Drugs / Niraparib
Niraparib
also known as
MK4827 · ZL-2306 · Nira · \[3S\]-3-\[4-\[7-(aminocarbonyl)-2H-indazol-2-yl\] phenyl\] piperidine \[tosylate monohydrate salt\] · GSK3985771 · JNJ-64091742 · MK-4827 TOSYLATE MONOHYDRATE · NIR · +8 more
Small molecule targets PARP1, PARP2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ovarian carcinoma 5 milestones | |||||
| Filed | China (NMPA) | ZEJULA | ovarian carcinoma | 2020-03-16 | “today announced the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib)” zailaboratory.com ↗ |
| Filed | EU (EMA) | Zejula | ovarian carcinoma | 2020-02-27 | “Zejula submission accepted by FDA and EMA in first-line maintenance treatment for women with ovarian cancer” gsk.com ↗ |
| Filed | US (FDA) | ZEJULA | ovarian carcinoma | 2019-06-24 | “TESARO, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZEJULA (niraparib).” gsk.com ↗ “Zejula submission accepted by FDA and EMA in first-line maintenance treatment for women with ovarian cancer” gsk.com ↗ |
| Filed | China (NMPA) | ZEJULA | ovarian carcinoma | 2018-12-12 | “Zai Lab’s new drug application for niraparib in China was accepted by the China National Medical Product Administration in December 2018” zailaboratory.com ↗ “the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZEJULA (niraparib, or ZL-2306)” zailaboratory.com ↗ “In March 2020, China NMPA accepted our sNDA for ZEJULA for first-line maintenance treatment of patients with ovarian cancer.” zailaboratory.com ↗ “Zai Lab’s new drug application for niraparib in China was accepted by the China National Medical Product Administration” zailaboratory.com ↗ |
| Filed | Other | — | ovarian carcinoma | — | “Zai Lab submitted a market registration application for niraparib in Hong Kong” zailaboratory.com ↗ |
| Filed primary peritoneal serous/papillary carcinoma 1 milestone | |||||
| Filed | US (FDA) | — | primary peritoneal serous/papillary carcinoma | 2016-09-29 | “TESARO已经开始向美国食品药品监督管理局(FDA)提交 Niraparib新药申请（NDA）” zailaboratory.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | ZEJULA | — | 2019-10-23 – 2025-06-18 | fda.gov ↗ |
| Approved | EU (EMA) | Zejula | — | 2017-11-16 | europa.eu ↗ |
| Approved | US (FDA) | ZEJULA | — | 2017-03-27 | fda.gov ↗ |
Trials 193 · started per year
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EU approved 2017
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT05289648 | May 2024 → Oct 2025 | endometrial cancer, serous adenocarcinoma | Sir Mortimer B. Davis - Jewish General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT05406700 | May 2023 → Jul 2026 overdue | low grade glioma, malignant glioma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 0 | NCT05076513 | Oct 2021 → Mar 2024 overdue | brain glioblastoma | Nader Sanai | Active not recruiting | No outcome recorded |
| Phase 140 trials · 1 met primary | ||||||
| Phase 1 | NCT06161493 | Jan 2024 → Dec 2026 | ovarian cancer | Haider Mahdi | Withdrawn | No outcome recorded |
| Phase 1 | NCT05666349 | Oct 2023 | glioblastoma | University College, London | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05694715 | May 2023 → Jan 2028 expected | ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, PALB2-related cancer predisposition +1 | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1 | NCT04149145 | May 2023 → May 2024 | ovarian carcinoma | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 1 | NCT04926324 | Jul 2022 → Nov 2024 | rectal cancer | University of Iowa | Terminated | No outcome recorded |
| Phase 1 | NCT04673448 | Oct 2021 → Dec 2025 overdue | fallopian tube carcinoma, female breast carcinoma, hereditary breast carcinoma, hereditary neoplastic syndrome +4 | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04991480 | Sep 2021 → Dec 2025 | breast cancer, metastatic malignant neoplasm | Artios Pharma Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03944902 | Sep 2021 → Jan 2022 | ovarian cancer | University of Alabama at Birmingham | Terminated | No outcome recorded |
| Phase 1 | NCT04481113 | Jun 2021 → Oct 2023 | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT04764084 | Apr → Nov 2021 | Her2-receptor negative breast cancer, cholangiocarcinoma, gastric adenocarcinoma, malignant pancreatic neoplasm | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1 | NCT04762901 | Apr 2021 → Jan 2026 | breast cancer | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04577833 | Nov 2020 → Oct 2021 overdue | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 1 | NCT04544995 | Oct 2020 → Apr 2025 | neoplasm | GlaxoSmithKline | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04502602 | Aug 2020 → Oct 2024 overdue | ovarian cancer | Virginia Commonwealth University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04235101 | Jun 2020 → Apr 2023 | cancer | Byondis B.V. | Completed | No outcome recorded |
| Phase 1 | NCT04267939 | Feb 2020 → Dec 2023 | ovarian cancer | Bayer | Terminated | No outcome recorded |
| Phase 1 | NCT04178460 | Feb 2020 → Mar 2022 | biliary tract cancer, endometrial carcinoma, gastric cancer, triple-negative breast carcinoma | Zai Lab (Shanghai) Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04170153 | Dec 2019 → Jul 2026 overdue | cancer of unknown primary site | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03945721 | Jul 2019 → Dec 2026 expected | triple-negative breast carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03891615 | Jun 2019 → Jul 2024 | lung cancer | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03586661 | Apr 2019 → Jun 2026 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, endometrium adenocarcinoma, fallopian tube carcinoma +2 | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03895788 | Jan → Dec 2019 | ovarian cancer | Hunan Cancer Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03695380 | Jan 2019 → Jul 2023 | ovarian cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03329937 | Apr 2018 → Jan 2020 | breast cancer | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03497429 | Apr 2018 → Feb 2020 | cancer | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03359850 | Feb 2018 → Sep 2019 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03551171 | Dec 2017 → May 2018 | ovarian cancer | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03209401 | Oct 2017 → Oct 2023 | cancer | Georgetown University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03307785 | Oct 2017 → Feb 2020 | metastatic malignant neoplasm, non-small cell lung carcinoma | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03076203 | Sep 2017 → Jan 2020 | hormone-resistant prostate carcinoma, metastatic carcinoma in the bone, prostate adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT03154281 | Jul 2017 → Apr 2021 | breast cancer, ovarian cancer | Avera McKennan Hospital & University Health Center | Completed | No outcome recorded |
