AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma - LARVOL DELTA

Bipolar androgen therapy sequential rezvilutamide combined with camrelizumab for patients with mCRPC: A single-arm prospective clinical study (ESMO 2026) - No abstract available

Clinical • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

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

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

Clinical characteristics, drug-drug interaction risk, and outcomes of darolutamide and rezvilutamide triplet therapy in Chinese patients with metastatic hormone‑sensitive prostate cancer (ESMO 2026) - No abstract available

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

A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer. (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Anhui Medical University

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

Rezvilutamide combined with ADT in an HIV-positive patient with high-volume mHSPC on efavirenz-based antiretroviral therapy: a case report. (PubMed, Front Oncol) - "This case directly addresses the controversies and challenges regarding the use of intensified therapy in patients with comorbidities in current clinical practice, suggesting that key drug-drug interaction barriers may be manageable through personalized strategies and proactive management. This case provides a practical reference for implementing guideline-recommended treatment intensification principles in similar complex clinical scenarios, offering clinically relevant insights."

Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Prostate Cancer • Solid Tumor • CYP3A4

Evaluation of triplet therapy combined with robot-assisted cytoreductive prostatectomy for high-volume metastatic prostate cancer: a multicentre randomised controlled trial protocol. (PubMed, BJU Int) - P=N/A | "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/m2 every 3 weeks), and an ARPI (rezvilutamide 240 mg once daily). PFS and OS will be estimated using Kaplan-Meier curves and compared with the log-rank test. Chinese Clinical Trial Registry: ChiCTR2600121819."

Journal • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

ARMOR: Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Real-world effectiveness of rezvilutamide plus androgen deprivation therapy in patients with high-volume metastatic hormone-sensitive prostate cancer: a retrospective multicenter cohort study. (PubMed, Transl Androl Urol) - "These real-world findings support the clinical utility of rezvilutamide combined with ADT in achieving durable PSA suppression in patients with high-volume mHSPC. However, the absence of comprehensive safety data and the retrospective nature of the study warrant cautious interpretation, and further prospective validation is needed."

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

Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Impact of hepatotoxicity and lipid metabolism-related toxicity on survival and quality of life in patients with high-volume metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial: a post hoc analysis. (PubMed, BMC Med) - P3 | "This is the first study to evaluate the association of hepatotoxicity and LMRT with clinical outcomes in patients with high-volume mHSPC treated with rezvilutamide plus ADT. Hepatotoxicity was not significantly associated with survival or QoL, whereas LMRT was associated with prolonged rPFS and OS, and grade ≥3 LMRT was associated with more pronounced improvements in QoL."

HEOR • Journal • Retrospective data • Dyslipidemia • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertriglyceridemia • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor

Hengrui Medicine's innovative drug, rezvilutamide tablets, for prostate cancer has been accepted by the European Medicines Agency (EMA). [Google translation] (Jiangsu Hengrui Press Release) - "This application for market approval is based on an international, multicenter, randomized, controlled phase III clinical trial—the SHR-3680-III-HSPC study (CHART study, NCT03520478)."

EMA filing • Hormone Sensitive Prostate Cancer

Bilateral renal metastasis following radical prostatectomy for prostate cancer: a case report. (PubMed, Front Med (Lausanne)) - "The patient had undergone laparoscopic radical prostatectomy 5 years prior and received intermittent postoperative endocrine therapy with leuprorelin acetate and bicalutamide...Following a change in the endocrine therapy regimen to rezvilutamide combined with degarelix, the patient's hematuria significantly improved. This case highlights the critical importance of rigorous postoperative surveillance and timely, standardized endocrine therapy in prostate cancer management. It also contributes to the limited literature on visceral metastases in castration-sensitive prostate cancer (HSPC) and underscores the need for further exploration of optimal treatment strategies for advanced metastatic disease."

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

Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed | N=18 ➔ 36

Enrollment change • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Rezvilutamide (Rez) versus bicalutamide (Bic) plus androgen-deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC): 5-year outcomes of the phase 3 CHART trial. (ASCO 2026) - P3 | "Rez plus ADT continued to show meaningful survival benefits with manageable toxicities after long-term follow-up, further supporting Rez plus ADT as frontline treatment for pts with high-volume mHSPC. Efficacy endpoints. Data are median (95% CI) unless otherwise indicated."

Metastases • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate 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. (ASCO 2026) - P4 | "Rezvilutamide, a second-generation ARPI, demonstrated superior efficacy over bicalutamide when combined with ADT in patients with mHSPC. No data analysis has been performed. ClinicalTrials.gov Identifier: ChiCTR2400093262."

Clinical • Combination therapy • Metastases • Endocrine Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Neuroendocrine Carcinoma • Oncology • Prostate Cancer • Solid Tumor

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov) - P3 | N=670 | Recruiting | Sponsor: AstraZeneca

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

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. (PubMed, BMJ Open) - P4 | "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."

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

MA-PCa-III-021: A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=206 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=156 ➔ 206

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

Open-label, single-arm, prospective clinical study of rezvilutamide combined with docetaxel and androgen deprivation therapy for high-volume metastatic hormone-sensitive prostate cancer (ChiCTR) - P=N/A | N=43 | Sponsor: The First Bethune Hospital of Jilin University; The First Bethune Hospital of Jilin University

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

Clinical study of Rezvilutamide and Adebrelimab combined with stereotactic body radiation therapy for metastatic castration-resistant prostate cancer (ChiCTR) - P=N/A | N=30 | Sponsor: The first affiliated hospital of anhui medical university; The first affiliated hospital of anhui medical university

IO biomarker • New trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

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

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Rezvilutamide plus docetaxel in chemotherapy-naive metastatic castration-resistant prostate cancer patients after progression on abiraterone: A multi-centre, open-label, phase II trial. (PubMed, Clin Transl Med) - "Rezvilutamide plus docetaxel followed by maintenance with rezvilutamide monotherapy demonstrated good tolerability and promising efficacy in chemotherapy-naive, abiraterone-refractory, mCRPC patients."

Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: Fudan University | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial primary completion date • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • AR • HER-2