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
Niraparib Efficacy in Patient With Unresectable Mesothelioma
- Conditions
- Mesothelioma, Malignant
- Interventions
- Other: Active Symptom Control
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2025-05-15
- Target Recruit Count
- 88
- Registration Number
- NCT05455424
- Locations
- 🇬🇧
University Hospital Southampton, Southampton General Hospital, Southampton, Hampshire, United Kingdom
🇬🇧Somerset NHS Foundation Trust, Musgrove Park Hospital, Taunton, Somerset, United Kingdom
🇬🇧Belfast Health and Social Care Trust, Belfast City Hospital, Belfast, United Kingdom
Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer
- First Posted Date
- 2022-07-05
- Last Posted Date
- 2023-03-30
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 28
- Registration Number
- NCT05442749
- Locations
- 🇫🇷
Centre Léon Bérard, Lyon, France
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
- First Posted Date
- 2022-06-09
- Last Posted Date
- 2023-09-08
- Lead Sponsor
- Ospedale Policlinico San Martino
- Registration Number
- NCT05412706
Niraparib In Recurrent IDH 1/2 Gliomas
- Conditions
- Low-grade GliomaGlioma, MalignantIDH2 Gene MutationRecurrent GliomaIDH1 Mutation
- Interventions
- First Posted Date
- 2022-06-06
- Last Posted Date
- 2024-03-29
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 16
- Registration Number
- NCT05406700
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- First Posted Date
- 2022-06-02
- Last Posted Date
- 2023-09-15
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT05401214
- Locations
- 🇲🇽
DUMMY, Dummy, Mexico
A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
- First Posted Date
- 2022-05-23
- Last Posted Date
- 2022-05-23
- Lead Sponsor
- Peking Union Medical College Hospital
- Target Recruit Count
- 35
- Registration Number
- NCT05385068
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
- Conditions
- Recurrent Ovarian CancerRecurrent Epithelial Cancer of OvaryPeritoneal CancerRecurrent Epithelial Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Carcinoma of OvaryAdenocarcinoma of Ovary
- Interventions
- Biological: Oregovomab
- First Posted Date
- 2022-04-20
- Last Posted Date
- 2024-01-16
- Lead Sponsor
- CanariaBio Inc.
- Target Recruit Count
- 10
- Registration Number
- NCT05335993
- Locations
- 🇺🇸
Duke Cancer Center, Durham, North Carolina, United States
🇺🇸Stephenson Cancer Center- University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
🇺🇸University of Virginia Health System, Charlottesville, Virginia, United States
PARP Inhibition for Gliomas (PI-4G or π4g)
- Conditions
- Recurrent GliomaRecurrent AstrocytomaRecurrent OligodendrogliomaRecurrent Glioblastoma
- Interventions
- First Posted Date
- 2022-03-28
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- University of Oklahoma
- Target Recruit Count
- 15
- Registration Number
- NCT05297864
- Locations
- 🇺🇸
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Niraparib in High-grade Endometrial Cancer Trial
- Conditions
- Endometrial CancerSerous AdenocarcinomaUterine Neoplasm
- Interventions
- First Posted Date
- 2022-03-21
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Target Recruit Count
- 31
- Registration Number
- NCT05289648
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
- Conditions
- HER2-negative Metastatic Breast Cancer
- Interventions
- First Posted Date
- 2022-03-02
- Last Posted Date
- 2023-12-13
- Lead Sponsor
- Dantari, Inc.
- Target Recruit Count
- 30
- Registration Number
- NCT05261269
- Locations
- 🇺🇸
UCLA - Parkside Cancer Center, Santa Monica, California, United States
🇺🇸Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸Icahn School of Medicine at Mount Sinai, New York, New York, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.