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Tazemetostat

  • 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 Tazemetostat does in the body

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

From the FDA-approved label: Tazemetostat is an inhibitor of the methyltransferase, EZH2, and some EZH2 gain-of-function mutations including Y646X, A682G, and A692V. Tazemetostat also inhibited EZH1 with a half-maximal inhibitory concentration (IC 50 ) of 392 nM, approximately 36 times higher than the IC 50 for inhibition of EZH2. The most well-characterized function of EZH2 is as the catalytic subunit of the polycomb repressive complex 2 (PRC2), catalyzing mono-, di-, and trimethylation of lysine 27 of histone H3. Trimethylation of histone H3 leads to transcriptional repression.

Why people take it. TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

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 · 6P89T5M073 · read 2026-08-29

Where each sentence above came from

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

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

No statement of the main limit is recorded.

The four opening statements run to 158 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.

Proportion of Pediatric Patients Whose Advanced Tumors Have Pathway Alterations That Can be Targeted by Select Anti-cancer Drugs

The study did not show it

Who was studied
NCT03155620
How many people
1377
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

Phase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)

The study did not show it

Who was studied
NCT04224493
How many people
599
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

Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)

The study did not show it

Who was studied
NCT01897571
How many people
400
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

Complete Pathologic Response (pCR)

The study did not show it

Who was studied
NCT04812366
How many people
315
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

Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR)

The study did not show it

Who was studied
NCT02601950
How many people
267
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

Number of participants with adverse events (AEs)

The study did not show it

Who was studied
NCT05372354
How many people
260
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
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.

  • TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

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 TAZVERIK in pediatric patients aged less than 16 years have not been established.”

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-30

  • On older people, the label states: “Clinical studies of TAZVERIK did not include sufficient numbers of patients with epithelioid sarcoma or relapsed or refractory follicular lymphoma aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 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 [see Clinical Pharmacology ( 12.1 )] , TAZVERIK can cause fetal harm when administered to pregnant women.”

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-30

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

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment of TAZVERIK is recommended for patients with mild hepatic impairment (total bilirubin > 1 to 1.5 times upper limit of normal [ULN] or AST > ULN).”

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment of TAZVERIK is recommended for patients with mild to severe renal impairment or end stage renal disease [see Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 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

  • 2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.

    FDA National Drug Code directory · 72607-100 · read 2026-08-29

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

    FDA National Drug Code directory · 72607-100 · read 2026-08-29

  • The regulator's established pharmacologic class for it is methyltransferase inhibitor [epc], methyltransferase inhibitors [moa] and multidrug and toxin extrusion transporter 1 inhibitors [moa].

    FDA National Drug Code directory · 72607-100 · 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 · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · read 2026-08-29

  • TAZVERIK is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg film-coated, red, round, biconvex shape and debossed with "EZM 200" on one side and plain on the other., recorded as fda label in effect 2026-04-29 in the United States.

    US prescribing information · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 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 Tazemetostat studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

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

Missing populations

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

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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

What would answer it

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

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

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

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

What would answer it

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

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

Formulation uncertainty

Several salts, forms or products of Tazemetostat 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)
6P89T5M073
RxNorm concept
2274384

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.

  • 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 NDA211723, approved 20200123 to EPIZYME INC.

    Drugs@FDA application register · NDA211723 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA211723 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20200123.

    FDA National Drug Code directory · 72607-100 · 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 Tazemetostat label: indicated for what?

"TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive…": indications and usage on Tazemetostat's label. DailyMed label · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 2026-04-29

55 registered trials of Tazemetostat — at which phases?

