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Pemigatinib

  • 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 Pemigatinib does in the body

PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

From the FDA-approved label: Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2 and 3 with IC 50 values of less than 2 nM. Pemigatinib also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3. Pemigatinib inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling. Constitutive FGFR signaling can support the proliferation and survival of malignant cells.

Why people take it. PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

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 · Y6BX7BL23K · read 2026-08-29

  • Its recorded molecular formula is C24H27F2N5O4.

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · 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 174 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.

Percentage of patients that are treated based on their molecular tumor profile

The study did not show it

Who was studied
NCT02925234
How many people
1550
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

Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)

The study did not show it

Who was studied
NCT03498521
How many people
529
Study design
Phase 2
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

OVERALL RESPONSE RATE (ORR)

The study did not show it

Who was studied
NCT04591431
How many people
400
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

Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen

The study did not show it

Who was studied
NCT02872714
How many people
263
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

Disease control rate

The study did not show it

Who was studied
NCT05159245
How many people
250
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

Group A - Objective Response Rate

The study did not show it

Who was studied
NCT04463771
How many people
206
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
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.

  • PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1, 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response.

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 PEMAZYRE have not been established in pediatric patients.”

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-30

  • On older people, the label states: “In FIGHT-202 in patients with cholangiocarcinoma, 32% of patients were 65 years and older, and 8% of patients were 75 years and older.”

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .”

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-30

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

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-30

  • On people with reduced liver function, the label states: “Reduce the recommended dosage of PEMAZYRE for patients with severe hepatic impairment (total bilirubin > 3 × ULN with any AST) [see Dosage and Administration ( 2.6 ) and Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Reduce the recommended dosage of PEMAZYRE for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 , estimated by MDRD equation) [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · 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, 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

  • 8 products list this as an active ingredient in the United States drug directory. 8 of them contain it and nothing else.

    FDA National Drug Code directory · 50881-026 · read 2026-08-29

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

    FDA National Drug Code directory · 50881-026 · read 2026-08-29

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

    FDA National Drug Code directory · 50881-026 · 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 · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · read 2026-08-29

  • PEMAZYRE is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 4.5 mg: round, white to off-white tablet debossed on one side with "I" and "4.5" on the other side. 9 mg: oval, white to off-white tablet debossed on one side with "I" and "9" on th…, recorded as fda label in effect 2026-06-09 in the United States.

    US prescribing information · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · 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 Pemigatinib studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

Missing populations

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

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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

What would answer it

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

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

Missing interaction studies

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

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

What would answer it

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

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

Formulation uncertainty

Several salts, forms or products of Pemigatinib 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)
Y6BX7BL23K
RxNorm concept
2359334

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 NDA213736, approved 20200417 to INCYTE CORP.

    Drugs@FDA application register · NDA213736 · read 2026-08-29

  • Marketing status on the register: none (tentative approval) and prescription.

    Drugs@FDA application register · NDA213736 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20200417.

    FDA National Drug Code directory · 50881-026 · 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 Pemigatinib label: indicated for what?

"PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved…": indications and usage on Pemigatinib's label. DailyMed label · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · 2026-06-09

47 registered trials of Pemigatinib — at which phases?

Registered studies posting no result
32 of 47

47 registered studies of Pemigatinib: 39 phase2, 7 phase1, 1 na, 1 na or unstated, 1 phase3. CLINICALTRIALS_SNAPSHOT · 2026-09-01

18 with a PubMed record

Show the evidence
  • phase2
    39
  • phase1
    7
  • na
    1
  • na or unstated
    1
  • phase3
    1
  • recruiting
    11
7 more recorded rows
  • unknown
    11
  • completed
    10
  • terminated
    10
  • not yet recruiting
    2
  • active not recruiting
    1
  • no longer available
    1
  • withdrawn
    1

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

10 of Pemigatinib's trials stopped: safety, accrual/recruitment, funding/business?

safety (4), accrual/recruitment (5) and funding/business (1): Pemigatinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision."; 10 of 47 registered studies

Show the evidence

Trial

  • NCT03656536
    terminated; "The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision."
  • NCT03822117
    terminated; "A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision."
  • NCT04003610
    terminated; "The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision."
  • NCT04003623
    terminated; "The study was closed due to lack of enrollment."
  • NCT04088188
    terminated; "Low accrual"
  • NCT04294277
    terminated; "Screening success and patient recruitment was much lower than projected and a clinical/scientific interpretation will not be possible."
4 further recorded trials
  • NCT04949191
    terminated; "A business decision due to availability of commercial drug and other options for accessing study drug treatment."
  • NCT05216120
    withdrawn; "enrollment challenges"
  • NCT05267106
    terminated; "Recruitment ceased after a pre-planned futility interim analysis indicated a low probability to confer a clinically meaningful improvement in objective response when compared to currently available therapies. There were no safety related…"
  • NCT05565794
    terminated; "slow recruitment"

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

Human studies of Pemigatinib used Pemigatinib 4.5 MG — over how long?

