A Prospective Study Based on Spatial Multi-Omics for Predicting the Efficacy of Androgen Deprivation Therapy Combined With Second-Generation Novel Endocrine Therapeutic Agents in Metastatic Hormone-Sensitive Prostate Cancer.

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

Start Date01 Oct 2026

Sponsor / Collaborator

Anhui Medical University

NCT07711314

/ RecruitingPhase 2IIT

Rezvilutamide Monotherapy as Adjuvant Treatment for Patients With High Recurrence Risk After Radical Prostatectomy: A Prospective, Multicenter, Single-Arm Study

Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of < 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.

Start Date01 Jul 2026

Sponsor / Collaborator

Nanjing Drum Tower Hospital

[+2]

NCT07490210

/ Not yet recruitingPhase 2IIT

Rezvilutamide Combined With Radical Prostatectomy and Metastasis-Directed Radiotherapy in Oligometastatic Prostate Cancer Patients: A Multicenter, Three-Arm, Open-Label, Randomized Controlled Phase II Clinical Trial

Prostate cancer represents the second most common malignancy in men worldwide. Oligometastatic prostate cancer (OMPC), defined as a transitional state between localized and widespread metastatic disease (≤10 metastatic lesions without visceral metastases), exhibits relatively indolent biological behavior, offering a window for curative-intent multimodal therapy. While standard systemic therapy with androgen deprivation therapy (ADT) plus novel hormonal agents (NHA) remains the backbone for metastatic hormone-sensitive prostate cancer (mHSPC), emerging evidence suggests that maximal cytoreductive therapy-combining systemic treatment with local interventions (Radical prostatectomy（RP） and Metastasis-directed radiotherapy（MDT）)-may improve survival outcomes. Rezvilutamide (SHR3680), a novel androgen receptor inhibitor independently developed by a Chinese pharmaceutical company, has demonstrated superior radiographic progression-free survival (rPFS) and overall survival (OS) compared to bicalutamide in high-volume mHSPC (CHART study). However, the value of adding metastasis-directed radiotherapy (MDRT) to rezvilutamide and radical prostatectomy in OMPC remains unproven. This trial hypothesizes that maximal cytoreductive therapy (systemic therapy + surgery + MDRT) will significantly prolong progression-free survival (PFS) compared to systemic therapy alone.
This is a multicenter, three-arm, open-label, randomized controlled phase II clinical trial (Protocol No.: MA-PCa-II-023; Lead Investigator: Prof. Bo Dai, Fudan University Shanghai Cancer Center). The study will enroll 300 patients randomized in a 2:2:1 ratio to:
Arm A (Experimental): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (if PSA decline ≥50%, castrate testosterone level, and resectable disease) → MDT (SBRT 30-40 Gy/3-5 fractions) to all evaluable metastases at month 6 （ 3 month post-surgery）
Arm B (Control): Rezvilutamide (240 mg QD) + ADT alone
Arm C (Factorial): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (without MDT)
Eligible patients are males ≥18 years with histologically confirmed prostate adenocarcinoma (no neuroendocrine differentiation), newly diagnosed mHSPC with oligometastatic disease (≤10 bone/lymph node metastases on conventional imaging; no visceral metastases), and planned ADT. Key exclusion criteria include prior radical prostatectomy, pelvic radiotherapy, systemic therapy for prostate cancer (except ≤4 weeks of ADT), or contraindications to surgery/radiotherapy.
The primary endpoint is PFS, defined as time from randomization to first biochemical progression (PSA rise ≥25% and ≥1 ng/mL above nadir confirmed after ≥3 weeks), radiographic progression (RECIST 1.1/PCWG4), clinical progression (new symptoms from local/metastatic disease), or death. Secondary endpoints include rPFS, OS, PSA response rates (PSA50/PSA90), local therapy completion rate, time to CRPC, quality of life (FACT-P and EPIC-26 questionnaires), and safety profiles. Exploratory endpoints evaluate the role of baseline PSMA PET/CT in staging and the development of artificial intelligence models using multimodal data (clinical, imaging, pathology, molecular) to predict prognosis.

