This page shows what was measured, who it was measured in, and what that does not settle.
What Ospemifene does in the body
Metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors
From the FDA-approved label: Toremifene is a nonsteroidal triphenylethylene derivative. Toremifene binds to estrogen receptors and may exert estrogenic, antiestrogenic, or both activities, depending upon the duration of treatment, animal species, gender, target organ, or endpoint selected. In general, however, nonsteroidal triphenylethylene derivatives are predominantly antiestrogenic in rats and humans and estrogenic in mice. In rats, toremifene causes regression of established dimethylbenzanthracene (DMBA)-induced mammary tumors.
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
Its recorded molecular formula is C26H28ClNO•C6H8O7, weighing 598.10.
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
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 91 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 26 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Fertility and sexual health
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Fertility and sexual health
female sexual function index
Pain
pain sex
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
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.
survival outcomes: disease free survival
✗ The study did not show it
Who was studied
NCT02132000
How many people
3036
Study design
Phase 2/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
5-year disease-free survival in the per-protocol population
✗ The study did not show it
Who was studied
NCT07153757
How many people
2934
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
3-year invasive disease-free survival
✗ The study did not show it
Who was studied
NCT07581834
How many people
2000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
✗ The study did not show it
Who was studied
NCT00106691
How many people
1589
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
Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine
✗ The study did not show it
Who was studied
NCT00129142
How many people
1200
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
iDFS
✗ The study did not show it
Who was studied
NCT05861271
How many people
1008
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.6 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.4 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
pain sex
peak increase in covid 19 sign and symptom
life quality questionnaire assessed by spf 36
life quality questionnaire assessed by eq 5d 5l
Measured
Things only a test, a scale or a device shows.
serum lipids
Meaningful
Things that change how a life goes, not only a number.
overall survival
disease free survival
disease free survival up to 16 years
invasive disease free survival up to 16 years
distant disease free survival up to 16 years
invasive disease free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (15)
time to tumor progression
time to progression
vaginal ph
superficial cells in maturation index of vaginal smear
recurrence free rate
incidence of adverse events
incidence of ovarian cyst
response rate
pathomorphological response
adverse events
female sexual function index
vaginal dryness
vaginal itching
vaginal irritation
detection of cell viability
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 26 hours hours
Read from the label, which states: “Excretion The apparent terminal half-life of ospemifene in postmenopausal women is approximately 26 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
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: “There is no indication for use of FARESTON in pediatric patients.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
On older people, the label states: “The pharmacokinetics of toremifene were studied in 10 healthy young males and 10 elderly females following a single 120 mg dose under fasting conditions.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
On people who are pregnant, the label states: “Category D [see Warnings and Precautions (5.7) .] Based on its mechanism of action in humans and findings of increased pregnancy loss and fetal malformation in animal studies, FARESTON can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
On people who are breastfeeding, the label states: “It is not known if toremifene is excreted in human milk.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
On people with reduced liver function, the label states: “The mean elimination half-life of toremifene was increased by less than twofold in 10 patients with hepatic impairment (cirrhosis or fibrosis) compared to subjects with normal hepatic function.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
On people with reduced kidney function, the label states: “The pharmacokinetics of toremifene and N-demethyltoremifene were similar in normals and in patients with impaired kidney function.”
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · 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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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 (10)
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: S6.
No source is stored against this line.
What is in the pack
Sold as tablet, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to 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.
Reports sent to a regulator
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.
Ospemifene appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 397 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
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
7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.
FDA National Drug Code directory · 54893-0079 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 54893-0079 · read 2026-08-29
The regulator's established pharmacologic class for it is estrogen agonist/antagonist [epc] and selective estrogen receptor modulators [moa].
FDA National Drug Code directory · 54893-0079 · 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 · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-29
Fareston is oral at 3 DOSAGE FORMS AND STRENGTHS Tablet is 60 mg, round, convex, unscored, uncoated, and white, or almost white, identified with TO 60 embossed on one side. 60 mg tablet is round, convex, unscored, uncoated, and white, or a…, recorded as fda label in effect 2024-11-13 in the United States.
US prescribing information · 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 · read 2026-08-30
Recorded price in US: 21.13191 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 2 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 Ospemifene 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 Ospemifene 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.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
3 documents were read for this substance.
RNAWiki source record
3 of them state the same halfLife, and they agree.
RNAWiki source record
3 of them state the same tMax, and they agree.
RNAWiki source record
3 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
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: S6.
✓ 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
3 approved applications cover products containing this substance. The earliest was NDA020497, approved 19970529 to KYOWA KIRIN.
This order is fixed in code and does not count clicks or time on the page.
What is not here
5 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.
The path through the body — 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 (12)
Q2
What did Ospemifene's largest trial (1589 people) and its longest (19 years) measure?
