Niraparib
- Generic Name
- Niraparib
- Brand Names
- Zejula
- Drug Type
- Small Molecule
- Chemical Formula
- C19H20N4O
- CAS Number
- 1038915-60-4
- Unique Ingredient Identifier
- HMC2H89N35
- Background
Niraparib is an orally active poly (ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells. Niraparib is selective towards PARP-1 and PARP-2. First approved by the FDA on March 27, 2017, niraparib is used to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer. Niraparib was approved by the European Commission on November 16, 2017 and by Health Canada on June 27, 2019.
- Indication
Niraparib is indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
In Canada and the US, niraparib is also available in a combination product with abiraterone, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.
- Associated Conditions
- Advanced Epithelial Ovarian Cancer, Advanced Primary Peritoneal Carcinoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Advanced Fallopian Tubes Cancer
- Associated Therapies
- Maintenance therapy
Trial of Niraparib in Participants with Newly-diagnosed Glioblastoma and Recurrent Glioma
- Conditions
- Glioblastoma MultiformeGliomaGlioblastoma Multiforme of BrainGlioblastomaGlioma, MalignantGBM
- Interventions
- Radiation: Radiation therapy
- First Posted Date
- 2021-10-13
- Last Posted Date
- 2025-02-27
- Lead Sponsor
- Nader Sanai
- Target Recruit Count
- 42
- Registration Number
- NCT05076513
- Locations
- 🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor
- Conditions
- High Grade Serous CancerHigh Grade Endometrioid CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
- Interventions
- First Posted Date
- 2021-10-01
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 40
- Registration Number
- NCT05065021
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
- First Posted Date
- 2021-08-25
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- Takeda
- Target Recruit Count
- 354
- Registration Number
- NCT05021562
- Locations
- 🇯🇵
Takeda Selected Site, Tokyo, Japan
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
- Conditions
- Ovarian CancerFallopian Tube CancerPeritoneal Cancer
- Interventions
- First Posted Date
- 2021-08-17
- Last Posted Date
- 2024-04-08
- Lead Sponsor
- AGO Study Group
- Target Recruit Count
- 970
- Registration Number
- NCT05009082
- Locations
- 🇩🇪
Klinikum Neumarkt, Neumarkt, Germany
🇩🇪MVZ Nordhausen, Nordhausen, Germany
🇩🇪Klinikum St. Marien Amberg, Amberg, Germany
Niraparib in Tumors Metastatic to the CNS
- Conditions
- Metastatic CancerCentral Nervous System Cancer
- Interventions
- First Posted Date
- 2021-08-05
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 20
- Registration Number
- NCT04992013
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
- Conditions
- Advanced CancerBreast CancerMetastatic Cancer
- Interventions
- First Posted Date
- 2021-08-05
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- Artios Pharma Ltd
- Target Recruit Count
- 390
- Registration Number
- NCT04991480
- Locations
- 🇺🇸
Yale School of Medicine, New Haven, Connecticut, United States
🇺🇸Florida Cancer Specialists, Orlando, Florida, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
- Conditions
- Epithelial Ovarian Cancer
- First Posted Date
- 2021-08-02
- Last Posted Date
- 2021-08-02
- Lead Sponsor
- Ling-Ying Wu
- Target Recruit Count
- 300
- Registration Number
- NCT04986371
Androgen Ablation Therapy with or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
- Conditions
- Prostate CarcinomaStage IIC Prostate Cancer AJCC V8Stage III Prostate Cancer AJCC V8Stage IIIA Prostate Cancer AJCC V8Stage IIIB Prostate Cancer AJCC V8Stage IIIC Prostate Cancer AJCC V8Stage IVA Prostate Cancer AJCC V8
- Interventions
- Drug: Antiandrogen TherapyProcedure: BiopsyRadiation: Radiation Therapy
- First Posted Date
- 2021-07-01
- Last Posted Date
- 2025-02-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 200
- Registration Number
- NCT04947254
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
- First Posted Date
- 2021-06-25
- Last Posted Date
- 2023-05-12
- Lead Sponsor
- University of Turin, Italy
- Target Recruit Count
- 70
- Registration Number
- NCT04940637
- Locations
- 🇮🇹
AOU San Luigi- Department of Oncology, Orbassano, Turin, Italy
A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
- Conditions
- Rectal NeoplasmsRectal Neoplasm Malignant
- Interventions
- First Posted Date
- 2021-06-15
- Last Posted Date
- 2025-02-27
- Lead Sponsor
- Joseph Caster, Ph.D., M.D.
- Target Recruit Count
- 3
- Registration Number
- NCT04926324
- Locations
- 🇺🇸
Holden Comprehensive Cancer Center at the University of Iowa, Iowa City, Iowa, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.