Start Date01 May 2026

Sponsor / Collaborator

Fudan University

[+1]

100 Clinical Results associated with Rezvilutamide

100 Translational Medicine associated with Rezvilutamide

100 Patents (Medical) associated with Rezvilutamide

Literatures (Medical) associated with Rezvilutamide

01 Nov 2026·BJU INTERNATIONAL

Evaluation of triplet therapy combined with robot‐assisted cytoreductive prostatectomy for high‐volume metastatic prostate cancer: a multicentre randomised controlled trial protocol

Article

Author: Yan, Binyuan ; Yang, Xiangwei ; Pang, Jun ; Chen, Linze ; He, Zhuobin ; Chen, Jian ; Lei, Hanqi ; Liu, Hong

Background:

Prostate cancer (PCa) is the second most common cancer in men. For patients with high‐volume metastatic PCa (mPCa) who are fit for docetaxel, a triplet therapy regimen consisting of androgen deprivation therapy (ADT), chemotherapy, and an androgen receptor pathway inhibitor (ARPI) is recommended. Adding local radiotherapy to triplet therapy has been shown to alleviate symptoms and reduce disease progression. However, the benefit of combining triplet therapy with local surgery remains unclear and warrants further investigation in the present study.

Study Design:

This is an open‐label, prospective, two‐arm, multicentre, randomised controlled trial.

Endpoints:

Primary endpoints are progression‐free survival (PFS) and the 1‐year PFS rate. Disease progression is defined as prostate‐specific antigen (PSA) progression, radiological progression, or unequivocal clinical progression. Secondary endpoints include overall survival (OS) and health‐related quality of life (HRQoL).

Patients and Methods:

Patients aged 18–75 years with high‐volume mPCa will receive ADT (triptorelin 15 mg every 3 months), four–six cycles of chemotherapy (docetaxel 75 mg/m 2 every 3 weeks), and an ARPI (rezvilutamide 240 mg once daily). Patients achieving a PSA level ≤0.2 ng/mL and deemed suitable candidates for surgery will be enrolled. A total of 88 eligible patients will be randomised in a 1:1 ratio. The control group will continue treatment with triptorelin and rezvilutamide, while the experimental group will receive robot‐assisted cytoreductive prostatectomy in addition to triptorelin and rezvilutamide. Baseline PSA levels will be recorded and re‐examined at each chemotherapy cycle and every 3 months thereafter. Radiological evaluations will be performed every 6 months. Clinical progression will be assessed based on pain severity, performance status, and the need to initiate new anticancer therapy. HRQoL will be evaluated every 3 months. PFS and OS will be estimated using Kaplan–Meier curves and compared with the log‐rank test.

Trial Registration:

Chinese Clinical Trial Registry: ChiCTR2600121819

01 May 2026·BMJ Open

Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer (REDOOM): study protocol for an open-label, parallel-cohort, multicentre clinical study

Article

Author: Chen, Hong-De ; Zhu, Xin-Xu ; Ding, Yuan-Zhe ; Huang, Hang ; Wang, Hui-Liang ; Deng, Zhe-Xian ; Li, Peng ; Li, Hai-Yan ; Li, Ping ; Huang, Ka-Te ; Yu, Kai-Yuan ; Zhuang, Yuan-Di ; Yang, Yu ; Chen, Wei ; Wang, Ling ; Ji, Xiao-Wei ; Cai, Bing ; Pan, Yue ; Chen, Zi-Jian ; Lin, Qi

Objective:

This trial investigates the efficacy of neoadjuvant therapy using rezvilutamide combined with androgen deprivation therapy (ADT), with or without docetaxel, in treating oligometastatic hormone-sensitive prostate cancer (omHSPC).

