AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

FZPL-Ⅲ-301-OC: A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients (clinicaltrials.gov) - P3 | N=252 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2025

Platinum sensitive • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Fluzoparib disrupts Golgi apparatus to inhibit O-GlcNAcylation and nuclear translocation of β-catenin to attenuate ovarian cancer invasion and metastasis. (PubMed, Int Immunopharmacol) - "Mechanistically, FZ disrupts the morphology and function of the Golgi apparatus, inhibits the O-GlcNAcylation of β-catenin, and promotes competitive phosphorylation of β-catenin, thereby preventing its translocation to the nucleus and ultimately inhibiting the invasion and metastasis of ovarian cancer. In summary, this study reveals that FZ disrupts the Golgi apparatus and inhibits the O-GlcNAcylation and nuclear translocation of β-catenin, thereby preventing the invasion and metastasis of ovarian cancer."

Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CTNNB1

A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Tongji Hospital

New P2 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=25 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant Treatment of Ovarian Cancer With Fluazoparib in Combination With Apatinib (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=424 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=144 ➔ 20 | Active, not recruiting ➔ Terminated; The sponsor's R&D strategy is adjusted.

Enrollment change • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EFFICACY AND SAFETY OF HETROMBOPAG FOR PARP INHIBITOR-INDUCED THROMBOCYTOPENIA: A PHASE II OPEN-LABEL, PROSPECTIVE TRIAL (EHA 2025) - "PARPi treatments included fuzuloparib (11.8%), olaparib (23.5%), and niraparib (64.7%). Hetrombopag demonstrated promising efficacy in platelet recovery and favorable tolerability in patients with PARPi-induced thrombocytopenia, enabling uninterrupted PARPi therapy. These results suggest that hetrombopag may be a viable treatment option for managing thrombocytopenia in patients receiving PARPi."

Clinical • P2 data • Cervical Cancer • Fatigue • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

Hepatitis B virus core protein promotes liver cancer progression by stabilizing CANX and suppressing IRF7 transcription. (PubMed, Acta Pharmacol Sin) - "We showed that a candidate compound fluzoparib effectively suppressed HBC-positive liver cancer cells in vitro and in vivo. Overall, this study underscores the crucial role of CANX and its regulatory mechanisms in promoting HBC-mediated liver cancer progression and reveals the therapeutic potential of targeting CANX in HBV infection-caused liver cancer."

Journal • Hepatitis B • Infectious Disease • Liver Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • CANX • HDAC3 • IRF7

Bioanalytical assay for the quantification of rucaparib in rat plasma using UPLC-MS/MS: development, and validation for interaction with myricetin. (PubMed, Front Pharmacol) - "In this study, acetonitrile was used as the protein precipitant, and fuzuloparib was used as the internal standard (IS). The results of the drug-drug interaction (DDI) study showed that myricetin had no significant effect on the pharmacokinetic parameters of rucaparib, which indicating that the clinician did not need to adjust the dosage of rucaparib when it was used in combination. The UPLC-MS/MS method developed in this study was successfully used for the determination of the plasma concentrations of rucaparib orally administered in rats, which provided a reference for DDI studies and clinical pharmacokinetic studies of rucaparib."

Journal • Preclinical • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and effectiveness of fuzuloparib in patients with ovarian cancer: A nationwide, multicenter, prospective real-world study. (ASCO 2025) - P=N/A | "This is the first large-scale real-world study assessing the safety and effectiveness of fuzuloparib. In the real-world setting, fuzuloparib shows favorable safety, with no new safety signals. The effectiveness outcomes align with trends observed in key clinical trials."

Clinical • Real-world • Real-world evidence • Anemia • Fallopian Tube Cancer • Leukopenia • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

Phase Ib/II study of fluzoparib in combination with dalpiciclib in patients with locally advanced or metastatic sarcoma. (ASCO 2025) - P2 | "This novel combination therapy of CDK4/6 inhibitor and PARP inhibitor showed manageable toxicity that could provide a strategy for advanced or metastatic sarcoma. Part 2 to evaluate safety and efficacy is currently recruiting pts. TRAEs with an incidence of ≥30% and any grade ≥3 TRAEs."

Clinical • Combination therapy • Metastases • P1/2 data • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia • HRD

Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor (clinicaltrials.gov) - P=N/A | N=70 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

Preliminary study of apatinib combined with fluzoparib in the treatment of HRP ovarian cancer via the HR pathway. (PubMed, Transl Cancer Res) - "The combination of apatinib and fluzoparib may cause changes in the HR pathway by down-regulating MEK signaling in ovarian cancer, leading to the down-regulation of RAD51. This eventually leads to the increased expression of DNA damage-related protein γH2AX, which plays a therapeutic role in ovarian cancer in vitro and in vivo."

Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Transplantation • BRCA1 • RAD51

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=424 | Not yet recruiting | Sponsor: Tongji Hospital

Monotherapy • New P3 trial • Oncology • Ovarian Cancer • Solid Tumor

PARTOM: Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Jianbin Bi

New P2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

RAFAS-001: Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Fujun Zhang | Trial completion date: Dec 2024 ➔ Dec 2028 | Trial primary completion date: Jun 2024 ➔ Dec 2028

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Case Report: Two cases of chemotherapy refractory aggressive variant prostate cancer with extreme durable response to PARP inhibitor. (PubMed, Front Oncol) - "He was treated with docetaxel/albumin-bound paclitaxel and cisplatin in the first line. Second-line therapy was applied with radiotherapy and Olaparib after failure of first-line therapy, resulting in a PSA response sustained for three years...Radiotherapy and Fluzoparib + abiraterone was applied as subsequent treatments with a PSA response for 2 years. These two cases demonstrating a satisfactorily durable response to PARP inhibitors indicating its clinical benefit in AVPC population with detected DNA damage response (DDR) defects. The survival improvement with PARP inhibitors observed in our clinical experiences, along with current advances in tumor sequencing provide more information on future clinical trials and explorations of innovative therapies in AVPC population."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA2 • FANCA • HDAC2 • PTEN • RB1 • TP53

Clinical Practice of Poly (ADP-Ribose) Polymerase Inhibitors for Maintenance Treatment of Platinum-Sensitive Recurrent Ovarian Cancer in China. (PubMed, BJOG) - "Clinical trials of three poly (ADP-ribose) polymerase (PARP) inhibitors, olaparib, niraparib and fuzuloparib, in platinum-sensitive recurrent ovarian cancer (PSR OC) in China showed that PARP inhibitors improved progression-free survival and achieved an all-comer indication in this population. We reviewed the efficacy and safety of these PARP inhibitors in patient populations studied in clinical trials and highlighted the positive role of PARP inhibitors in improving patient outcomes using clinical trials and real-world studies conducted in China. This article also discusses the issues encountered in clinical practice and how to evaluate the different indications for PSR OC in China and abroad."

Journal • Platinum sensitive • Review • Oncology • Ovarian Cancer • Solid Tumor

Research Progress of M6A Methylation Modification in Immunotherapy of Colorectal Cancer. (PubMed, Curr Cancer Drug Targets) - "This review has sys-tematically summarized the latest clinical application of six authorized PARPi, including olaparib, rucaparib, niraparib, talazoparib, fuzuloparib and pamiparib, in monotherapy and combination therapies with chemotherapy, radiotherapy, and immunotherapy, in different kinds of cancer. Furthermore, probable challenges in PARPi application and drug resistance mechanisms have also been discussed. Despite these challenges, further development of new PARP1 inhibitors appears promising as a valuable approach to cancer treatment."

Journal • Colorectal Cancer • Oncology • Solid Tumor

Engaging an engineered PARP-2 catalytic domain mutant to solve the complex structures harboring approved drugs for structure analyses. (PubMed, Bioorg Chem) - "Consequently, the complex structures of Fluzoparib, Pamiparib, Rucaparib, and Niraparib within PARP-2 were achieved. It suggested that the residues adjacent to Asp766 in the HD and ASL domains and the αJ-αF and ASL-αD interfaces were closely related to the selectivity and trapping mechanism. These results would provide some insights for the design and development of novel PARP-1/2 inhibitors with improved pharmacodynamic properties."

Journal • Oncology • PARP1 • PARP2

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Fluzoparib plus apatinib maintenance in patients with platinum-sensitive recurrent ovarian cancer who had received first-line maintenance with a PARP inhibitor (FLASH): A single-arm exploratory trial (SGO 2025) - No abstract available

Clinical • Oncology • Ovarian Cancer • Solid Tumor