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

1 recorded entry; human; also "Pemigatinib 4.5 MG"

Show the evidence
  • human NCT05216120
    Pemigatinib 4.5 MG

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

Which running trial of Pemigatinib could settle lifespan?

NCT07780838 measures Overall survival (OS), reading out 2027-12-31.

1 open trial; n 29; "Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations"

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  • Trial NCT07780838
    "Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations"; n 29; "Overall survival (OS)"; 2027-12-31

Which 3 trials of Pemigatinib posted no result?

Posted no result
3 of 3 completed trials
Registrations
NCT03235570, NCT04258527 and NCT04256980
Completion dates
oldest 2020-03-04; newest 2023-08-31
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Trial

  • NCT03235570
    2020-03-04
  • NCT04258527
    2021-03-08
  • NCT04256980
    2023-08-31

At the median, Pemigatinib's trials enrolled 30 people — anything larger?

Median enrolment
30
Largest enrolment
1550
Registered trials counted
46

What do 14 spontaneous reports say about Pemigatinib — 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.

Pemigatinib appears in spontaneous reports to regulators. Across the 3 most-reported reaction terms, 14 reaction mentions were counted: hospice care 9; calciphylaxis 3; fgfr2 gene mutation 2. FAERS via Open Targets · CHEMBL4297522 · 2026-06-24

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  • hospice care
    9
  • calciphylaxis
    3
  • fgfr2 gene mutation
    2

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

Which 3 reactions does Pemigatinib's label not list?

calciphylaxis, fgfr2 gene mutation and hospice care reported for Pemigatinib, absent from its label. FAERS via Open Targets · CHEMBL4297522 · 2026-06-24

2 label terms; 3 reported and unlisted; 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4

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  • calciphylaxis
    count not stated
  • fgfr2 gene mutation
    count not stated
  • hospice care
    count not stated

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

Pemigatinib and CYP3A and CYP3A4: shared by which compounds?

CYP3A and CYP3A4 appear in Pemigatinib's recorded interaction sentences, 8 in all. DailyMed label · 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4 · 2026-06-09

CYP3A, CYP3A, CYP3A4; 3 shared nodes; drug_interactions, pharmacokinetics

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Interaction statement

  • drug_interactions
    Strong and Moderate CYP3A Inducers: Avoid concomitant use of PEMAZYRE.
  • drug_interactions
    ( 7.1 ) Strong and Moderate CYP3A Inhibitors: Avoid concomitant use.
  • drug_interactions
    ( 2.4 , 7.1 ) 7.1 Effect of Other Drugs on PEMAZYRE Strong and Moderate CYP3A Inducers Concomitant use of PEMAZYRE with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations [ see Clinical Pharmacology ( 12.3 )], which may reduce the efficacy of PEMAZYRE.
  • drug_interactions
    Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE.
  • drug_interactions
    Strong and Moderate CYP3A Inhibitors Concomitant use of a strong or moderate CYP3A inhibitor with PEMAZYRE increases pemigatinib plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the incidence and severity of adverse reactions.
  • drug_interactions
    Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE.
2 more recorded rows
  • Interaction statement drug_interactions
    Reduce PEMAZYRE dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided [see Dosage and Administration ( 2.4 )] .
  • Interaction statement pharmacokinetics
    Metabolism Pemigatinib is predominantly metabolized by CYP3A4 in vitro.

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
  • CYP3A4
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4297522
PubChem CID
86705695
CAS number
1513857-77-6
RxCUI
2359268
InChIKey
HCDMJFOHIXMBOV-UHFFFAOYSA-N
Also called
Fgfr inhibitor incb054828, Incb-054828, Incb054828, PEMIGATINIB [JAN], PEMIGATINIB [MI], PEMIGATINIB [ORANGE BOOK], PEMIGATINIB [USAN], Pemigatinib [WHO-DD], pemigatinib [INN]
Trade name
Pemazyre
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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