Methods and analysis:

This prospective, open-label, multicentre trial aims to enrol 100 patients newly diagnosed with omHSPC (defined as ≤5 bone or lymph node metastases confirmed by conventional imaging, without visceral metastasis) who must express a desire to undergo surgery. All patients undergo a prostate-specific membrane antigen positron emission tomography/CT (PSMA-PET/CT) scan at enrolment or within 4 weeks before enrolment to assess and confirm the number of metastases at baseline. Scans should be performed before initiating ADT to avoid compromising test sensitivity. Then patients will be allocated into groups in parallel according to their own preferences: one group will receive an LHRH agonist or antagonist for 24 weeks to maintain continuous ADT or have undergone bilateral orchiectomy. Treatment with rezvilutamide will be maintained daily. The other group will be scheduled to complete up to six cycles of docetaxel within 24 weeks, with maintenance of continuous ADT and rezvilutamide for 24 weeks. Both groups will receive a conventional imaging evaluation at the 12th week. After neoadjuvant therapy, patients will undergo conventional imaging and a second PSMA-PET/CT assessment, followed by cytoreductive radical prostatectomy within the subsequent 6 weeks. After surgery, patients may choose to continue with ADT or rezvilutamide at their own discretion, until disease progression. The primary endpoint is pathological complete response, defined as the absence of residual viable tumour cells in the tumour bed on pathological evaluation of the postoperative specimen. Secondary endpoints include 1 year biochemical progression-free survival, overall survival, radiographic progression-free survival, time to prostate-specific antigen progression, quality of life scores (total and subscale) assessed using the Functional Assessment of Cancer Therapy-Prostate questionnaire, time to symptomatic progression, time to deterioration in Eastern Cooperative Oncology Group performance status, the interval from enrolment to an increase in score from baseline, the proportion of patients with a ≥30% reduction in prostate volume on imaging before cytoreductive surgery compared with pre-neoadjuvant therapy, minimal residual disease and major pathological response. The study plans to enrol a total of 100 patients. Patient recruitment for this study is scheduled to begin in May 2025.

Ethics and dissemination:

This has been approved by the Ethics Committee in Clinical Research of the First Affiliated Hospital of Wenzhou Medical University (number KY2024-231). Results will be published in peer-reviewed publications.

Discussion:

This study is expected to provide prospective evidence on the feasibility and potential clinical value of rezvilutamide combined with ADT, with or without docetaxel, as neoadjuvant treatment for newly diagnosed omHSPC.

Trial registration number:

Chinese Clinical Trial Registry (ChiCTR2400093262).

01 Apr 2026·Clinical and Translational Medicine

Rezvilutamide plus docetaxel in chemotherapy‐naive metastatic castration‐resistant prostate cancer patients after progression on abiraterone: A multi‐centre, open‐label, phase II trial

Article

Author: Feng Liu ; Qiang Wei ; Zhenhua Liu ; Zhiwen Chen ; Zeng Li ; Yike Wang ; Tao Dai ; Hong Bai ; Bo Chen ; Dexin Yu ; Dahong Zhang ; Hong Luo ; Hong Liao ; Shusuan Jiang ; Jiaqin Lin ; Ping Feng ; Zhiqiang Zhang

Abstract:

Background:

A multi‐centre, 2‐part, phase II study assessed adding rezvilutamide (a novel androgen receptor antagonist) to docetaxel in abiraterone‐refractory, metastatic castration‐resistant prostate cancer (mCRPC) patients who were naive to chemotherapy. Herein, we report results from part 1.

Methods:

Part 1 encompassed both dose‐escalation and dose‐expansion phases. Eligible patients received oral rezvilutamide (160/240 mg, once daily [QD]) plus intravenous docetaxel (75 mg/m 2 , on the first day of every 3‐week cycle) for more than 10 cycles, followed by maintenance with rezvilutamide monotherapy (240 mg, QD). Rezvilutamide was administered daily starting from the second day of cycle 1. Docetaxel was co‐administered with oral prednisone at 5 mg twice daily. Safety served as the primary objective in Part 1.

