Drugs / Fluzoparib
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Fluzoparib

Small molecule

Developed for
ovarian cancer · triple-negative breast carcinoma · Her2-receptor negative breast cancer · small cell lung carcinoma · breast cancer · castration-resistant prostate carcinoma · fallopian tube cancer · neoplasm
+29 more · cancer · female breast carcinoma · hormone receptor-positive breast cancer · non-small cell lung carcinoma · primary peritoneal carcinoma · prostate cancer · soft tissue sarcoma · breast carcinoma · colorectal cancer · malignant pancreatic neoplasm · ovarian carcinoma · ovarian serous adenocarcinoma · bone sarcoma · cancer of unknown primary site · endometrial carcinoma · Ewing sarcoma · glioblastoma · high grade malignant neoplasm · malignant epithelial tumor of ovary · melanoma · metastatic malignant neoplasm · metastatic prostate carcinoma · nasopharyngeal carcinoma · ovarian endometrioid adenocarcinoma · pancreatic neoplasm · peritoneum cancer · renal cell carcinoma · salivary gland carcinoma · sarcoma
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Fudan University · Sun Yat-sen University · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Peking University Cancer Hospital & Institute · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
+54 more · Chongqing University Cancer Hospital · Affiliated Hospital of Nantong University · Atridia Pty Ltd. · First Affiliated Hospital Xi'an Jiaotong University · First Hospital of China Medical University · Fujian Medical University Union Hospital · Liaoning Cancer Hospital & Institute · Ningbo Medical Center Lihuili Hospital · Northern Jiangsu People's Hospital · Qilu Hospital of Shandong University · Shanghai 6th People's Hospital · Shanghai First Maternity and Infant Hospital · Tianjin Medical University Cancer Institute and Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Hospital of Jilin University · Tianjin Medical University Second Hospital · 307 Hospital of PLA · Anhui Provincial Hospital · Beijing Jishuitan Hospital · Fujian Cancer Hospital · Fujun Zhang · Guangdong Provincial People's Hospital · Guangxi Medical University · Huazhong University of Science and Technology · Hunan Cancer Hospital · Hunan Province Tumor Hospital · Jianbin Bi · Jin Li · Jinhua Zhou · Jun Guo · Nanchang People's Hospital · Peking Union Medical College · Peking Union Medical College Hospital · Peking University Hospital of Stomatology · Peking University People's Hospital · Peking University Third Hospital · Qinglei Gao · Risen (Suzhou) Pharma Tech Co., Ltd. · Ruijin Hospital · Shandong University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital with Nanjing Medical University · The Second Affiliated Hospital of Shandong First Medical University · The Third Xiangya Hospital of Central South University · Tongji Hospital · Xing Xie · Ying Lin · Yongpeng Wang · Zhejiang Cancer Hospital · Zhimin Shao · wang shusen

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed EU (EMA) Wevdury castration-resistant prostate carcinoma 2026-10-09

“欧洲药品管理局(EMA)已确认受理氟唑帕利胶囊” hengrui.com ↗

Filed China (NMPA) 艾瑞颐 castration-resistant prostate carcinoma 2025-10-30

“氟唑帕利胶囊(艾瑞颐 ® )的药品上市许可申请获受理” hengrui.com ↗

Trials 97 · started per year

today
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2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 123 trials
Phase 1 NCT05440006 Jul 2022 neoplasm Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT05032235 Nov 2021 → Dec 2023 impaired renal function disease Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04718740 Jun 2021 → Oct 2022 ovarian cancer Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04694365 Mar 2021 → Jun 2024 — Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04425876 Dec 2020 → Mar 2023 malignant pancreatic neoplasm Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04333134 Apr → May 2020 — Atridia Pty Ltd. Completed No outcome recorded
Phase 1 NCT04341077 Apr 2020 — Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04108247 Sep 2019 → Jun 2023 castration-resistant prostate carcinoma Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04041011 Sep 2019 → Apr 2021 small cell lung carcinoma Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04108676 Sep 2019 neoplastic disease or syndrome Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT07141771 Dec 2025 → Jun 2030 expected small cell lung carcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 1/2 NCT06208410 Jan 2024 → Feb 2027 expected neoplasm Risen (Suzhou) Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05983237 Aug 2023 → Dec 2026 expected melanoma Jun Guo Recruiting No outcome recorded
Phase 1/2 NCT05928780 Jul 2023 → Mar 2024 triple-negative breast carcinoma Fudan University Unknown No outcome recorded
Phase 1/2 NCT04518501 Jul 2020 → Dec 2024 overdue — Xing Xie Recruiting No outcome recorded
Phase 1/2 NCT04659785 Jul 2020 → Jul 2021 small cell lung carcinoma Tianjin Medical University Second Hospital Unknown No outcome recorded
Phase 1/2 NCT04400188 Jun 2020 → Jan 2022 small cell lung carcinoma Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT04228601 Jan 2020 → Aug 2022 pancreatic neoplasm Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT03805399 Oct 2018 → Dec 2022 triple-negative breast carcinoma Fudan University Unknown No outcome recorded
Phase 251 trials
Phase 2 NCT07647653 Jun 2026 → Feb 2031 expected ovarian cancer Shandong University Not yet recruiting No outcome recorded
Phase 2 NCT07353437 Mar 2026 → Dec 2031 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07382713 Feb 2026 → Dec 2030 expected ovarian cancer Jinhua Zhou Not yet recruiting No outcome recorded
Phase 2 NCT07321015 Jan 2026 → Nov 2027 expected triple-negative breast carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07339553 Jan 2026 → Jan 2029 expected ovarian carcinoma Peking University Third Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07355010 Dec 2025 → Dec 2028 expected ovarian cancer Qinglei Gao Not yet recruiting No outcome recorded
Phase 2 NCT07047066 Jul 2025 → Jul 2026 overdue glioblastoma Tongji Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07033819 Jun 2025 → Jun 2027 expected ovarian carcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT06827717 Apr 2025 → Apr 2027 expected Ewing sarcoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT06971211 Nov 2024 → Oct 2027 expected castration-resistant prostate carcinoma Jianbin Bi Recruiting No outcome recorded
Phase 312 trials · 3 met primary
Phase 3 NCT06913777 Apr 2025 → Oct 2026 expected — Fudan University Recruiting No outcome recorded
Phase 3 NCT06188455 Dec 2024 → Dec 2025 overdue ovarian cancer The First Affiliated Hospital of Xiamen University Not yet recruiting No outcome recorded
Phase 3 NCT06539091 Oct 2024 → Oct 2025 overdue malignant epithelial tumor of ovary Anhui Provincial Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06612814 Sep 2024 → Oct 2027 expected breast carcinoma Zhimin Shao Active not recruiting No outcome recorded
Phase 3 NCT06533384 Aug 2024 → Dec 2026 expected triple-negative breast carcinoma Guangdong Provincial People's Hospital Recruiting No outcome recorded
Phase 3 NCT06255392 Jun 2024 → Mar 2031 expected Her2-receptor negative breast cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 3 NCT05891093 Jun 2023 → May 2028 expected breast cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT04691804 Mar 2021 → Dec 2026 expected castration-resistant prostate carcinoma Jiangsu HengRui Medicine Co., Ltd. Active not recruiting Met primary
Phase 3 NCT04300114 Aug 2020 → Feb 2022 malignant pancreatic neoplasm Jiangsu HengRui Medicine Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 3 NCT04296370 Jul 2020 → Jun 2022 Her2-receptor negative breast cancer Jiangsu HengRui Medicine Co., Ltd. Unknown Met primary
Phase not applicable2 trials
— NCT07000344 Jul 2025 → Mar 2026 ovarian cancer Peking Union Medical College Hospital Terminated No outcome recorded
— NCT04782089 May 2021 → May 2023 small cell lung carcinoma Qilu Hospital of Shandong University Unknown No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT05479487 Comparator Aug 2022 → Nov 2023 overdue — Xiaohua Wu MD Not yet recruiting No outcome recorded
Phase 2 NCT04517357 Comparator Oct 2020 → Nov 2023 — Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 3 NCT06954584 Background May 2025 → May 2030 expected ovarian cancer Tongji Hospital Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-10-09 Jiangsu HengRui Medicine Co., Ltd. Regulatory 恒瑞医药创新药氟唑帕利联合阿比特龙治疗转移性去势抵抗性前列腺癌适应症上市申请获欧洲药品管理局(EMA)受理 hengrui.com ↗
近日,恒瑞医药宣布欧洲药品管理局(EMA)已确认受理氟唑帕利胶囊(Wevdury ® ,中文商品名:艾瑞颐 ® )的上市许可申请(Marketing Authorisation Application,简称“MAA”),申请的适应症为 联合醋酸阿比特龙和泼尼松或泼尼松龙用于治疗转移性去势抵抗性前列腺癌(mCRPC)成年患者 。
2026-06-02 Jiangsu HengRui Medicine Co., Ltd. Results 2026 ASCO口头报告|恒瑞创新药氟唑帕利联合AA-P一线治疗转移性去势抵抗性前列腺癌期中分析结果重磅发布 hengrui.com ↗
研究结果显示,氟唑帕利联合AA-P组较安慰剂联合AA-P组显著延长rPFS(中位rPFS 24.8个月 [95% CI:20.4-30.4] vs. 19.9个月 [95% CI:15.2-22.2];HR 0.71 [95% CI:0.55-0.91];单侧p=0.0034),达到了主要研究终点。
2025-12-17 Jiangsu HengRui Medicine Co., Ltd. Results 中国智慧·世界看见|恒瑞医药创新药氟唑帕利卵巢癌FZOCUS-1研究登顶全球肿瘤学顶级期刊 hengrui.com ↗
研究证实 1 ,以氟唑帕利为基础的维持治疗可以带来显著的生存获益。
2025-10-30 Jiangsu HengRui Medicine Co., Ltd. Regulatory 恒瑞创新药氟唑帕利胶囊前列腺癌新适应症上市申请获受理 hengrui.com ↗
近日,恒瑞医药收到国家药品监督管理局下发的《受理通知书》,公司自主研发的1类新药氟唑帕利胶囊(艾瑞颐 ® )的药品上市许可申请获受理,适应症为: 本品联合阿比特龙和泼尼松或泼尼松龙用于DNA修复基因缺陷阳性(DRD+)的转移性去势抵抗性前列腺癌的一线治疗 。

