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Idelalisib

  • 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 Idelalisib does in the body

Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

From the FDA-approved label: Idelalisib is an inhibitor of phosphatidylinositol 3-kinase, PI3Kδ, which is expressed in normal and malignant B-cells. Idelalisib induced apoptosis and inhibited proliferation in cell lines derived from malignant B-cells and in primary tumor cells. Idelalisib inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and the CXCR4 and CXCR5 signaling, which are involved in trafficking and homing of B-cells to the lymph nodes and bone marrow. Treatment of lymphoma cells with idelalisib resulted in inhibition of chemotaxis and adhesion, and reduced cell viability.

Why people take it. Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

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 · YG57I8T5M0 · read 2026-08-29

  • Its recorded molecular formula is C22H18FN7O, weighing 415.42 g/mol.

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-30

Where each sentence above came from

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

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

No statement of the main limit is recorded.

The four opening statements run to 161 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.

Maximum Tolerated Dose (MTD)

The study did not show it

Who was studied
NCT03740529
How many people
803
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

Progression-free Survival (PFS)

The study did not show it

Who was studied
NCT01732926
How many people
475
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

Progression-Free Survival (PFS)

The study did not show it

Who was studied
NCT01569295
How many people
416
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

Progression-Free Survival

The study did not show it

Who was studied
NCT01980888
How many people
311
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

Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment

The study did not show it

Who was studied
NCT02970318
How many people
310
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

Progression Free Survival

The study did not show it

Who was studied
NCT01732913
How many people
295
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
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.

  • Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Who is missing from the studies

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

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of Zydelig in pediatric patients have not been established.”

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-30

  • On older people, the label states: “Of the 490 patients with relapsed CLL who were treated with Zydelig in combination trials, 271 (55%) were 65 years of age and older.”

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-30

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

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-30

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

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with ALT or AST or bilirubin > upper limit of normal (ULN); however, limited safety and efficacy data are available for patients with baseline AST or ALT > 2.5 × ULN or bilirubin > 1.5 × ULN.”

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · 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, S6.

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

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

    FDA National Drug Code directory · 63285-753 · read 2026-08-29

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

    FDA National Drug Code directory · 63285-753 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cytochrome p450 3a inhibitors [moa], kinase inhibitor [epc] and kinase inhibitors [moa].

    FDA National Drug Code directory · 63285-753 · 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 · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · read 2026-08-29

  • Zydelig is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 100 mg: orange, oval-shaped, film-coated tablet debossed with "GSI" on one side and "100" on the other side. 150 mg: pink, oval-shaped, film-coated tablet debossed with "GSI" on one…, recorded as fda label in effect 2025-02-20 in the United States.

    US prescribing information · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · 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 Idelalisib 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)
YG57I8T5M0
RxNorm concept
1544465

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, 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

  • 3 approved applications cover products containing this substance. The earliest was NDA205858, approved 20140723 to GILEAD SCIENCES INC.

    Drugs@FDA application register · NDA205858 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA205858 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20140723.

    FDA National Drug Code directory · 63285-753 · 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 Idelalisib label: indicated for what?

"Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic…": indications and usage on Idelalisib's label. DailyMed label · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · 2025-02-20

60 registered trials of Idelalisib — at which phases?

Registered studies posting no result
22 of 60

60 registered studies of Idelalisib: 25 phase2, 19 phase1, 14 phase3, 4 na or unstated, 2 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

58 with a PubMed record

Show the evidence
  • phase2
    25
  • phase1
    19
  • phase3
    14
  • na or unstated
    4
  • phase4
    2
  • terminated
    27
5 more recorded rows
  • completed
    22
  • recruiting
    4
  • active not recruiting
    3
  • withdrawn
    3
  • approved for marketing
    1

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

16 of Idelalisib's trials stopped: safety, accrual/recruitment, funding/business, other?

safety (6), accrual/recruitment (7), funding/business (1) and other (2): Idelalisib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Unable to recruit enough eligible subjects"; 16 of 60 registered studies

Show the evidence

Trial

  • NCT01620216
    terminated; "Unable to recruit enough eligible subjects"
  • NCT01796470
    terminated; "Study was terminated due to safety measures."
  • NCT02439138
    terminated; "Safety issues from trials in CLL"
  • 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."
  • NCT02536300
    terminated; "Gilead has made the decision to close the study due to enrollment challenges"
  • NCT02590588
    terminated; "Poor accrual"
10 further recorded trials
  • NCT02662296
    withdrawn; "Low enrollment"
  • NCT02928510
    terminated; "withdrawn by sponsor"
  • NCT03151057
    terminated; "Safety endpointreached"
  • NCT03257722
    terminated; "The study was terminated due to poor accrual."
  • NCT03349346
    withdrawn; "The European Medical Agency granted a Paediatric Investigational Product-specific waiver on the grounds that idelalisib is likely to be unsafe in paediatrics"
  • NCT03742323
    terminated; "Because of low recruitment"
  • NCT03878524
    terminated; "Low accrual"
  • NCT03890289
    terminated; "Study was halted prematurely due to safety, since tocity stopping rules have been met"
  • NCT04699461
    terminated; "Administrative decision (not due to safety reason)"
  • NCT06205290
    withdrawn; "Business objectives have changed."

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

Human studies of Idelalisib used Idelalisib 100 MG — over how long?

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

1 recorded entry; human; also "Idelalisib 100 MG"

Show the evidence
  • human NCT03151057
    Idelalisib 100 MG

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

Idelalisib's half-life is 8.2 hours — which schedules were studied?

8.2 hours, the half-life Idelalisib's label states: "The population terminal elimination half-life of idelalisib is 8.2 hours." DailyMed label · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · 2025-02-20

tmax 1.5 hours.

Show the evidence
  • half life pharmacokinetics
    8.2 hours; The population terminal elimination half-life of idelalisib is 8.2 hours.
  • tmax pharmacokinetics
    1.5 hours; Absorption The median time to peak concentration (T max ) was observed at 1.5 hours.
  • metabolism pharmacokinetics
    Metabolism Idelalisib is metabolized via aldehyde oxidase and CYP3A with additional minor metabolism by UGT1A4.

recorded 2025-02-20 · last checked 2026-09-04

Which running trial of Idelalisib could settle lifespan?

NCT04666038 measures Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC), reading out 2027-05.

4 open trials; n 238; "Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small…"

Show the evidence

Trial

  • NCT04666038
    "Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)"; n 238; "Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)"; 2027-05
  • NCT02970318
    "A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL"; n 310; "Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment"; 2027-10-01
  • NCT07139873
    "A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)"; n 250; "Progression free survival (PFS) assessed by Independent Review Committee (IRC)"; 2029-12
  • NCT06846671
    "A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors"; n 250; "Progression-Free Survival (PFS) by Independent Review Committee (IRC)"; 2030-02-14

Which 10 trials of Idelalisib posted no result?

Posted no result
10 of 10 completed trials
Registrations
NCT00836914, NCT01644799, NCT01838434, NCT02603445, NCT02779283 and NCT03582098, and 4 more
Completion dates
oldest 2009-03; newest 2023-04-13
Show the evidence

Trial

  • NCT00836914
    2009-03
  • NCT01644799
    2017-05
  • NCT01838434
    2017-05-01
  • NCT02603445
    2018-07-10
  • NCT02779283
    2018-09-20
  • NCT03582098
    2019-03-26
4 further recorded trials
  • NCT03576443
    2021-09-30
  • NCT03568929
    2021-10-29
  • NCT02445131
    2022-03-09
  • NCT02962401
    2023-04-13

At the median, Idelalisib's trials enrolled 36 people — anything larger?

Median enrolment
36
Largest enrolment
475
Registered trials counted
59

What do 2160 spontaneous reports say about Idelalisib — 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.

Idelalisib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2160 reaction mentions were counted: disease progression 831; diarrhoea 408; pyrexia 187; pneumonia 141. FAERS via Open Targets · CHEMBL2216870 · 2026-06-24

Show the evidence
  • disease progression
    831
  • diarrhoea
    408
  • pyrexia
    187
  • pneumonia
    141
  • dehydration
    123
  • neutropenia
    123
4 more recorded rows
  • colitis
    110
  • pneumonitis
    101
  • febrile neutropenia
    74
  • lung disorder
    62

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

Which 10 reactions does Idelalisib's label not list?

colitis, dehydration and diarrhoea and 7 more reported for Idelalisib, absent from its label. FAERS via Open Targets · CHEMBL2216870 · 2026-06-24

2 label terms; 10 reported and unlisted; efbdafa9-d18c-4e85-b4a2-1e620fc74e50

Show the evidence
  • colitis
    count not stated
  • dehydration
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • febrile neutropenia
    count not stated
  • lung disorder
    count not stated
4 more recorded rows
  • neutropenia
    count not stated
  • pneumonia
    count not stated
  • pneumonitis
    count not stated
  • pyrexia
    count not stated

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

Idelalisib and CYP3A and CYP3A4: shared by which compounds?

CYP3A and CYP3A4 appear in Idelalisib's recorded interaction sentences, 8 in all. DailyMed label · efbdafa9-d18c-4e85-b4a2-1e620fc74e50 · 2025-02-20

CYP3A, CYP3A, CYP3A, CYP3A, CYP3A4; 5 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Strong CYP3A Inhibitors : Additional monitoring required if alternative therapy is not available.
  • drug_interactions
    ( 7.1 ) Strong CYP3A Inducers : Avoid coadministration of strong CYP3A inducers.
  • drug_interactions
    ( 7.1 ) CYP3A Substrates : Avoid coadministration of sensitive CYP3A substrates.
  • drug_interactions
    ( 7.2 ) 7.1 Effects of Other Drugs on Zydelig Table 6 lists the potential effects of the coadministration of strong CYP3A modulators on Zydelig.
  • drug_interactions
    Table 6 Drug Interactions with Zydelig that affect Idelalisib Concentrations Strong CYP3A Inhibitors Clinical Impact Coadministration with strong CYP3A inhibitors may increase idelalisib concentrations [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Prevention or Management Use other drugs that are not strong CYP3A inhibitors.
2 more recorded rows
  • Interaction statement drug_interactions
    Strong CYP3A Inducers Clinical Impact Coadministration with strong CYP3A inducers may decrease idelalisib concentrations [see Clinical Pharmacology (12.3) ] .
  • Interaction statement drug_interactions
    Prevention or Management Avoid coadministration of Zydelig with strong CYP3A4 inducers.

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
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • CYP3A4
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2025-02-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2216870
PubChem CID
11625818
CAS number
870281-82-6
RxCUI
1544460
InChIKey
IFSDAJWBUCMOAH-HNNXBMFYSA-N
Also called
CAL 101, GS-1101, Gs-11cal-101, IDELALISIBCT-CAL101IDEALISIBCAL-101CAL 101GS-1101GS 1101ZYDELIGA-1138CAL101, ZYDELIG, idela, IDELALISIB [JAN], IDELALISIB [MI], IDELALISIB [ORANGE BOOK], IDELALISIB [USAN], IDELALISIB [VANDF], Idelalisib [WHO-DD]
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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