Niraparib
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Niraparib
- Molecular weight
- 320.4
- Structure (SMILES)
- NC(=O)c1cccc2cn(-c3ccc([C@@H]4CCCNC4)cc3)nc12
- zejula
- Zejula
- jnj 64091742
- JNJ-64091742
- mk 4827
- MK 4827
- MK-4827
- mk4827
- MK4827
- niraparib
- Niraparib
- NIRAPARIB
- NIRAPARIB (MK-4827)
- Niraparib [INN]
- NIRAPARIB [MI]
- Niraparib [USAN]
- Niraparib [WHO-DD]
- niraparib inn
- niraparib mi
- niraparib mk 4827
- niraparib usan
- niraparib who dd
- zejula
- ZEJULA
- zl 2306
- zl 2306 nirapairb
- ZL-2306
And 2 more, listed on the interactive page.
- ATC classification codes
- L01XK02
Sources for recorded values
- CAS registry numbers
- 1038915-60-4
- ChEMBL ID
- CHEMBL1094636
- InChIKey
- PCHKPVIQAHNQLW-CQSZACIVSA-N
- PubChem compound IDs
- 24958200
- RxNorm IDs (RxCUI)
- 1918231
- FDA ingredient codes (UNII)
- HMC2H89N35
- Applicant
- JANSSEN BIOTECH
- Approval date
- 11 Aug 2023
- Application number
- NDA216793
- Status
- Authorised
- Status date
- 16 Nov 2017
- Authorisation date
- 16 Nov 2017
- Approved indications
- Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.
- Product number
- EMEA/H/C/004249
- Authorisation holder
- GlaxoSmithKline Trading Services Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Fallopian Tube Neoplasms
- Ovarian Neoplasms
- Peritoneal Neoplasms
European medicines record
- Patents
- 13
- Designations
- 6
- Earliest recorded loss of exclusivity
- 27 Mar 2038
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- niraparib
- Type
- Synthetic organic
- Drug name stem
- -parib
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Binding
- Action type
- Binding
- Target
- poly(ADP-ribose) polymerase 2
- Gene symbol
- PARP2
- Protein identifier
- Q9UGN5
- Median affinity
- 8.68
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- poly(ADP-ribose) polymerase 1
- Gene symbol
- PARP1
- Protein identifier
- P09874
- Median affinity
- 8.42
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Poly [ADP-ribose] polymerase 2 inhibitor
- Action type
- Inhibitor
- Target
- Poly [ADP-ribose] polymerase 2
- Protein identifier
- Q9UGN5
- Mechanism
- Poly [ADP-ribose] polymerase-1 inhibitor
- Action type
- Inhibitor
- Target
- Poly [ADP-ribose] polymerase 1
- Protein identifier
- P09874
- Mechanism
- Poly [ADP-ribose] polymerase 2 inhibitor
- Action type
- Inhibitor
- Target
- Poly [ADP-ribose] polymerase 2
- Mechanism
- Poly [ADP-ribose] polymerase-1 inhibitor
- Action type
- Inhibitor
- Target
- Poly [ADP-ribose] polymerase 1
- Action type
- Inhibitor
- Gene symbol
- PARP1
- Protein identifier
- P09874
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- PARP2
- Protein identifier
- Q9UGN5
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001061
- Subject identifier
- D002583
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002617
- Subject identifier
- D008545
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Urogenital Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003863
- Subject identifier
- D014565
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Biliary Tract Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003891
- Subject identifier
- D001661
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003893
- Subject identifier
- D010051
- Condition
- Endometrial Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004230
- Subject identifier
- D016889
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0006859
- Subject identifier
- D006258
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
And 18 more, listed on the interactive page.
- Condition identifier
- EFO_0000174
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000196
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001663
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002617
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003863
- Condition identifier
- EFO_0003869
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003893
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008528
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000294
- Condition identifier
- EFO_1000465
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001480
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000448
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000548
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002087
- Highest recorded phase
- 3
And 63 more, listed on the interactive page.
- Event
- anaemia
- Reports
- 120
- Reporting signal score
- 98.2981
- Event
- ascites
- Reports
- 28
- Reporting signal score
- 35.7053
- Event
- asthenia
- Reports
- 87
- Reporting signal score
- 33.0472
- Event
- blood count abnormal
- Reports
- 37
- Reporting signal score
- 75.1873
- Event
- blood creatinine increased
- Reports
- 58
- Reporting signal score
- 65.3116
- Event
- blood pressure increased
- Reports
- 72
- Reporting signal score
- 75.5842
- Event
- carbohydrate antigen 125 increased
- Reports
- 121
- Reporting signal score
- 650.987
- Event
- constipation
- Reports
- 169
- Reporting signal score
- 239.505
- Event
- decreased appetite
- Reports
- 97
- Reporting signal score
- 90.9063
- Event
- dehydration
- Reports
- 49
- Reporting signal score
- 26.8775
- Event
- disease progression
- Reports
- 195
- Reporting signal score
- 392.673
- Event
- drug hypersensitivity
- Reports
- 1
- Reporting signal score
- 23.5583
- Event
- dry mouth
- Reports
- 35
- Reporting signal score
- 35.931
- Event
- eastern cooperative oncology group performance status
- Reports
- 7
- Reporting signal score
- 40.5849
- Event
- eastern cooperative oncology group performance status worsened
- Reports
- 12
- Reporting signal score
- 46.9148
- Event
- emotional distress
- Reports
- 57
- Reporting signal score
- 137.046
- Event
- fatigue
- Reports
- 226
- Reporting signal score
- 138.155
- Event
- feeling abnormal
- Reports
- 44
- Reporting signal score
- 20.6059
- Event
- haematocrit decreased
- Reports
- 28
- Reporting signal score
- 40.2503
- Event
- haemoglobin decreased
- Reports
- 86
- Reporting signal score
- 89.8887
- Event
- headache
- Reports
- 109
- Reporting signal score
- 25.9245
- Event
- heart rate increased
- Reports
- 58
- Reporting signal score
- 76.7096
- Event
- hypertension
- Reports
- 58
- Reporting signal score
- 22.8337
- Event
- ileus
- Reports
- 21
- Reporting signal score
- 33.8705
- Event
- insomnia
- Reports
- 108
- Reporting signal score
- 102.585
And 24 more, listed on the interactive page.
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- NCT03695380
And 100 more, listed on the interactive page.
- Dose
- 200 mg or 300 mg
- Route
- Oral
- How often
- Once daily
- Swallow tablets whole, do not chew, crush, or split
- Take with or without food
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 2
- Polar surface area
- 72.94
- Calculated partition coefficient (ALogP)
- 2.59
- Calculated partition coefficient (XLogP)
- 2.2
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 3
- Heavy atoms
- 24
- Molecular formula
- C19H20N4O
- Monoisotopic mass
- 320.16371127
- Natural product
- Yes
- Recorded assays
- 775
- Active assays
- 202
- Confirmatory
- Other
- Screening
- Poly(ADP-ribose) Polymerase Inhibitors
These details could not be displayed.
Related records
Trials (197)
- 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer
- A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer
- A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
- A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
- A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
- A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
- A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients
- A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
- A MolEcularly Guided Anti-Cancer Drug Off-Label Trial
- A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
- A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr
- A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients
- A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
- A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
- A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
- A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
- A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
- A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
- A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
- A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
Approved for (2)
- Cancer
- Neoplasm
In development for (39)
- B-cell chronic lymphocytic leukemia Phase 1
- Biliary tract cancer Phase 3
- Biliary tract neoplasm Phase 3
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Cervical cancer Phase 2
- Cervical carcinoma Phase 2
- Colorectal adenocarcinoma Phase 2
- Endometrial cancer Phase 2
- Endometrial carcinoma Phase 2
- Ewing sarcoma Phase 1
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 1
- Gastric cancer Phase 1
- Glioblastoma Phase 2
- Head and neck cancer Phase 2
- Head and neck squamous cell carcinoma Phase 2
- HER2 positive breast carcinoma Phase 3
- Hereditary breast ovarian cancer syndrome Phase 3
- Lung cancer Phase 1
Other linked conditions (1)
- Malignant epithelial tumor of ovary