Skip to content

Encorafenib

  • 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 Encorafenib does in the body

Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test

3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. 9 µM). Encorafenib inhibited in vitro growth of tumor cell lines expressing BRAF V600 E, D, and K mutations.

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 · 8L7891MRB6 · read 2026-08-29

  • Its recorded molecular formula is C22H27ClFN7O4S, weighing 540 daltons.

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 74 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.

Part 1: Progression Free Survival (PFS) by BIRC in Combo 450 Group as Compared to Vemurafenib Group

The study did not show it

Who was studied
NCT01909453
How many people
921
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

SLI: Number of Participants With Dose Limiting Toxicity (DLTs)

The study did not show it

Who was studied
NCT04607421
How many people
841
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Recurrence-free survival (RFS)

The study did not show it

Who was studied
NCT05270044
How many people
815
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Progression-free survival (PFS)

The study did not show it

Who was studied
NCT05615818
How many people
800
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

(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)

The study did not show it

Who was studied
NCT02928224
How many people
702
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Overall Survival (OS)

The study did not show it

Who was studied
NCT05639413
How many people
400
Study design
Not applicable
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.

  • BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.

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 BRAFTOVI have not been established in pediatric patients.”

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

  • On older people, the label states: “Of the 690 patients with BRAF mutation-positive melanoma who received BRAFTOVI in combination with binimetinib across multiple clinical trials, 20% were aged 65 to 74 years and 8% were aged 75 years and older [see Clinical Studies (14.1) ] .”

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

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

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

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

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

  • On people with reduced liver function, the label states: “No BRAFTOVI dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Class A) [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-30

  • On people with reduced kidney function, the label states: “No BRAFTOVI dosage adjustment is recommended in patients with mild to moderate renal impairment (CLcr 30 to <90 mL/min) [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · 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, 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

  • 13 products list this as an active ingredient in the United States drug directory. 13 of them contain it and nothing else.

    FDA National Drug Code directory · 59651-641 · read 2026-08-29

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

    FDA National Drug Code directory · 59651-641 · 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 · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · read 2026-08-29

  • BRAFTOVI is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 75 mg, hard gelatin, stylized "A" on beige cap and "LGX 75mg" on white body., recorded as fda label in effect 2026-02-26 in the United States.

    US prescribing information · 235dfc38-0f0b-4037-b501-7a9f4294740c · 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 Encorafenib 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 Encorafenib 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)
8L7891MRB6
RxNorm concept
2049119

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: Written into the record, not signed off.

  • 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 NDA210496, approved 20180627 to ARRAY BIOPHARMA INC.

    Drugs@FDA application register · NDA210496 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA210496 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20180117.

    FDA National Drug Code directory · 59651-641 · 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 Encorafenib label: indicated for what?


"BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and…": indications and usage on Encorafenib's label. DailyMed label · 235dfc38-0f0b-4037-b501-7a9f4294740c · 2026-02-26

61 registered trials of Encorafenib — at which phases?


Registered studies posting no result
43 of 61

61 registered studies of Encorafenib: 39 phase2, 20 phase1, 5 phase3, 3 na or unstated, 2 early phase1, 1 na, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

59 with a PubMed record

Show the evidence
  • phase2
    39
  • phase1
    20
  • phase3
    5
  • na or unstated
    3
  • early phase1
    2
  • na
    1
9 more recorded rows
  • phase4
    1
  • active not recruiting
    15
  • completed
    15
  • terminated
    14
  • recruiting
    12
  • unknown
    2
  • not yet recruiting
    1
  • suspended
    1
  • withdrawn
    1

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

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


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

"Study was withdrawn due to scientific and business considerations."; 16 of 61 registered studies

