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Olaparib

  • 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 Olaparib does in the body

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

From the FDA-approved label: Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer, both as monotherapy or following platinum-based chemotherapy.

Why people take it. Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

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 · WOH1JD9AR8 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 173 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.

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

The study did not show it

Who was studied
NCT01042379
How many people
5000
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

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

The study did not show it

Who was studied
NCT02693535
How many people
4200
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. 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
NCT03486873
How many people
3500
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

16 weeks clinical response

The study did not show it

Who was studied
NCT04817956
How many people
3000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. 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

Accrual of patients to ComboMATCH treatment trials

The study did not show it

Who was studied
NCT05564377
How many people
2900
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery

The study did not show it

Who was studied
NCT06966700
How many people
2400
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
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.

  • Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

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 Lynparza have not been established in pediatric patients.”

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-30

  • On older people, the label states: “Of the 2901 patients with advanced solid tumors who received Lynparza as a single agent, 680 (23%) patients were aged ≥65 years, and this included 206 (7%) patients who were aged ≥75 years.”

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-30

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

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of olaparib in human milk, or on its effects on the breastfed infant or on milk production.”

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-30

  • On people with reduced liver function, the label states: “No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B).”

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage modification is recommended in patients with mild renal impairment (CLcr 51 to 80 mL/min estimated by Cockcroft-Gault).”

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · 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 tablet, capsule, 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 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

  • 22 products list this as an active ingredient in the United States drug directory. 22 of them contain it and nothing else.

    FDA National Drug Code directory · 17228-0668 · read 2026-08-29

  • They are sold as powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 17228-0668 · read 2026-08-29

  • The regulator's established pharmacologic class for it is poly(adp-ribose) polymerase inhibitor [epc] and poly(adp-ribose) polymerase inhibitors [moa].

    FDA National Drug Code directory · 17228-0668 · 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 · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · read 2026-08-29

  • Lynparza is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: • 150 mg: green to green/grey, oval, bi-convex, film-coated, with debossment ‘OP150’ on one side and plain on the reverse side. • 100 mg: yellow to dark yellow, oval, bi-convex, fil…, recorded as fda label in effect 2025-07-10 in the United States.

    US prescribing information · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · 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 Olaparib 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 Olaparib 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)
WOH1JD9AR8
RxNorm concept
1942482

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 6 approved applications cover products containing this substance. The earliest was NDA206162, approved 20141219 to ASTRAZENECA.

    Drugs@FDA application register · NDA206162 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA206162 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20110101.

    FDA National Drug Code directory · 17228-0668 · 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 Olaparib label: indicated for what?

"Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial…": indications and usage on Olaparib's label. DailyMed label · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · 2025-07-10

371 registered trials of Olaparib — at which phases?

Registered studies posting no result
264 of 371

371 registered studies of Olaparib: 224 phase2, 118 phase1, 43 phase3, 10 early phase1, 8 na or unstated, 6 phase4, 2 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

306 with a PubMed record

Show the evidence
  • phase2
    224
  • phase1
    118
  • phase3
    43
  • early phase1
    10
  • na or unstated
    8
  • phase4
    6
11 more recorded rows
  • na
    2
  • completed
    122
  • active not recruiting
    94
  • recruiting
    60
  • terminated
    36
  • unknown
    36
  • withdrawn
    14
  • not yet recruiting
    6
  • approved for marketing
    1
  • enrolling by invitation
    1
  • no longer available
    1

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

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

safety (1), futility/efficacy (3), accrual/recruitment (18), funding/business (7), sponsor decision unspecified (5) and other (15): Olaparib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study stopped due to issues surrounding development and formulation of olaparib"; 49 of 371 registered studies

Show the evidence

Trial

  • NCT01491139
    withdrawn; "Study stopped due to issues surrounding development and formulation of olaparib"
  • NCT01661868
    withdrawn; "Drug not available."
  • NCT02392676
    withdrawn; "Study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand."
  • NCT02419495
    terminated; "Administratively Complete"
  • NCT02485990
    terminated; "Withdrawal of sponsor support"
  • NCT02561832
    terminated; "This decision was based upon strategic considerations impacting the clinical development of olaparib in this indication."
14 further recorded trials
  • NCT02576444
    terminated; "The study was paused during COVID and without the ability to initiate the 4th arm in the study, the decision was to terminate the study in 2022."
  • NCT02679963
    terminated; "study design, change of standard of care, enrollment difficulties"
  • NCT02686008
    withdrawn; "The study was stopped due to lack of funding."
  • NCT02769962
    terminated; "Accrual and drug manufacturing and supply were discontinued in 2025."
  • NCT02899728
    terminated; "Inadequate accrual rate"
  • NCT03251872
    terminated; "OPTION pilot trial merged with the new NCT03782818 - OPTION multicenter trial"
  • NCT03367689
    terminated; "Very slow recruitment due to subject profile"
  • NCT03570476
    terminated; "Terminated due to slow accrual"
  • NCT03782818
    terminated; "The recruitment was stopped on October 31st 2024 due to limited recruitment within the last year, as well as the end of funding (Spring 2025)."
  • NCT03801369
    terminated; "loss of funding"
  • NCT03810105
    terminated; "Due to low accrual"
  • NCT03878524
    terminated; "Low accrual"
  • NCT03924245
    terminated; "Change in participant landscape and other treatment availability"
  • NCT03955640
    terminated; "PI decided not to move forward because of low accrual"

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

Human studies of Olaparib used Olaparib 300mg tablets — over how long?