Results:

From 2, December 2020, to 5, August 2021, 36 patients were eligible for enrolment (18 patients with rezvilutamide 160 mg plus docetaxel and 18 patients with rezvilutamide 240 mg plus docetaxel). No one experienced dose‐limiting toxicity. 32 (88.9%) patients experienced grade 3 or higher treatment‐related adverse events. At week 12, 67.7% of the 31 evaluable patients showed a response in prostate‐specific antigen (PSA) levels. Among all 36 patients, the median times were 10.5 months (95% CI: 5.6–14.1) for PSA progression, 13.8 months (95% CI: 8.4–19.2) for radiological progression‐free survival and 16.2 months (95% CI: 12.9–22.5) for overall survival. The limitations were a small sample size and a non‐randomised design.

Conclusions:

Rezvilutamide plus docetaxel followed by maintenance with rezvilutamide monotherapy demonstrated good tolerability and promising efficacy in chemotherapy‐naive, abiraterone‐refractory, mCRPC patients.

News (Medical) associated with Rezvilutamide

20 Oct 2025

·www.prnewswire.com

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma's Emerging Innovation Power

BERLIN, Oct. 20, 2025 /PRNewswire/ -- From October 17 to 21, the European Society for Medical Oncology (ESMO) Annual Congress convened in Berlin, bringing together global leaders in oncology and pharmaceutical innovation. Representing China's advancing biopharmaceutical landscape, Hengrui Pharma not only returned with a comprehensive portfolio of oncology research but also debuted as an exhibitor, marking a new milestone in its global academic engagement. Since 2016, Hengrui has presented pioneering research at the ESMO Annual Congress for ten consecutive years. This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology. In parallel, Hengrui scheduled a series of academic events, fostering in-depth dialogue with leading global experts and clinical researchers on cutting-edge topics in oncology. These initiatives established a dynamic platform for international academic exchange and infused Chinese innovation into the global landscape of cancer diagnosis and treatment – marking a new chapter in Hengrui's journey of international scientific engagement. As one of the world's premier oncology platforms, the ESMO Annual Congress attracts more than ten thousand experts and hundreds of leading international pharmaceutical companies each year. The meeting showcases the latest advances in cancer research and therapeutics, serving as a high-level hub for academic exchange and collaboration. It continues to catalyze innovation and clinical translation across the oncology community, aligning with the 2025 Congress vision: "Standing by those who care about cancer." Global Vision: China Innovation Going Global At the ESMO 2025 Annual Congress, Hengrui co-hosted the roundtable "China Innovation Going Global," bringing together leading Chinese and international experts to discuss strategic pathways and future prospects for the globalization of China-origin innovations. During the global launch of the CARES-009 study, featuring Hengrui's innovative therapeutic combination of camrelizumab and rivoceranib, Academician Jia Fan of the Chinese Academy of Sciences and Professor Jian Zhou of Zhongshan Hospital, Fudan University, jointly presented the latest global data from the study, garnering widespread attention from the international oncology community. Ms. Jo Feng, President and Chief Operating Officer of Hengrui Pharma, led the company's delegation at this year's Congress. She stated, "ESMO serves as a premier global platform for oncology exchange, and this year, Hengrui proudly presented 46 research achievements – highlighting our growing academic presence on the world stage. As an innovation-driven global pharmaceutical company, Hengrui places medical innovation at the heart of its strategic vision, with a steadfast commitment to addressing unmet clinical needs. Looking ahead, we remain firmly patient-centric, continuing to advance groundbreaking therapies to improve the lives of patients worldwide." Breakthroughs Across Multiple Cancer Types At this year's ESMO Annual Congress, Hengrui had 46 oncology research projects accepted, including four LBAs, spanning 14 innovative therapeutic programs. Among these, nine were selected for oral presentations, two for mini oral sessions, 32 as posters, and three as e-posters. Collectively, these studies encompass more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, pancreatic cancer, lung cancer, sarcoma, biliary tract cancer, head and neck squamous cell carcinoma, prostate cancer, and thyroid cancer. In breast cancer, Hengrui had 11 research studies accepted, comprising one oral presentation, one mini oral, eight posters, and one e-poster. Notably, an LBA featuring Hengrui's antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) compared with pyrotinib plus capecitabine for patients with HER2-positive advanced or metastatic