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Trametinib

  • 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 Trametinib does in the body

MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Trametinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 activation and of MEK1 and MEK2 kinase activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF V600E mutations result in constitutive activation of the BRAF pathway which includes MEK1 and MEK2. Trametinib inhibits cell growth of various BRAF V600 mutation-positive tumors in vitro and in vivo.

Why people take it. MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations 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 · BSB9VJ5TUT · read 2026-08-29

  • Its recorded molecular formula is C26H23FIN5O4•C2H6OS.

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · 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 148 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.

Objective response rate (ORR)

The study did not show it

Who was studied
NCT02465060
How many people
6452
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria

The study did not show it

Who was studied
NCT02693535
How many people
4200
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

16 weeks clinical response

The study did not show it

Who was studied
NCT04817956
How many people
3000
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Incidence of Adverse Events (AEs)

The study did not show it

Who was studied
NCT03899155
How many people
1500
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Percentage of Participants With Relapse-free Survival (RFS) Events

The study did not show it

Who was studied
NCT01682083
How many people
870
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · 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

No description of who was studied is recorded.

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 MEKINIST in combination with dabrafenib have not been established for these indications in pediatric patients less than 1 year old.”

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-30

  • On older people, the label states: “Of the 214 patients with melanoma who received single agent MEKINIST in the METRIC study, 27% were aged 65 years and older and 4% were over 75 years old [see Clinical Studies (14.1)] .”

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-30

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

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-30

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

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended in patients with mild (bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or bilirubin > 1x to 1.5x ULN and any AST) hepatic impairment.”

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.

    FDA National Drug Code directory · 52482-014 · read 2026-08-29

  • They are sold as powder.

    FDA National Drug Code directory · 52482-014 · 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 · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · read 2026-08-29

  • Mekinist is oral at 3 DOSAGE FORMS AND STRENGTHS MEKINIST tablets: 0.5 mg tablets: Yellow, ovaloid, biconvex, unscored film-coated tablets with beveled edges and with the Novartis logo debossed on one side and ‘TT’ on the other side. 2 mg…, recorded as fda label in effect 2026-05-07 in the United States.

    US prescribing information · 0002ad27-779d-42ab-83b5-bc65453412a1 · 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 Trametinib 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 Trametinib 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)
BSB9VJ5TUT
RxNorm concept
1425110

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

  • 1 approved application covers products containing this substance. The earliest was NDA217513, approved 20230316 to NOVARTIS.

    Drugs@FDA application register · NDA217513 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA217513 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20140902.

    FDA National Drug Code directory · 52482-014 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (11)

On the Trametinib label: indicated for what?


"MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the…": indications and usage on Trametinib's label. DailyMed label · 0002ad27-779d-42ab-83b5-bc65453412a1 · 2026-05-07

215 registered trials of Trametinib — at which phases?


Registered studies posting no result
150 of 215

215 registered studies of Trametinib: 124 phase2, 91 phase1, 12 na or unstated, 12 phase3, 3 phase4, 2 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

175 with a PubMed record

Show the evidence
  • phase2
    124
  • phase1
    91
  • na or unstated
    12
  • phase3
    12
  • phase4
    3
  • na
    2
9 more recorded rows
  • early phase1
    1
  • completed
    74
  • active not recruiting
    43
  • terminated
    33
  • recruiting
    29
  • withdrawn
    18
  • unknown
    11
  • no longer available
    4
  • not yet recruiting
    3

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

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


safety (2), futility/efficacy (2), accrual/recruitment (23), funding/business (7), sponsor decision unspecified (2) and other (13): Trametinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"PI leaving VICC, low future accrual predicted, continued funding improbable,"; 49 of 215 registered studies

