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

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

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (PubMed, Eur Urol) - "Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction."

HEOR • Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A multi-center, prospective, observational study of patients with prostate cancer being treated with relugolix: OPTYX. (ASCO-GU 2023) - P=N/A | "In the phase 3 HERO trial, relugolix maintained suppression of testosterone to castration levels in 96.7% of men from Day 29 to 48 weeks, with superiority to leuprolide acetate. In addition to assessing routine clinical care and disease progression, patient reported outcomes will be assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for HRQoL and Simplified Medication Adherence Questionnaire (SMAQ) for adherence at 3 and 6 months then every 6 months. Clinical trial information: NCT05467176."

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

Safety and tolerability of relugolix in combination with abiraterone or apalutamide for treatment of advanced prostate cancer: Data from a 52-week clinical trial. (ASCO-GU 2025) - P1 | "REL used in combination with ABI or APA showed safety profiles consistent with individual drugs over 52 wks. REL levels were stable, and testosterone was sustained below castration level. These findings support the safety and tolerability of REL combination therapy with ABI or APA for aPC."

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

The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy: a randomized controlled noninferiority study (MyLacR study). (PubMed, Fertil Steril) - "Patients will benefit from preoperative therapy with the gonadotropin-releasing hormone agonist leuprorelin or the gonadotropin-releasing hormone antagonist relugolix in reducing blood loss. However, relugolix was associated with a more rapid recovery from the postoperative hypoestrogenic state than was leuprorelin."

Head-to-Head • Journal • Endocrine Cancer • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. (PubMed, N Engl J Med) - P3 | "In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.)."

Journal • P3 data • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Results of relugolix/estradiol/norethisterone acetate combination therapy in real-world clinical practice: Effectiveness, tolerability, and factors influencing discontinuation. (PubMed, Eur J Obstet Gynecol Reprod Biol X) - "Discontinuation was most commonly due to planned surgery or perceived lack of efficacy. Relugolix CT demonstrates strong real-world effectiveness and tolerability for managing symptomatic uterine fibroids, with marked improvements in bleeding and quality of life, and a favourable safety profile."

Journal • Real-world evidence • Gynecology • Osteoporosis • Pain • Rheumatology • Solid Tumor • Uterine Leiomyoma • Women's Health

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 | "Clinical Trial Registry Number: NCT05467176. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Optyx study: Clinical characteristics and preferences for initiating relugolix in a cohort of US patients in real-world care settings. (ASCO-GU 2025) - P | "The OPTYX study enrolled 999 patients to assess real-world experience with relugolix. Nearly half started relugolix with other therapies. Many patients and physicians preferred the oral formulation, and other top reasons for initiation included safety and rapid testosterone suppression and recovery."

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

Oral Relugolix for the Treatment of Advanced Prostate Cancer. (PubMed, Oncologist) - No abstract available

Journal • 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) - "Clinical Trial Registry Number: CTIS ID: 36502. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (PubMed, JAMA Oncol) - "This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy."

Clinical • Journal • Metastases • Atrial Fibrillation • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Pain • Prostate Cancer • Solid Tumor

Venous Thromboembolism Risk Associated With Relugolix-estradiol-norethisterone Acetate Combination Therapy. (PubMed, J Endocr Soc) - "Nonetheless, patient selection is essential, particularly for those with thrombotic risk factors. Continued real-world surveillance is crucial to refining its safety profile in clinical practice."

Journal • Review • Cardiovascular • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Venous Thromboembolism • Women's Health

A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. (PubMed, Target Oncol) - P1 | "Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs."

Journal • Metastases • P1 data • Genito-urinary Cancer • Oncology • 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

Initial Results of a Phase 2 Trial of Stereotactic Body Radiation Therapy, Hormone/Androgen Deprivation Therapy and Radium 223 Dichloride for Oligometastatic Castrate Sensitive Prostate Cancer (SHARP) (ASTRO 2024) - P2 | "Materials/ ADT (degarelix [n=4], relugolix [n=2], or leuprolide [n=19]) was administered starting at least 4 weeks prior to SBRT and continued for 36 weeks. Ra-223 combined with SBRT to oligometastases and 36 weeks ADT in mCSPC is well-tolerated and results in favorable OS and PFS compared to historical controls. Longer follow-up is necessary to assess if the early use of Ra-223 delays development of new bone metastases."

Metastases • P2 data • Anemia • Cardiovascular • Gastroenterology • Genito-urinary Cancer • Hematological Disorders • Hepatology • Hypertension • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Diseases • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CXCL8 • TNFA

APEX: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jan 2026 ➔ Jan 2027

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

Sexual function in perimenopausal women treated with relugolix and add back therapy for uterine fibroids: an observational study. (PubMed, Eur J Contracept Reprod Health Care) - "The study included 21 premenopausal women affected by uterine fibroids with moderate-to-severe symptoms, treated with oral combination of relugolix 40 mg with ABT (oestradiol hemihydrate 1 mg + norethisterone acetate 0.5 mg). At 6 months no statistically significant changes in total FSFI scores were detected (23.0 +/- 8.0 vs 23.1 +/- 7.1, p 0.70); treatment resulted in a significant reduction in total volume (p 0.019) and mean diameter of fibroids (p 0.011) and in 87.5% of cases bleeding was effectively controlled. Treatment with relugolix-ABT was not associated with statistically significant changes in sexual function, with a good tolerability profile, while effectively reducing the fibroid size and controlling bleeding in most cases."

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

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 | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

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

Insights in Endocervical Mucus Secretion (clinicaltrials.gov) - P4 | N=15 | Recruiting | Sponsor: Oregon Health and Science University | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2025 ➔ Jan 2026

Enrollment open • Trial initiation date

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial (clinicaltrials.gov) - P2 | N=532 | Recruiting | Sponsor: Mayo Clinic | N=220 ➔ 532

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

REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients) (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: National Cancer Institute, Naples

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

Efficacy and safety of relugolix therapy for symptomatic uterine fibroids: a systematic review and meta-analysis. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "Relugolix significantly reduces fibroid burden and symptoms with favourable safety profile. It offers a well-tolerated, fertility-preserving alternative to surgery. Further large-scale RCTs are needed to confirm these findings and optimize treatment protocols."

Journal • Retrospective data • Review • Gynecology • Oncology • Pain • Solid Tumor • Uterine Leiomyoma • Women's Health