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AboutPricing
Drug ReportsNiraparib
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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Drug
Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Zejula (discontinued: Zejula)
Combinations
Akeega
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-214876 RX2023-04-26
3 products, RLD, RS
Show 1 discontinued
Abiraterone acetate
+
Niraparib tosylate
Tradename
Company
Number
Date
Products
AKEEGAJohnson & JohnsonN-216793 RX2023-08-11
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
akeegaNew Drug Application2024-08-19
zejulaNew Drug Application2024-05-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ovarian neoplasmsEFO_0003893D010051C56
fallopian tube neoplasms—D005185—
peritoneal neoplasms—D010534—
castration-resistant prostatic neoplasms—D064129—
Agency Specific
FDA
EMA
Expiration
Code
NIRAPARIB TOSYLATE, ZEJULA, GLAXOSMITHKLINE
2027-04-29ODE-295
2026-10-23ODE-277
2024-03-27ODE-133
ABIRATERONE ACETATE / NIRAPARIB TOSYLATE, AKEEGA, JANSSEN BIOTECH
2026-08-11NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Niraparib Tosylate, Zejula, Glaxosmithkline
117307252039-01-04DP
Abiraterone Acetate / Niraparib Tosylate, Akeega, Janssen Biotech
110914592038-03-27DP
116738772038-03-27DPU-3646, U-3647
112073112037-07-28U-2830
88595622031-08-04U-2655, U-2830
80716232031-03-27DS, DP
84361852029-04-24DP
80715792027-08-12U-2655, U-2830
81432412027-08-12U-2655, U-2830
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
230 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_0003893C565631216
Ovarian epithelial carcinomaD000077216——4411211
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50351——8
RecurrenceD012008——331——7
GlioblastomaD005909EFO_0000515—321——5
Fallopian tube neoplasmsD005185——121——4
Peritoneal neoplasmsD010534——1—1——2
Triple negative breast neoplasmsD064726———11——2
Lung neoplasmsD008175HP_0100526C34.90—11——2
Non-small-cell lung carcinomaD002289————1——1
Brain neoplasmsD001932EFO_0003833C71——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8089———15
CarcinomaD002277—C80.045———7
Pancreatic neoplasmsD010190EFO_0003860C2524———5
AdenocarcinomaD000230——23———4
GliomaD005910EFO_0000520—32———4
Neoplasm metastasisD009362EFO_0009708—12———3
Colorectal neoplasmsD015179——13———3
Malignant mesotheliomaD000086002———2———2
MesotheliomaD008654—C45—2———2
Head and neck neoplasmsD006258———2———2
Show 22 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Unilateral breast neoplasmsD000069584——1————1
Invasive hydatidiform moleD002820—D39.21————1
Hereditary breast and ovarian cancer syndromeD061325——1————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)Loading
Structure (InChI/SMILES or Protein Sequence)
NC(=O)c1cccc2cn(-c3ccc([C@@H]4CCCNC4)cc3)nc12
Identifiers
PDB—
CAS-ID1038915-60-4
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Zejula – Tesaro
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Zejula – Zai Lab
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,327 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,071 adverse events reported
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