| Phase 1 | NCT02924766 | Oct 2016 → Jul 2019 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02500901 | Mar → May 2016 | metastatic prostate carcinoma | Paul Mathew, MD | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02476552 | Feb → Dec 2015 | cancer | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02044120 | May 2014 → Jan 2021 | Ewing sarcoma | Sarcoma Alliance for Research through Collaboration | Completed | No outcome recorded |
| Phase 1 | NCT01294735 | Feb 2011 → Apr 2012 | glioblastoma, melanoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01227941 | Nov 2010 → Sep 2011 | ovarian cancer | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01226901 | Nov 2010 → Feb 2011 | neoplasm | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 1 | NCT01110603 | Jul 2010 → Jul 2011 | — | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT00749502 | Sep 2008 → Sep 2011 | B-cell chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, cancer | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1/222 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT06682780 | Sep 2025 → Dec 2028 expected | neoplasm | LaNova Medicines Limited | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06953323 | Jul 2025 → Jun 2029 expected | neoplasm | Wigen Biomedicine Technology (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05672095 | Apr 2025 → Nov 2026 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06329830 | Oct 2024 → Oct 2026 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Baptist Health South Florida | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06594679 | Sep 2024 → Mar 2027 expected | ovarian cancer | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06258018 | Sep 2024 → Dec 2026 expected | malignant glioma | Armando Santoro, MD | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05784012 | Nov 2023 → Mar 2027 expected | head and neck squamous cell carcinoma | Spanish Head And Neck Cancer Cooperative Group | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06077877 | Oct 2023 → Jun 2026 overdue | neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05519670 | Mar 2023 → Sep 2027 expected | breast cancer | Institut Paoli-Calmettes | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05198804 | Jan 2022 → Oct 2025 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT04972110 | Jul 2021 → Nov 2024 | — | Repare Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT04655183 | Dec 2020 → Sep 2023 | breast cancer | EMD Serono Research & Development Institute, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04194554 | Nov 2020 → May 2027 expected | prostate cancer | University of Michigan Rogel Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03425201 | Oct 2019 → Jul 2024 | urothelial carcinoma | CRIS Cancer Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT04037254 | Oct 2019 → Jul 2024 | prostate adenocarcinoma | NRG Oncology | Completed | No outcome recorded |
| Phase 1/2 | NCT03368729 | Sep 2019 → Nov 2027 expected | HER2 positive breast carcinoma | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03644342 | Jul 2019 → Apr 2022 | cervical carcinoma | Michelle S Ludwig | Terminated | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03830918 | Mar 2019 → Jan 2027 expected | small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03404960 | Jan 2018 → Apr 2022 | pancreatic adenocarcinoma | University of Pennsylvania | Completed | Mixed |
| Phase 1/2 | NCT02657889 | Apr 2016 → May 2018 | fallopian tube cancer, ovarian cancer, peritoneum cancer, triple-negative breast carcinoma | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02354131 | Feb 2015 → Nov 2018 | ovarian cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Completed | Met primary |
| Phase 2102 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT06392841 | Oct 2025 → Jan 2028 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition, Fanconi anemia complementation group A +2 | Qian Qin | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06747845 | May 2025 → Jun 2028 expected | pancreatic adenocarcinoma | Abramson Cancer Center at Penn Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06527690 | Apr 2025 → Sep 2027 | castration-resistant prostate carcinoma | Latin American Cooperative Oncology Group | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06365970 | Jan 2025 → Jan 2027 | colorectal cancer | Ibrahim Halil Sahin | Withdrawn | No outcome recorded |
| Phase 2 | NCT06180356 | Dec 2024 → Jan 2028 expected | ovarian cancer, ovarian serous tumor | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06433219 | Oct 2024 → Aug 2026 | ovarian carcinoma | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06535893 | Jul 2024 → Jun 2027 expected | breast cancer | Nagoya City University | Recruiting | No outcome recorded |
| Phase 2 | NCT05990192 | Jun 2024 → Dec 2027 expected | ovarian carcinoma | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 2 | NCT05689021 | Mar 2024 → Jul 2026 overdue | castration-resistant prostate carcinoma, prostate adenocarcinoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06237205 | Feb 2024 → Jun 2026 overdue | — | Korea University Anam Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05718323 | Dec 2023 → Dec 2026 expected | small cell lung carcinoma | ETOP IBCSG Partners Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT05174455 | Dec 2023 → Dec 2024 | leiomyosarcoma, retroperitoneal sarcoma | David Liebner, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT05126342 | Nov 2023 → Nov 2024 | fallopian tube cancer, ovarian cancer, peritoneum cancer | AGO Research GmbH | Withdrawn | No outcome recorded |
| Phase 2 | NCT06141265 | Nov 2023 → Mar 2027 expected | female reproductive organ cancer | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05870761 | Oct 2023 → Sep 2025 overdue | endometrial serous adenocarcinoma | Casey Cosgrove | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05412706 | Sep 2023 | colorectal cancer | Ospedale Policlinico San Martino | Withdrawn | No outcome recorded |
