Skip to content
RNAWiki

Selumetinib

  • 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 Selumetinib does in the body

KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ].

From the FDA-approved label: Selumetinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Both MEK and ERK are critical components of the RAS-regulated RAF-MEK-ERK pathway, which is often activated in different types of cancers. In genetically modified mouse models of NF1 that generate neurofibromas that recapitulate the genotype and phenotype of human NF1, oral dosing of selumetinib inhibited ERK phosphorylation, and reduced neurofibroma numbers, volume, and proliferation.

Why people take it. KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ].

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 6UH91I579U · 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 164 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.

Accrual of patients to ComboMATCH treatment trials

The study did not show it

Who was studied
NCT05564377
How many people
2900
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 in the targeted drug arm compared to standard maintenance therapy arm

The study did not show it

Who was studied
NCT02299999
How many people
1460
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

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

progression-free survival in the targeted drug arm compared to standard maintenance therapy arm

The study did not show it

Who was studied
NCT02117167
How many people
999
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

Percentage of Enrolled Participants Testing Positive for Genomic Abnormality

The study did not show it

Who was studied
NCT01306045
How many people
647
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)

The study did not show it

Who was studied
NCT01933932
How many people
510
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.

  • KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ].

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 KOSELUGO have not been established in pediatric patients younger than 1 year of age.”

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · read 2026-08-30

  • On older people, the label states: “Clinical studies of KOSELUGO did not include a sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients.”

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · 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) ] , KOSELUGO can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · read 2026-08-30

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

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · read 2026-08-30

  • On people with reduced liver function, the label states: “Selumetinib exposures increased in patients with moderate or severe hepatic impairment [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · 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 capsule, granule, 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

  • 14 products list this as an active ingredient in the United States drug directory. 14 of them contain it and nothing else.

    FDA National Drug Code directory · 0310-0625 · read 2026-08-29

  • They are sold as capsule, granule and powder, taken oral.

    FDA National Drug Code directory · 0310-0625 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kinase inhibitor [epc], mitogen-activated protein kinase kinase 1 inhibitors [moa] and mitogen-activated protein kinase kinase 2 inhibitors [moa].

    FDA National Drug Code directory · 0310-0625 · 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 · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · read 2026-08-29

  • KOSELUGO is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: • 10 mg selumetinib: white to off-white, opaque, hard capsule sealed with a clear band and marked with “SEL 10” in black ink. • 25 mg selumetinib: blue, opaque, hard capsule sealed…, recorded as fda label in effect 2026-05-26 in the United States.

    US prescribing information · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · 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 Selumetinib 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 Selumetinib 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)
6UH91I579U
RxNorm concept
2289418

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 NDA213756, approved 20200410 to ASTRAZENECA.

    Drugs@FDA application register · NDA213756 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA213756 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20200410.

    FDA National Drug Code directory · 0310-0625 · 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 Selumetinib label: indicated for what?

"KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric…": indications and usage on Selumetinib's label. DailyMed label · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · 2026-05-26

103 registered trials of Selumetinib — at which phases?

Registered studies posting no result
57 of 103

103 registered studies of Selumetinib: 61 phase2, 45 phase1, 7 phase3, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

91 with a PubMed record

Show the evidence
  • phase2
    61
  • phase1
    45
  • phase3
    7
  • na or unstated
    1
  • completed
    55
  • active not recruiting
    17
6 more recorded rows
  • terminated
    12
  • recruiting
    7
  • not yet recruiting
    6
  • withdrawn
    3
  • unknown
    2
  • approved for marketing
    1

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

13 of Selumetinib's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?

futility/efficacy (1), accrual/recruitment (4), funding/business (3) and other (5): Selumetinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Closed early for futility."; 13 of 103 registered studies