Registered studies posting no result
40 of 55

55 registered studies of Tazemetostat: 34 phase2, 30 phase1, 3 na or unstated, 1 early phase1, 1 phase3. CLINICALTRIALS_SNAPSHOT · 2026-09-01

12 with a PubMed record

Show the evidence
  • phase2
    34
  • phase1
    30
  • na or unstated
    3
  • early phase1
    1
  • phase3
    1
  • active not recruiting
    16
7 more recorded rows
  • completed
    14
  • terminated
    8
  • withdrawn
    8
  • recruiting
    4
  • no longer available
    2
  • not yet recruiting
    2
  • suspended
    1

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

17 of Tazemetostat's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?

safety (4), futility/efficacy (1), accrual/recruitment (1), funding/business (1) and other (10): Tazemetostat's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Other - Drug Manufacturer decision to close study"; 17 of 55 registered studies

Show the evidence

Trial

  • NCT03217253
    withdrawn; "Other - Drug Manufacturer decision to close study"
  • NCT04179864
    terminated; "The study was terminated early as Sponsor decided to discontinue the development of tazemetostat in metastatic castration resistant prostate cancer and the primary endpoint was not met for this study. There were no safety concerns."
  • NCT04204941
    terminated; "FDA and Ipsen alignelment: Due to unfeasibility and the resulting inability to meet the required enrolment targets. No safety concerns"
  • NCT04241835
    terminated; "Ipsen decided to discontinue all active tazemetostat clinical trials."
  • NCT04624113
    terminated; "Ipsen bought out Epizyme"
  • NCT04762160
    terminated; "Decision to terminate EZH-1401 was solely due to company business decision."
11 further recorded trials
  • NCT05018975
    withdrawn; "FDA recommendation cited safety issues"
  • NCT05023655
    terminated; "Ipsen has discontinued all active tazemetostat clinical trials and expanded access programs due to the emergence of a clinically unfavorable benefit risk profile for tazemetostat in combination with lenalidomide and rituximab."
  • NCT05152459
    withdrawn; "Feasibility"
  • NCT05205252
    withdrawn; "Epizyme Inc. has revised the Tazemetostat development strategy and made the decision to terminate the hematological malignancies basket trial."
  • NCT05567679
    withdrawn; "PI voluntarily closed the study."
  • NCT05604417
    withdrawn; "Termination of Zandelisib clinical development globally"
  • NCT05618366
    terminated; "Low accrual"
  • NCT05983965
    terminated; "Ipsen, drug company requested all studies using the drug Taxemetostat be terminated due to increased risk of secondary malignancies in subjects."
  • NCT06068881
    withdrawn; "Never started"
  • NCT06575686
    suspended; "Pending Interim Analysis"
  • NCT06692452
    withdrawn; "Ipsen requested a temporary closure due to a safety concern."

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

Tazemetostat's half-life is 3.1 hours — which schedules were studied?

3.1 hours, the half-life Tazemetostat's label states: "Elimination At steady-state, the estimated mean (CV%) terminal elimination half-life of tazemetostat is 3.1 hours (14%) and the apparent total clearance (CL ss /F) is 274 L/h (49%)." DailyMed label · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 2026-04-29

tmax 0-12 h; bioavailability 33 %.

Show the evidence
  • half life pharmacokinetics
    3.1 hours; Elimination At steady-state, the estimated mean (CV%) terminal elimination half-life of tazemetostat is 3.1 hours (14%) and the apparent total clearance (CL ss /F) is 274 L/h (49%).
  • tmax pharmacokinetics
    0-12 h; The mean (coefficient of variation [CV]%) steady-state peak plasma concentration (C max ) was 829 (56%) ng/mL and AUC 0-12h was 3340 (49%) ng•h/mL.
  • bioavailability pharmacokinetics
    33 %; Absorption The mean absolute oral bioavailability of tazemetostat is approximately 33%.
  • metabolism pharmacokinetics
    Metabolism In vitro, tazemetostat is metabolized by CYP3A to form the inactive major metabolites M5 (EPZ-6930) and M3 (EPZ006931).

recorded 2026-04-29 · last checked 2026-09-04

Which running trial of Tazemetostat could settle lifespan?

NCT06242834 measures Event free survival, reading out 2028-11-24.

2 open trials; n 32; "Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma"

Show the evidence

Trial

  • NCT06242834
    "Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma"; n 32; "Event free survival"; 2028-11-24
  • NCT05890352
    "Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment"; n 227; "Progression-free survival (PFS)"; 2029-01

Which one trial of Tazemetostat posted no result?

Posted no result
1 of 1 completed trials
Registrations
NCT02220842
Completion dates
oldest 2020-01-21
Show the evidence
  • Trial NCT02220842
    2020-01-21

At the median, Tazemetostat's trials enrolled 32 people — anything larger?