Show the evidence

Trial

  • NCT01777776
    terminated; "Study was withdrawn due to scientific and business considerations."
  • NCT01820364
    terminated; "Study was withdrawn due to scientific and business considerations."
  • NCT03878719
    terminated; "The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns."
  • NCT03911869
    terminated; "Study terminated due to lack of enrollment of the target population. There were no safety, efficacy, or regulatory interaction involved in the decision to stop enrollment."
  • NCT03973918
    terminated; "NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer"
  • NCT04044430
    terminated; "Sponsor funding"
10 further recorded trials
  • NCT04221438
    terminated; "Slow accrual"
  • NCT04390243
    terminated; "Slow accrual"
  • NCT04585815
    terminated; "Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions"
  • NCT04655157
    terminated; "Study terminated due to slow enrollment"
  • NCT04800822
    terminated; "The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue"
  • NCT04801966
    terminated; "low recruitment"
  • NCT05743036
    terminated; "Study terminated due to change in therapeutic landscape."
  • NCT05926960
    terminated; "Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment."
  • NCT06102902
    suspended; "Other - Pending amendment."
  • NCT07092410
    withdrawn; "The study was terminated early due to insufficient patient recruitment."

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

Human studies of Encorafenib used Encorafenib 75 MG — over how long?


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

1 recorded entry; human; also "Encorafenib 75 MG"

Show the evidence
  • human NCT04526782
    Encorafenib 75 MG

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

Encorafenib's half-life is 3.5 hours — which schedules were studied?


3.5 hours, the half-life Encorafenib's label states: "Elimination The mean (CV%) terminal half-life (t 1/2 ) of encorafenib is 3.5 hours (17%), and the apparent clearance is 14 L/h (54%) at day 1, increasing to 32 L/h (59%) at steady-state at the maximum recommended dose of 450 mg." DailyMed label · 235dfc38-0f0b-4037-b501-7a9f4294740c · 2026-02-26

tmax 2 hours.

Show the evidence
  • half life pharmacokinetics
    3.5 hours; Elimination The mean (CV%) terminal half-life (t 1/2 ) of encorafenib is 3.5 hours (17%), and the apparent clearance is 14 L/h (54%) at day 1, increasing to 32 L/h (59%) at steady-state at the maximum recommended dose of 450 mg.
  • tmax pharmacokinetics
    2 hours; Absorption The median T max of encorafenib is 2 hours.
  • metabolism pharmacokinetics
    Metabolism Encorafenib is primarily metabolized by CYP3A4 (83%) and to a lesser extent by CYP2C19 (16%) and CYP2D6 (1%).

recorded 2026-02-26 · last checked 2026-09-04

Which running trial of Encorafenib could settle lifespan?


NCT06640166 measures 6-month Progression Free Survival rate, reading out 2026-06-30.

11 open trials; n 25; "Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab."

Show the evidence

Trial

  • NCT06640166
    "Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab."; n 25; "6-month Progression Free Survival rate"; 2026-06-30
  • NCT04673955
    "BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment"; n 500; "Overall Survival"; 2027-01
  • NCT05217446
    "A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer"; n 108; "Progression-free Survival (PFS)"; 2027-01-26
  • NCT05026983
    "Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases"; n 35; "Progression free survival (PFS) (Cohort A)"; 2027-02-02
  • NCT04074096
    "Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis"; n 10; "Intracranial (IC) progression-free survival (PFS)"; 2027-03-27
  • NCT05308446
    "Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation"; n 86; "Progression-free survival (PFS)"; 2027-06-01
5 further recorded trials
  • NCT04511013
    "A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases"; n 112; "Progression-free survival"; 2027-06-30
  • NCT04045691
    "Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment"; n 750; "Progression-free survival"; 2027-09
  • NCT05615818
    "Personalized Medicine for Advanced Biliary Cancer Patients"; n 800; "Progression-free survival (PFS)"; 2028-06
  • NCT03563729
    "Melanoma Metastasized to the Brain and Steroids"; n 80; "6 months progression-free survival rate"; 2028-06-06
  • NCT06411600
    "Combination Therapy for BRAF-V600E Metastatic CRCm"; n 94; "Progression-Free Survival (PFS)"; 2029-05-01

Which 3 trials of Encorafenib posted no result?