| Phase 2 | NCT05961124 | Aug 2023 → Sep 2025 overdue | ovarian serous adenocarcinoma | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05601440 | Jun 2023 → Dec 2027 expected | female breast carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05700721 | Jun 2023 → Dec 2029 expected | metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05065021 | Feb 2023 → Jun 2025 | endometrioid adenocarcinoma, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma +1 | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2 | NCT05523440 | Feb 2023 → Jan 2025 | endometrial carcinoma, ovarian carcinoma | University of Oklahoma | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05526989 | Dec 2022 → Nov 2026 expected | penile carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05442749 | Oct 2022 → Aug 2024 | malignant pancreatic neoplasm | Centre Leon Berard | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05461690 | Sep 2022 → Dec 2024 | triple-negative breast carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05515575 | Aug 2022 → Aug 2027 expected | soft tissue sarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05335993 | Jul 2022 → Dec 2026 expected | fallopian tube cancer, ovarian adenocarcinoma, peritoneum cancer | CanariaBio Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05455424 | Jul 2022 → Jan 2025 | malignant mesothelioma | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT05297864 | Jun 2022 → Nov 2023 | astrocytoma (excluding glioblastoma), glioblastoma, oligodendroglioma | University of Oklahoma | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05162196 | Jun 2022 → Jun 2024 | small cell lung carcinoma | Wuhan University | Unknown | No outcome recorded |
| Phase 2 | NCT05385068 | Jun 2022 → Mar 2024 | malignant epithelial tumor of ovary | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05232006 | May 2022 → Sep 2024 overdue | PALB2-related cancer predisposition | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06964165 | Apr 2022 → Jun 2024 | ovarian neoplasm | Tesaro, Inc. | Terminated | Missed primary |
| Phase 2 | NCT04992013 | Apr 2022 → Dec 2026 expected | central nervous system cancer, metastatic malignant neoplasm | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05311579 | Mar 2022 → Mar 2023 | ovarian carcinoma | Lei Li | Unknown | No outcome recorded |
| Phase 2 | NCT05169437 | Mar 2022 → Aug 2024 | breast neoplasm, endometrial cancer, esophageal cancer, head and neck cancer +6 | Tempus AI | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05183984 | Feb 2022 → Feb 2027 expected | ovarian cancer | ARCAGY/ GINECO GROUP | Recruiting | No outcome recorded |
| Phase 2 | NCT05130515 | Dec 2021 → Jan 2023 | carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 2 | NCT04983745 | Nov 2021 → Aug 2024 | neoplastic disease or syndrome | West Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT04895046 | Oct 2021 → Sep 2022 | cholangiocarcinoma, metastatic malignant neoplasm | Walid Shaib, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05162872 | Aug 2021 → Jun 2023 | nasopharyngeal carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04947254 | Aug 2021 → Jun 2028 expected | prostate carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04837209 | Jul 2021 → Feb 2027 expected | triple-negative breast carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04734665 | Jul 2021 → Mar 2023 | — | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT04885413 | Jul 2021 → Aug 2022 | endometrium adenocarcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04716686 | Jun 2021 → Dec 2025 overdue | endometrial carcinoma, serous neoplasm | Shandong University | Recruiting | No outcome recorded |
| Phase 2 | NCT04641247 | Apr 2021 → Dec 2026 expected | breast neoplasm, ovarian neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT04779151 | Apr 2021 → Feb 2025 | biliary tract cancer, clear cell renal carcinoma, gastric adenocarcinoma, gastroesophageal adenocarcinoma +3 | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04681469 | Feb 2021 → Jun 2023 overdue | head and neck squamous cell carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT04701307 | Feb 2021 → Apr 2027 expected | small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04584255 | Jan 2021 → Jul 2025 overdue | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, PALB2-related cancer predisposition +1 | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04507841 | Jan 2021 → Sep 2023 overdue | ovarian cancer | Tongji Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04715620 | Jan 2021 → Jan 2022 | glioblastoma | Tianjin Huanhu Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04592237 | Dec 2020 → Dec 2027 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate small cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04493060 | Dec 2020 → Dec 2023 | pancreatic ductal adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04940637 | Dec 2020 → Jun 2024 | lung cancer, mesothelioma | University of Turin, Italy | Unknown | No outcome recorded |
| Phase 2 | NCT04556071 | Nov 2020 → Mar 2022 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, endocrine gland neoplasm, fallopian tube neoplasm +1 | Xiaoxiang Chen | Unknown | No outcome recorded |
| Phase 2 | NCT04313504 | Nov 2020 → Jun 2025 | head and neck cancer | Trisha Wise-Draper | Completed | No outcome recorded |
| Phase 2 | NCT04185831 | Oct 2020 → Jan 2024 overdue | cancer | Uppsala University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04288687 | Oct 2020 → Feb 2024 | prostate adenocarcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04508803 | Sep 2020 → Aug 2022 | — | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT04423185 | Aug 2020 → Jul 2026 overdue | — | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT04392102 | Aug 2020 → Apr 2021 | ovarian cancer | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04409002 | Jul 2020 → Jan 2022 | malignant pancreatic neoplasm | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04240106 | Jun 2020 → Nov 2022 | breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04376073 | May 2020 → Dec 2021 | refractory malignant neoplasm | Jihong Liu | Unknown | No outcome recorded |
