ClN7O7S, weighing 868.44.

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

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 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.

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.

Overall survival

The study did not show it

Who was studied
NCT02416388
How many people
3100
Study design
Phase 2/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. Oral

Interval reported. Not recorded in this summary

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

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

Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment

The study did not show it

Who was studied
NCT03013998
How many people
3000
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. Oral

Interval reported. Not recorded in this summary

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

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

Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

The study did not show it

Who was studied
NCT05564390
How many people
2000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

To investigate if Group B[2*(14-day blinatumomab + HDMTX*2)] can result in noninferior event-free survival (EFS) compared to Group A [28-day blinatumomab + HDMTX*4

The study did not show it

Who was studied
NCT06764238
How many people
1800
Study design
Phase 2/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. Oral

Interval reported. Not recorded in this summary

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

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

Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)

The study did not show it

Who was studied
NCT07007312
How many people
1300
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. Oral

Interval reported. Not recorded in this summary

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

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

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)

The study did not show it

Who was studied
NCT03768063
How many people
1000
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. Oral

Interval reported. Not recorded in this summary

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

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

What 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.

  • VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

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 VENCLEXTA have not been established in pediatric patients.”

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

  • On older people, the label states: “Clinical studies of VENCLEXTA in patients with AML did not include sufficient numbers of younger adults to determine if patients 65 years of age and older respond differently from younger adults.”

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman.”

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

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

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.”

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Due to the increased risk of TLS, patients with reduced renal function (CLcr <80 mL/min, calculated by Cockcroft-Gault formula) require more intensive prophylaxis and monitoring to reduce the risk of TLS when initiating treatment with VENCLEXTA [see Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) and Warnings and Precautions ( 5.1 )] .”

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · 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

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

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.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, given by the oral 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

Oral

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

  • 15 products list this as an active ingredient in the United States drug directory. 15 of them contain it and nothing else.

    FDA National Drug Code directory · 68513-0561 · read 2026-08-29

  • They are sold as powder, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 68513-0561 · read 2026-08-29

  • The regulator's established pharmacologic class for it is bcl-2 inhibitor [epc], increased cellular death [pe] and p-glycoprotein inhibitors [moa].

    FDA National Drug Code directory · 68513-0561 · 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 · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · read 2026-08-29

  • Venclexta is oral at 3 DOSAGE FORMS AND STRENGTHS Table 9., recorded as fda label in effect 2026-05-20 in the United States.

    US prescribing information · b118a40d-6b56-cee3-10f6-ded821a97018 · 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 Venetoclax 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.

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)
N54AIC43PW
RxNorm concept
1747561

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.

  • 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

  • 2 approved applications cover products containing this substance. The earliest was NDA208573, approved 20160411 to ABBVIE.

    Drugs@FDA application register · NDA208573 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA208573 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20160321.

    FDA National Drug Code directory · 68513-0561 · 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 (11)

On the Venetoclax label: indicated for what?


"VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years…": indications and usage on Venetoclax's label. DailyMed label · b118a40d-6b56-cee3-10f6-ded821a97018 · 2026-05-20

608 registered trials of Venetoclax — at which phases?


Registered studies posting no result
524 of 608

608 registered studies of Venetoclax: 349 phase2, 265 phase1, 72 phase3, 23 na, 15 na or unstated, 6 phase4, 5 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

329 with a PubMed record

Show the evidence
  • phase2
    349
  • phase1
    265
  • phase3
    72
  • na
    23
  • na or unstated
    15
  • phase4
    6
12 more recorded rows
  • early phase1
    5
  • recruiting
    209
  • active not recruiting
    116
  • completed
    109
  • terminated
    70
  • not yet recruiting
    38
  • unknown
    29
  • withdrawn
    27
  • suspended
    6
  • no longer available
    2
  • available
    1
  • enrolling by invitation
    1

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

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


safety (8), futility/efficacy (10), accrual/recruitment (14), funding/business (30), sponsor decision unspecified (6) and other (35): Venetoclax's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"\<75% participants"; 103 of 608 registered studies

Show the evidence

Trial

  • NCT02392572
    terminated; "\<75% participants"
  • NCT02640833
    withdrawn; "Study Stopped"
  • NCT02951117
    withdrawn; "No participants enrolled"
  • NCT03000660
    terminated; "partial clinical hold per FDA"
  • NCT03135262
    terminated; "Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2."
  • NCT03136497
    terminated; "Lack of enrollment"
14 further recorded trials
  • NCT03217838
    terminated; "strategic decision"
  • NCT03343678
    withdrawn; "Company strategic decision"
  • NCT03379051
    terminated; "Strategic/Business Decision"
  • NCT03404193
    terminated; "\<75% participation"
  • NCT03484520
    terminated; "Strategic considerations"
  • NCT03492125
    terminated; "The study is terminated due to major protocol revisions. A new study in CLL patients is planned."
  • NCT03530683
    terminated; "A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational…"
  • NCT03547115
    terminated; "Business reasons, not related to safety or efficacy results."
  • NCT03552692
    terminated; "efficacy lower than expected"
  • NCT03567616
    terminated; "Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study."
  • NCT03576547
    terminated; "The study was terminated early due to slow accrual and low level of interest both by the sponsor and by the department"
  • NCT03584009
    terminated; "Sponsor's decision, no safety concerns."
  • NCT03634228
    terminated; "This study was terminated early due to lack of adequate response, and did not move to the Phase II portion of the study"
  • NCT03701321
    withdrawn; "Drug supply issues"

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

Human studies of Venetoclax used Venetoclax 50 MG — over how long?


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

6 recorded entries; human; also "Venetoclax 50 MG", "Venetoclax 100 MG", "Venetoclax 200 MG"

Show the evidence

human

  • NCT04543916
    Venetoclax 50 MG
  • NCT04543916
    Venetoclax 100 MG
  • NCT04543916
    Venetoclax 200 MG
  • NCT05451771
    Venetoclax Oral Tablet, 200 mg
  • NCT05451771
    Venetoclax Oral Tablet, 400 mg
  • NCT05941585
    Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)

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

Venetoclax's half-life is 26 hours — which schedules were studied?


26 hours, the half-life Venetoclax's label states: "Elimination The terminal elimination half-life of venetoclax was approximately 26 hours." DailyMed label · b118a40d-6b56-cee3-10f6-ded821a97018 · 2026-05-20

Show the evidence
  • half life pharmacokinetics
    26 hours; Elimination The terminal elimination half-life of venetoclax was approximately 26 hours.
  • metabolism pharmacokinetics
    Metabolism Venetoclax is predominantly metabolized by CYP3A in vitro.

recorded 2026-05-20 · last checked 2026-09-04

Which running trial of Venetoclax could settle lifespan?


NCT02993523 measures Overall Survival (OS), reading out 2026-06-15.

61 open trials; n 443; "A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy"

Show the evidence

Trial

  • NCT02993523
    "A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy"; n 443; "Overall Survival (OS)"; 2026-06-15
  • 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
  • NCT04128501
    "Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting"; n 100; "Relapse-free survival (RFS) time"; 2026-12-31
  • NCT04216524
    "Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm"; n 40; "Progression free survival (PFS)"; 2026-12-31
  • 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
  • NCT05388006
    "Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 27; "Progression free survival"; 2027-02-22
14 further recorded trials
  • NCT06384261
    "A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy"; n 140; "Overall survival"; 2027-06
  • NCT04401748
    "Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome"; n 531; "Overall survival (OS)"; 2027-07
  • NCT04447768
    "The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)"; n 100; "progression-free survival (PFS)"; 2027-07
  • NCT07187505
    "Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia"; n 28; "Early Mortality (Day 0-30)"; 2027-07-01
  • NCT06554626
    "Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL"; n 20; "Event free survival(EFS)"; 2027-08-01
  • 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
  • NCT04965493
    "A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)"; n 600; "To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)"; 2027-10
  • NCT02250937
    "Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome"; n 116; "Progression free survival"; 2027-10-31
  • NCT03336333
    "A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL"; n 590; "Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)"; 2027-10-31
  • NCT03539744
    "A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma."; n 265; "Progression-Free Survival (PFS)"; 2027-11
  • NCT04708054
    "Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS"; n 324; "1-year progression free survival (PFS)"; 2027-12-31
  • NCT05365035
    "A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts"; n 60; "To establish the overall survival (OS)."; 2027-12-31
  • NCT06621199
    "Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML"; n 42; "2-year event-free survival (EFS) rate"; 2027-12-31
  • NCT07392242
    "A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia"; n 45; "Event free survival"; 2028-01

Which 47 trials of Venetoclax posted no result?


Posted no result
47 of 47 completed trials
Registrations
NCT03255096, NCT02391480, NCT01685892, NCT01671904, NCT01742988 and NCT03181126, and 41 more
Completion dates
oldest 2019-07-03; newest 2024-09-01
Show the evidence

Trial

  • NCT03255096
    2019-07-03
  • NCT02391480
    2019-07-05
  • NCT01685892
    2019-08-23
  • NCT01671904
    2020-08-11
  • NCT01742988
    2020-10-09
  • NCT03181126
    2020-11-14
14 further recorded trials
  • NCT02670044
    2020-12-10
  • NCT03441555
    2021-01-25
  • NCT03755947
    2021-02-01
  • NCT02265731
    2021-03-12
  • NCT04509622
    2021-04-15
  • NCT02419560
    2021-05
  • NCT03357627
    2021-08-03
  • NCT03625505
    2021-08-31
  • NCT02987400
    2021-10-19
  • NCT03036904
    2021-11-11
  • NCT03082209
    2022-01-21
  • NCT02758665
    2022-03
  • NCT03000257
    2022-03-29
  • NCT02877550
    2022-05-04

At the median, Venetoclax's trials enrolled 50 people — anything larger?


