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

Does race predict adherence to relugolix among patients with prostate cancer? A Veterans Health Administration data analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Bothersome hot flashes following relugolix and stereotactic body radiotherapy for localized prostate cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Acute bowel symptoms following relugolix and stereotactic body radiotherapy for localized prostate cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Evaluating medication adherence and testosterone suppression in patients with prostate cancer treated with relugolix: Results from the OPTYX study. (ASCO 2025) - P | "Clinical Trial Registration Number: NCT05467176 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

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

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

Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients with High-risk Locally Advanced Prostate CAncer (RENAPCA) (AUA 2025) - No abstract available

Clinical • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Emergency surgery for fibroid expulsion complicated by pelvic organ prolapse: a case report. (PubMed, J Surg Case Rep) - "Preoperative anemia was managed using oral Relugolix, a gonadotropin-releasing hormone (GnRH) antagonist, to reduce uterine bleeding...Abdominal and vaginal surgical approaches have been used for total hysterectomy, colporrhaphy and perineoplasty. This case highlights the necessity of surgical innovation in treating coexisting fibroid expulsion and POP and the potential risk of AUB during GnRH antagonist therapy."

Journal • Cervical Cancer • Gynecologic Cancers • Gynecology • Hematological Disorders • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health

Comparison of Cardiovascular Events in Patients with Advanced Prostate Cancer treated with Luteinizing Hormone Releasing Hormone Agonists versus Antagonists in the US: An Analysis of the TriNetX Database (AUA 2025) - "INTRODUCTION AND OBJECTIVE: The standard of care for metastatic castrate-sensitive prostate cancer (mCSPCa) is the androgen deprivation therapy (ADT) using LHRH agonists (LHRH-A: leuprolide, goserelin or triptorelin) or LHRH antagonists (LHRH-An: degarelix or relugolix). In a real-world, multi-center cohort, patients receiving LHRH agonists as compared to LHRH antagonists were found to be at 1.38 times higher risk of experiencing a major adverse cardiovascular event and 2.36 times higher risk of stroke. These data support the potential use of LHRH antagonists preferentially in at-risk patients while prospective data is awaited."

Clinical • Metastases • Cardiovascular • Cerebral Hemorrhage • Genito-urinary Cancer • Hematological Disorders • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

Study of persistence and adherence to ADT in prostate cancer: relugolix, degarelix, and GnRH agonists in the US. (PubMed, Future Oncol) - "This retrospective study evaluates persistence and adherence of relugolix, degarelix, and GnRH agonists (leuprolide, goserelin, triptorelin, histrelin) using data from the IBM MarketScan Research Database (Jan 2017 - Dec 2022). Persistence and adherence rates were higher in metastatic prostate cancer. Findings support relugolix use as an oral treatment due to its favorable persistence and long-term adherence profiles."

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

The Effect of Relugolix Combination Therapy in Black/African American Women with Uterine Fibroids. (PubMed, J Obstet Gynaecol) - No abstract available

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

REPLACE-CV: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (clinicaltrials.gov) - P3 | N=387 | Completed | Sponsor: Sumitomo Pharma Switzerland GmbH | Active, not recruiting ➔ Completed | N=2250 ➔ 387

Adverse events • Enrollment change • Trial completion • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Rana McKay, MD, on persistence and adherence to relugolix for prostate cancer (Urology Times) - "McKay noted the limitations of the study, namely that the data were collected retrospectively using pharmacy records rather than prospectively using drug diaries, for example. Overall, the authors concluded, 'Further research is needed to understand what other characteristics are associated with persistence on [relugolix].'"

Video

Two Studies for Patients With Unfavorable Intermediate 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 Higher Gene Risk Score, The Guidance Trial (clinicaltrials.gov) - P3 | N=2050 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Apr 2037 ➔ Nov 2026 | Trial primary completion date: Apr 2032 ➔ Nov 2026

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

Safety and Tolerability of Relugolix in Combination with Abiraterone or Apalutamide for Treatment of Patients with Advanced Prostate Cancer: Data from a 52-Week Clinical Trial. (PubMed, Target Oncol) - P1 | "The safety/tolerability profile of both combination therapies was consistent with those of the individual drugs. These findings support using relugolix in combination with abiraterone or apalutamide as treatment of aPC."