| Phase 2 | NCT04217798 | May 2020 → Mar 2022 | ovarian carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04395612 | May 2020 → Apr 2022 | cervical cancer | Chongqing University Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04284852 | May 2020 → Oct 2023 | ovarian cancer | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04068753 | Feb 2020 → Dec 2026 expected | cervical carcinoma | University of Oklahoma | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04030559 | Feb 2020 → Jan 2024 | ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition +6 | University of California, Davis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04221503 | Dec 2019 → Jan 2026 overdue | glioblastoma | Abramson Cancer Center at Penn Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04080284 | Dec 2019 → Jan 2025 | endometrial carcinoma, endometrial serous adenocarcinoma | Northwell Health | Completed | No outcome recorded |
| Phase 2 | NCT03891576 | Nov 2019 → Aug 2024 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Mario Negri Institute for Pharmacological Research | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT03983226 | Oct 2019 → Jun 2025 overdue | fallopian tube cancer, ovarian carcinoma, primary peritoneal carcinoma | Shanghai Gynecologic Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03983993 | Oct 2019 → May 2023 overdue | colorectal carcinoma | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03955471 | Oct 2019 → Aug 2021 | ovarian neoplasm | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03945084 | Aug 2019 → Sep 2021 | urothelial carcinoma | University of Turin, Italy | Completed | No outcome recorded |
| Phase 2 | NCT03840967 | Jul 2019 → Nov 2022 | adenocarcinoma, esophageal cancer, gastric cancer | Shadia Jalal, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03925350 | Mar 2019 → Feb 2022 | metastatic melanoma | California Pacific Medical Center Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03654833 | Jan 2019 → Oct 2023 | malignant mesothelioma | University of Leicester | Unknown | Met primary |
| Phase 2 | NCT03553004 | Jan 2019 → Apr 2023 | malignant pancreatic neoplasm | University of Kansas Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03759587 | Dec 2018 → Mar 2019 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT03759600 | Dec 2018 → Dec 2022 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT03783949 | Nov 2018 → Sep 2023 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT05751629 | Nov 2018 → Apr 2022 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03574779 | Nov 2018 → Jun 2024 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03601923 | Aug 2018 → Dec 2025 | malignant pancreatic neoplasm | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT03207347 | Aug 2018 → Aug 2022 | cholangiocarcinoma, mesothelioma, renal cell carcinoma, uveal melanoma | University of Florida | Completed | Missed primary |
| Phase 2 | NCT02826512 | May 2018 → Jul 2022 | breast cancer | The Netherlands Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03431350 | Mar 2018 → Aug 2021 overdue | castration-resistant prostate carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03326193 | Dec 2017 → Dec 2020 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03088059 | Nov 2017 → Jun 2025 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 2 | NCT03016338 | Nov 2017 → Jan 2021 overdue | endometrial cancer | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03308942 | Sep 2017 → May 2020 | neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02854436 | Aug 2016 → Jan 2021 | prostate neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02354586 | Mar 2015 → Feb 2018 | ovarian cancer | Tesaro, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01244009 | Dec 2010 → Aug 2013 | mantle cell lymphoma | Tesaro, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04159155 | Nov 2020 → May 2025 | endometrial carcinoma, serous neoplasm | University Health Network, Toronto | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03651206 | Jul 2020 → Jun 2027 expected | ovarian carcinosarcoma, uterine carcinosarcoma | ARCAGY/ GINECO GROUP | Recruiting | No outcome recorded |
| Phase 316 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06388733 | Jun 2024 → Dec 2027 expected | glioblastoma, primary brain neoplasm | Ivy Brain Tumor Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04915755 | Jun 2021 → Jun 2024 overdue | breast neoplasm | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04679064 | Dec 2020 → Jan 2025 | ovarian cancer | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 3 | NCT04475939 | Oct 2020 → Feb 2025 | non-small cell lung carcinoma | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT04497844 | Sep 2020 → Jan 2025 overdue | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03806049 | Dec 2019 → Dec 2022 | ovarian cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03903835 | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | Met primary |
| Phase 3 | NCT03748641 | Jan 2019 → Oct 2021 overdue | castration-resistant prostate carcinoma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03602859 | Oct 2018 → Oct 2024 overdue | female reproductive organ cancer, ovarian neoplasm | Tesaro, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03516084 | Aug 2018 → Feb 2020 | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03709316 | Jun 2018 → Jan 2022 | ovarian cancer | Zai Lab (Shanghai) Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03705156 | Jun 2017 → Feb 2020 | — | Zai Lab (Shanghai) Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT02655016 | Jul 2016 → May 2019 overdue | ovarian neoplasm | Tesaro, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT01905592 | Feb 2014 → May 2018 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, ovarian neoplasm | Tesaro, Inc. | Terminated | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06412120 | Jun 2026 → Jun 2029 expected | ovarian cancer | University of Miami | Recruiting | No outcome recorded |
| Phase 4 | NCT06887933 | Apr 2025 → Mar 2026 overdue | ovarian neoplasm | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05187208 | Jan 2022 → Dec 2025 | ovarian carcinoma, uterine adnexa cancer | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04861181 | May 2021 → Apr 2025 | — | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 4 | NCT03752216 | Apr 2019 → Aug 2021 | ovarian cancer | ARCAGY/ GINECO GROUP | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05401214 | — | prostate carcinoma | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| — | NCT03025867 | — | ovarian cancer | Tesaro, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT05261269 Background | Feb 2022 → Sep 2023 | Her2-receptor negative breast cancer | Dantari, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04826198 Background | Oct 2020 → Apr 2024 | ovarian cancer | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
