Drug · Small Molecule

Niraparib

CI-DRUG-00000409Explore in graph →NCIt C80059 CHEMBL1094636 CIViC Approved

Regulatory

Approvals (9)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ZEJULA (DIN 02530031) under ATC L01XK02 NIRAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 13, 2023	health-canada-dpd
CA Health Canada	—	Marketed in Canada as AKEEGA (DIN 02538563) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 14, 2023	health-canada-dpd
CA Health Canada	—	Marketed in Canada as AKEEGA (DIN 02538555) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 14, 2023	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	64	27	18	163	9	CA, EU, US	Nov 16, 2017	2008-09
Malignant Prostate Neoplasm	Approved	Phase 2	4	2	0	9	1	EU	Apr 19, 2023	2016-03
Malignant Ovarian Neoplasm	Phase4	Phase 4	13	9	8	46	0	—	—	Jun 21, 2013
Malignant Breast Neoplasm	Phase3	Phase 3	6	1	1	17	0

Curated evidence

Clinical evidence (13)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–13 of 13 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRCA1 Mutation + BRCA2 MutationBRCA2 BRCA14

Clinical trials

Trials with this intervention (173)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–173 of 173 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04217798	Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer	unknown	Phase 2	36	Peking Union Medical College HospitalOTHER	1	Sep 1, 2021	clinicaltrials
NCT04679064	Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Molecule

Record

Kind: Small Molecule
Mechanism: Poly [ADP-ribose] polymerase 2 inhibitor; Poly [ADP-ribose] polymerase-1 inhibitor
Targets: 2 genes
UNII: 195Q483UZD
Aliases: AKEEGA, JNJ-64091742, MK 4827, MK-4827, MK4827, Niraparib, NIRAPARIB (MK-4827), Niraparib Tosylate, ZEJULA, ZL-2306

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (13)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01	Antineoplastic agents
ATC (WHO)	L01XK02	NIRAPARIB
ATC (WHO)	L01XK52

BAP1 Q267fs1
Niraparib	Clear Cell Renal Cell Carcinoma	Predictive	C	Supports Sensitivity Response	1	submitted	EID11199 A patient with Clear cell renal cell carcinoma previously treated with sorafenib, axitinib, and everolimus was found to harbor a BAP1 frameshift mutation described as c.799_800del (p.Q267fs). Based o… (full text at CIViC) PMID 35875073 · Lian et al., 2022 · Open in CIViC	civic

BAP1 Q267fs1

Niraparib

Clear Cell Renal Cell Carcinoma

Predictive

Supports Sensitivity Response

submitted

EID11199

A patient with Clear cell renal cell carcinoma previously treated with sorafenib, axitinib, and everolimus was found to harbor a BAP1 frameshift mutation described as c.799_800del (p.Q267fs). Based o… (full text at CIViC)

PMID 35875073 · Lian et al., 2022 · Open in CIViC

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SLFN11 EXPRESSION1
Niraparib + TemozolomideCombination	Ewing Sarcoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID5884 SLFN11 is an ETS transcription factor response gene and a predictive marker for therapeutic response to topoisomerase I inhibitors and temozolomide-PARP inhibitor combinations in ETS-activated cancers… (full text at CIViC) PMID 25779942 · Tang et al., 2015 · Open in CIViC	civic

SLFN11 EXPRESSION1

Niraparib + TemozolomideCombination

Ewing Sarcoma

Predictive

Supports Sensitivity Response

submitted

EID5884

SLFN11 is an ETS transcription factor response gene and a predictive marker for therapeutic response to topoisomerase I inhibitors and temozolomide-PARP inhibitor combinations in ETS-activated cancers… (full text at CIViC)

PMID 25779942 · Tang et al., 2015 · Open in CIViC

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PBRM1 Loss-of-function1
Niraparib	Malignant Biliary Tract NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID12697 In biliary tract cancer (BTC) models with PBRM1 loss-of-function (EGI1 and CCC5), sensitivity to PARP inhibitors increased significantly, with lower IC50 values for niraparib (2.25 µM vs 6.62 µM, p = … (full text at CIViC) PMID 37400502 · Zimmer et al., 2023 · Open in CIViC	civic

PBRM1 Loss-of-function1

Niraparib

Malignant Biliary Tract NeoplasmALIAS

Predictive

Supports Sensitivity Response

submitted

EID12697

In biliary tract cancer (BTC) models with PBRM1 loss-of-function (EGI1 and CCC5), sensitivity to PARP inhibitors increased significantly, with lower IC50 values for niraparib (2.25 µM vs 6.62 µM, p = … (full text at CIViC)

PMID 37400502 · Zimmer et al., 2023 · Open in CIViC

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MYCN Overexpression1
Niraparib + Olaparib + Talazoparib + VeliparibSubstitutes	Neuroblastoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID9006 A preclinical study investigated the sensitivity of PARP inhibitors in Neuroblastoma with MYCN-amplified (IMR-32) cells and found a decrease in cellular viability in comparison to the non-MYCN amplifi… (full text at CIViC) PMID 32577161 · King et al., 2020 · Open in CIViC	civic

MYCN Overexpression1

Niraparib + Olaparib + Talazoparib + VeliparibSubstitutes

Neuroblastoma

Predictive

Supports Sensitivity Response

submitted

EID9006

A preclinical study investigated the sensitivity of PARP inhibitors in Neuroblastoma with MYCN-amplified (IMR-32) cells and found a decrease in cellular viability in comparison to the non-MYCN amplifi… (full text at CIViC)

PMID 32577161 · King et al., 2020 · Open in CIViC

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RB1 Loss-of-function1
Niraparib + Olaparib + TalazoparibSubstitutes	Osteosarcoma	Predictive	D	Supports Sensitivity Response	4	submitted	EID12032 The study investigated the sensitivity of RB1-mutant osteosarcoma cell lines to PARPi. It found that cell viability, measured by AUC values after 5 days, was significantly lower in RB1-defective cell … (full text at CIViC) PMID 34862364 · Zoumpoulidou et al., 2021 · Open in CIViC	civic

RB1 Loss-of-function1

Niraparib + Olaparib + TalazoparibSubstitutes

Osteosarcoma

Predictive

Supports Sensitivity Response

submitted

EID12032

The study investigated the sensitivity of RB1-mutant osteosarcoma cell lines to PARPi. It found that cell viability, measured by AUC values after 5 days, was significantly lower in RB1-defective cell … (full text at CIViC)

PMID 34862364 · Zoumpoulidou et al., 2021 · Open in CIViC

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BRCA1 Mutation2
Niraparib	High Grade Ovarian Serous CarcinomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	5	submitted	EID13120 ENGOT-OV16/NOVA was a phase 3, placebo-controlled maintenance trial conducted in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, the majority of whom… (full text at CIViC) PMID 27717299 · Mirza et al., 2016 · Open in CIViC	civic
〃	High Grade Ovarian Serous CarcinomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	4	submitted	EID13122 PRIMA/ENGOT-OV26/GOG-3012 was a phase 3 placebo-controlled maintenance trial that included 733 patients with newly diagnosed, advanced FIGO stage III–IV high-grade serous or endometrioid malignancies … (full text at CIViC) PMID 31562799 · González-Martín et al., 2019 · Open in CIViC	civic

BRCA1 Mutation2

Niraparib

High Grade Ovarian Serous CarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID13120

ENGOT-OV16/NOVA was a phase 3, placebo-controlled maintenance trial conducted in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, the majority of whom… (full text at CIViC)

PMID 27717299 · Mirza et al., 2016 · Open in CIViC

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〃

High Grade Ovarian Serous CarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID13122

PRIMA/ENGOT-OV26/GOG-3012 was a phase 3 placebo-controlled maintenance trial that included 733 patients with newly diagnosed, advanced FIGO stage III–IV high-grade serous or endometrioid malignancies … (full text at CIViC)

PMID 31562799 · González-Martín et al., 2019 · Open in CIViC

civic

BRCA2 Mutation2
Niraparib	High Grade Ovarian Serous CarcinomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	5	submitted	EID13119 ENGOT-OV16/NOVA was a phase 3, placebo-controlled maintenance trial conducted in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, the majority of whom… (full text at CIViC) PMID 27717299 · Mirza et al., 2016 · Open in CIViC	civic
〃	High Grade Ovarian Serous CarcinomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	4	submitted	EID13121 PRIMA/ENGOT-OV26/GOG-3012 was a phase 3 randomized maintenance trial involving 733 patients with newly diagnosed, advanced FIGO stage III or IV high-grade serous or endometrioid cancer of the ovary, f… (full text at CIViC) PMID 31562799 · González-Martín et al., 2019 · Open in CIViC	civic

BRCA2 Mutation2

Niraparib

High Grade Ovarian Serous CarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID13119

PMID 27717299 · Mirza et al., 2016 · Open in CIViC

civic

〃

High Grade Ovarian Serous CarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID13121

PRIMA/ENGOT-OV26/GOG-3012 was a phase 3 randomized maintenance trial involving 733 patients with newly diagnosed, advanced FIGO stage III or IV high-grade serous or endometrioid cancer of the ovary, f… (full text at CIViC)

PMID 31562799 · González-Martín et al., 2019 · Open in CIViC

civic