Show the evidence

Trial

  • NCT01701037
    terminated; "PI leaving VICC, low future accrual predicted, continued funding improbable,"
  • NCT01721603
    terminated; "Low accrual"
  • NCT01907815
    terminated; "Lack of efficacy."
  • NCT01912625
    terminated; "Inadequate accrual rate"
  • NCT01938456
    withdrawn; "This study was Cancelled Before Active"
  • NCT01940809
    terminated; "Inadequate accrual rate"
14 further recorded trials
  • NCT01958112
    terminated; "Drug supply"
  • NCT01978236
    terminated; "This study was terminated due to the limited enrollment."
  • NCT02097225
    terminated; "Drug supply issues"
  • NCT02140840
    withdrawn; "PI left institution"
  • NCT02143050
    withdrawn; "No participant enrollment"
  • NCT02300935
    withdrawn; "Study concept was terminated."
  • NCT02314143
    terminated; "The study was terminated early due to slow enrollment and limited numbers of viable tissue samples."
  • NCT02342600
    withdrawn; "Supporting company withdrew interest"
  • NCT02357732
    withdrawn; "PI decided not to proceed"
  • NCT02410863
    terminated; "lack of recruitment due to changed therapy options"
  • NCT02447939
    withdrawn; "Change in strategy"
  • NCT02538627
    terminated; "Sponsor decision"
  • NCT02580708
    terminated; "Discontinued development of rociletinib in NSCLC. Stopped enrollment of new patients into all studies involving rociletinib."
  • NCT02672358
    withdrawn; "Company Decision"

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

Human studies of Trametinib used Trametinib 2.0 mg — over how long?


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

8 recorded entries; human; also "Trametinib 2.0 mg", "Trametinib 0.5 mg", "Trametinib 2 mg"

Show the evidence

human

  • NCT01978236
    Trametinib 2.0 mg
  • NCT02292732
    Trametinib 0.5 mg
  • NCT02292732
    Trametinib 2 mg
  • NCT03704688
    Trametinib 1 MG
  • NCT03704688
    Trametinib 1.5 MG
  • NCT04326283
    Trametinib (0.5 mg)
2 more recorded rows
  • human NCT04326283
    Trametinib (1 mg)
  • human NCT05182931
    Trametinib 2 MG

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

Trametinib's half-life is 3.9 to 4.8 days — which schedules were studied?


3.9 to 4.8 days, the half-life Trametinib's label states: "Elimination The estimated elimination half-life is 3.9 to 4.8 days." DailyMed label · 0002ad27-779d-42ab-83b5-bc65453412a1 · 2026-05-07

tmax 1.5 hours; bioavailability 72 %.

Show the evidence
  • half life pharmacokinetics
    3.9 to 4.8 days; Elimination The estimated elimination half-life is 3.9 to 4.8 days.
  • tmax pharmacokinetics
    1.5 hours; Absorption The median time to achieve peak plasma concentrations (T max ) is 1.5 hours post-dose.
  • bioavailability pharmacokinetics
    72 %; The mean absolute bioavailability of MEKINIST tablets is 72% and MEKINIST for oral solution is 81%.
  • metabolism pharmacokinetics
    Metabolism Trametinib is metabolized predominantly via deacetylation alone or with mono-oxygenation or in combination with glucuronidation biotransformation pathways in vitro.

recorded 2026-05-07 · last checked 2026-09-04

Which running trial of Trametinib could settle lifespan?


NCT03085056 measures Progression-Free Survival (PFS), reading out 2026-09.

16 open trials; n 13; "Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer"