1589 people in Ospemifene's largest registered study, 19 years in its longest registered window, measuring Overall survival. ClinicalTrials.gov · 2026-09-01
20 phase3, 8 phase2, 5 phase4, 3 na or unstated, 1 phase1; NCT00002595; 2010-09; no ageing endpoint recorded. Last human test completed 2023, NCT04677491.
Interpretation These counts include studies where Ospemifene was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
20
phase2
8
phase4
5
na or unstated
3
phase1
1
Last recorded human testNCT04677491
2023-12-01
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Ospemifene shown lifespan?
Interpretation Overall survival — the recorded outcome words.
Show the evidence
mouse
lifespan
humanNCT00002529
mechanism-only; Overall survival; 37
recorded 2026-09-01 · last checked 2026-09-04
Q4
7 of Ospemifene's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (2), accrual/recruitment (2), funding/business (1) and other (2): Ospemifene's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Withdrawn due to change in standard of care - new protocol required"; 7 of 37 registered studies
Show the evidence
Trial
NCT00010322
terminated; "Withdrawn due to change in standard of care - new protocol required"
NCT00097344
terminated; "Identical study Biomed 777-CLP-029 did not meet superiority endpoint"
NCT00267553
terminated; "This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint"
NCT01214291
withdrawn; "cost of conducting the study and increased burden on the clinical trial professionals make it impossible for us to proceed with the development of the drug."
NCT03018106
terminated; "Obstacles with recruitment"
NCT03238703
withdrawn; "Administrative closure based on sponsor recommendation, prior to subject enrollment"
1 further recorded trialNCT04531748
withdrawn; "Funding"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ospemifene used Toremifene 20 mg — over how long?
6 recorded entries; human; also "Toremifene 20 mg", "Ospemifene 30 mg", "Ospemifene 60 mg"
Show the evidence
human
NCT00106691
Toremifene 20 mg
NCT00276094
Ospemifene 30 mg
NCT00276094
Ospemifene 60 mg
NCT00630539
Ospemifene 5 mg
NCT00630539
Ospemifene 15 mg
NCT01586364
Ospemifene 60Mg Oral Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q6
Ospemifene's half-life is 26 hours — which schedules were studied?
26 hours, the half-life Ospemifene's label states. openfda-label · 9accbcc9-78ee-4f84-9b7e-704f2ab1c413 · 2026-08-30
Show the evidence
half life
26 hours hours; Excretion The apparent terminal half-life of ospemifene in postmenopausal women is approximately 26 hours.
bioavailability
The absolute bioavailability of ospemifene was not evaluated.
metabolism
The apparent volume of distribution is 448 L. Metabolism In vitro experiments with human liver microsomes indicated that ospemifene primarily undergoes metabolism via CYP3A4, CYP2C9, and CYP2C19.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adverse events, detection of cell viability and disease free survival did Ospemifene's trials measure?
adverse events, detection of cell viability and disease free survival lead 26 outcome terms across Ospemifene's trials. ClinicalTrials.gov · 2026-09-01
Interpretation vaginal ph, superficial cells in maturation index of vaginal smear, recurrence free rate, incidence of adverse events, serum lipids and disease free survival follow.
Show the evidence
overall survival
1
time to tumor progression
1
time to progression
1
vaginal ph
1
superficial cells in maturation index of vaginal smear
1
recurrence free rate
1
14 more recorded rows
incidence of adverse events
1
serum lipids
1
disease free survival
1
incidence of ovarian cyst
1
response rate
1
pathomorphological response
1
adverse events
1
female sexual function index
1
pain sex
1
vaginal dryness
1
vaginal itching
1
vaginal irritation
1
detection of cell viability
1
peak increase in covid 19 sign and symptom
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
What will the one ongoing trial of Ospemifene report, and when?
"Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)"; n 766; "invasive disease free survival (iDFS)"; 2031-05-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ospemifene could settle lifespan?
NCT05891093 measures invasive disease free survival (iDFS), reading out 2031-05-31.
1 open trial; n 766; "Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)"
Show the evidence
TrialNCT05891093
"Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)"; n 766; "invasive disease free survival (iDFS)"; 2031-05-31
Q10
Which 10 trials of Ospemifene posted no result?
Posted no result
10 of 10 completed trials
Registrations
NCT00044291, NCT00129142, NCT00534846, NCT00020735, NCT00002529 and NCT00002595, and 4 more
Completion dates
oldest 2006-01; newest 2023-12-01
Show the evidence
Trial
NCT00044291
2006-01
NCT00129142
2007-11
NCT00534846
2009-02
NCT00020735
2009-06
NCT00002529
2010-08
NCT00002595
2010-09
4 further recorded trials
NCT01417754
2011-06
NCT02271282
2016-05
NCT02344940
2018-08
NCT04677491
2023-12-01
Q11
At the median, Ospemifene's trials enrolled 220 people — anything larger?
Median enrolment
220
Largest enrolment
1589
Registered trials counted
36
Q12
What do 397 spontaneous reports say about Ospemifene — 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.
