AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

An open,non randomized, multicenter clinical studies of rezvilutamide or standard androgen deprivation therapy as adjuvant therapy in prostate cancer patients with poor PSA control after radical prostatectomy (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: The First Bethune Hospital of Jilin University; The First Bethune Hospital of Jilin University

New trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Efficacy of rezvilutamide in preventing the flare phenomenon induced by GnRH agonists in newly diagnosed metastatic hormone-sensitive prostate cancer: An exploratory multicenter randomized controlled trial. (ASCO-GU 2026) - P4 | "Clinical Trial Registry Number: ChiCTR2300076106. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 3 trial of SHR3680 versus bicalutamide in combination with androgen deprivation therapy (ADT) in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). (ASCO 2022) - P3 | "SHR3680 plus ADT significantly improved rPFS versus Bica plus ADT in pts with high-volume mHSPC, with a desirable safety profile. New drug application has been submitted to seek approval based on the data presented here."

Clinical • Combination therapy • P3 data • CNS Disorders • Epilepsy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "In the two interim analyses, rezvilutamide plus ADT significantly improved radiographic progression-free survival and overall survival compared with bicalutamide plus ADT in patients with high-volume, metastatic, hormone-sensitive prostate cancer, with a tolerable safety profile."

Combination therapy • Journal • P3 data • Cardiovascular • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertension • Oncology • Prostate Cancer • Solid Tumor

MA-PCa-III-021: A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=156 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Cost-effectiveness analysis of eight first-line treatments for metastatic hormone-sensitive prostate cancer in China. (PubMed, Front Pharmacol) - "This study aims to perform a 10-year horizon health economic evaluation to comparatively analyze the cost-effectiveness of eight treatment regimens for mHSPC from the perspective of China's healthcare system, including (1) ADT alone and ADT plus one of the following: (2) docetaxel, (3) abiraterone, (4) apalutamide, (5) enzalutamide, (6) rezvilutamide, (7) darolutamide and docetaxel, (8) abiraterone and docetaxel. Abiraterone plus ADT emerged as the most cost-effective strategy, indicative of an ICER of US$17437.16 per QALY, substantially below WTP threshold. Abiraterone plus ADT was likely to be cost-effective for mHSPC treatment at a WTP threshold of three-time per capita GDP per QALY."

HEOR • Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Primary high-grade urothelial carcinoma of the prostate combined with acinar adenocarcinoma: first rare case report and treatment experience summary. (PubMed, Front Oncol) - "Postoperatively, a surgery combined with targeted and immunotherapy regimen was initiated: leuprorelin + rezvilutamide for the acinar adenocarcinoma and disitamab vedotin + toripalimab for the urothelial carcinoma. The protocol of surgery combined with targeted and immunotherapy offers a new treatment strategy for this rare malignancy. This study provides valuable insights for clinical diagnosis and management."

Journal • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Urothelial Cancer • GATA3

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: Fudan University | Recruiting ➔ Active, not recruiting

Enrollment closed • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • AR • HER-2

Indirect treatment comparisons of darolutamide plus docetaxel and androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. (PubMed, Sci Rep) - "The addition of docetaxel (DOC) and/or androgen receptor axis-targeted therapies (ARATs) such as darolutamide (DAR), enzalutamide (ENZ), apalutamide (APA), abirateone (ABI), and rezvilutamide (REZ) has been shown to significantly improve overall survival (OS) over standard-of-care in mHSPC, including standard of care plus DOC. Results numerically favoured DAR+DOC+ADT on OS and PFS across all comparisons, with strong evidence against APA+ADT (in the high-volume population only), DOC+ADT, ADT, and SNA+ADT on OS and all comparators on PFS (excluding ABI+ADT in ITT). Findings support the continued use of DAR+DOC+ADT as frontline treatment in mHSPC, particularly in China where REZ is approved."

Clinical • Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Cost-effectiveness Analysis of Eight First-Line Treatments for Metastatic Hormone-sensitive Prostate Cancer in China (Frontiers) - "For costs, the 10-year cost estimates ranged from US$120,844 for ADT alone to US$216,294 for darolutamide plus ADT with docetaxel. For clinical effectiveness, enzalutamide plus ADT yielded the highest QALYs (4.55), while ADT alone gained lowest QALYs (3.01). For cost-effectiveness, the three treatment regimens of ADT alone, abiraterone plus ADT and enzalutamide plus ADT constituted the cost-effectiveness frontier. Abiraterone plus ADT emerged as the most cost-effective strategy, indicative of an ICER of US$17437.16 per QALY, substantially below WTP threshold. Conclusions: Abiraterone plus ADT was likely to be cost-effective for mHSPC treatment at a WTP threshold of three-time per capita GDP per QALY."