Show the evidence

Trial

  • NCT03085056
    "Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer"; n 13; "Progression-Free Survival (PFS)"; 2026-09
  • NCT02224781
    "Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma"; n 267; "2-year Overall Survival (OS)"; 2026-12-19
  • NCT02196181
    "Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread"; n 280; "Progression-free survival (PFS)"; 2027-03-15
  • NCT02231775
    "Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation"; n 58; "Relapse-free survival (RFS)"; 2027-04-01
  • NCT06739395
    "Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion"; n 300; "PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)"; 2027-05-01
  • NCT04940052
    "Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer"; n 153; "Progression Free Survival (PFS)"; 2027-05-25
10 further recorded trials
  • NCT04943224
    "Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients"; n 12; "Event-free survival (EFS)"; 2027-06-30
  • NCT01979523
    "Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma"; n 42; "Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST"; 2027-07-15
  • NCT03919071
    "Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma"; n 58; "Event-free survival (EFS) for stratum 1"; 2027-09-30
  • NCT04666272
    "Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection"; n 78; "Relapse-free survival (RFS)"; 2028-02-04
  • NCT07477457
    "A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma"; n 45; "12-month progression free survival (PFS) (cohort 1)"; 2028-03-11
  • NCT03563729
    "Melanoma Metastasized to the Brain and Steroids"; n 80; "6 months progression-free survival rate"; 2028-06-06
  • NCT07131059
    "MRD-positive AML Clinical Study"; n 537; "relapse-free survival rate"; 2028-10-30
  • NCT07010393
    "Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study"; n 335; "Real-World Progression-Free Survival (rwPFS)"; 2028-12-31
  • NCT06475989
    "Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer"; n 264; "Progression free survival (PFS)"; 2030-09-30
  • NCT05180825
    "Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy"; n 134; "The primary endpoint is the 3-year PFS (Progression Free Survival rates) comparing the two arms (standard vs experimental)."; 2031-12-01

Which 27 trials of Trametinib posted no result?


Posted no result
27 of 27 completed trials
Registrations
NCT01647659, NCT01192165, NCT01767454, NCT01935973, NCT01938443 and NCT02065063, and 21 more
Completion dates
oldest 2012-11-12; newest 2024-05-24
Show the evidence

Trial

  • NCT01647659
    2012-11-12
  • NCT01192165
    2013-10-07
  • NCT01767454
    2015-09-04
  • NCT01935973
    2015-09-08
  • NCT01938443
    2016-06-23
  • NCT02065063
    2016-06-23
14 further recorded trials
  • NCT02439411
    2016-09
  • NCT02016729
    2017-07-31
  • NCT02027961
    2018-04-24
  • NCT03553329
    2018-06-02
  • NCT01438554
    2018-08
  • NCT02110355
    2018-12-27
  • NCT02230553
    2019-08-06
  • NCT02705963
    2019-08-29
  • NCT03352947
    2020-11-27
  • NCT02292173
    2021-01
  • NCT02900664
    2021-03-17
  • NCT01740648
    2021-09-29
  • NCT02399943
    2022-03-31
  • NCT02428270
    2022-10-27

At the median, Trametinib's trials enrolled 35 people — anything larger?


Median enrolment
35
Largest enrolment
6452
Registered trials counted
211

What do 3788 spontaneous reports say about Trametinib — 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.

Trametinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3788 reaction mentions were counted: pyrexia 1612; rash 492; malignant neoplasm progression 428; chills 416. FAERS via Open Targets · CHEMBL2103875 · 2026-06-24

Show the evidence
  • pyrexia
    1612
  • rash
    492
  • malignant neoplasm progression
    428
  • chills
    416
  • dehydration
    189
  • ejection fraction decreased
    150
4 more recorded rows
  • blood creatine phosphokinase increased
    142
  • visual impairment
    141
  • uveitis
    126
  • metastases to central nervous system
    92

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

Which 10 reactions does Trametinib's label not list?


blood creatine phosphokinase increased, chills and dehydration and 7 more reported for Trametinib, absent from its label. FAERS via Open Targets · CHEMBL2103875 · 2026-06-24

2 label terms; 10 reported and unlisted; 0002ad27-779d-42ab-83b5-bc65453412a1

Show the evidence
  • blood creatine phosphokinase increased
    count not stated
  • chills
    count not stated
  • dehydration
    count not stated
  • ejection fraction decreased
    count not stated
  • malignant neoplasm progression
    count not stated
  • metastases to central nervous system
    count not stated
4 more recorded rows
  • pyrexia
    count not stated
  • rash
    count not stated
  • uveitis
    count not stated
  • visual impairment
    count not stated

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

Trametinib and P-GP, BCRP and CYP1A2: shared by which compounds?


