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

Timing and Resolution of Bothersome Hot Flashes Following Short Course Oral Gonadotropin-Releasing Hormone Receptor Antagonist Relugolix, and Stereotactic Body Radiotherapy for Localized Prostate Cancer. (PubMed, Cureus) - "Hot flash resolution mirrored testosterone recovery at relatively low levels. Reassurance of the temporary nature of hot flashes may reduce patient anxiety and limit associated bother."

Journal • Genito-urinary Cancer • Mood Disorders • Oncology • Prostate Cancer • Psychiatry • Solid Tumor

Insights on Medical Therapy for Uterine Fibroids: A Review. (PubMed, Adv Ther) - "Oral GnRH antagonists, which include elagolix, relugolix, and linzagolix, signify a substantial progression, providing rapid and reversible suppression of ovarian hormone synthesis with dose-dependent effects and enhanced convenience. Innovative treatment modalities that target nonhormonal mechanisms, such as extracellular matrix remodeling, angiogenesis, and gene modulation, provide promising prospects for future uterus-sparing interventions. This narrative review evaluates the current and advancing landscape of medical therapies for uterine fibroids, presenting evidence-based perspectives to inform clinical decision-making within an increasingly personalized therapeutic context."

Journal • Review • Gynecology • Hematological Disorders • Infertility • Oncology • Pain • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health • PGR

Coronary Artery Plaque Progression After Androgen Deprivation Therapy in Men with Prostate Cancer: A Randomized Controlled Trial Comparing Relugolix Versus Leuprolide (SUO 2025) - P2 | "ADT for prostate cancer is associated with accelerated coronary atherosclerosis within 12 months and is higher with GnRH-agonist leuprolide compared with GnRH-antagonist relugolix."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Coronary Artery Disease • Genito-urinary Cancer • Myocardial Infarction • 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

Quality of life, adherence, and adverse events among patients with advanced prostate cancer treated with relugolix: 6-month results of the OPTYX multicenter registry. (ASCO-GU 2026) - P | "Real-world utilization of relugolix was associated with stable QoL, high treatment adherence, and a low rate of serious AEs over the first 6 months. Patients will continue to be followed for a longer-term analysis in this ongoing study."

Adherence • Adverse events • Clinical • HEOR • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultra-hypofractionated radiotherapy and concomitant oral relugolix for treatment of intermediate risk prostate cancer (ULTRA-HERO). (ASCO-GU 2026) - "Relugolix is an oral, highly selective, GnRH antagonist recently tested in a randomized phase III trial showing reduced risk in terms of cardiovascular events and rapid testosterone recovery if compared to Leuprolide. Enrollment started in May 2025 and 20 patients have been enrolled up to date. A final sample size of sample size of 73 patients will be needed to estimate the expected proportion of patients with complete biochemical response with a 5% precision margin and a 95% confidence interval."

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

IMPACT OF CLONAL HEMATOPOIESIS ON ANDROGEN DEPRIVATION THERAPY-ASSOCIATED CORONARY PLAQUE PROGRESSION IN MEN WITH PROSTATE CANCER: A SECONDARY ANALYSIS OF THE REVELUTION RANDOMIZED CLINICAL TRIAL (ACC 2026) - P2 | " We conducted a secondary analysis of REVELUTION (NCT05320406), a randomized trial comparing gonadotropin-releasing hormone (GnRH)-agonist leuprolide versus GnRH-antagonist relugolix on coronary plaque progression in men with localized PCa receiving prostate radiation therapy (RT), all of whom underwent CCTA at baseline and again at 12 months after ≥6 months of ADT. CH may amplify coronary plaque progression in men with prostate cancer receiving RT or GnRH-agonist therapy."

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

CAMO959A12103: A clinical trial to learn about the effects of AMO959 given with AAA617 and an androgen receptor pathway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body.athway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body. (clinicaltrialsregister.eu) - P1/2 | N=61 | Not yet recruiting | Sponsor: Novartis Pharma AG

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

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

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

A concept for a new approach to combined oral contraception from adolescence to perimenopause: Continuous use of the oral GnRH antagonist Relugolix and the fetal estrogen estetrol. (PubMed, Acta Obstet Gynecol Scand) - "The introduction of oral GnRH antagonists has created the possibility to replace progestins in combined oral contraceptives as the suppressor of ovarian function. An additional long-term effect of RE4W is the expected strong reduction of the incidence of breast cancer due to the absence of luteal progesterone and progestins. The dose of estetrol maintaining estrogen function, preventing perimenopausal symptoms, and not causing unacceptable endometrial growth and/or breakthrough bleeding will be assessed in two Phase 2 studies in women aged 18-35 and 36-51 years, respectively."

Journal • Breast Cancer • Endometriosis • Oncology • Solid Tumor • Women's Health

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Baptist Health South Florida

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

HEALTHCARE RESOURCE UTILIZATION AND COSTS IN MEN WITH PROSTATE CANCER TREATED WITH ANDROGEN DEPRIVATION THERAPY USING REAL-WORLD DATA (ISPOR 2026) - "All-cause preindex and postindex HCRU and costs were analyzed and presented as per-patient-per-month (PPPM) to address the variable follow-up period. Among 17,336 patients (mean age 69±10 y), 90.4% received gonadotropin hormone-releasing hormone (GnRH) agonists and 9.6% received GnRH antagonists (3.6% relugolix)... While use of inpatient and ER services was similar in GnRH agonist and antagonist initiators, men with baseline CVD had higher HCRU than those without. Careful selection of ADT and management of baseline CVD may decrease HCRU for men treated for PC."

