Delving into the Latest Updates on Fluzoparib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fuzuloparib, HS-10160, SHR 3162

+ [2]

Target

PARP

Mechanism

PARP inhibitors(Poly (ADP-Ribose) polymerase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [4]

Active Indication

Germline BRCA-mutated, HER2-negative metastatic breast cancerFallopian Tube CarcinomaOvarian Epithelial Carcinoma+ [20]

Inactive Indication

Advanced cancerExtensive stage Small Cell Lung CancerMetastatic Gastric Carcinoma+ [3]

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Luzsana Biotechnology, Inc.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Inactive Organization

Atridia Pty Ltd.Fujian Provincial Hospital

Drug Highest PhaseApproved

First Approval Date

CN (11 Dec 2020),

Platinum-Sensitive Fallopian Tube CarcinomaPlatinum-Sensitive Ovarian CarcinomaPlatinum-Sensitive Primary Peritoneal Carcinoma

RegulationPriority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN)

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Structure

Molecular FormulaC22H16F4N6O2

InChIKeyXJGXCBHXFWBOTN-UHFFFAOYSA-N

CAS Registry1358715-18-0

This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.
Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.
The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.

Start Date01 Oct 2024

Sponsor / Collaborator

Anhui Provincial Hospital

100 Clinical Results associated with Fluzoparib

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100 Translational Medicine associated with Fluzoparib

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100 Patents (Medical) associated with Fluzoparib

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40

Literatures (Medical) associated with Fluzoparib

01 Oct 2024·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development of UPLC–MS/MS method for studying the pharmacokinetic interactions of fuzuloparib with curcumin in rats

Article

Author: Xia, Hailun ; Xie, Saili ; Shen, Yuxin ; Chen, Xiaohai ; Tan, Wei ; Wu, Hualu ; Zhan, Ruanjuan ; Xu, Ren-Ai

Fuzuloparib is a novel orally bioactive poly-ADP-ribose polymerase inhibitor (PARPi), which was approved by the Chinese Regulatory Agency (CRA) in 2020 for the treatment of platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancers. This study firstly presents a rapid and accurate ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for analyzing the levels of fuzuloparib and its major metabolite (SHR165202), and to investigate drug-drug interaction between fuzuloparib and curcumin in vitro and in vivo studies. After protein precipitation with acetonitrile, mobile phase consisted of acetonitrile and 0.1 % formic acid with a gradient elution was used to successfully separate fuzuloparib, SHR165202 and talazoparib (internal standard, IS). The results indicated that fuzuloparib and SHR165202 had good linearity over the calibration range of 2-50 ng/mL and 1-20 ng/mL, respectively. The precision, accuracy, stability, matrix effect, and extraction recovery required for methodological validation all complied with the requirements of the Bioanalytical Method Validation Guidelines. In vitro microsome incubation experiments, curcumin exhibited inhibitory effect on fuzuloparib in both rat liver microsomes (RLM) and human liver microsomes (HLM) with half-maximal inhibitory concentration (IC₅₀) value of 10.54 μM and 47.64 μM, respectively, and the corresponding mechanism was non-competitive. Furthermore, the inhibitory mechanism of curcumin on fuzuloparib was validated through molecular docking. In pharmacokinetic experiments in rats, curcumin significantly altered the plasma exposure of fuzuloparib, resulting in significant increases in AUC_(0-t) and C_max of fuzuloparib and a significant decrease in CL_z/F. Moreover, the metabolite SHR165202 showed significant increases in AUC_(0-t), AUC_(0-∞), T_max and C_max and a significant decrease in CL_z/F. This further supports the notion that curcumin could inhibit the metabolism of fuzuloparib. Therefore, when co-administering fuzuloparib and curcumin in clinic, it is recommended to monitor plasma levels of fuzuloparib and pay close attention to adverse effects. If necessary, the dose of fuzuloparib needs to be reduced.

01 Sep 2024·Biochemistry and Biophysics Reports

Proteasome and PARP1 dual-target inhibitor for multiple myeloma: Fluzoparib

Article

Author: Cheng, Zhiyong ; Wang, Luting ; Wang, Suyun ; Deng, Kai ; Li, Qiongqiong ; Lu, Lina

One of the current mainstream treatments for multiple myeloma (MM) is chemotherapy. However, due to the high clonal heterogeneity and genomic complexity of MM, single-target drugs have limited efficacy and are prone to drug resistance. Therefore, there is an urgent need to develop multi-target drugs against MM. We screened drugs that simultaneously inhibit poly(ADP-ribose) polymerase 1 (PARP1) and 20S proteasome through computer-aided drug discovery (CADD) techniques, and explored the binding mode and dynamic stability of selected inhibitor to proteasome through Molecular biology (MD) simulation method. Thus, the dual-target inhibition effect of fluzoparib was proposed for the first time, and the ability of dual-target inhibition and tumor killing was explored at the enzyme, cell and animal level, respectively. This provides a theoretical and experimental basis for exploring multi-target inhibitory drugs for cancers.

