This page shows what was measured, who it was measured in, and what that does not settle.
What Niraparib does in the body
Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.
From the FDA-approved label: Niraparib is an inhibitor of PARP enzymes, including PARP-1 and PARP-2, that play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased niraparib‑induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2 . Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient-derived xenograft tumor models with homologous recombination deficiency (HRD) that had either mutated or wild-type BRCA1/2 .
Why people take it. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.
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 · 195Q483UZD · read 2026-08-29
Its recorded molecular formula is C26H30N4O5S, weighing 510.61.
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 143 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
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
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
Percentage of patients that are treated based on their molecular tumor profile
✗ The study did not show it
Who was studied
NCT02925234
How many people
1550
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Progression Free Survival (PFS)
✗ The study did not show it
Who was studied
NCT03602859
How many people
1400
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
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
✗ The study did not show it
Who was studied
NCT03768063
How many people
1000
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
Progression Free Survival (PFS)
✗ The study did not show it
Who was studied
NCT05009082
How many people
970
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
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or…
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of ZEJULA have not been established in pediatric patients.”
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
On older people, the label states: “In PRIMA, 39% of patients were aged 65 years or older and 10% were aged 75 years or older.”
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, ZEJULA can cause fetal harm when administered to pregnant women [see Clinical Pharmacology ( 12.1 )] .”
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed child or milk production.”
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
On people with reduced liver function, the label states: “For patients with moderate hepatic impairment, the recommended dosage of ZEJULA is 200 mg once daily, regardless of body weight or platelet count.”
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4.
No source is stored against this line.
What is in the pack
Sold as capsule, tablet, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
19 products list this as an active ingredient in the United States drug directory. 17 of them contain it and nothing else.
FDA National Drug Code directory · 54893-0516 · read 2026-08-29
They are sold as capsule, powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 54893-0516 · 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 · 54893-0516 · read 2026-08-29
2 published labels name 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 · 8245a990-3268-4613-b5c5-9537858a1eb9 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 8245a990-3268-4613-b5c5-9537858a1eb9 · read 2026-08-29
ZEJULA is oral at 3 DOSAGE FORMS AND STRENGTHS • Tablets: 100-mg gray, oval-shaped, film-coated tablet debossed with “100” on one side and “Zejula” on the other side. • Tablets: 200-mg blue, oval-shaped, film-coated tablet debossed with…, recorded as fda label in effect 2026-07-28 in the United States.
US prescribing information · b7f675e2-159c-490c-b6f4-3f16d9492b7d · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Niraparib 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 Niraparib 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.
Where else this substance is registered
FDA substance identifier (UNII)
195Q483UZD
RxNorm concept
2637449
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 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 NDA208447, approved 20170327 to GLAXOSMITHKLINE.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q2
On the Niraparib label: indicated for what?
"ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with…": indications and usage on Niraparib's label. DailyMed label · b7f675e2-159c-490c-b6f4-3f16d9492b7d · 2026-07-28
Q3
185 registered trials of Niraparib — at which phases?
Registered studies posting no result
142 of 185
185 registered studies of Niraparib: 111 phase2, 57 phase1, 19 phase3, 11 na or unstated, 4 early phase1, 4 phase4, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
terminated; "The study was terminated due to futility."
NCT02500901
terminated; "Suspended by funder"
NCT02826512
terminated; "Not enough eligble patient can be found, too many screen failures"
NCT03209401
terminated; "Lack of accrual"
NCT03644342
terminated; "A recent change in treatment landscape may make study futile"
14 further recorded trials
NCT03806049
withdrawn; "Lack of financial support"
NCT03840967
terminated; "Due to slow accruals"
NCT03869190
terminated; "Study was closed early as the sponsor decided not to continue development of certain treatment combinations."
NCT03891576
terminated; "Low accrual rate"
NCT03944902
terminated; "will not resume. company choosing not to continue with drug. one participant now off study."
NCT03955471
terminated; "The study will not resume based on the results of a planned interim analysis that showed futility"
NCT04030559
terminated; "PI choice; poor accrual"
NCT04159155
terminated; "Low accrual"
NCT04267939
terminated; "There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation."
NCT04544995
terminated; "Sponsor Decision"
NCT04655183
withdrawn; "Trial withdrawn based on portfolio prioritization; oral ATRi M1774 in combination with niraparib is under investigation in DDRiver Solid Tumor 301"
NCT04762901
withdrawn; "Funding was terminated."
NCT04779151
terminated; "Abandon of the partner, GSK"
NCT04826198
terminated; "Treatment availability issue: The manufacturer of AsiDNA™ decided to cease production to develop an improved version, and the contract ensuring access to this molecule has expired."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Niraparib used Niraparib 200 mg — over how long?
studies of Niraparib used the recorded amount. ClinicalTrials.gov · 2026-09-01
4 recorded entries; human; also "Niraparib 200 mg", "Niraparib 100 mg", "Niraparib 300 mg"
Show the evidence
human
NCT03431350
Niraparib 200 mg
NCT04502602
Niraparib 100 mg
NCT04502602
Niraparib 300 mg
NCT04812366
Niraparib 100mg Oral Capsule
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which running trial of Niraparib could settle lifespan?
NCT06827353 measures Progression-free survival of patients with high-grade stage III and IV epithelial ovarian carcinoma who received chemotherapy between those who received maintenance treatment with bevacizumab and those who received niraparib., reading out 2025-09-30.