Median enrolment
32
Largest enrolment
1377
Registered trials counted
53

What do 239 spontaneous reports say about Tazemetostat — 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.

Tazemetostat appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 239 reaction mentions were counted: disease progression 58; fatigue 48; nausea 48; product dose omission issue 20. FAERS via Open Targets · CHEMBL3414621 · 2026-06-24

Show the evidence
  • disease progression
    58
  • fatigue
    48
  • nausea
    48
  • product dose omission issue
    20
  • decreased appetite
    17
  • constipation
    16
4 more recorded rows
  • platelet count decreased
    10
  • taste disorder
    10
  • covid-19
    6
  • myelodysplastic syndrome
    6

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

Which 10 reactions does Tazemetostat's label not list?

constipation, covid-19 and decreased appetite and 7 more reported for Tazemetostat, absent from its label. FAERS via Open Targets · CHEMBL3414621 · 2026-06-24

2 label terms; 10 reported and unlisted; 7db07b5f-4e22-467c-9c0a-f830b08dbb1d

Show the evidence
  • constipation
    count not stated
  • covid-19
    count not stated
  • decreased appetite
    count not stated
  • disease progression
    count not stated
  • fatigue
    count not stated
  • myelodysplastic syndrome
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • platelet count decreased
    count not stated
  • product dose omission issue
    count not stated
  • taste disorder
    count not stated

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

Tazemetostat and CYP3A and CYTOCHROME P450: shared by which compounds?

CYP3A and CYTOCHROME P450 appear in Tazemetostat's recorded interaction sentences, 8 in all. DailyMed label · 7db07b5f-4e22-467c-9c0a-f830b08dbb1d · 2026-04-29

CYP3A, CYP3A; 2 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Strong or Moderate Cytochrome P450 (CYP)3A Inhibitors : Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK.
  • drug_interactions
    Reduce the dose of TAZVERIK if coadministration of strong or moderate CYP3A inhibitors cannot be avoided.
  • drug_interactions
    ( 2.3 , 7.1 ) Strong or Moderate CYP3A Inducers : Avoid coadministration with TAZVERIK.
  • drug_interactions
    ( 7.1 ) 7.1 Effect of Other Drugs on TAZVERIK Strong or Moderate CYP3A Inhibitors Coadministration of TAZVERIK with a strong or moderate CYP3A inhibitor increases tazemetostat plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the frequency or severity of adverse reactions.
  • drug_interactions
    Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK.
  • drug_interactions
    If coadministration of strong or moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose [see Dosage and Administration ( 2.4 )].
2 more recorded rows
  • Interaction statement drug_interactions
    Strong or Moderate CYP3A Inducers Coadministration of TAZVERIK with a strong CYP3A inducer decreases tazemetostat plasma concentrations [see Clinical Pharmacology ( 12.3 )] , and coadministration of TAZVERIK with a moderate CYP3A inducer may also decrease tazemetostat plasma concentrations.
  • Interaction statement drug_interactions
    Avoid coadministration of moderate or strong CYP3A inducers with TAZVERIK.

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

recorded 2026-04-29 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3414621
PubChem CID
66558664
CAS number
1403254-99-8
RxCUI
2274378
InChIKey
NSQSAUGJQHDYNO-UHFFFAOYSA-N
Also called
CT-EPZ438EPZ-6438EPZ6438A-1623E-7438E7438, E-7438, E7438, EPZ 6438, EPZ6438, TAZEMETOSTAT HYDROBROMIDE, Tazemetostat monohydrobromide, TAZEMETOSTAT HYDROBROMIDE [JAN], TAZEMETOSTAT HYDROBROMIDE [ORANGE BOOK], TAZEMETOSTAT HYDROBROMIDE [USAN], Tazemetostat hydrobromide [WHO-DD]
Salt form
E-7438 HYDROBROMIDE, EPZ-6438 HYDROBROMIDE
Development code
EPZ-6438 MONOHYDROBROMIDE, EZ-438, EZ438
Trade name
Tazverik
Sources (5)

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: 5 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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