01 Aug 2024·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Effect of food on the pharmacokinetics and safety profiles of a new PARP inhibitor fuzuloparib capsules in healthy volunteers

Article

Author: Jia, Yuanwei ; Chen, Xinyan ; Long, Yao ; Lin, Yuhong ; Shen, Jie ; Wang, Yaqin ; Huang, Yunzhe ; Du, Pengfei ; Wang, Minhui ; Wu, Jianbang

PURPOSE:

This study assessed effect of food on pharmacokinetics (PK) and safety of fuzuloparib capsules.

METHODS:

A randomized, open-label, two-cycle, two-sequence, crossover clinical trial was conducted. 20 subjects were randomly assigned to 2 groups at a 1:1 ratio. The first group subjects were orally administered 150 mg fuzuloparib capsules under fasting condition in first dosing cycle. The same dose of fuzuloparib capsules were taken under postprandial state after a 7-day washout period. The second group was reversed. 3 ml whole blood was collected at each blood collection point until 72 h post dose. PK parameters were calculated. Furthermore, safety assessment was performed.

RESULTS:

The time to maximum concentration (T_max) was prolonged to 3 h and maximum concentration (C_max) decreased by 18.6% on high-fat diets. 90% confidence intervals (CIs) of geometric mean ratios (GMRs) for C_max, area under the concentration-time curve from time zero to time t (AUC_0-t), and area under the concentration-time curve extrapolated to infinity (AUC_0-∞) after high-fat meal were 71.6-92.6%, 81.7-102.7% and 81.6-102.5%, respectively. All treatment-emergent adverse events (TEAEs) were grade 1; No serious adverse events (SAEs), serious unexpected suspected adverse reaction (SUSAR) or deaths were reported.

CONCLUSION:

Food decreased the absorption rate and slowed time to peak exposure of fuzuloparib capsules, without impact on absorption extent. Dosing with food was found to be safe for fuzuloparib capsules in this study.

CLINICAL TRIAL REGISTRATION:

This study was registered with chinadrugtrials.org.cn (identifier: CTR20221498).