Journal • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor

Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database. (PubMed, Expert Opin Drug Saf) - "There are differences in the types of cardiac adverse events induced by relugolix and degarelix. Clinicians should consider their differences and enhanced electrocardiogram monitoring when prescribing GnRH antagonists to their patients."

Adverse events • Journal • Cardiovascular • Congestive Heart Failure • Genito-urinary Cancer • Heart Failure • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

Sequential therapy of dienogest following relugolix for adenomyosis and impact on symptoms and serum CA125 levels: a case series. (PubMed, BMC Womens Health) - "Our findings demonstrate that sequential therapy provides effective symptom management and long-term disease control. Further, CA125 remains a valuable biomarker for monitoring therapeutic success."

Biomarker • Journal • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov) - P2 | N=392 | Recruiting | Sponsor: NYU Langone Health | Phase classification: P3 ➔ P2 | Trial completion date: Apr 2028 ➔ Apr 2031 | Trial primary completion date: Apr 2028 ➔ Apr 2030

Phase classification • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

First daily pill for endometriosis approved for NHS use (NICE) - "Today we've recommended the first long-term daily pill to treat endometriosis that could transform how this painful condition is managed....The treatment, called relugolix–estradiol–norethisterone (also known as relugolix combination therapy or Ryeqo), works by blocking specific hormones that contribute to endometriosis, while also providing necessary hormone replacement in a single daily tablet....The treatment will be available through routine NHS commissioning for patients for whom medical or surgical treatment for endometriosis has failed."

Reimbursement • Endometriosis

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2027 ➔ Jan 2027 | Trial primary completion date: Dec 2027 ➔ Jan 2027

Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Inhibition of ovulation and pharmacologic mechanism of action of relugolix combination therapy. (PubMed, Fertil Steril) - "Relugolix combination therapy inhibits ovulation, which, in the context of this study, was achieved within the first cycle following treatment initiation. The rapid and predictable return of ovarian activity and ovulation following treatment discontinuation is advantageous for patients who wish to conceive thereafter."

Journal

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Feb 2030 ➔ Feb 2029

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

The impact of concomitant therapies on the efficacy and safety of relugolix in advanced prostate cancer. (PubMed, Future Oncol) - "In this podcast, we review studies which evaluate relugolix with concomitant next-generation hormonal therapies (abiraterone, apalutamide, and enzalutamide), chemotherapy (docetaxel), radiotherapy, and common cardiovascular medications (antihypertensives, antithrombotics, and lipid‑lowering agents). Based on these studies, these therapies do not appear to affect relugolix efficacy and no new safety concerns were reported."

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

Neoadjuvant darolutamide and relugolix combination preceding radical prostatectomy for high risk localized and locally advanced prostate cancer: A phase I/Ib trial. (ASCO-GU 2025) - P1 | "Blood, tumor and urine are stored for future correlative studies. The trial was activated in October 2024."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A 40-Year-Old Woman with Inoperable Uterine Fibroids Treated with Combined Uterine Artery Embolization and Relugolix. (PubMed, Am J Case Rep) - "CONCLUSIONS This case underscores the effectiveness of UAE and Relugolix-CT as a pre-surgical strategy for large uterine fibroids in patients who are not immediately suitable candidates for major surgery. This new combined approach can lead to improved patient outcomes and reduced surgical risks."

Journal • Anesthesia • Gynecology • Hematological Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Use of Relugolix for the Prevention of Impending Oliguria and Progressive Renal Failure in a Suspected Case of Prostate Carcinoma. (PubMed, Cureus) - "Timely intervention and therapeutic adherence are crucial for optimal outcomes. Additionally, it highlights the preference for LHRH agonists in emergencies and the potential of oral GnRH antagonists like relugolix in prostate cancer management."

Journal • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease