This page shows what was measured, who it was measured in, and what that does not settle.
What Tafenoquine does in the body
Acute P
4 )] .
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 · 262P8GS9L9 · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. 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 16 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 people◇Read 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.
Cumulative Incidence of Plasmodium vivax infections
✗ The study did not show it
Who was studied
NCT05690841
How many people
7530
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
Effectiveness focus
✗ The study did not show it
Who was studied
NCT05540470
How many people
1991
Study design
Not applicable
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
Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA
✗ The study did not show it
Who was studied
NCT06575647
How many people
1242
Study design
Phase 4
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
The incidence risk of vivax parasitaemia
✗ The study did not show it
Who was studied
NCT06148792
How many people
1090
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
Incidence risk any P vivax PQ7 / PQ14
✗ The study did not show it
Who was studied
NCT04411836
How many people
960
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
Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose
✗ The study did not show it
Who was studied
NCT01376167
How many people
851
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read 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.
KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )]. Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria.
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: “Safety and effectiveness of ARAKODA in pediatric patients have not been established.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-30
On older people, the label states: “Clinical trials of ARAKODA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The use of ARAKODA during pregnancy may cause hemolytic anemia in a fetus who is G6PD-deficient.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary A breastfed infant with G6PD deficiency is at risk for hemolytic anemia from exposure to ARAKODA.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-30
On people with reduced liver function, the label states: “The pharmacokinetics of ARAKODA have not been studied in patients with hepatic impairment.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-30
On people with reduced kidney function, the label states: “The pharmacokinetics of ARAKODA have not been studied in patients with renal impairment.”
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · 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 take◇Read 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 take◇Read 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: S3.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing 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 unclear◇Read 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
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 71475-258 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 71475-258 · read 2026-08-29
3 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · read 2026-08-29
Arakoda is oral at 3 DOSAGE FORMS AND STRENGTHS ARAKODA tablets are dark pink, film-coated, capsule-shaped tablets debossed with ‘TQ100’ on one side containing 100 mg of tafenoquine., recorded as fda label in effect 2025-01-10 in the United States.
US prescribing information · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · 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 take◇Read 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 Tafenoquine 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 unclear◇Read 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 Tafenoquine 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 people◇Read 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.
How many documents were read
3 documents were read for this substance.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
262P8GS9L9
RxNorm concept
2054096
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: S3.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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 NDA210795, approved 20180720 to GLAXOSMITHKLINE.
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)
Q2
On the Tafenoquine label: indicated for what?
"ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.": indications and usage on Tafenoquine's label. DailyMed label · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · 2025-01-10
Q3
37 registered trials of Tafenoquine — at which phases?
Registered studies posting no result
29 of 37
37 registered studies of Tafenoquine: 15 phase2, 6 phase3, 5 phase1, 5 phase4, 4 na or unstated, 2 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Failure to meet pre-specified endpoint for the day 28 cure rate"; 2 of 37 registered studies
Show the evidence
Trial
NCT01290601
terminated; "Failure to meet pre-specified endpoint for the day 28 cure rate"
NCT04984759
withdrawn; "Local EC requested that the arms of study be submitted as separate protocols so they could respond to the different risk of each arm. In response investigators have withdrawn this protocol and begun separate submissions, starting with…"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Tafenoquine used Tafenoquine 50mg — over how long?
studies of Tafenoquine used the recorded amount. ClinicalTrials.gov · 2026-09-01
14 recorded entries; human; also "Tafenoquine 50mg", "Tafenoquine 100mg", "Tafenoquine 300mg"
Show the evidence
human
NCT01376167
Tafenoquine 50mg
NCT01376167
Tafenoquine 100mg
NCT01376167
Tafenoquine 300mg
NCT01376167
Tafenoquine 600mg
NCT01376167
Tafenoquine 300mg (Part 2)
NCT01928914
Tafenoquine 1200mg
8 more recorded rows
humanNCT02488902
Tafenoquine 25mg
humanNCT02488902
Tafenoquine 100 mg
humanNCT02488902
Tafenoquine 200 mg
humanNCT02658435
Tafenoquine 150 mg
humanNCT04609098
Tafenoquine 100mg [Arakoda]
humanNCT07052162
Single dose tafenoquine (10 mg/kg) given with water
humanNCT07052162
Single dose tafenoquine (10 mg/kg) given with fat
humanNCT07403643
Single dose tafenoquine (10 mg/kg)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tafenoquine's half-life is 16.5 days — which schedules were studied?
16.5 days, the half-life Tafenoquine's label states: "The mean terminal half-life following administration of ARAKODA is approximately 16.5 days (range: 10.8 days to 27.3 days) in healthy adult subjects." DailyMed label · 299e49d8-470f-4779-a010-4a1ee0e0c6cd · 2025-01-10
tmax 14 hr.