Show the evidence

Trial

  • NCT00780676
    terminated; "Closed early for futility."
  • NCT01134601
    terminated; "As per Cancer Therapy Evaluation Program (CTEP), this protocol has only enrolled one participant and it is unlikely that the study will be able to be completed successfully. CTEP slated the protocol to be administratively closed."
  • NCT01278615
    terminated; "Closed Prematurely."
  • NCT01519427
    terminated; "Study terminated due to slow accrual"
  • NCT01752569
    terminated; "Poor recruitment"
  • NCT01843062
    terminated; "Study was terminated based on the findings of primary analysis at 18 months post-RAI treatment. Patients pending 3 year follow up had end of study phone call."
7 further recorded trials
  • NCT01949870
    terminated; "change in the development strategy"
  • NCT03004105
    withdrawn; "Inadequate funding"
  • NCT03095248
    terminated; "Results review of patient data"
  • NCT03705507
    terminated; "Poor recruitment, due to a change in the standard of care for this patient population with the use of CAR-T cells"
  • NCT03801369
    terminated; "loss of funding"
  • NCT03833427
    terminated; "Business Reasons"
  • NCT05825365
    withdrawn; "Selumetinib launch approval achieved in advance,strategy changesa new study will be generated in place of this study."

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

Human studies of Selumetinib used Selumetinib 75 mg — over how long?

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

12 recorded entries; human; also "Selumetinib 75 mg", "75mg selumetinib", "Selumetinib 50mg"

Show the evidence

human

  • NCT01750281
    Selumetinib 75 mg
  • NCT01974752
    75mg selumetinib
  • NCT02063230
    Selumetinib 50mg
  • NCT02063230
    Selumetinib 25mg
  • NCT02238782
    selumetinib 75mg single dose
  • NCT02768766
    Selumetinib, 100mg
6 more recorded rows
  • human NCT02768766
    Selumetinib, 125mg
  • human NCT02768766
    Selumetinib, 150mg
  • human NCT02768766
    Selumetinib, 175mg
  • human NCT02768766
    Selumetinib, 200mg
  • human NCT02768766
    Selumetinib, 225mg
  • human NCT07713745
    Selumetinib 25mg/m2

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

Which running trial of Selumetinib could settle lifespan?

NCT02299999 measures Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm, reading out 2025-12.

7 open trials; n 1460; "SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"

Show the evidence

Trial

  • NCT02299999
    "SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
  • NCT01933932
    "Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC"; n 510; "Progression-Free Survival (PFS)"; 2026-12-31
  • NCT06621082
    "The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule"; n 19; "2-year progression-free survival (2-year PFS rate)"; 2026-12-31
  • NCT03871257
    "A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma"; n 165; "Event-free survival (EFS)"; 2027-12-31
  • NCT05554328
    "Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial"; n 165; "Progression-free survival"; 2028-10-01
  • NCT04166409
    "A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma"; n 170; "Event-free survival (EFS)"; 2030-12-31
  • 1 further recorded trial NCT06188741
    "Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1"; n 200; "Progression free survival (PFS)"; 2032-09-01

Which 22 trials of Selumetinib posted no result?

Posted no result
22 of 22 completed trials
Registrations
NCT01116271, NCT01931761, NCT01974349, NCT02046850, NCT01217450 and NCT01960374, and 16 more
Completion dates
oldest 2012-07; newest 2024-02-14
Show the evidence

Trial

  • NCT01116271
    2012-07
  • NCT01931761
    2013-11
  • NCT01974349
    2014-02
  • NCT02046850
    2014-04
  • NCT01217450
    2014-05
  • NCT01960374
    2014-05
14 further recorded trials
  • NCT02093728
    2014-06
  • NCT02063204
    2014-07
  • NCT01061749
    2014-09
  • NCT01242605
    2016-05
  • NCT01160718
    2016-09
  • NCT01146756
    2017-02-08
  • NCT02025114
    2018-03-08
  • NCT01783197
    2019-04-02
  • NCT02188264
    2019-04-26
  • NCT02586987
    2019-09-20
  • NCT02503358
    2020-07-16
  • NCT02768766
    2020-09-18
  • NCT04495127
    2023-03-24
  • NCT02664935
    2023-11-29

At the median, Selumetinib's trials enrolled 39 people — anything larger?

Median enrolment
39
Largest enrolment
2900
Registered trials counted
102

What do 56 spontaneous reports say about Selumetinib — 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.

Selumetinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 56 reaction mentions were counted: rash 12; blood creatine phosphokinase increased 8; paronychia 8; dermatitis acneiform 7. FAERS via Open Targets · CHEMBL1614701 · 2026-06-24

Show the evidence
  • rash
    12
  • blood creatine phosphokinase increased
    8
  • paronychia
    8
  • dermatitis acneiform
    7
  • acne
    5
  • detachment of retinal pigment epithelium
    5
4 more recorded rows
  • neoplasm
    3
  • retinal detachment
    3
  • retinopathy
    3
  • blood creatine phosphokinase decreased
    2

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

Which 10 reactions does Selumetinib's label not list?

acne, blood creatine phosphokinase decreased and blood creatine phosphokinase increased and 7 more reported for Selumetinib, absent from its label. FAERS via Open Targets · CHEMBL1614701 · 2026-06-24

2 label terms; 10 reported and unlisted; 7d042c61-f28f-4ab5-ab10-d7558c0d49ff

Show the evidence
  • acne
    count not stated
  • blood creatine phosphokinase decreased
    count not stated
  • blood creatine phosphokinase increased
    count not stated
  • dermatitis acneiform
    count not stated
  • detachment of retinal pigment epithelium
    count not stated
  • neoplasm
    count not stated
4 more recorded rows
  • paronychia
    count not stated
  • rash
    count not stated
  • retinal detachment
    count not stated
  • retinopathy
    count not stated

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

Selumetinib and CYP3A4, CYP1A2 and CYP2C9: shared by which compounds?

CYP3A4, CYP1A2 and CYP2C9 appear in Selumetinib's recorded interaction sentences, 8 in all. DailyMed label · 7d042c61-f28f-4ab5-ab10-d7558c0d49ff · 2026-05-26

CYP1A2, CYP2C19, CYP2C9, CYP2E1, CYP3A4, CYP3A4; 8 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    • Strong or Moderate CYP3A4 Inhibitors or Fluconazole : Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO.
  • drug_interactions
    ( 2.5 , 7.1 ) • Strong or Moderate CYP3A4 Inducers : Avoid concomitant use of strong and moderate CYP3A4 inducers.
  • drug_interactions
    ( 7.1 ) 7.1 Effect of Other Drugs on KOSELUGO Strong or Moderate CYP3A4 Inhibitors or Fluconazole Management • Avoid concomitant use of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO.
  • drug_interactions
    If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce KOSELUGO dosage [see Dosage Modifications for Drug Interactions (2.5) ].
  • drug_interactions
    Clinical Impact • Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inhibitor or fluconazole increased selumetinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions.
  • drug_interactions
    Strong or Moderate CYP3A4 Inducers Management • Avoid concomitant use of strong or moderate CYP3A4 inducers with KOSELUGO.
2 more recorded rows
  • Interaction statement drug_interactions
    Clinical Impact • Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may reduce KOSELUGO efficacy.
  • Interaction statement pharmacokinetics
    Metabolism Selumetinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19, CYP1A2, CYP2C9, CYP2E1, and CYP3A5.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • CYP2C19
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP2E1
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, Rasagiline, Tinidazole, Naldemedine, Methylnaltrexone, Alosetron, Metaxalone

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • CYP3A5
    Levamlodipine, Prasugrel, Avapritinib, Ponesimod, Paliperidone, Tezacaftor, Etripamil, Trastuzumab emtansine

recorded 2026-05-26 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1614701
PubChem CID
10127622
CAS number
606143-52-6
RxCUI
2289380
InChIKey
CYOHGALHFOKKQC-UHFFFAOYSA-N
Also called
ARRAY142886, ARRY-142886, ARRY-886, AZD 6244, AZD6244, arry142886, mk-5618, 1H-BENZIMIDAZOLE-6-CARBOXAMIDE, 5-((4-BROMO-2-CHLOROPHENYL)AMINO)-4-FLUORO-N-(2- HYDROXYETHOXY)-1-METHYL-, SELUMETINIB [MI], SELUMETINIB [USAN], Selumetinib [WHO-DD], selumetinib [INN]
Salt form
AZD-6244 HYDROGEN SULFATE, AZD-6244 HYD-SULFATE, SELUMETINIB SULFATE, azd6244 hyd sulfate, hyd-sulfate azd6244, smetinib bisulfate capsule, AZD6244 HYDROGEN SULFATE, Azd-6244 hydrogen sulphate, Azd6244 hydrogen sulphate, Selumetinib hydrogen sulfate, Selumetinib sulphate
Trade name
Koselugo
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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.