breast cancer was selected for presentation. Multiple studies highlighting both established and emerging therapies, including pyrotinib, dalpiciclib, and adebrelimab, demonstrate Hengrui's deep and sustained commitment to advancing breast cancer research. In gastrointestinal cancers, 14 studies were accepted, including two oral presentations, 11 posters, and one e-poster. Alongside flagship therapies such as camrelizumab and rivoceranib, four studies on adebrelimab in the gastrointestinal field were featured. In addition, investigational agents including HRS-4642 (a KRAS G12D inhibitor) and SHR-1701 (a PD-L1/TGF-β bifunctional antibody) were also presented, reflecting the strong momentum of both Hengrui's established portfolio and emerging pipeline in advancing care for patients with gastrointestinal malignancies. In lung cancer, six poster presentations featuring camrelizumab and adebrelimab were accepted, underscoring Hengrui's expanding footprint in this therapeutic area. These studies covered both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), further validating the clinical potential and versatility of these regimens. Across additional disease areas, including gynecologic tumors, thymic epithelial tumors, head and neck squamous cell carcinoma, sarcoma, prostate cancer, and thyroid cancer, Hengrui had 13 studies accepted, featuring a diverse range of innovative therapies such as camrelizumab, fuzuloparib, rivoceranib, rezvilutamide, adebrelimab, famitinib, HRS-7058, and HRS-4642. These included six oral presentations, one mini oral, five posters, and one e-poster, highlighting Hengrui's robust and broad-based R&D capabilities. In addition, two posters were accepted on hetrombopag and ondansetron oral soluble films, focusing on the prevention and management of chemotherapy-induced thrombocytopenia, nausea, and vomiting. Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, stated: "At this year's ESMO Annual Congress, we unveiled a broader and more impactful portfolio of research findings. The concentrated release of these breakthrough data not only reflects Hengrui's robust R&D capabilities, but also highlights the results of our science-driven, globally oriented innovation R&D strategy. Our pipeline is both deep and forward-looking – while reinforcing our existing product portfolio, we are also actively expanding into cutting-edge therapeutic areas. We firmly believe that through this in-depth engagement with the global oncology community, we can better enable our breakthroughs to benefit more patients worldwide." A Decade of ESMO Participation: China Innovation Going Global Since 2016, Hengrui Oncology has participated in the ESMO Annual Congress for 10 consecutive years, consistently setting new benchmarks for Chinese pharmaceutical companies. Between 2023 and 2025, Hengrui presented a total of 119 research achievements: 2023: 36 studies accepted, including two preferred oral presentations, six mini oral presentations, and 28 posters, covering multiple therapeutic areas such as gastrointestinal cancers, breast cancer, cervical cancer, pancreatic cancer, and melanoma. 2024: 37 studies accepted, spanning 13 innovative therapies and more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, and lung cancer. 2025: Marking its first-ever exhibition booth at ESMO, Hengrui presented 46 studies across 14 innovative medicines. This milestone represents a significant step forward in Hengrui's internationalization strategy and its commitment to advancing global cancer care. Commitment to Global Impact with the Promise of Patient Focus Hengrui remains steadfast in its commitment to science and innovation driven by the goal of addressing unmet patient needs. Leveraging a global R&D network, the company is advancing innovative medicines onto the international stage. Through a strategically structured pipeline, continuous breakthroughs across multiple cancer types, and active participation in global academic exchange, Hengrui Oncology is accelerating the internationalization and bringing new hope and broader treatment options to patients worldwide. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Hengrui Oncology Hengrui Oncology specializes in the development, production, and global commercialization of innovative cancer therapies. It is the first business unit within Hengrui to achieve technological breakthroughs and successfully enter international markets. Hengrui Oncology has established a robust and diversified oncology pipeline encompassing multiple tumor types, with a comprehensive portfolio that includes immunotherapies, targeted therapies, and ADCs. In key areas such as breast cancer, Hengrui Oncology provides full-course treatment solutions that span multiple lines of therapy. To date, 14 novel oncology agents developed by Hengrui have been approved for marketing in China. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOImmunotherapyDrug Approval