| Phase 1/2 | NCT03221400 Background | Aug 2017 → Jan 2023 | anal squamous cell carcinoma, cervical squamous cell carcinoma, endometrium adenocarcinoma, gastric adenocarcinoma +5 | Tarveda Therapeutics | Unknown | No outcome recorded |
| Phase 2 | NCT06212583 Comparator | Apr 2024 → Dec 2028 expected | prostate cancer | University of Maryland, Baltimore | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05641506 Background | Dec 2022 → Oct 2023 | ovarian cancer | Sichuan Cancer Hospital and Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04812366 Comparator | Sep 2021 → Apr 2026 overdue | prostate cancer | University of British Columbia | Recruiting | No outcome recorded |
| Phase 3 | NCT06915025 Background | Jul 2025 → Oct 2032 expected | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Imunon | Recruiting | No outcome recorded |
| Phase 3 | NCT05009082 Comparator | Sep 2022 → Dec 2028 expected | fallopian tube cancer, ovarian carcinoma, peritoneum cancer | AGO Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT03981796 Comparator | Jul 2019 → Nov 2026 expected | neoplasm | Tesaro, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01847274 Comparator | Jun 2013 → Apr 2016 | ovarian neoplasm | Tesaro, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 75
| Date | Issuer | Release |
|---|---|---|
| 2026-03-09 | Janssen Research & Development, LLC | Regulatory European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC) jnj.com ↗
Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression. |
| 2026-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations jnj.com ↗
Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA®(niraparib and abiraterone acetate dual action tablet). |
| 2025-12-12 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care* jnj.com ↗ |
| 2025-12-12 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care* jnj.com ↗ |
| 2025-12-07 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Updates to China’s National Reimbursement Drug List zailaboratory.com ↗
ZEJULA® (niraparib) is renewed for the maintenance treatment of adult patients with platinum-sensitive, first-line and recurrent ovarian cancer. |
| 2025-10-16 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives U.S. FDA Priority Review for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic castration-sensitive prostate cancer jnj.com ↗ |
| 2025-07-03 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations jnj.com ↗ |
| 2025-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC jnj.com ↗
Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA. |
| 2025-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC jnj.com ↗ |
| 2025-05-29 | GlaxoSmithKline | Results GSK data at ASCO and EHA showcase latest research and innovation across the oncology portfolio gsk.com ↗
New data across phase III studies at ASCO show the impact of dostarlimab and niraparib in advanced gynaecologic cancers |
| 2025-01-29 | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Results Zentalis Pharmaceuticals Shares Updated Clinical Data Demonstrating Meaningful Azenosertib Activity In Cyclin E1+, Platinum-Resistant Ovarian Cancer zentalis.com ↗
Results from the combination cohorts of MAMMOTH and from the ZN-c3-016 study in colorectal cancer were also disclosed today. |
| 2024-12-20 | GlaxoSmithKline | Results GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer gsk.com ↗
The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. |
| 2024-07-15 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab-Supported Study Published in Cell Provides New Insights with Potential to Improve Treatment of HRD-Positive Ovarian Cancers, Including Through Combination PARP Inhibitor and CCR8 Therapy zailaboratory.com ↗
The study revealed niraparib preferentially suppresses certain immune cells that support the growth of HRD-positive ovarian tumors. |
| 2024-06-03 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany’s Innovative Oncology Pipeline of DNA Damage Response Inhibitors and Antibody-Drug Conjugates Poised to Advance Cancer Treatment emdserono.com ↗
Data from DDRiver 301 Part B presented today at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting show the ability to combine tuvusertib at a predicted efficacious dose with the PARP inhibitor niraparib |
| 2024-05-23 | GlaxoSmithKline | Results New data at ASCO showcases the transformational potential of GSK's oncology portfolio gsk.com ↗
Treatment with niraparib achieved a median overall survival of 20.3 months, compared to a historical control of 12.7 months. |
| 2024-05-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024 emdserono.com ↗
Data show a manageable safety profile and preliminary efficacy in patients with advanced solid tumors, confirming suitability of this combination for further evaluation. |
| 2024-03-16 | GlaxoSmithKline | Results Positive RUBY phase III data show potential for Jemperli (dostarlimab) combinations in more patients with primary advanced or recurrent endometrial cancer gsk.com ↗
37% reduction in risk of disease progression or death and 6-month improvement in median progression-free survival observed with the addition of Zejula (niraparib) to dostarlimab maintenance following dostarlimab plus chemotherapy versus chemotherapy in MMRp/MSS population where treatment options are still needed |
| 2023-12-18 | GlaxoSmithKline | Results Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial gsk.com ↗ |
| 2023-12-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗
ZEJULA® (niraparib) is renewed for the maintenance treatment of adult patients with platinum-sensitive, first-line and recurrent ovarian cancer. |
| 2023-10-22 | Janssen Research & Development, LLC | Results Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone jnj.com ↗ |
| 2023-10-22 | Janssen Research & Development, LLC | Results Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in OS in Patients with mCRPC with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone jnj.com ↗
Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy |
| 2023-08-11 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2023-08-11 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2023-07-19 | Zai Lab (Shanghai) Co., Ltd. | Results JAMA Oncology Publishes Data from Zai Lab Study Demonstrating Significant Reduction in Disease Progression or Death with ZEJULA (Niraparib) Maintenance Therapy in Broad Population of Advanced Ovarian Cancer Patients zailaboratory.com ↗
These data demonstrate that maintenance treatment with ZEJULA significantly prolongs progression-free survival (PFS) versus placebo and reduces the risk of disease progression or death by 55%. |
| 2023-06-01 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Highlight New Data from its Oncology Pipeline at 2023 ASCO Annual Meeting zailaboratory.com ↗
The data indicate that, in these patients, niraparib maintenance therapy tended to induce additional antitumor activity and led to a clinically meaningful increase in progression free survival (PFS) versus placebo. |
| 2023-04-21 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations jnj.com ↗
The EC authorisation, which also marks the first worldwide approval for AKEEGA®, is based on results of the randomised, double-blind, placebo controlled, Phase 3 MAGNITUDE study (NCT03748641). |
| 2023-04-21 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations jnj.com ↗ |
| 2023-03-01 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations jnj.com ↗
today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate |
| 2023-02-28 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations jnj.com ↗
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate |
| 2023-02-27 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer jnj.com ↗ |
| 2023-02-24 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer jnj.com ↗ |
| 2023-02-22 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Present Two New Phase 3 Analyses for Niraparib in Ovarian Cancer at the 2023 ESMO Gynaecological Cancers Congress zailaboratory.com ↗ |
| 2023-02-16 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
Updated review of the primary endpoints in radiographic progression free survival (rPFS) were consistent with the initial results, which showed a statistically significant benefit in both the HRR-positive population and BRCA subgroup. |
| 2023-02-16 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration - Resistant Prostate Cancer jnj.com ↗ |
| 2022-12-15 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Presents Interim Overall Survival Data for ZEJULA® (niraparib) from the NORA Phase 3 Study at the ESMO Virtual Plenary zailaboratory.com ↗
mOS in the ITT population: 46.3 months for patients receiving ZEJULA versus 43.4 months for placebo group [HR=0.82; 95% CI, 0.56-1.21]. |
| 2022-11-11 | GlaxoSmithKline | Regulatory GSK provides an update on Zejula (niraparib) US prescribing information gsk.com ↗
at the request of the US Food and Drug Administration (FDA) it will restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). |
| 2022-09-20 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Present Analysis of the Impact of Timing for ZEJULA® (niraparib) Maintenance Treatment in Newly Diagnosed Advanced Ovarian Cancer at the 2022 International Gynecologic Cancer Society Meeting zailaboratory.com ↗
For patients who received niraparib treatment less than 9 weeks after chemotherapy completion, the median progression-free survival (PFS) (95% CI) was measured at 29.4 months with niraparib versus 8.3 months with placebo (HR =0.31; 95% CI, 0.20–0.48). |
| 2022-09-09 | GlaxoSmithKline | Results Zejula (niraparib) shows durable and sustained long-term progression-free survival benefit in the PRIMA study of first-line platinum-responsive advanced ovarian cancer gsk.com ↗
The estimated probability of no progressive disease or death at four years was 38% for Zejula vs 17% for placebo, respectively. |
| 2022-05-31 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Present New PRIME Subgroup Analysis for Niraparib in Ovarian Cancer at 2022 ASCO Annual Conference zailaboratory.com ↗
The median progression-free survival was measured at 29.4 months for niraparib vs 8.3 months for placebo (HR=0.45; 95% CI, 0.32–0.61; P<0.001) in the complete response group. |
| 2022-03-20 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Presents Positive Results from Phase 3 PRIME Study of ZEJULA® (Niraparib) at Society of Gynecologic Oncology Meeting zailaboratory.com ↗
ZEJULA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status. |
| 2022-02-14 | Janssen Research & Development, LLC | Results Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone demonstrated a statistically significant improvement in patients with HRR gene alterations. |
| 2022-02-14 | Janssen Research & Development, LLC | Results Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone demonstrated a statistically significant improvement in patients with HRR gene alterations. |
| 2021-12-03 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Inclusion of ZEJULA® (Niraparib) in China’s National Reimbursement Drug List for First-Line Ovarian Cancer zailaboratory.com ↗ |
| 2021-11-30 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Positive Topline Results from Phase 3 PRIME Study of ZEJULA® (Niraparib) as First-Line Monotherapy Maintenance Treatment in Chinese Women with Platinum-Responsive Advanced Ovarian Cancer zailaboratory.com ↗
PRIME study demonstrates that niraparib treatment had a clinically meaningful and statistically significant benefit in improving progression-free survival in the overall study population regardless of biomarker status when compared to placebo |
| 2021-08-25 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in Hong Kong zailaboratory.com ↗
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that the Hong Kong Department of Health has approved its post-approval variation for ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment for adult patients with high grade serous epithelial ovarian cancer who are in a complete response or partial response to first-line platinum-based chemotherapy. |
| 2020-12-28 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Inclusion of ZEJULA® (Niraparib) in China’s National Reimbursement Drug List zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that ZEJULA® has been included in the updated National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA). |