21 open trials; n 300; "Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency"
Show the evidence
Trial
NCT06827353
"Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency"; n 300; "Progression-free survival of patients with high-grade stage III and IV epithelial ovarian carcinoma who received chemotherapy between those who received maintenance treatment with bevacizumab and those who received niraparib."; 2025-09-30
NCT02655016
"A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy"; n 733; "Progression Free Survival"; 2026-05-29
NCT05515575
"A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA"; n 8; "Progression free survival (PFS)"; 2026-08
NCT03981796
"A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer"; n 785; "Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment"; 2026-11-26
NCT03903835
"ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
NCT03748641
"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer"; n 765; "Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)"; 2027-02-27
14 further recorded trials
NCT04701307
"Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas"; n 48; "6-month Progression free survival (PFS)"; 2027-04-30
NCT05718323
"Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC"; n 44; "Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)"; 2027-06
NCT06141265
"Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab"; n 116; "Progression Free Survival (PFS) Rate at 24 months (PFS24)"; 2027-09
NCT04592237
"Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer"; n 120; "Progression-free survival"; 2027-12-31
NCT05990192
"SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy"; n 42; "Progression free survival"; 2027-12-31
NCT06180356
"Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression"; n 30; "Progression-free survival (PFS)"; 2028-01
NCT06388733
"A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma"; n 450; "Overall survival"; 2028-03
NCT05615818
"Personalized Medicine for Advanced Biliary Cancer Patients"; n 800; "Progression-free survival (PFS)"; 2028-06
NCT04947254
"Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer"; n 200; "Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)"; 2028-06-07
NCT06747845
"Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy"; n 68; "Progression-free survival (PFS) in the experimental arm"; 2029-01-30
NCT05784012
"Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma"; n 34; "1-year disease free survival"; 2029-03
NCT03602859
"A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer"; n 1400; "Progression Free Survival (PFS)"; 2029-04-30
NCT05009082
"Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer"; n 970; "Progression Free Survival (PFS)"; 2031-12
NCT05183984
"Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer"; n 390; "Progression-Free survival (PFS) rate up to 24 months"; 2032-02-01
Q7
Which 20 trials of Niraparib posted no result?
Posted no result
20 of 20 completed trials
Registrations
NCT01294735, NCT00749502, NCT02476552, NCT02924766, NCT04785716 and NCT02044120, and 14 more
Completion dates
oldest 2012-05; newest 2024-08-05
Show the evidence
Trial
NCT01294735
2012-05
NCT00749502
2013-06
NCT02476552
2018-01
NCT02924766
2019-07-19
NCT04785716
2020-08-03
NCT02044120
2021-01
14 further recorded trials
NCT04546373
2021-07-31
NCT03945084
2021-09-01
NCT02354131
2021-12-15
NCT04392102
2022-08-11
NCT06086665
2022-10-31
NCT03076203
2022-11-07
NCT03752216
2022-12-13
NCT05130515
2023-01-01
NCT05734911
2023-02-07
NCT03695380
2023-07-12
NCT04284852
2023-10-01
NCT05261269
2023-10-11
NCT04240106
2023-11-17
NCT03598270
2024-08-05
Q8
At the median, Niraparib's trials enrolled 42 people — anything larger?
Median enrolment
42
Largest enrolment
3000
Registered trials counted
184
Q9
What do 1783 spontaneous reports say about Niraparib — 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.
Niraparib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1783 reaction mentions were counted: nausea 309; platelet count decreased 245; fatigue 226; disease progression 195. FAERS via Open Targets · CHEMBL1094636 · 2026-06-24
Show the evidence
nausea
309
platelet count decreased
245
fatigue
226
disease progression
195
constipation
169
thrombocytopenia
166
4 more recorded rows
vomiting
123
carbohydrate antigen 125 increased
121
anaemia
120
headache
109
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Niraparib's label not list?
Drug Interaction Studies In Vitro Studies: Cytochrome P450 ( CYP) Enzymes: Niraparib and M1 did not inhibit CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
pharmacokinetics
Niraparib and M1 do not induce CYP3A.
pharmacokinetics
Uridine 5'-Diphospho-Glucuronosyltransferases (UGTs): Niraparib did not inhibit UGT1A1, UGT1A4, UGT1A9, and UGT2B7.
pharmacokinetics
Transporters: Niraparib inhibits BCRP, MATE1, and MATE2K, but does not inhibit P-glycoprotein (P-gp), BSEP, or MRP2.
pharmacokinetics
M1 did not inhibit P‑gp, BCRP, BSEP, MRP2, MATE1 or MATE2K.
pharmacokinetics
Niraparib and M1 did not inhibit OATP1B1, OATP1B3, OCT1, OAT1, OAT3, or OCT2.
2 more recorded rows
Interaction statementpharmacokinetics
Niraparib is a substrate of P-gp and BCRP, but not of BSEP, MRP2, MATE1, MATE2K, OATP1B1, OATP1B3, OCT1, OAT1, OAT3, or OCT2.
Interaction statementpharmacokinetics
M1 is a substrate of MATE1 and MATE2K, but not of P-gp, BCRP, BSEP, MRP2, OATP1B1, OATP1B3, OCT1, OAT1, OAT3, or OCT2.
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
✗ 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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