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 102 sources stand behind the page.

FieldValueCited text
Known as Fluzoparib “Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle.” NCT07000344 ↗
81

“Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.” NCT05406999 ↗

“A single oral dose of fluzoparib on Day 1” NCT04341077 ↗

“fluzoparib 150 mg PO bid” NCT06145308 ↗

“SHR-1701 +fluzoparib” NCT04937972 ↗

NCT05759546 ↗

NCT04108676 ↗

NCT06612814 ↗

NCT04535687 ↗

NCT05932264 ↗

NCT06561022 ↗

Show 71 more sources

Known as Fluzoparib Capsules “Drug: Fluzoparib Capsules” NCT06188455 ↗
Known as fuzuloparib “Phase 2: Zeprumetostat Tablets in Combination with Fuzuloparib Dose: Zeprumetostat Tablets 250 mg, bid, po, Fuzuloparib 100 mg, bid, po.” NCT07339553 ↗
9

“fuzuloparib (formerly fluzoparib) versus placebo as a maintenance treatment” PMID 35404684 ↗ Apr 2022

NCT04518501 ↗

NCT05440006 ↗

NCT04691804 ↗

NCT07355010 ↗

NCT05819060 ↗

NCT06533384 ↗

NCT07033819 ↗

NCT05753826 ↗

Known as Fuzuopali ChEMBL registry synonym — accepted as the source's own label CHEMBL3930624 ↗
Known as HS-10160 ChEMBL registry synonym — accepted as the source's own label CHEMBL3930624 ↗
Known as SHR-3162 “Drug Fluzoparib 100mg bid PO qd, administered continuously until disease progression, unacceptable toxicity or death. 28 days as a treatment cycle. Other names: SHR-3162” NCT05952128 ↗
12

“Drug Fluzoparib 50mg PO bid, administered continuously until disease progression, unacceptable toxicity or death. 28 days as a treatment cycle. Other names: SHR-3162.” NCT06827717 ↗

“A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer” NCT04400188 ↗

“A Study of SHR-1316 and Fluzoparib(SHR-3162) in Small Cell Lung Cancer Patients” NCT04041011 ↗

“she will receive PARP inhibitor SHR3162 150mg bid” NCT03805399 ↗

NCT03182673 ↗

NCT04102124 ↗

NCT04355858 ↗

NCT04108247 ↗

NCT05928780 ↗

NCT02759666 ↗

Show 2 more sources

Action Inhibit “PARP-1 and PARP-2 inhibitor” NCT02575651 ↗
Modality Small molecule “Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 1/2 being developed for treatment of...” NCT03509636 ↗
Route Oral “when given orally to Chinese patients with advanced solid malignancies” NCT02575651 ↗