| 2020-10-29 | GlaxoSmithKline | Regulatory European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer gsk.com ↗
GlaxoSmithKline (GSK) plc today announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy. |
| 2020-09-19 | Zai Lab (Shanghai) Co., Ltd. | Results Phase 3 NORA data of ZEJULA® (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian cancer zailaboratory.com ↗
Niraparib treatment resulted in a 68% reduction in the risk of disease progression or death in the overall population (PFS HR 0.32; 95% CI, 0.23–0.45; p<0.0001). |
| 2020-09-18 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion recommending approval of Zejula (niraparib) as first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer gsk.com ↗
Today’s positive opinion from the CHMP will give all women in response to platinum-based chemotherapy the option to receive Zejula in the maintenance setting, reinforcing our belief in the important role this innovative medicine may play in helping these patients and the physicians working to treat them. |
| 2020-09-10 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NMPA Approval of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China zailaboratory.com ↗
The NMPA ’s rapid approval of our sNDA for ZEJULA underscores the unmet medical needs it serves and further enables Zai Lab to make a meaningful impact on the way ovarian cancer is treated in China. |
| 2020-05-28 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Positive Topline Results from the NORA Phase 3 Study of ZEJULA® as Maintenance Therapy for Chinese Patients with Platinum-sensitive, Recurrent Ovarian Cancer zailaboratory.com ↗
The study met its primary endpoint of a statistically significant improvement in progression free survival for patients with ovarian cancer regardless of their biomarker status. |
| 2020-04-29 | GlaxoSmithKline | Regulatory FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status gsk.com ↗
The supplemental New Drug Application was approved under the FDA’s Real-Time Oncology Review pilot program |
| 2020-04-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces China’s NMPA Grants Priority Review to the sNDA for ZEJULA (Niraparib) for First-Line Ovarian Cancer Maintenance Treatment zailaboratory.com ↗
Zai Lab Announces China’s NMPA Grants Priority Review to the sNDA for ZEJULA (Niraparib) for First-Line Ovarian Cancer Maintenance Treatment |
| 2020-04-03 | GlaxoSmithKline | Regulatory FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status gsk.com ↗
The supplemental New Drug Application was approved under the FDA’s Real-Time Oncology Review pilot program |
| 2020-03-30 | GlaxoSmithKline | Regulatory Zejula (niraparib) is the first and only once-daily PARP inhibitor FDA-approved as a first-line monotherapy maintenance treatment for women with advanced ovarian cancer regardless of biomarker status gsk.com ↗
Zejula is the only once daily PARP inhibitor approved in the US as monotherapy treatment for women with advanced ovarian cancer beyond those with BRCAm ovarian cancer in the first-line and recurrent maintenance treatment, as well as late-line treatment settings. |
| 2020-03-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of sNDA Submission of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China by the NMPA zailaboratory.com ↗
Zai Lab Announces Acceptance of sNDA Submission of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China by the NMPA |
| 2020-02-27 | GlaxoSmithKline | Regulatory European Medicines Agency accepts submission of GSK’s Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer gsk.com ↗
Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). |
| 2020-02-24 | GlaxoSmithKline | Regulatory U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer gsk.com ↗ |
| 2019-12-27 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NMPA Approval of ZEJULA® (Niraparib) in China as Maintenance Therapy for Patients with Recurrent Ovarian Cancer zailaboratory.com ↗
Zai Lab Announces NMPA Approval of ZEJULA® (Niraparib) in China as Maintenance Therapy for Patients with Recurrent Ovarian Cancer |
| 2019-10-24 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Partner, GSK, Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced that its partner GlaxoSmithKline plc (GSK) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens |
| 2019-10-03 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib |
| 2019-10-03 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cance jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy. |
| 2019-09-29 | Zai Lab (Shanghai) Co., Ltd. | Results Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer zailaboratory.com ↗
Niraparib treatment resulted in a 38% reduction in the risk of disease progression or death in the overall population (PFS, HR 0.62; 95% CI, 0.50–0.75; p<0.001). |
| 2019-09-28 | GlaxoSmithKline | Results Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer gsk.com ↗
Niraparib treatment resulted in a 38% reduction in the risk of disease progression or death in the overall population (PFS, HR 0.62; 95% CI, 0.50–0.75; p<0.001). |
| 2019-08-27 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Publication of Pharmacokinetic Study of Niraparib in Chinese Ovarian Cancer Patients zailaboratory.com ↗
Results from the study show a PK profile of niraparib in Chinese patients comparable to that of patients evaluated in GSK’s global PK study. |
| 2019-07-15 | GlaxoSmithKline | Results GSK announces positive headline results in Phase 3 PRIMA study of ZEJULA (niraparib) for patients with ovarian cancer in the first line maintenance setting gsk.com ↗
The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status. |
| 2019-06-24 | GlaxoSmithKline | Regulatory U.S. Food and Drug Administration accepts GSK’s application for ZEJULA (niraparib) in late stage ovarian cancer with priority review gsk.com ↗
The application was granted priority review and has an action date of 24 October 2019. |
| 2019-06-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval to Commercialize ZEJULA (Niraparib) in Macau for Patients with Relapsed Ovarian Cancer zailaboratory.com ↗
Zai Lab Announces Approval to Commercialize ZEJULA (Niraparib) in Macau for Patients with Relapsed Ovarian Cancer |
| 2019-02-14 | Janssen Research & Development, LLC | Results Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD) jnj.com ↗
Data showed niraparib demonstrated an objective response rate of approximately 40 percent in patients with metastatic castration-resistant prostate cancer and DNA-repair pathway defects, specifically BRCA1/2 |
