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Zejula(niraparib)
Akeega, Zejula (niraparib) is a small molecule pharmaceutical. Niraparib was first approved as Zejula on 2017-03-27. It is used to treat fallopian tube neoplasms, ovarian neoplasms, and peritoneal neoplasms in the USA. It has been approved in Europe to treat castration-resistant prostatic neoplasms, fallopian tube neoplasms, ovarian neoplasms, and peritoneal neoplasms. The pharmaceutical is active against poly [ADP-ribose] polymerase 1 and poly [ADP-ribose] polymerase 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Zejula
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Niraparib tosylate
Tradename
Company
Number
Date
Products
ZEJULAGSKN-208447 RX2017-03-27
1 products, RLD, RS
ZEJULAGSKN-214876 RX2023-04-26
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zejulaNew Drug Application2021-03-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
fallopian tube neoplasms—D005185—
ovarian neoplasmsEFO_0003893D010051C56
peritoneal neoplasms—D010534—
Agency Specific
FDA
EMA
Expiration
Code
NIRAPARIB TOSYLATE, ZEJULA, GLAXOSMITHKLINE
2027-04-29ODE-295
2026-10-23ODE-277, ODE-278
2024-03-27ODE-133
2023-04-29I-833
Patent Expiration
Patent
Expires
Flag
FDA Information
Niraparib Tosylate, Zejula, Glaxosmithkline
110914592038-03-27DP
88595622031-08-04U-2655
80716232031-03-27DS, DP
84361852029-04-24DP
80715792027-08-12U-2655
81432412027-08-12U-2655
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XK: Poly (adp-ribose) polymerase (parp) inhibitors
— L01XK02: Niraparib
HCPCS
No data
Clinical
Clinical Trials
178 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C56172992455
Ovarian epithelial carcinomaD000077216—3—227
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8020101—128
Breast neoplasmsD001943EFO_0003869C5010142——21
Fallopian tube neoplasmsD0051855121—217
Prostatic neoplasmsD011471C61481——12
Endometrial neoplasmsD016889EFO_0004230371——10
Castration-resistant prostatic neoplasmsD064129232—17
Peritoneal neoplasmsD010534121—25
Biliary tract neoplasmsD001661C24.9111——3
Non-small-cell lung carcinomaD0022891—1——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C2548———10
AdenocarcinomaD00023037———9
Triple negative breast neoplasmsD06472654———8
GlioblastomaD005909EFO_000051533———6
Lung neoplasmsD008175C34.9023———4
Urologic neoplasmsD014571C64-C6813———3
Pancreatic ductal carcinomaD02144113———3
Stomach neoplasmsD013274EFO_0003897C1622———3
Small cell lung carcinomaD05575213———3
Head and neck neoplasmsD006258—3———3
Show 40 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ewing sarcomaD012512EFO_00001731————1
Unilateral breast neoplasmsD0000695841————1
Invasive hydatidiform moleD002820D39.21————1
Hepatic insufficiencyD0485501————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
Prolymphocytic leukemia t-cellD015461C91.61————1
Uterine neoplasmsD014594EFO_0003859C551————1
Serous cystadenocarcinomaD0182841————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNIRAPARIB
INNniraparib
Description
Niraparib is a 2-[4-(piperidin-3-yl)phenyl]-2H-indazole-7-carboxamide that has S-configuration. It is a potent inhibitor of PARP1 and PARP2 (IC50 of 3.8 and 2.1 nM, respectively) and approved as a first-line maintenance treatment for women with advanced ovarian cancer after responding to platinum-based chemotherapy. It has a role as an antineoplastic agent, an EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor, a radiosensitizing agent and an apoptosis inducer.
Classification
Small molecule
Drug classpoly-ADP-ribose polymerase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC(=O)c1cccc2cn(-c3ccc([C@@H]4CCCNC4)cc3)nc12
Identifiers
PDB—
CAS-ID1038915-60-4
RxCUI1918231
ChEMBL IDCHEMBL1094636
ChEBI ID—
PubChem CID24958200
DrugBankDB11793
UNII IDHMC2H89N35 (ChemIDplus, GSRS)
Target
Agency Approved
PARP1
PARP1
PARP2
PARP2
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
142
Protein name
poly [ADP-ribose] polymerase 1
Protein synonyms
ADP-ribosyltransferase (NAD+; poly (ADP-ribose) polymerase), ADP-ribosyltransferase diphtheria toxin-like 1, ADP-ribosyltransferase NAD(+), ADPRT 1, ARTD1, DNA ADP-ribosyltransferase PARP1, NAD(+) ADP-ribosyltransferase 1, poly (ADP-ribose) polymerase family, member 1, poly(ADP-ribose) synthetase, poly(ADP-ribosyl)transferase, Poly[ADP-ribose] synthase 1, Protein poly-ADP-ribosyltransferase PARP1
Uniprot ID
Q8IUZ9
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zejula - Tesaro
$
€
£
₣
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Zejula - Zai Lab
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,674 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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26,608 adverse events reported
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