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

9 recorded entries; human; also "Olaparib 300mg tablets", "Placebo to match olaparib 300mg", "Olaparib (300 mg BID)"

Show the evidence

human

  • NCT01844986
    Olaparib 300mg tablets
  • NCT01874353
    Placebo to match olaparib 300mg
  • NCT02029001
    Olaparib (300 mg BID)
  • NCT02861573
    Olaparib 400 mg
  • NCT02861573
    Olaparib 300 mg
  • NCT03561870
    Olaparib 150 MG
3 more recorded rows
  • human NCT04624204
    Olaparib 300 mg BID
  • human NCT05258747
    Olaparib tablets, 150 mg
  • human NCT05258747
    Lynparza® (olaparib) tablets 150 mg

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

Olaparib's half-life is 14.9 ± 8.2 hours — which schedules were studied?

14.9 ± 8.2 hours, the half-life Olaparib's label states: "Elimination The mean (± standard deviation) terminal plasma half-life of olaparib is 14.9 ± 8.2 hours and the apparent plasma clearance is 7.4 ± 3.9 L/h following a single 300 mg dose of Lynparza." DailyMed label · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · 2025-07-10

tmax 1.5 hours.

Show the evidence
  • half life pharmacokinetics
    14.9 ± 8.2 hours; Elimination The mean (± standard deviation) terminal plasma half-life of olaparib is 14.9 ± 8.2 hours and the apparent plasma clearance is 7.4 ± 3.9 L/h following a single 300 mg dose of Lynparza.
  • tmax pharmacokinetics
    1.5 hours; Absorption Following oral administration of olaparib, the median time to peak plasma concentration is 1.5 hours.
  • metabolism pharmacokinetics
    Metabolism Olaparib is metabolized by cytochrome P450 (CYP) 3A in vitro.

recorded 2025-07-10 · last checked 2026-09-04

Which running trial of Olaparib could settle lifespan?

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

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

Show the evidence

Trial

  • NCT02299999
    "SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
  • NCT05536128
    "Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor"; n 64; "6-month progression-free survival (PFS) rate"; 2025-12-31
  • NCT04753879
    "Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer."; n 38; "Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria."; 2026-07-01
  • NCT03775486
    "Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)"; n 401; "Progression-free Survival"; 2026-09-27
  • NCT04548752
    "Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations"; n 88; "Progression-free survival (PFS)"; 2026-10-01
  • NCT06419179
    "Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)"; n 29; "Progression-free survival (PFS)"; 2026-12
14 further recorded trials
  • NCT03737643
    "Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients"; n 1407; "Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set"; 2026-12-23
  • NCT05222971
    "Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy"; n 62; "6-month progression-free survival rate"; 2026-12-30
  • NCT01081951
    "Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer"; n 162; "Progression Free Survival (PFS)"; 2026-12-31
  • NCT01874353
    "Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy"; n 327; "Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)"; 2026-12-31
  • NCT03459846
    "A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)"; n 154; "Progression-free Survival (PFS)"; 2026-12-31
  • NCT05457257
    "Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations"; n 43; "Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)"; 2026-12-31
  • NCT04666740
    "A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy"; n 63; "Progression free survival (PFS)"; 2027-01
  • NCT03012321
    "Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects"; n 70; "Objective Progression Free Survival (PFS)"; 2027-01-16
  • NCT05432791
    "Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working"; n 74; "Progression Free Survival (PFS) (Phase II)"; 2027-01-30
  • NCT03732820
    "Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer"; n 895; "Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment"; 2027-02-05
  • NCT05171816
    "Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)"; n 110; "Radiological Progression Free Survival (rPFS)"; 2027-02-05
  • NCT04034927
    "Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer"; n 61; "Progression Free Survival (PFS)"; 2027-02-21
  • NCT05463848
    "Surgical Pembro +/- Olaparib w TMZ for rGBM"; n 52; "6-month Progression-Free Survival (PFS6)"; 2027-03-01
  • NCT02345265
    "Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer"; n 70; "Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer"; 2027-03-04

Which 52 trials of Olaparib posted no result?