P-GP, BCRP and CYP1A2 appear in Trametinib's recorded interaction sentences, 8 in all. DailyMed label · 0002ad27-779d-42ab-83b5-bc65453412a1 · 2026-05-07

CYP1A2, CYP2A6, CYP2B6, CYP2C19, CYP2C8, CYP2C9; 26 shared nodes; pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • pharmacokinetics
    Effect of Trametinib on CYP Substrates: Coadministration of MEKINIST tablets 2 mg once daily with a sensitive CYP3A4 substrate had no clinically relevant effect on the AUC and C max of the sensitive CYP3A4 substrate.
  • pharmacokinetics
    Based on in vitro studies, trametinib is an inhibitor of CYP2C8, but is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at a clinically relevant systemic concentration.
  • pharmacokinetics
    Effect of Transporters on Trametinib: Trametinib is a substrate of P-glycoprotein (P-gp) and BSEP.
  • pharmacokinetics
    Inhibition of P-gp is unlikely to result in a clinically important increase in trametinib concentrations as trametinib exhibits high passive permeability and bioavailability.
  • pharmacokinetics
    Trametinib is not a substrate of BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, or MATE1 in vitro.
  • pharmacokinetics
    Effect of Trametinib on Transporters: Based on in vitro studies, trametinib is not an inhibitor of P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, BSEP, MRP2, or MATE1 at a clinically relevant systemic concentration.
2 more recorded rows
  • Interaction statement clinical_pharmacology
    Effect of Trametinib on CYP Substrates: Coadministration of MEKINIST tablets 2 mg once daily with a sensitive CYP3A4 substrate had no clinically relevant effect on the AUC and C max of the sensitive CYP3A4 substrate.
  • Interaction statement clinical_pharmacology
    Based on in vitro studies, trametinib is an inhibitor of CYP2C8, but is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at a clinically relevant systemic concentration.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • CYP2A6
    FINGOLIMOD LAURYL SULFATE, Rasagiline, Naldemedine, Methylnaltrexone, Tivozanib, Metaxalone, Selegiline, Fingolimod
  • CYP2B6
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Tinidazole, Naldemedine
  • CYP2C19
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C8
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Golodirsen, Naldemedine, Methylnaltrexone, Lapatinib, Tivozanib
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
2 more recorded rows
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • CYP3A4
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

BCRP

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline

BSEP

  • Ceftobiprole Medocaril, Eravacycline, Prucalopride, Chenodeoxycholic acid, Eluxadoline, Histidine, Tirbanibulin, Trastuzumab deruxtecan
  • Ceftobiprole Medocaril, Eravacycline, Prucalopride, Chenodeoxycholic acid, Eluxadoline, Histidine, Tirbanibulin, Trastuzumab deruxtecan

MATE1

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid

MRP2

  • Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Omadacycline, Prucalopride, Methylnaltrexone, Sonidegib, Gadobenate Dimeglumine
  • Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Omadacycline, Prucalopride, Methylnaltrexone, Sonidegib, Gadobenate Dimeglumine
  • OAT1
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Prucalopride
  • OAT3
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Pemetrexed, Eravacycline

OATP1B1

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline

recorded 2026-05-07 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2103875
PubChem CID
11707110
CAS number
871700-17-3
RxCUI
1425099
InChIKey
LIRYPHYGHXZJBZ-UHFFFAOYSA-N
Also called
CPD 8B, GSK 1120212, GSK1120212, GSK1120212B, GSK-1120212TRAMETINIBMEKINISTA-1083G1357N-(3-{3-CYCLOPROPYL-5-[(2-FLUORO-4-IODOPHENYL)AMINO]-6,8-DIMETHYL-2,4,7-TRIOXO-3,4,6,7-TETRAHYDROPYRIDO[4,3-D]PYRIMIDIN-1(2H)-YL}PHENYL)ACETAMIDE GENERAL, JTP 74057, MEKINIST, TMT-212, Tmt212, TRAMETINIB DIMETHYL SULFOXIDE, Trametinib [INN], Trametinib [MI]
Development code
GSK-1120212B
Trade name
Spexotras
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: 3 required field(s) not terminal: 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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