Median enrolment
50
Largest enrolment
3100
Registered trials counted
605

What do 3398 spontaneous reports say about Venetoclax — 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.

Venetoclax appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3398 reaction mentions were counted: febrile neutropenia 660; neutropenia 618; pneumonia 375; thrombocytopenia 357. FAERS via Open Targets · CHEMBL3137309 · 2026-06-24

Show the evidence
  • febrile neutropenia
    660
  • neutropenia
    618
  • pneumonia
    375
  • thrombocytopenia
    357
  • tumour lysis syndrome
    284
  • pancytopenia
    249
4 more recorded rows
  • platelet count decreased
    234
  • disease progression
    214
  • infection
    205
  • sepsis
    202

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

Which 10 reactions does Venetoclax's label not list?


disease progression, febrile neutropenia and infection and 7 more reported for Venetoclax, absent from its label. FAERS via Open Targets · CHEMBL3137309 · 2026-06-24

2 label terms; 10 reported and unlisted; b118a40d-6b56-cee3-10f6-ded821a97018

Show the evidence
  • disease progression
    count not stated
  • febrile neutropenia
    count not stated
  • infection
    count not stated
  • neutropenia
    count not stated
  • pancytopenia
    count not stated
  • platelet count decreased
    count not stated
4 more recorded rows
  • pneumonia
    count not stated
  • sepsis
    count not stated
  • thrombocytopenia
    count not stated
  • tumour lysis syndrome
    count not stated

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

Venetoclax and CYP3A and P-GP: shared by which compounds?


CYP3A and P-GP appear in Venetoclax's recorded interaction sentences, 8 in all. DailyMed label · b118a40d-6b56-cee3-10f6-ded821a97018 · 2026-05-20

CYP3A, CYP3A, P-gp, P-gp; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Strong or moderate CYP3A inhibitors or P-gp inhibitors: Adjust dosage of VENCLEXTA.
  • drug_interactions
    ( 2.6 , 7.1 ) Strong or moderate CYP3A inducers: Avoid co-administration.
  • drug_interactions
    ( 7.1 ) P-gp substrates: Take at least 6 hours before VENCLEXTA.
  • drug_interactions
    ( 7.2 ) 7.1 Effects of Other Drugs on VENCLEXTA Strong or Moderate CYP3A Inhibitors or P-gp Inhibitors Concomitant use with a strong or moderate CYP3A inhibitor or a P-gp inhibitor increases venetoclax C max and AUC 0-INF [see Clinical Pharmacology ( 12.3 )] , which may increase VENCLEXTA toxicities, including the risk of TLS [see Warnings and Precautions ( 5.1 )] .
  • drug_interactions
    Concomitant use with a strong CYP3A inhibitor at initiation and during the ramp-up phase in patients with CLL/SLL is contraindicated [see Contraindications ( 4 )] .
  • drug_interactions
    Resume the VENCLEXTA dosage that was used prior to concomitant use with a strong or moderate CYP3A inhibitor or a P-gp inhibitor 2 to 3 days after discontinuation of the inhibitor [see Dosage and Administration ( 2.5 , 2.6 )] .
2 more recorded rows
  • Interaction statement drug_interactions
    Avoid grapefruit products, Seville oranges, and starfruit during treatment with VENCLEXTA, as they contain inhibitors of CYP3A.
  • Interaction statement drug_interactions
    Strong or Moderate CYP3A Inducers Concomitant use with a strong CYP3A inducer decreases venetoclax C max and AUC 0-INF [see Clinical Pharmacology ( 12.3 )] , which may decrease VENCLEXTA efficacy.

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-05-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3137309
PubChem CID
49846579
CAS number
1257044-40-8
RxCUI
1747556
InChIKey
LQBVNQSMGBZMKD-UHFFFAOYSA-N
Also called
ABBVIE, ABT 199, Abt199, C45H50CLN7O7S, CHRONIC LYMPHOCYTIC LEUKAEMIA THERAPY, GDC-0199, RG-7601, RG7601, UNII-N54AIC43PW, VENCLEXTA, VENCLYXTO, VENETOCLAXVENCLEXTAABT-199A-12314-[4-[[2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL]METHYL]PIPERAZIN-1-YL]-N-[[3-NITRO-4-[[(TETRAHYDRO-2H-PYRAN-4-YL)METHYL]AMINO]PHENYL]SULFONYL]-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY]BENZAMIDE
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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