Posted no result
52 of 52 completed trials
Registrations
NCT00633269, NCT00516802, NCT00572364, NCT00516438, NCT00710268 and NCT00515866, and 46 more
Completion dates
oldest 2008-10; newest 2024-04-11
Show the evidence

Trial

  • NCT00633269
    2008-10
  • NCT00516802
    2009-01
  • NCT00572364
    2009-06
  • NCT00516438
    2009-11
  • NCT00710268
    2009-11
  • NCT00515866
    2012-07
14 further recorded trials
  • NCT00535353
    2015-02-13
  • NCT02338622
    2017-03-21
  • NCT01851265
    2017-06-06
  • NCT01390571
    2017-06-20
  • NCT00707707
    2018-02-19
  • NCT02340611
    2018-06
  • NCT02324998
    2019-05
  • NCT02511795
    2019-10-16
  • NCT02398058
    2019-12-01
  • NCT01237067
    2019-12-12
  • NCT02882308
    2020-01-10
  • NCT04152941
    2020-02-11
  • NCT01562210
    2020-03-13
  • NCT03534492
    2020-03-16

At the median, Olaparib's trials enrolled 55 people — anything larger?

Median enrolment
55
Largest enrolment
4200
Registered trials counted
369

What do 1745 spontaneous reports say about Olaparib — 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.

Olaparib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1745 reaction mentions were counted: malignant neoplasm progression 421; anaemia 390; nausea 255; myelodysplastic syndrome 149. FAERS via Open Targets · CHEMBL521686 · 2026-06-24

Show the evidence
  • malignant neoplasm progression
    421
  • anaemia
    390
  • nausea
    255
  • myelodysplastic syndrome
    149
  • acute myeloid leukaemia
    113
  • disease progression
    108
4 more recorded rows
  • interstitial lung disease
    88
  • thrombocytopenia
    88
  • pancytopenia
    76
  • neutrophil count decreased
    57

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

Which 10 reactions does Olaparib's label not list?

acute myeloid leukaemia, anaemia and disease progression and 7 more reported for Olaparib, absent from its label. FAERS via Open Targets · CHEMBL521686 · 2026-06-24

2 label terms; 10 reported and unlisted; 741ff3e3-dc1a-45a6-84e5-2481b27131aa

Show the evidence
  • acute myeloid leukaemia
    count not stated
  • anaemia
    count not stated
  • disease progression
    count not stated
  • interstitial lung disease
    count not stated
  • malignant neoplasm progression
    count not stated
  • myelodysplastic syndrome
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • neutrophil count decreased
    count not stated
  • pancytopenia
    count not stated
  • thrombocytopenia
    count not stated

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

Olaparib and CYP3A and CYTOCHROME P450: shared by which compounds?

CYP3A and CYTOCHROME P450 appear in Olaparib's recorded interaction sentences, 8 in all. DailyMed label · 741ff3e3-dc1a-45a6-84e5-2481b27131aa · 2025-07-10

CYP3A, CYP3A; 2 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    • Strong or moderate CYP3A inhibitors: Avoid concomitant use.
  • drug_interactions
    ( 2.4 , 7.2 , 12.3 ) • Strong or moderate CYP3A inducers: Avoid concomitant use.
  • drug_interactions
    7.2 Effect of Other Drugs on Lynparza Strong and Moderate CYP3A Inhibitors Coadministration of CYP3A inhibitors can increase olaparib concentrations, which may increase the risk for adverse reactions [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Avoid coadministration of strong or moderate CYP3A inhibitors.
  • drug_interactions
    Strong and Moderate CYP3A Inducers Concomitant use with a strong or moderate CYP3A inducer decreased olaparib exposure, which may reduce Lynparza efficacy [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Avoid coadministration of strong or moderate CYP3A inducers.
2 more recorded rows
  • Interaction statement pharmacokinetics
    Metabolism Olaparib is metabolized by cytochrome P450 (CYP) 3A in vitro.
  • Interaction statement pharmacokinetics
    Drug Interaction Studies Clinical Studies CYP3A Inhibitors: Concomitant use of itraconazole (strong CYP3A inhibitor) increased olaparib C max by 42% and AUC by 170%.

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

recorded 2025-07-10 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL521686
PubChem CID
23725625
CAS number
763113-22-0
RxCUI
1597582
InChIKey
FDLYAMZZIXQODN-UHFFFAOYSA-N
Also called
AZ-2281, AZ2281, AZD 2281, AZD2281, KU-0059436, KU0059436, KU-59436, LYNPARZA, NSC-747856, OLAPARIBAZD-2281AZD 2281KU 59436KU-59436LYNPARZAAZD2281KU59436O-9201, OLAPARIB COMPONENT OF KEYLYNK-010, mk-7339
Salt form
olaparib tablets
Development code
KEYLYNK-010 COMPONENT OLAPARIB
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

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