1

News (Medical) associated with Fluzoparib

02 Jan 2023

·www.prnewswire.com

Propulsion of Pancreatic Cancer Pipeline as Novel and Extensive 170+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of pancreatic cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Pancreatic Cancer drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Eli Lilly and Company, CARsgen Therapeutics, and several others. LAS VEGAS, Jan. 2, 2023 /PRNewswire/ -- DelveInsight's ' Pancreatic Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline pancreatic cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the pancreatic cancer pipeline domain. Key Takeaways from the Pancreatic Cancer Pipeline Report DelveInsight's pancreatic cancer pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for pancreatic cancer treatment. Key pancreatic cancer companies such as FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc.Amgen, Biomea Fusion, and others are evaluating pancreatic cancer drugs to improve the treatment landscape. Promising pancreatic cancer pipeline therapies in various stages of development include Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72, PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. In December 2022, Targovax ASA announced that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy. In December 2022, Bluestar Genomics, Inc. announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics' proprietary epigenomic methods for the detection of the disease. In December 2022, iOnctura BV, a clinical-stage biotech developing novel cancer therapies, had been granted €17.5 million ($18.6 million) funding from the European Investment Council's (EIC) accelerator program to develop IOA-289 for pancreatic cancer.The EIC's funding consists of a grant of €2.5 million ($2.7 million) and €15 million ($16 million) of equity investment. In December 2022, In the Phase I/II CodeBreaK 100 trial, the KRAS G12C inhibitor sotorasib achieved meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer, according to researchers at The University of Texas MD Anderson Cancer Center. The results of the trial, published in the The New England Journal of Medicine, indicate an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months, and overall survival was 6.9 months. In December 2022, Oncolytics Biotech® Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation. In December 2022, RemeGen Co., Ltd. announced that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been granted ODD twice for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Panbela Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela's application for orphan designation of ivospemin ( SBP-101) in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). In September 2022, Qualigen Therapeutics, Inc. announced the presentation of two posters on QN-302 at the AACR 8th Special Conference on Pancreatic Cancer. The data presented include information on the compound's safety, tolerability, and efficacy in a pancreatic cancer model. The poster included preclinical toxicology data that showed QN-302 does not produce adverse toxicological reactions in mouse models at therapeutic doses. In in vitro tests, QN-302 inhibits acetylcholinesterase (AChE) by 53% and muscarinic receptor (M2) by 70% at 1 µM. Request a sample and discover the recent advances in pancreatic cancer drugs @ Pancreatic Cancer Pipeline Report The pancreatic cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage pancreatic cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the pancreatic cancer clinical trial landscape. Pancreatic Cancer Overview Pancreatic cancer develops in the pancreas tissues, an abdomen organ located behind the stomach's bottom portion. The pancreas secretes hormones that help control blood sugar and enzymes that aid digestion. Pancreatic cancer is a condition in which malignant (cancer) cells develop in pancreatic tissues. The pancreas can develop tumors in various ways, including malignant and noncancerous tumors. However, the precise causes of pancreatic cancer are unknown. Individuals diagnosed with pancreatic cancer before the tumor develops or spreads have an average life expectancy of pancreatic cancer of 3 to 3.5 years. Pancreatic cancer symptoms may include jaundice, dark urine, weight loss, loss of appetite, fatigue, and others. A pancreatic cancer diagnosis is difficult because symptoms are frequently confused with those of other disorders, such as irritable bowel syndrome. The extent of the cancer determines the treatment of pancreatic cancer options. Pancreatic cancer treatment options may include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Learn more about the diseases and pancreatic cancer diet @ Pancreatic Cancer Tests A snapshot of the Pancreatic Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging pancreatic cancer treatment options @ Pancreatic Cancer Clinical Trials Pancreatic Cancer Therapeutics Assessment The pancreatic cancer pipeline report proffers an integral view of pancreatic cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Pancreatic Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Growth differentiation factor 15 inhibitors, Endothelin B receptor antagonists, Image enhancers Key Pancreatic Cancer Companies: FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc., Amgen, Biomea Fusion, and others. Key Pancreatic Cancer Pipeline Therapies: Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72,PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. Dive deep into rich insights for pancreatic cancer research; visit @ New Treatment for Pancreatic Cancer Table of Contents For further information on pancreatic cancer prevention, reach out @ Pancreatic Cancer Drug Treatment Related Reports Pancreatic Cancer Epidemiology Pancreatic Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted pancreatic cancer epidemiology in the 7MM. Pancreatic Cancer Market Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Advanced Pancreatic Cancer Market Advanced Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key advanced pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others. Advanced Pancreatic Cancer Pipeline Advanced Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Metastatic Pancreatic Cancer Market Metastatic Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Metastatic Pancreatic Cancer Pipeline Metastatic Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Fast TrackOrphan DrugClinical ResultImmunotherapy

100 Deals associated with Fluzoparib

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB15637

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Germline BRCA-mutated, HER2-negative metastatic breast cancer	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Dec 2024
Fallopian Tube Carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 May 2024
Ovarian Epithelial Carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 May 2024
Primary peritoneal carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 May 2024
Platinum-sensitive epithelial ovarian cancer	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Jun 2021
Platinum-Sensitive Fallopian Tube Carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Dec 2020
Platinum-Sensitive Ovarian Carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Dec 2020
Platinum-Sensitive Primary Peritoneal Carcinoma	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	-	Luzsana Biotechnology, Inc.	18 May 2022
Metastatic castration-resistant prostate cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Mar 2021
Secondary malignant neoplasm of pancreas	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	19 Aug 2020
Metastatic breast cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	03 Jul 2020
Recurrent ovarian cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Apr 2019
Prostatic Cancer	Phase 3	US	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
Hormone receptor positive HER2 positive breast cancer	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Apr 2024
Ewing Sarcoma	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jul 2023
Metastatic Soft Tissue Sarcoma	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jul 2023
Triple Negative Breast Cancer	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	08 Apr 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Ovarian Cancer First line \| Maintenance	224	氟唑帕利 (一线维持治疗)	eddwgfpcoj(yluzhtgmzx) = tfrjbaeffq xbnbhvyxvs (lovtyfbfeb, NR - NR) View more	Positive	27 Sep 2024
NEWS Manual	Not Applicable	Ovarian Cancer First line \| Maintenance	224	氟唑帕利 (铂敏感复发(PSR)维持治疗)	eddwgfpcoj(yluzhtgmzx) = fwsmhgrzox xbnbhvyxvs (lovtyfbfeb, 10.2 - 20.7) View more	Positive	27 Sep 2024
NCT04108247 (ESMO2024) Manual	Phase 1	Metastatic castration-resistant prostate cancer First line \| Second line	39	Fuzuloparib abiraterone acetate	yxwcpnogzz(qczaclxmna) = awjostxofk bsbcmhxpsn (cbpbtygman ) View more	Positive	15 Sep 2024
NCT05223582 (FAST-PC, ESMO2024) Manual	Phase 2	Prostatic Cancer Neoadjuvant	35	Fuzuloparib + Abiraterone + Prednisone + Medical castration	vztwtgnhfi(qtuvozgbsc) = eihosudzhl yuubbisgxx (nrnwcggypc, 28.8 - 63.4) View more	Positive	15 Sep 2024
NCT04228601 (Phase 1b study of first-line fuzuloparib combined with modified FOLFIRINOX followed by fuzuloparib maintenance monotherapy in pancreatic adenocarcinoma, Pubmed \| BMC Med) Manual	Phase 1	Pancreatic adenocarcinoma Maintenance \| First line	39	Fuzuloparib 60 mg BID	hotprbeisk(rfnbvuwlpx) = occurred in 1 patient in 60 mg cohort and 1 patient in 100 mg cohort. otlopujywz (ytcbmsmwsg ) View more	Positive	04 Sep 2024
NCT04296370 (FZPL-Ⅲ-303, ESMO_Virtual2024 \| NEWS) Manual	Phase 3	HER2-negative breast cancer Second line \| Third line BRCA2 Mutation (Germline) \| HER2 Negative	203	Fuzuloparib + Apatinib	cgyfonmvpz(wtvdcofhov) = dgqpwtgfvk naorsjtnpv (bmqzgsbhsd, 8.4 - 13.1) View more	Positive	09 May 2024
NCT04296370 (FZPL-Ⅲ-303, ESMO_Virtual2024 \| NEWS) Manual	Phase 3		203	Fuzuloparib	cgyfonmvpz(wtvdcofhov) = lkupolrfci naorsjtnpv (bmqzgsbhsd, 4.2 - 7.6) View more	Positive	09 May 2024
NCT04228601 (ESMO2023) Manual	Phase 1	Pancreatic Cancer First line \| Maintenance	39	Fuzuloparib+mFOLFIRINOX	gvqvqryghy(lmwyeibwnp) = wqyshcdvks yctajhvrfg (rdkcbtvmdq, 71.0–96.5) View more	Positive	23 Oct 2023
NCT04228601 (ESMO2023) Manual	Phase 1	Pancreatic Cancer First line \| Maintenance	39	Fuzuloparib+mFOLFIRINOX (30 mg)	gvqvqryghy(lmwyeibwnp) = cnrrnnzdhw yctajhvrfg (rdkcbtvmdq, 51.6–97.9) View more	Positive	23 Oct 2023
NCT03075462 (NEWS) Manual	Phase 1	Primary peritoneal carcinoma \| Ovarian Cancer \| Triple Negative Breast Cancer ... View more	52	氟唑帕利+阿帕替尼	hjbfgfhhba(tgonmcdjgg) = dxpgrynulc ugzezfgexp (muwtjwkisf ) View more	Positive	12 Oct 2023
NCT03075462 (phase 1 trial of fuzuloparib in combination with apatinib, Pubmed \| BMC Med)	Phase 1	Triple Negative Breast Cancer germline BRCA mutation (gBRCAmut)	-	Fuzuloparib 100 mg	ljtpezjgij(mrwzcjiiqm) = 2 dose-limiting toxicities occurred: grade 4 febrile neutropenia (fuzuloparib 100 mg plus apatinib 250 mg) and thrombocytopenia (fuzuloparib 100 mg plus apatinib 375 mg) nbqjbgeldo (yivvsvjwbg ) View more	Positive	29 Sep 2023
NCT04229615 (FZPL-III-302, NEWS) Manual	Phase 3	Primary peritoneal carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma Maintenance	674	氟唑帕利	mjtnpehrba(zjrjcslyoj) = 可显著延长患者的无进展生存期，降低疾病进展/死亡风险 bygmgwimhm (jacnxeycyb )	Positive	22 Aug 2023
NCT04229615 (FZPL-III-302, NEWS) Manual	Phase 3		674	氟唑帕利+阿帕替尼		Positive	22 Aug 2023
NCT05223582 (FAST trial, ASCO_GU2023) Manual	Phase 2	Prostatic Cancer Neoadjuvant	12	fluzoparib 150mg+abiraterone 1000mg+prednisone 5mg	gxadtzwpoz(elacioffcb) = fmpllhlngk rqyhysoiuz (wnkfdqorsr, 18.4 - 102.5) View more	Positive	21 Feb 2023