Clinical • HEOR • Real-world • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Testosterone suppression and recovery in patients with advanced prostate cancer treated with relugolix: an interim analysis of the OPTYX study (AUA 2026) - No abstract available

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

Improvement of vasomotor symptoms of perimenopausal women with symptomatic fibroids treated with relugolix 40 mg combination therapy (ISGE 2026) - "Objective: To evaluate the effects of relugolix 40 mg + continuous combined hormone therapy preparation containing 1mg estradiol (E2) and 0.5 mg norethisterone acetate on the number and intensity of moderate and severe hot flushes in women in perimenopause treated for symptomatic uterine fibroids. Treatment of fibroids with relugolix CT induced a significant reduction of moderate and severe hot flushes in perimenopausal symptomatic women. This initial clinical observation could revolutionize the way we can treat climacteric symptoms during perimenopausal period in the near future in women with fibroids but maybe in the general population."

Clinical • Combination therapy • Alopecia • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Quality of life and sexual function in women with uterine fibromatosis treated with Relugolix Combination Therapy (ISGE 2026) - "These benefits can be achieved with the combination therapy of relugolix, estradiol, and norethisterone acetate (Relugolix Combination Therapy- Relugolix CT), which acts by centrally inhibiting the secretion of Gonadotropin-releasing Hormone (GnRH), thereby providing control over the menstrual cycle and excessive uterine bleeding. In conclusion, women with uterine fibromatosis undergoing Relugolix CT reported overall good symptom control and quality of life, with benefits becoming more evident and stable after several months of therapy. No significant improvement or deterioration in sexual function was observed."

Clinical • Combination therapy • HEOR • Fibrosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

GnRH Antagonist with Add-Back in Uterine Fibroids: Real-World Experience with Ryeqo® (ISGE 2026) - "Context: Real-world evidence on relugolix/estradiol/norethindrone acetate (Ryeqo®) for fibroid-related heavy menstrual bleeding is expanding, but pragmatic series with routine-care follow-up remain limited. In real-world practice, Ryeqo® showed high bleeding control (approximately 80%) with good persistence (approximately 3 in 4 ongoing). No firm conclusions on age can be drawn due to group imbalance and the small <40 sample, but these data support further study with standardized volumetric measures. Discontinuations were mostly due to expected situations."

Clinical • Real-world • Real-world evidence • CNS Disorders • Endometriosis • Gynecology • Migraine • Solid Tumor • Uterine Leiomyoma • Women's Health

Relugolix combination therapy: one pill for two indications (ISGE 2026) - "Sponsored by Gedeon Richter"

Combination therapy • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma

REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients with Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery (clinicaltrialsregister.eu) - P1/2 | N=50 | Recruiting | Sponsor: IRCCS Istituto Nazionale Tumori Fondazione Pascale | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Industry Expert Theater: Clinical Insights in the Treatment of Advanced Prostate Cancer: Androgen Deprivation Therapy and Cardiovascular Risk (ASCO-GU 2026) - "Studies suggest that androgen deprivation therapies may carry varying cardiovascular (CV) risk. This symposium will review CV disease in prostate cancer and evidence from a recent clinical trial assessing coronary atherosclerosis in men receiving the GnRH antagonist relugolix vs a GnRH agonist."

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

Prevalence of major adverse cardiac events in men with prostate cancer receiving androgen deprivation therapy in real-world clinical practice. (ASCO-GU 2026) - "Reporting was carried out for the entire group, men who initiated GnRH agonists (eg, leuprolide) or antagonists (eg, degarelix, relugolix), and men who started ADT before or after relugolix approval (January 2021). In practice, MACE prevalence remained low after initiating ADT. Although differences in baseline characteristics remain, MACE rates were numerically lower in men receiving GnRH antagonists. Use of GnRH antagonists increased following relugolix approval and coincided with a greater awareness of CV risk factors, potentially leading to a decline in MACE rates."

Adverse events • Clinical • Real-world • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

OPTIMAS: A phase II randomized, decentralized, de-escalation trial in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response. (ASCO-GU 2026) - P2 | "Background: An optimal PSA response, defined as ≤0.2 ng/mL is achieved by ~51% of pts with mHSPC at 6–8 months after treatment (Rx) with androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPIs) +/- docetaxel and is associated with a 61% reduction in risk of death (HR 0.39, 95% CI 0.30–0.50; Naqvi SAA ASCO GU 2023)...Cohort A will enroll 100 pts (step 1) with mHSPC who haven't initiated systemic Rx for metastatic disease and will be treated with relugolix (R)+ARPI +/-standard of care Rx...Exploratory objectives: ecological momentary assessments, safety, PRO association with testosterone, tissue and blood biomarker assessment. Clinical Trial Information: NCT07216248"

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

RELAX: Relugolix for Endometriosis Associated Pain (clinicaltrials.gov) - P=N/A | N=33 | Not yet recruiting | Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

New trial • Real-world evidence • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Letter: Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the United States Medicare Fee-for-Service Population. (PubMed, Urol Pract) - No abstract available

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

NICE Appraisals of Relugolix-CT and Linzagolix for Endometriosis Symptom Management: Commentary on Clinical and Economic Uncertainties. (PubMed, Pharmacoeconomics) - No abstract available

Journal • Endometriosis • Gynecology • Women's Health

Coronary Plaque Progression After Androgen Deprivation Therapy in Men With Prostate Cancer: A Randomized Clinical Trial. (PubMed, JAMA Cardiol) - P2 | "Patients were randomly assigned 1:1 to either the GnRH agonist leuprolide or the GnRH antagonist relugolix. This change was driven by an increase in noncalcified plaque volume and may be mediating ADT-associated CV risk. ClinicalTrials.gov Identifier: NCT05320406."

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