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.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2025-06-18 (see label)	approved	Jun 18, 2025	openfda
US FDA	Malignant Peritoneal Neoplasm	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 suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.	approved	Apr 26, 2023	openfda
US FDA	Malignant Peritoneal Neoplasm	for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.	approved	Apr 26, 2023	openfda

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 12 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 101–150 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
NCT06258018	Niraparib and Temozolomide in Patients Glioblastoma(ONC-2022-001)	not yet recruiting	Phase 1 / Phase 2	86	Armando Santoro, MDOTHER	1	Aug 30, 2024	clinicaltrials
NCT04185831	A MolEcularly Guided Anti-Cancer Drug Off-Label Trial(MEGALiT)	unknown

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 15 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

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

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