Show the evidence
half lifepharmacokinetics
16.5 days; The mean terminal half-life following administration of ARAKODA is approximately 16.5 days (range: 10.8 days to 27.3 days) in healthy adult subjects.
tmaxpharmacokinetics
14 hr; C max 147 ng/mL (20.7%) a T max 14 hr (6 – 72 hr) b AUC inf 70 hr*mcg/mL (24.6%) a, c Following administration of a single dose of tafenoquine orally under fasted conditions in healthy adult subjects, AUC and C max increased dose proportionally over the dose range from 100 mg to 400 mg.
metabolismpharmacokinetics
Metabolism Negligible metabolism of tafenoquine was observed in vitro in human liver microsomes and hepatocytes.
recorded 2025-01-10 · last checked 2026-09-04
Q7
Which running trial of Tafenoquine could settle lifespan?
NCT07430592 measures Parasitological Recurrence Free survival (RFS), reading out 2028-11-20.
1 open trial; n 104; "This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria"
Show the evidence
TrialNCT07430592
"This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria"; n 104; "Parasitological Recurrence Free survival (RFS)"; 2028-11-20
Q8
Which 10 trials of Tafenoquine posted no result?
Posted no result
10 of 10 completed trials
Registrations
NCT02491606, NCT02488902, NCT00871156, NCT01928914, NCT01205178 and NCT02184637, and 4 more
Completion dates
oldest 1998-09; newest 2023-10-01
Show the evidence
Trial
NCT02491606
1998-09
NCT02488902
2003-03
NCT00871156
2009-08-26
NCT01928914
2012-06-04
NCT01205178
2013-04-01
NCT02184637
2015-04-08
4 further recorded trials
NCT02658435
2017-09-14
NCT04609098
2020-12-23
NCT05081089
2022-01-13
NCT05753150
2023-10-01
Q9
At the median, Tafenoquine's trials enrolled 187 people — anything larger?
Median enrolment
187
Largest enrolment
16000
Registered trials counted
36
Q10
What do 5 spontaneous reports say about Tafenoquine — 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.
Tafenoquine appears in spontaneous reports to regulators. Across the 4 most-reported reaction terms, 5 reaction mentions were counted: malaria 2; lip discolouration 1; manganese increased 1; blood methaemoglobin present 1. FAERS via Open Targets · CHEMBL2364635 · 2026-06-24
Show the evidence
malaria
2
lip discolouration
1
manganese increased
1
blood methaemoglobin present
1
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 4 reactions does Tafenoquine's label not list?
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters ( 7.1 ) 7.1 Effect of ARAKODA on Organic Cation Transporter-2 (OCT2) and Multidrug and Toxin Extrusion (MATE) Substrates The effect of coadministration of tafenoquine on the pharmacokinetics of OCT2 and MATE substrates in humans is unknown.
drug_interactions
Avoid coadministration of ARAKODA with OCT2 and MATE substrates (e.g., dofetilide, metformin).
pharmacokinetics
Drug Interaction Studies Clinical Studies No clinically significant effects on the pharmacokinetics of substrates of cytochrome P450 isoenzymes (CYP)1A2 (caffeine), CYP2D6 (desipramine), CYP2C9 (flurbiprofen), or CYP3A4 (midazolam) were observed following coadministration with tafenoquine in healthy adult subjects.
pharmacokinetics
In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically Tafenoquine inhibited metformin transport via human OCT2, MATE1 and MATE2-K transporters [see Drug Interactions ( 7 )] .
pharmacokinetics
Tafenoquine is not an inhibitor of human breast cancer resistance protein (BCRP), P-glycoprotein (P-gp), Organic anion transporter 1/3 (OAT1 or OAT3), Organic anion transporting polypeptide 1B1/1B3 (OATP1B1 or OATP1B3) mediated transport at clinically relevant concentrations.
pharmacokinetics
Tafenoquine is also not a substrate of human OATP1B1 or OATP1B3 at clinically relevant concentrations.
2 more recorded rows
Interaction statementpharmacokinetics
It is inconclusive as to whether tafenoquine is a substrate of P-gp and/or BCRP mediated transport.
Interaction statementclinical_pharmacology
Drug Interaction Studies Clinical Studies No clinically significant effects on the pharmacokinetics of substrates of cytochrome P450 isoenzymes (CYP)1A2 (caffeine), CYP2D6 (desipramine), CYP2C9 (flurbiprofen), or CYP3A4 (midazolam) were observed following coadministration with tafenoquine in healthy adult subjects.
ChEMBL 37 — CC BY-SA 3.0 Unported · 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
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