14 Nov 2023

·synapse.patsnap.com

What are androgen receptor inhibitors and how do you quickly get the latest development progress?

AR, or Androgen Receptor, plays a crucial role in the human body. It is a protein found in cells that binds to androgens, such as testosterone and dihydrotestosterone. Once bound, AR regulates gene expression, leading to the development and maintenance of male sexual characteristics. Additionally, AR is involved in various physiological processes, including bone and muscle growth, hair growth, and the regulation of mood and cognition. Dysregulation of AR activity can contribute to several diseases, including prostate cancer and androgen insensitivity syndrome. Understanding the role of AR is essential for developing targeted therapies and improving patient outcomes in the pharmaceutical industry. The androgen receptor (AR) signaling pathway plays a crucial role in all stages of the development and progression of prostate cancer. The ligament (dihydrotestosterone) binds to the AR, inducing its activation and entry into the nucleus. Within the cell nucleus, the AR binds to the androgen response element (ARE), acting as a transcriptional activator, promoting tumor cell proliferation and invasion, among other biological functions. Androgen deprivation therapy (ADT), which targets the AR, has become the fundamental treatment for late-stage prostate cancer. Moreover, the formation process of some splice isoforms of AR (e.g., AR-V7) results in incomplete AR proteins. Due to the absence of the LBD functional domain for ligament binding, these proteins can retain activation independent of androgens. This abnormal transcriptional regulation can lead to the progression of hormone-sensitive prostate cancer to castration-resistant prostate cancer (CRPC) after ADT, becoming a bottleneck stage in the treatment of advanced prostate cancer. Interestingly, the AR signaling pathway not only plays a key role in male reproductive malignancies but also plays a significant role in other malignant tumors such as bladder cancer and breast cancer. The occurrence, progression, prognosis and drug treatment response of these tumors show clear gender differences, the mechanism of which is unclear. How do they work?AR inhibitors, also known as androgen receptor inhibitorsare a type of medication that block the activity of theandrogen receptor. The androgen receptor is a proteinfound in cells that binds to androgen hormones, such astestosterone and dihydrotestosterone (DHT). By inhibitingthe androgen receptor, AR inhibitors can interfere with thesignaling pathway that is activated by androgens. In the context of biomedicine, AR inhibitors are primarilyused in the treatment of hormone-dependent cancers,particularly prostate cancer. Prostate cancer cells oftenrely on androgen signaling for their growth and survivalBy blocking the androgen receptor, AR inhibitors cansuppress the growth of prostate cancer cells and slowdown the progression of the disease. AR inhibitors can be classified into different types basedon their mechanism of action. Some AR inhibitors directlycompete with androgens for binding to the androgenreceptor, while others prevent the androgen receptor fromtranslocating into the nucleus of the cell or interacting withcoactivator proteins. Examples ofAR inhibitors includeenzalutamide,bicalutamide. and abiraterone acetate. lt is important to note that AR inhibitors are prescribed andused under medical supervision, as they can have sideeffects and interactions with other medications. Commonside effects may include fatique, hot flashes, decreasedlibido, and gastrointestinal disturbances. Additionally,ARinhibitors are generally not recommended for use inwomen, as they can interfere with normal hormonalfunction. List of androgen receptor InhibitorsThe currently marketed androgen receptor inhibitors include: RezvilutamideProxalutamideClascoteroneDarolutamideDrospirenoneApalutamidePrasteroneTestosterone UndecanoateEnzalutamideDrospirenone/EstetrolFor more information, please click on the image below. What are androgen receptor inhibitors used for?Androgen receptor inhibitors can use to several diseases, including prostate cancer and androgen insensitivity syndrome. For more information, please click on the image below to log in and search. How to obtain the latest development progress of androgen receptor inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of androgen receptor inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

