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
Trade Name
FDA
EMA
Zejula (discontinued: Zejula)
CombinationsAkeega
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Niraparib tosylate
Abiraterone acetate
+
Niraparib tosylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKEEGA | Johnson & Johnson | N-216793 RX | 2023-08-11 | 2 products, RLD, RS |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NIRAPARIB TOSYLATE, ZEJULA, GLAXOSMITHKLINE | |||
| 2027-04-29 | ODE-295 | ||
| 2026-10-23 | ODE-277 | ||
| 2024-03-27 | ODE-133 | ||
ABIRATERONE ACETATE / NIRAPARIB TOSYLATE, AKEEGA, JANSSEN BIOTECH | |||
| 2026-08-11 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Niraparib Tosylate, Zejula, Glaxosmithkline | |||
| 11730725 | 2039-01-04 | DP | |
| Abiraterone Acetate / Niraparib Tosylate, Akeega, Janssen Biotech | |||
| 11091459 | 2038-03-27 | DP | |
| 11673877 | 2038-03-27 | DP | U-3646, U-3647 |
| 11207311 | 2037-07-28 | U-2830 | |
| 8859562 | 2031-08-04 | U-2655, U-2830 | |
| 8071623 | 2031-03-27 | DS, DP | |
| 8436185 | 2029-04-24 | DP | |
| 8071579 | 2027-08-12 | U-2655, U-2830 | |
| 8143241 | 2027-08-12 | U-2655, U-2830 | |
HCPCS
No data
Clinical
Clinical Trials
229 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 neoplasms | D010051 | EFO_0003893 | C56 | 21 | 40 | 12 | 4 | 18 | 88 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 18 | 37 | 8 | 4 | 16 | 77 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 27 | 21 | 3 | — | 3 | 46 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 13 | 16 | 2 | — | — | 27 |
| Prostatic neoplasms | D011471 | — | C61 | 8 | 13 | 5 | — | 2 | 25 |
| Carcinoma | D002277 | — | C80.0 | 10 | 18 | 2 | — | — | 24 |
| Recurrence | D012008 | — | — | 8 | 12 | 1 | — | 1 | 21 |
| Fallopian tube neoplasms | D005185 | — | — | 6 | 14 | 2 | — | 2 | 21 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 3 | 7 | 2 | — | — | 11 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 3 | 5 | 3 | — | 1 | 10 |
| Triple negative breast neoplasms | D064726 | — | — | 5 | 5 | 1 | — | — | 10 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 5 | 2 | — | — | 9 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 6 | 8 | — | — | — | 12 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 5 | 8 | — | — | — | 11 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 3 | — | — | — | 6 |
| Mesothelioma | D008654 | — | C45 | — | 4 | — | — | — | 4 |
| Squamous cell carcinoma | D002294 | — | — | 2 | 4 | — | — | — | 4 |
| Endometrioid carcinoma | D018269 | — | — | 2 | 3 | — | — | — | 4 |
| Sarcoma | D012509 | — | — | 2 | 2 | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | — | — | — | 4 |
| Melanoma | D008545 | — | — | 1 | 3 | — | — | — | 4 |
| Glioma | D005910 | EFO_0000520 | — | 3 | 2 | — | — | — | 4 |
Show 56 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | — | — | — | — | 1 |
| Unilateral breast neoplasms | D000069584 | — | — | 1 | — | — | — | — | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | — | — | — | — | 1 |
| Residual neoplasm | D018365 | — | — | 1 | — | — | — | — | 1 |
| Disease progression | D018450 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancytopenia | D010198 | HP_0001876 | D61.81 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 1 | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | — | — | 1 | 1 |
| Preleukemia | D011289 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Niraparib |
| INN | niraparib |
| 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 class | poly-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-ID | 1038915-60-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1094636 |
| ChEBI ID | — |
| PubChem CID | 24958200 |
| DrugBank | DB11793 |
| UNII ID | HMC2H89N35 (ChemIDplus, GSRS) |
Target
Agency Approved
PARP1
PARP1
PARP2
PARP2
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
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
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Alternate
No data
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,474 adverse events reported
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