HEOR • Hormone Sensitive Prostate Cancer

Jiangsu Hengrui Pharmaceuticals…announced today that its second‑generation androgen‑receptor inhibitor rezvilutamide has received National Medical Products Administration (NMPA) approval to commence a Phase III pivotal study in patients with prostate cancer (flcube.com)

New P3 trial • Prostate Cancer

A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=156 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase II study combining ADT, novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide for patients with newly diagnosed, metastatic prostate cancer (ESMO 2025) - P2 | "Eligible participants will receive ADT in combination with one of the following nARIs (enzalutamide, apalutamide, darolutamide, rezvilutamide), initiated within three months of ADT commencement. Legal entity responsible for the study Sun Yat-sen University Cancer Center. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluating treatment efficacy in metastatic hormone-sensitive prostate cancer with visceral disease: A systematic review and network meta-analysis (ESMO 2025) - "ADT + Docetaxel + Darolutamide emerged as the most effective regimen (HR 0.42; 95% CI: 0.21-0.82), followed by ADT + Docetaxel (HR 0.53; 95% CI: 0.30-0.93) and ADT + Abiraterone (HR 0.58; 95% CI: 0.41-0.83). Conversely, ARPI-based doublets with Enzalutamide, Apalutamide, Darolutamide and Rezvilutamide showed modest efficacy...These findings provide crucial evidence to the current clinical decision-making and highlight the need for VD-specific clinical trials to further optimize treatment strategy. Legal entity responsible for the study The Authors."

Metastases • Retrospective data • Review • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Rezvilutamide (REZ) in combination with androgen-deprivation therapy (ADT) for prostate cancer patients with biochemical recurrence (BCR) post radical prostatectomy (RP): preliminary results from a phase II trial (ESMO 2025) - P2 | "Conclusions The combination of REZ and ADT manifested the ability to achieve and sustain an undetectable PSA level over 12 months in the specific population of BCR. Ongoing follow-up is in progress to comprehensively assess the long-term efficacy and safety."

Clinical • Combination therapy • P2 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

The efficacy of rezvilutamide (Rez) plus androgen-deprivation therapy (ADT) in patients (pts) with high-volume, nonvisceral metastatic hormone-sensitive prostate cancer (HSPC): A post hoc analysis of CHART study (ESMO 2025) - P3 | "Compared with bicalutamide (Bic), Rez + ADT improved radiographic progression-free survival (rPFS) and overall survival (OS). Table: 2434P R group (mos) B group (mos) P value HR (95% CI) mrPFS ≤10 NR NR 0.013 0.46 (0.25–0.86) 11-20 NR 22.4 0.009 0.46 (0.25-0.83) >20 NR 15.7 20 NR 36.2 0.005 0.56 (0.38-0.85) Conclusions This analysis showed that, compared with Bic, Rez + ADT showed improved survival benefit in pts with nonvisceral metastatic HSPC, regardless of the number of bone metastases. Legal entity responsible for the study The authors."

Clinical • Metastases • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world multicenter study of rezvilutamide plus androgen deprivation therapy in Chinese patients with high-volume metastatic hormone-sensitive prostate cancer. (PubMed, Front Oncol) - "Rezvilutamide plus ADT provides rapid and profound PSA responses with a favorable safety profile in real-world Chinese patients with high-volume mHSPC. Baseline PSA serves as an important predictor for short-term biochemical response, supporting its clinical value as a standard first-line therapy."

Clinical • Journal • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Novel hormone therapies for advanced prostate cancer: Understanding and countering drug resistance. (PubMed, J Pharm Anal) - "This review offers a comprehensive overview of NHT, including abiraterone, enzalutamide, apalutamide, darolutamide, and rezvilutamide, which have demonstrated efficacy in delaying disease progression and improving patient survival and quality of life. Additionally, advanced sequencing technologies and resistance research models should be leveraged to identify novel therapeutic targets and improve drug delivery efficiencies. These advancements hold the potential to overcome NHT resistance and significantly enhance the management and prognosis of patients with advanced prostate cancer."

Journal • Review • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

RWS-GU001: Real-world Study on Preoperative Application of Rezvilutamide (clinicaltrials.gov) - P=N/A | N=115 | Not yet recruiting | Sponsor: Shanghai Pudong New Area Gongli Hospital

New trial • Real-world evidence

Real-World Multicenter Study of Rezvilutamide Plus Androgen Deprivation Therapy in Chinese Patients with High-Volume Metastatic Hormone-Sensitive Prostate Cancer (Front Oncol) - "A total of 236 patients with high-volume mHSPC were enrolled....The rates of achieving PSA50, PSA90, and PSA ≤0.2 ng/mL at 3 months were 99.15%, 88.98%, and 39.41%, respectively....Multivariable analysis further indicated that baseline PSA showed a trend toward being an independent predictor for achieving PSA ≤0.2 ng/mL (P=0.063)."

Retrospective data • Hormone Sensitive Prostate Cancer

Clinical Study of Rezvilutamide Combined With Docetaxel Chemotherapy in the Treatment of Abiraterone-Resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=20 | Enrolling by invitation | Sponsor: Zhujiang Hospital

New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

An open-label, parallel-cohort, multicenter clinical study of Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University | Initiation date: Dec 2024 ➔ Apr 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Exploratory Study of Rezvilutamide Combined with ADT as Neoadjuvant Therapy for Patients with Locally Advanced Prostate Cancer (ChiCTR) - P4 | N=68 | Not yet recruiting | Sponsor: The First Affiliated Hospital of AFMU (Xijing Hospital); The First Affiliated Hospital of AFMU (Xijing Hospital)

New P4 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor