Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer, Knight Therap - LARVOL DELTA

ARPI-based triple and double therapy in metastatic hormone-sensitive prostate cancer: a real-world analysis (ESMO 2025) - "Darolutamide and relugolix had a positive effect on OS whereas lung/liver metastases and the use of docetaxel worsened the prognosis in the metachronous population (p<0.0001). Limitations include retrospective nature, potential selection and confounding biases. Legal entity responsible for the study The authors."

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

Influence of GnRH agonist and GnRH antagonist initiation on platelet activity in patients with prostate cancer (ESMO 2025) - "Methods In this prospective study, platelet activity was assessed before (T1) and 8 (± 4) weeks after (T2) initiation of first-line leuprolide or relugolix treatment using flow cytometric analysis of P-selectin and PAC-1 expression on resting platelets and after stimulation with adenosine diphosphate (ADP) and arachidonic acid (AA). Enrollment continues and additional analyses will investigate changes in the platelet transcriptome and correlate the platelet phenotype with clinical response. Legal entity responsible for the study The authors."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ITGB3 • PTPRC

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: OHSU Knight Cancer Institute | N=32 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • IO biomarker • Trial withdrawal • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PD-L1

Knight Therapeutics Announces Relaunch of ORGOVYX in Canada (GlobeNewswire)

Relaunch • Prostate Cancer

PRESCRIPTION TRENDS AND THE ACCEPTANCE OF NEW ORAL GNRH ANTAGONISTS; USING OPEN DATABASE IN JAPAN (FIGO 2025) - " We collected prescription data of the oral GnRH antagonist, relugolix, from the NDB Open Database... Economic factors significantly impact the prescription of high-cost medications, such as oral GnRH antagonists. The disparity in access to approved treatments due to economic inequality highlights the need for potential financial assistance to ensure equitable treatment access nationwide."

Endometriosis • Gynecology • Obstetrics • Solid Tumor • Uterine Leiomyoma • Women's Health

Accelerated Coronary Atherosclerosis Following Relugolix Versus Leuprolide Androgen Deprivation Therapy in Men with Prostate Cancer (REVELUTION): An Open-Label Randomized Controlled Trial (AHA 2025) - "Available on Saturday, November 08, 2025 at 03:15pm CDT."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Coronary Artery Disease • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Radiation Oncology Drug Prescription Patterns in Medicare Part D (ASTRO 2025) - "While differences exist between male and female prescribing patterns, they may reflect variations in disease sites managed rather than true prescribing differences. The notable costs associated with female prescribers and diabetes medications, including Semaglutide & insulins, raise questions about the growing role of metabolic management in cancer care. Table 1 Claims - Female Claims - Male $ Cost - Female $ Cost - Male 1 Tamsulosin (13835) Tamsulosin (107146) Relugolix (564,524) Enzalutamide (13,652,547) 2 Mometasone (3522) Hydrocodone Acetaminophen (14492) Insulin (Glargine, Aspart, Lispro) (478,317) Apalutamide (13,090,914) 3 Dexamethasone (3389) Dexamethasone (12741) Semaglutide (413,559) Relugolix (7,883,362) 4 Naloxone (2869) Lidocaine (11480) Leuprolide (386,005) Tamsulosin (1,882,331) 5 Silver Sulfadiazine (2842) Ciprofloxacin (8973) Dulaglutide (285,559) Lenalidomide (1,728,589) 6 Lidocaine (2764) Bicalutamide (8463) Naloxone (283,125) Abiraterone..."

Medicare • Reimbursement • US reimbursement • Hematological Malignancies • Oncology

PSMA-PET Guided Metastasis-Directed Therapy (ASTRO 2025) - "The most common type of systemic therapy at time of SBRT consisted of leuprolide acetate or relugolix (18/25) with or without intensification (17/25). The majority of patients experienced a decrease in PSA level following PSMA-PET guided MDT. These findings support the ability of PSMA-PET to identify lesions driving biochemical progression and suggest further exploration of molecular imaging guided MDT as a consolidation or salvage strategy to enhance disease control among patients with a low burden of PSMA-PET avid disease on systemic therapy."

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

Safety and efficacy of relugolix combination therapy in symptomatic uterine fibroids. (PubMed, Facts Views Vis Obgyn) - "Relugolix-combination therapy (CT) (oestradiol 1 mg and norethindrone acetate 0.5 mg) is a new gonadotropin-releasing hormone antagonist licensed to treat heavy menstrual bleeding (HMB) associated with uterine fibroids; but little real-world data exists to guide practice. This real-world study supports previous controlled trial data showing relugolix-CT to be a safe, efficacious medical treatment for HMB with fibroids. Real-life clinical data support the use of relugolix-CT to treat symptomatic fibroids in isolation or combined with myomectomy."

Journal • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Testosterone Recovery after Cessation of Luteinizing Hormone-Releasing Hormone Antagonists in Treatment of Prostate Cancer (ASTRO 2025) - "Few existing studies report faster testosterone recovery (TR) with relugolix (3 months) than degarelix (9 months) and leuprolide (4 months). Over half of patients receiving LHRH antagonists achieved TR to a laboratory-defined normal range with a median TTR of 4.25 months. Though the median duration of relugolix was longer than degarelix, patients receiving relugolix had a shorter median TTR. No association was found between age and TTR."

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

REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov) - P2 | N=94 | Active, not recruiting | Sponsor: Emory University | Trial completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov) - P3 | N=2753 | Active, not recruiting | Sponsor: NRG Oncology | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CD4

The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain (clinicaltrials.gov) - P3 | N=130 | Recruiting | Sponsor: University of Michigan | Initiation date: Aug 2025 ➔ Nov 2025

Trial initiation date • Endometriosis • Gynecology • Inflammation • Musculoskeletal Pain • Pain • Women's Health • CCL3

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

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

Relugolix for Metastatic Hormone-sensitive Prostate Cancer with Impending Paraplegia. (PubMed, Ann Afr Med) - "We report a 72-year-old man with suspected metastatic prostate cancer, presenting with severe neuritic pain and lower limb weakness. Relugolix, started before biopsy along with zoledronic acid and steroids, led to symptom relief within 24 h. This case supports Relugolix's utility in urgent hormone-sensitive metastatic prostate cancer care."

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

Safety and Quality-of-Life Considerations Shape ADT Use in Prostate Cancer: With Tanya B. Dorff, MD (OncLive) - "In our conversation, Dr Dorff discussed the role of ADT in prostate cancer management, highlighting where this class of agents fits into National Comprehensive Cancer Network guidelines and how this class has evolved with the development of LHRH antagonists and agonists. She explained how the observational OPTYX study (NCT05467176), a registry of relugolix (Orgovyx) use, aims to address safety and efficacy in combination with androgen receptor pathway inhibitors in patients with advanced prostate cancer...Dorff also talked through relugolix's safety profile, particularly regarding cardiovascular risk, as well as the quality-of-life effects associated with ADT. She also addressed strategies to mitigate financial toxicity, along with the potential for future ADT-sparing treatments."

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Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Endeavor Health | N=60 ➔ 0 | Trial completion date: Aug 2025 ➔ Nov 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Aug 2025 ➔ Nov 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Gynecology • Musculoskeletal Pain • Pain

Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the US Medicare Fee-For-Service Population. (PubMed, Urol Pract) - "Patients who were persistent on relugolix demonstrated high adherence throughout the study, regardless of metastatic status. These results suggest that relugolix has practical utility in real-world clinical practice."

Journal • Medicare • Reimbursement • US reimbursement • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy (clinicaltrials.gov) - P=N/A | N=530 | Active, not recruiting | Sponsor: Sumitomo Pharma Switzerland GmbH | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Mayo Clinic | Initiation date: Jul 2025 ➔ Oct 2025

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

Pharmacokinetics and pharmacodynamics studies of Relugolix long-acting microcrystalline formulation in male Beagle dogs. (PubMed, Eur J Pharm Sci) - "This suggests potential concerns regarding hemodynamic effects, hepatotoxicity, and lipid metabolism abnormalities. This study is the first to systematically evaluate the PK/PD characteristics of the long-acting micronized formulation of relugolix, providing key data for its clinical translation, but further validation through large sample and cross-species studies is needed."

Journal • PK/PD data • Hematological Disorders • Metabolic Disorders

Relugolix in Monotherapy and Combined Therapy for the Treatment of Uterine Diseases and Its Effects on Bones: A Systematic Review. (PubMed, Biomedicines) - "To mitigate this, combination therapy with estradiol and norethisterone acetate has been developed. Relugolix combination therapy is an effective and well-tolerated treatment for UFs and endometriosis, minimizing the risk of hypoestrogenism-related bone loss while maintaining clinical benefits. Although monotherapy may lead to transient BMD reduction, combination therapy appears to stabilize bone health."

Journal • Monotherapy • Review • Endometriosis • Gynecology • Osteoporosis • Rheumatology • Solid Tumor • Uterine Leiomyoma • Women's Health

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain (clinicaltrials.gov) - P3 | N=130 | Recruiting | Sponsor: University of Michigan | Not yet recruiting ➔ Recruiting

Enrollment open • Endometriosis • Gynecology • Inflammation • Musculoskeletal Pain • Pain • Women's Health • CCL3