| 2019-01-28 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Priority Review Granted to Zai Lab's NDA Application for ZEJULA (Niraparib) in China zailaboratory.com ↗ |
| 2018-12-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of NDA Submission of ZEJULA (Niraparib) in Mainland China by the NMPA zailaboratory.com ↗
The NMPA ’s acceptance of our NDA submission for ZEJULA represents a major milestone for Zai Lab as this is our first ever NDA submission in Mainland China,” said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. |
| 2018-10-22 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval of ZEJULA® (Niraparib) for Patients with Relapsed Ovarian Cancer in Hong Kong zailaboratory.com ↗
ZEJULA is the first and only PARP inhibitor approved in Hong Kong for the maintenance treatment of platinum-sensitive relapsed ovarian cancer irrespective of BRCA mutation status |
| 2018-09-26 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Presents Results of its Pharmacokinetics (PK) Study for ZL-2306 (niraparib) in Chinese Ovarian Cancer Patients Showing Comparable Profile to non-Chinese Patients at the 21st Annual Meeting of the Chinese Society of Clinical Oncology zailaboratory.com ↗
Results from the study show comparable PK profile of the Chinese patients administered ZL-2306 to that of patients evaluated in Tesaro’s global PK study. |
| 2018-08-20 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab’s ZL-2306 (niraparib) Completes Pharmacokinetics (PK) Study in Chinese Ovarian Cancer Patients Showing Comparable Profile to non-Chinese Patients zailaboratory.com ↗
The study demonstrated comparable PK profile of Chinese patients who were administered ZL-2306 to the PK profile of patients evaluated in Tesaro’s clinical trials using product manufactured outside of China. |
| 2018-03-19 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Preclinical Data at the American Association for Cancer Research 2018 Annual Meeting karyopharm.com ↗
Chang et al. show that the combination of selinexor with the PARP inhibitor Zejula® (niraparib) provide enhanced efficacy over either agent alone in preclinical models of ovarian cancer. |
All press releases naming this drug 91 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 207 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Niraparib | “This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic,...” NCT04983745 ↗197“Niraparib (MK4827) is an oral potent, selective PARP-1 and PARP-2 inhibitor that induces synthetic lethality in preclinical tumour models with loss of BRCA and PTEN function.” PMID 23810788 ↗ Jun 2013 “Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial.” PMID 31474354 ↗ Aug 2019 “A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer” NCT03709316 ↗ “Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC” NCT06535893 ↗ “RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)” NCT04972110 ↗ “Participants will receive a fixed dose of Niraparib and CB-839, 800mg.” NCT03944902 ↗ “Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient” NCT03705156 ↗ “niraparib, an orally available small molecule PARP inhibitor” NCT03644342 ↗ “Niraparib is a PARP inhibitor.” NCT03516084 ↗ “niraparib 300 mg PO qd” NCT06145308 ↗ |
| Known as | \[3S\]-3-\[4-\[7-(aminocarbonyl)-2H-indazol-2-yl\] phenyl\] piperidine \[tosylate monohydrate salt\] | “Niraparib (\[3S\]-3-\[4-\[7-(aminocarbonyl)-2H-indazol-2-yl\] phenyl\] piperidine \[tosylate monohydrate salt\]) is an orally available, potent, and highly selective PARP1 and...” NCT05455424 ↗ |
| Known as | GSK3985771 | “A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy” NCT02655016 ↗ |
| Known as | JNJ-64091742 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | MK-4827 TOSYLATE MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | MK4827 | “Niraparib (MK4827) is an oral potent, selective PARP-1 and PARP-2 inhibitor that induces synthetic lethality in preclinical tumour models with loss of BRCA and PTEN function.” PMID 23810788 ↗ Jun 2013 |
| Known as | NIR | “This study evaluated the safety and dosing of the PARP1/2 inhibitor niraparib (NIR) with temozolomide (TMZ; arm 1) or irinotecan (IRN; arm 2) in patients with pretreated ES.” PMID 33289920 ↗ Dec 2020 |
| Known as | Nira | “Participants will receive atezolizumab and Niraparib (Nira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated...” NCT03869190 ↗1“Niraparib plus Abiraterone Acetate (Nira/AA) combination” NCT05401214 ↗ |
| Known as | NIRAPARIB (MK-4827) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Niraparib (tosilate monohydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Niraparib tosilate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Niraparib tosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Niraparib tosylate component of akeega | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | NIRAPARIB TOSYLATE MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Niraparib tosylate monohydrate component of akeega niraparib tosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1094636 ↗ |
| Known as | Zejula | “The PRIMA study evaluated how well the drug niraparib, also known as Zejula, worked at delaying or preventing ovarian cancer from coming back (recurring) or getting worse...” PMID 38501262 ↗ Mar 2024 |
| Known as | ZL-2306 | “A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in...” NCT03516084 ↗6“A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and...” NCT04395612 ↗ “An Open-Label, Single-Arm, Phase I Clinical Trial to Evaluate the Safety and Tolerability of ZL-2306 (Niraparib) in Combination With Brivanib in Patients With Recurrent Ovarian Cancer” NCT03895788 ↗ “A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer” NCT03709316 ↗ “Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient” NCT03705156 ↗ “ZL-2306(Niraparib）” NCT04392102 ↗ |
| Action | Inhibit | “Niraparib is an orally active PARP inhibitor.” NCT01847274 ↗ |
| Modality | Small molecule | “orally available small molecule PARP inhibitor” NCT03644342 ↗ |
| Route | Oral | “Niraparib (MK4827) is an oral potent, selective PARP-1 and PARP-2 inhibitor” PMID 23810788 ↗ Jun 2013 |
| Target | PARP1 | “This study evaluated the safety and dosing of the PARP1/2 inhibitor niraparib (NIR) with temozolomide (TMZ; arm 1) or irinotecan (IRN; arm 2) in patients with pretreated ES.” PMID 33289920 ↗ Dec 2020 |