Ospemifene appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 397 reaction mentions were counted: hot flush 89; muscle spasms 53; labelled drug-drug interaction medication error 48; vaginal discharge 43. open-targets-adr · CHEMBL2105395 · 2026-06-24
Show the evidence
hot flush
89
muscle spasms
53
labelled drug-drug interaction medication error
48
vaginal discharge
43
vaginal haemorrhage
36
headache
32
4 more recorded rows
therapeutic response unexpected
32
hyperhidrosis
30
alopecia
18
weight increased
16
recorded 2026-06-24 · last checked 2026-09-04
Q13
Ospemifene and CYP3A4, CYP2C19 and CYP2C9: shared by which compounds?
CYP3A4, CYP2C19 and CYP2C9 appear in Ospemifene's recorded interaction sentences, 28 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2B6
pharmacokinetics
Bupropion Ospemifene 60 mg was administered once daily for seven consecutive days after the evening meal in sixteen postmenopausal women (not homozygous for CYP2B6*6).
pharmacokinetics
The geometric mean ratio (90% CI) for hydroxybupropion, an active metabolite formed via CYP2B6, with and without ospemifene for C max and AUC 0-inf was 1.16 (1.09-1.24) and 0.98 (0.92-1.04), respectively.
pharmacokinetics
In order of decreasing potency, ospemifene was suggested to be a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8, CYP2D6, and CYP3A4 in in vitro studies.
CYP2C19
pharmacokinetics
Metabolism In vitro experiments with human liver microsomes indicated that ospemifene primarily undergoes metabolism via CYP3A4, CYP2C9, and CYP2C19.
pharmacokinetics
CYP2C19 and other pathways contribute to the metabolism of ospemifene.
pharmacokinetics
It is unclear if ospemifene will affect the pharmacokinetics of drugs metabolized by CYP2C19 due to the significant time gap between ospemifene and omeprazole administration.
pharmacokinetics
Rifampin (CYP3A4/CYP2C9/CYP2C19 Inducer) Rifampin 600 mg was given once daily for 5 consecutive days (given at least one hour before or two hours after a meal) in the late afternoon.
pharmacokinetics
In order of decreasing potency, ospemifene was suggested to be a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8, CYP2D6, and CYP3A4 in in vitro studies.
pharmacokinetics
Effect of Co-Administered Drugs on the Pharmacokinetics of Ospemifene Fluconazole (CYP3A4/CYP2C9/CYP2C19 Inhibitor) Fluconazole (a moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor) 400 mg was given on Day 1 followed by 200 mg on Days 2 to 5 under fasted condition.
1 more recorded row
CYP2C19pharmacokinetics
Omeprazole (CYP2C19 Inhibitor) Omeprazole (a moderate CYP2C19 inhibitor) 40 mg was given for 5 days.
CYP2C8pharmacokinetics
In order of decreasing potency, ospemifene was suggested to be a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8, CYP2D6, and CYP3A4 in in vitro studies.
CYP2C9
pharmacokinetics
Metabolism In vitro experiments with human liver microsomes indicated that ospemifene primarily undergoes metabolism via CYP3A4, CYP2C9, and CYP2C19.
pharmacokinetics
Drug Interactions Ospemifene is metabolized primarily by CYP3A4 and CYP2C9.
pharmacokinetics
Effect of Ospemifene on the Pharmacokinetics of the Co-Administered Drug Warfarin Ospemifene 60 mg was given after a light breakfast (two slices of bread with ham and cheese, and juice) once daily for 12 days in sixteen postmenopausal women who were determined to be rapid metabolizers of CYP2C9 (CYP2C9*1/*1 or CYP2C9*1/*2).
pharmacokinetics
Rifampin (CYP3A4/CYP2C9/CYP2C19 Inducer) Rifampin 600 mg was given once daily for 5 consecutive days (given at least one hour before or two hours after a meal) in the late afternoon.
pharmacokinetics
In order of decreasing potency, ospemifene was suggested to be a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8, CYP2D6, and CYP3A4 in in vitro studies.
pharmacokinetics
Effect of Co-Administered Drugs on the Pharmacokinetics of Ospemifene Fluconazole (CYP3A4/CYP2C9/CYP2C19 Inhibitor) Fluconazole (a moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor) 400 mg was given on Day 1 followed by 200 mg on Days 2 to 5 under fasted condition.
CYP2D6pharmacokinetics
In order of decreasing potency, ospemifene was suggested to be a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8, CYP2D6, and CYP3A4 in in vitro studies.
CYP3A4
pharmacokinetics
Metabolism In vitro experiments with human liver microsomes indicated that ospemifene primarily undergoes metabolism via CYP3A4, CYP2C9, and CYP2C19.
pharmacokinetics
Drug Interactions Ospemifene is metabolized primarily by CYP3A4 and CYP2C9.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 10 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.