Posted no result
3 of 3 completed trials
Registrations
NCT02902042, NCT02857270 and NCT02834364
Completion dates
oldest 2020-11-30; newest 2023-03-29
Show the evidence

Trial

  • NCT02902042
    2020-11-30
  • NCT02857270
    2022-10-24
  • NCT02834364
    2023-03-29

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


Median enrolment
35
Largest enrolment
841
Registered trials counted
61

What do 628 spontaneous reports say about Encorafenib — 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.

Encorafenib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 628 reaction mentions were counted: pyrexia 92; diarrhoea 89; nausea 89; vomiting 63. FAERS via Open Targets · CHEMBL3301612 · 2026-06-24

Show the evidence
  • pyrexia
    92
  • diarrhoea
    89
  • nausea
    89
  • vomiting
    63
  • disease progression
    62
  • rash
    57
4 more recorded rows
  • neoplasm progression
    56
  • acute kidney injury
    47
  • serous retinal detachment
    45
  • vision blurred
    28

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

Which 10 reactions does Encorafenib's label not list?


acute kidney injury, diarrhoea and disease progression and 7 more reported for Encorafenib, absent from its label. FAERS via Open Targets · CHEMBL3301612 · 2026-06-24

2 label terms; 10 reported and unlisted; 235dfc38-0f0b-4037-b501-7a9f4294740c

Show the evidence
  • acute kidney injury
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • nausea
    count not stated
  • neoplasm progression
    count not stated
  • pyrexia
    count not stated
4 more recorded rows
  • rash
    count not stated
  • serous retinal detachment
    count not stated
  • vision blurred
    count not stated
  • vomiting
    count not stated

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

Encorafenib and CYP3A4, BCRP and OATP1B1: shared by which compounds?


CYP3A4, BCRP and OATP1B1 appear in Encorafenib's recorded interaction sentences, 8 in all. DailyMed label · 235dfc38-0f0b-4037-b501-7a9f4294740c · 2026-02-26

CYP3A4, CYP3A4, CYP3A4, BCRP, OATP1B1, OATP1B3; 6 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • Strong or moderate CYP3A4 inhibitors: Avoid coadministration.
  • drug_interactions
    ( 2.6 , 7.1 ) • Strong CYP3A4 inducers: Avoid coadministration.
  • drug_interactions
    ( 7.1 ) • Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate.
  • drug_interactions
    ( 7.2 ) • Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.
  • drug_interactions
    ( 7.2 , 12.3 ) 7.1 Effect of Other Drugs on BRAFTOVI Strong or Moderate CYP3A4 Inhibitors Coadministration of BRAFTOVI with a strong or moderate CYP3A4 inhibitor increases encorafenib plasma concentrations [see Clinical Pharmacology (12.3) ] and may increase encorafenib adverse reactions.
  • drug_interactions
    Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice.
2 more recorded rows
  • Interaction statement drug_interactions
    Strong CYP3A4 Inducers Coadministration of BRAFTOVI with a strong CYP3A4 inducer may decrease encorafenib plasma concentrations [see Clinical Pharmacology (12.3) ] and may decrease encorafenib efficacy.
  • Interaction statement drug_interactions
    Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

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
  • BCRP
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline
  • OATP1B1
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline
  • OATP1B3
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline

recorded 2026-02-26 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3301612
PubChem CID
50922675
CAS number
1269440-17-6
RxCUI
2049106
InChIKey
CMJCXYNUCSMDBY-ZDUSSCGKSA-N
Trade name
Braftovi
Also called
Lgx-818, Lgx818, CARBAMIC ACID, N-((1S)-2-((4-(3-(5-CHLORO-2-FLUORO-3-((METHYLSULFONYL)AMINO)PHENYL)-1-(1-METHYLETHYL)-1H-PYRAZOL-4-YL)-2-PYRIMIDINYL)AMINO)-1-METHYLETHYL)-, METHYL ESTER, ENCORAFENIB [JAN], ENCORAFENIB [MI], ENCORAFENIB [ORANGE BOOK], ENCORAFENIB [USAN], Encorafenib [WHO-DD]
Development code
NVP-LGX818, NVP-LGX-818-NXA, NVP-LGX818-NXA
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.