10 Aug 2023

·www.pharmaceutical-technology.com

Palisade Bio terminates its post-surgical abdominal adhesions treatment trial

Phalguni Deswal @Phalguni_GD Tranexamic acid is also under development for post-operative ileus, and accelerating the return of bowel function post-abdominal surgery. Image Credit: Buravleva stock / Shutterstock. Palisade Bio has terminated the development of its lead clinical candidate, tranexamic acid (LB1148), for reducing intra-abdominal adhesions in patients after elective bowel resection surgery. The news led to a sharp 69% decline in Palisade’s stock at market open on 9 August, compared to market close on the previous day. The company’s market cap stands at $4.8m. Recommended Reports Reports LOA and PTSR Model - Rezvilutamide in Liver Failure (Hepatic Insufficiency) GlobalData Reports LOA and PTSR Model - Aramchol in Liver Failure (Hepatic Insufficiency) GlobalData View all Companies Intelligence Palisade Bio, Inc Palisade Corp View all Tranexamic acid is a broad-spectrum serum protease inhibitor . It reduces damage to the intestine by neutralising digestive enzymes. The drug was investigated for the indication in a randomised, placebo-controlled, multicentre Phase II clinical trial (NCT02836470) that failed to meet its primary endpoint. Furthermore, 16 serious adverse events were observed in the tranexamic acid group, compared to 14 events in the placebo group, as per the press release . The clinical trial was wrought with difficulties. It was paused in July 2020 due to Covid-19, leading to low patient recruitment. After its restart in May 2022, the study’s protocol was changed to investigate the use of LB1148 in reducing adhesions from its original indication of the return of gastrointestinal function in patients post-elective bowel resection surgery. Tranexamic acid is also under development for post-operative ileus and accelerating the return of bowel function post-abdominal surgery . Palisade has a development and licencing agreement with Newsora for the tranexamic acid programme in China. The agreement grants Palisade clinical, regulatory, and commercial milestone-based payments, as well as tiered royalty payments for net annual sales in greater China. Palisade reduced its workforce by 30% at the start of 2023, as part of a cost-reduction strategy. As per the company’s 2022 financial report , it has cash reserves of $12.4m to fund its operation to mid-2024.

Phase 2Financial Statement

100 Deals associated with Rezvilutamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rezvilutamide	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	28 Jun 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hormone-dependent prostate cancer	NDA/BLA	European Union	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Jun 2026
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	05 Dec 2025
Prostatic Cancer	Phase 3	-	Luzsana Biotechnology, Inc.	18 May 2022
Locally Advanced Prostate Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Nov 2021
Prostate Cancer, Hereditary, 7	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Nov 2021
Castration-Resistant Prostatic Cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	28 Jun 2018
Oligometastatic Prostate Carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 May 2026
Salivary duct carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	10 Oct 2024
Adenocarcinoma of prostate	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	26 Nov 2020
Metastatic castration-resistant prostate cancer	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	19 Mar 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Hormone-dependent prostate cancer	189	Darolutamide triplet therapy	dhffuztlud(dnafdpzdgr) = liobhtvtmk wciqirwmqi (mnxdkivhcd ) View more	Positive	23 Oct 2026
				Rezvilutamide triplet therapy	dhffuztlud(dnafdpzdgr) = qbyfnsvhkk wciqirwmqi (mnxdkivhcd ) View more
CSCO2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	78	ADT+比卡鲁胺/氟他胺	iewgzktwrm(treicxcgrg) = ahmuatuzwb sviuqabgkn (ntwvsddark )	Positive	11 Sep 2026
				ADT+阿比特龙/阿帕他胺/瑞维鲁胺	iewgzktwrm(treicxcgrg) = bmsfsytmzx sviuqabgkn (ntwvsddark )
NCT03520478 (CHART, Pubmed \| BMC Med)	Phase 3	Metastatic castration-resistant prostate cancer	323	Rezvilutamide plus ADT	atmnrajjkb(okztfacbgl) = njjjkyansw iwtluldjrl (dgvvluscvz ) View more	Positive	30 Jun 2026
				Rezvilutamide plus ADT (without hepatotoxicity)	-
ChiCTR2400093262 (ASCO2026)	Phase 2	Oligometastatic Prostate Carcinoma Neoadjuvant	100	Rezvilutamide + ADT	zoykxijdnk(atxjemuyen) = ggeszjszty srjzobdzei (ioirnfhfrd )	Positive	29 May 2026
				Rezvilutamide + ADT + Docetaxel	imjuehjaqo(yfuyeeipkn) = hjqqpvnaeg swupnlthxc (fjguuagbrm ) View more
NCT03520478 (CHART, ESMO2025)	Phase 3	Hormone-dependent prostate cancer	520	Rezvilutamide+ADT	oubgujitzh(tjpqofvjwe) = meyxjdihjq itdiofqdsa (zlcurlluwz ) View more	Positive	17 Oct 2025
				Bicalutamide+ADT	oubgujitzh(tjpqofvjwe) = lhfsidigsd itdiofqdsa (zlcurlluwz ) View more
NCT05753566 (ESMO2025)	Phase 2	Non-metastatic prostate cancer	45	Rezvilutamide + ADT	zyaccugjjf(smgxttcfof) = shhhhllvaz lhodhegfpg (kvdxzhbjyn ) View more	Positive	17 Oct 2025
CSCO2025	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	1,170	瑞维鲁胺联合雄激素剥夺治疗	fxsvijuqtm(eluulwyckt) = rxxlqiagdh fdegdqpqxw (qsrclmqmkq, 80 - 94) View more	Positive	10 Sep 2025
				瑞维鲁胺联合雄激素剥夺治疗 (高瘤负荷)	fxsvijuqtm(eluulwyckt) = fqlecobope fdegdqpqxw (qsrclmqmkq, 78 - 95) View more
NCT03520478 (CHART, Pubmed \| Med)	Phase 3	Hormone-dependent prostate cancer prostate-specific antigen	654	Rezvilutamide plus ADT	mcuassainm(xjkloofuow) = jouyirfzmz iyzkzvmmdu (yzjmzogomt ) View more	Positive	01 Feb 2025
				Bicalutamide plus ADT	mcuassainm(xjkloofuow) = geianjiidj iyzkzvmmdu (yzjmzogomt ) View more
NCT03520478 (CHART, Pubmed \| NEWS) Manual	Phase 3	Hormone-dependent prostate cancer \| Metastatic castration-resistant prostate cancer	-	rezvilutamide + ADT	xobqygbcwj(koiqvsjybk) = ogblqmwjrq lriiiqvwan (ctgkfowizt, 7.4 - 16.6) View more	Superior	18 Dec 2024
				bicalutamide + ADT	xobqygbcwj(koiqvsjybk) = pkqqjeopgk lriiiqvwan (ctgkfowizt, 5.5 - 8.3) View more
NCT03520478 (CHART, ESMO_ASIA2024) Manual	Phase 3	Castration-sensitive prostate cancer	654	Rezvilutamide + ADT (≤64 years)	xzhfqrhavs(plyhhvrbnn): HR = 0.83 (95% CI, 0.48 - 1.44) View more	Positive	09 Dec 2024
				Bicalutamide + ADT (≤64 years)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis