leuprolide acetate for depot suspension / Generic mfg. - LARVOL DELTA

Skeletal Health and Bone Marrow Composition Among Youth (clinicaltrials.gov) - P=N/A | N=80 | Active, not recruiting | Sponsor: Amy DiVasta, MD | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders

Van Maldergem syndrome-1 in a patient with central precocious puberty: A case report. (PubMed, Medicine (Baltimore)) - "This case highlights the hallmark clinical features of VMS-1, including neurodevelopmental impairment and craniofacial anomalies, while also expanding the known genetic spectrum of the disorder. These findings provide valuable insights into the diagnosis and management of this extremely rare genetic condition."

Journal • Developmental Disorders • Endocrine Disorders • Genetic Disorders • Mental Retardation

Impact of Relugolix versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study (European Urology, 2023) (UAA 2025) - "Impact of Relugolix versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study (European Urology, 2023)"

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

Cardiovascular Effects of Androgen Deprivation Therapy in Prostate Cancer Patients: A Prospective Study (UAA 2025) - "Seventy prostate cancer patients (mean age 68.1 ± 8.4 years) who required ADT were recruited and classified into treatment groups receiving Degarelix (GnRH antagonist), Leuprolide and Goserelin (GnRH agonist), or bilateral orchiectomy. This study confirms that ADT in prostate cancer patients is associated with early cardiovascular changes, including reduced cardiac function (GLS%, LVEF), ECG changes (QRS, QTc), and elevated myocardial injury markers (Hs Trop-I, NT Pro-BNP), within the first three months of therapy. These findings underscore the need for cardiac evaluation before and during ADT treatment in prostate cancer patients, particularly for those with preexisting cardiovascular risk factors. Further longitudinal studies with larger sample sizes are warranted to substantiate these findings and to guide clinical monitoring protocols."

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

Drug-Induced Androgen Suppression: the Importance of Galenic Formulation for Carcinological Efficacy (UAA 2025) - "The improvement in prognosis obtained by achieving deep castration thanks to the addition of abiraterone is proof of this. Not all leuprorelin products are the same and the clinician's choice must consider the specificity of each. During this state of the art, the rationale for deep androgen suppression will be presented and the advantages of specific galenic leuproreline formulations will be detailed."

Clinical • CNS Disorders • Genito-urinary Cancer • Prostate Cancer • Psychiatry • Solid Tumor

How to Optimize ADT Therapy in PC and BPH Treatment: From Evidence to Practice (UAA 2025) - "The improvement in prognosis obtained by achieving deep castration thanks to the addition of abiraterone is proof of this. In this context, the effectiveness of leuprorelin in reducing testicular testosterone levels should not be underestimated and the choice of dosage form is therefore crucial...Patients on PDE5-Is treatment can be safely managed with silodosin. Preliminary results seem to demonstrate a potential role of silodosin in the treatment of chronic prostatitis/chronic pelvic pain syndrome and to facilitate ureteral stone passage, as well."

Benign Prostatic Hyperplasia • CNS Disorders • Genito-urinary Cancer • Gynecology • Musculoskeletal Pain • Prostate Cancer • Psychiatry • Renal Calculi • Solid Tumor

Enzalutamide (ENZA)±leuprolide (L) in biochemically recurrent (BCR) prostate cancer (PC): EMBARK post hoc analysis of Asia Pacific (APAC) population (UAA 2025) - P3 | "This post hoc analysis suggests ENZA±L benefits the APAC population with high-risk BCR PC, with comparable efficacy to the overall population and without increased risk of TEAEs."

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

Prostate cancer inducing secondary linitis plastica of the rectum: a rare case report and literature review. (PubMed, Front Oncol) - "Combination therapy (prophylactic colostomy, leuprorelin, and abiraterone) reduced PSA from 392 to 2.16 ng/mL within 8 months. Clinicians should consider RLP in elderly men presenting with gastrointestinal symptoms. Definitive diagnosis requires the integration of multi-modality imaging, endoscopy, and histopathological biopsy."

Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Rectal Adenocarcinoma • Solid Tumor

VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov) - P2/3 | N=464 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2025 ➔ Mar 2029 | Trial primary completion date: Jul 2025 ➔ Mar 2026

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

Spinal and bulbar muscular atrophy with hand tremors and chronic limb weakness, Kennedy disease. (PubMed, BMJ Case Rep) - "Treatment included leuprorelin acetate and rehabilitation using a wearable cyborg hybrid-assistive limb. As SBMA progresses slowly and symptoms like hand tremors and decreased serum creatinine precede significant weakness, early recognition is critical for diagnosis."

Journal • CNS Disorders • Hepatology • Liver Failure • Movement Disorders • Muscular Atrophy • Pain • Parkinson's Disease

CARLHA-2: Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy (clinicaltrials.gov) - P3 | N=490 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting

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

Chronic periadolescent leuprolide exposure affects the expression of multiple genes in the hypothalamus and pituitary gland with a different pattern of expression in female and male Long-Evans rats. (PubMed, Horm Behav) - "LEU affected expression of genes involved in reproduction, potentially explaining sex-specific effects of LEU on behavior reported earlier. The changes in hypothalamic and pituitary gene expression may represent compensation that permits early stages of pubertal development (e.g., VO and PPS), but not complete maturation (e.g., estrous cyclicity, sexual behavior) during LEU treatment."

Journal • Preclinical • ER • GNRH1 • GNRHR

Relugolix in prostate cancer therapy: Clinical evidence and practical considerations. (PubMed, Fr J Urol) - "Clinical trials and real-world evidence support relugolix as a convenient and effective ADT option for PC. It offers rapid and sustained testosterone suppression, potential cardiovascular benefits, and an alternative to injectable therapies. Long-term adherence, the use of combination treatments and related drug-drug interactions require further investigation."

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

LH-RH agonist monotherapy for androgen receptor-positive recurrent and/or metastatic salivary gland cancer: a retrospective study. (PubMed, Int J Clin Oncol) - "LH-RH agonist monotherapy demonstrated a well-balanced profile between efficacy and safety and could be an alternative therapeutic option, especially for subjects not tolerable to combination therapy. (242 words)."

Journal • Monotherapy • Retrospective data • Oncology • Salivary Gland Cancer • AR

Orchiepididymitis as a rare complication of TURP performed four weeks after high-dose-rate brachytherapy for prostate cancer. (PubMed, J Contemp Brachytherapy) - "A 73-year-old patient with prostate cancer (intermediate-risk group) was eligible for high-dose-rate (HDR) BT combined with androgen deprivation therapy (ADT) for 6 months (leuprorelin)...Conservative and pharmacological treatment must be introduced in the occurrence of urinary disorders after BT, and any intervention (TURP) should be performed at least 3-6 months after BT. This is especially crucial because of the development of radiation effect over time."

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

Adverse event profile differences among long-acting gonadotropin-releasing hormone analogs: A real-world, pharmacovigilance study. (PubMed, PLoS One) - "Significant disparities exist between the adverse event profiles of long-acting GnRHa. The identification of high-risk factors and the enhancement of AEs monitoring are crucial during clinical application."

Adverse events • Journal • Real-world evidence • Breast Cancer • CNS Disorders • Endocrine Disorders • Endometriosis • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Gynecology • Mental Retardation • Oncology • Pediatrics • Prostate Cancer • Psychiatry • Solid Tumor • Uterine Leiomyoma • Women's Health

Efficacy and safety of leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2- breast cancer. (PubMed, Front Pharmacol) - "Bone soreness (6.1%) was the most common adverse event, followed by hot flushes (3.5%), morning stiffness (1.3%), and muscle soreness (1.3%). Leuprorelin (Boennuokang®) plus endocrine therapy reduces gonadotropins and sex hormones and results in satisfactory survival rates with good safety profiles in premenopausal women with HR+/HER2- breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Oncology • Solid Tumor • HER-2

Adverse Cardiovascular Outcomes of Individuals Treated with Androgen Deprivation Therapy. (PubMed, Urol Pract) - "Patients using leuprolide or degarelix were stratified into pre-relugolix (Jan 2018-Nov 2020) and post-relugolix (Dec 2020-Mar 2024) eras. Relugolix was not associated with lower risk of MACE in our analysis. Strategies to optimize the cardiovascular management of patients receiving ADT are needed."

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

FDA-approved drugs as potential covalent inhibitors of key SARS-CoV-2 proteins: an in silico approach. (PubMed, Turk J Biol) - "Several promising drug repurposing candidates were identified: bremelanotide, lanreotide, histrelin, and leuprolide as potential RdRp inhibitors; azlocillin, cefiderocol, and sultamicillin for Mpro inhibition; tenapanor, isavuconazonium, and ivosidenib targeting TMPRSS2; and cefiderocol, cefoperazone, and ceftolozane as potential ACE2 inhibitors. This study provides valuable insights into repurposing existing drugs as potential COVID-19 therapeutics by targeting crucial viral proteins. However, further experimental validation and preclinical studies are necessary to confirm the efficacy and safety of these compounds before consideration for clinical application."

FDA event • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

GnRHa 45 mg SC LA Positively Impacts Predicted Adult Height Depending on the Degree of Bone Age Advancement (ENDO 2025) - "Aims: To perform secondary analyses of impact on predicted adult height (PAH) depending on the degree of BA advancement using data from the pivotal trial of the first small-volume, long-acting, subcutaneously administered leuprolide acetate for CPP... 45 mg SC LA increases PAH by ~3-5 cm in girls over 48 weeks treatment across a range of BA/CA1 categories. Girls with BA/CA ≥1.4 showed benefit from treatment by week 24 which persisted until at least week 48. For girls with BA/CA ≤1.4, longer treatment may be needed to observe PAH increase."

Clinical • Endocrine Disorders

Progesterone Hypersensitivity Manifesting as Cyclical Urticaria (ENDO 2025) - "A leuprolide-induced progesterone suppression test, a diagnostic procedure involving leuprolide administration to suppress endogenous progesterone production, was performed instead. Progesterone hypersensitivity should be considered in the differential diagnosis of cyclical urticaria/allergic reactions, especially if they are noticed to occur in the luteal phase of the menstrual cycle."

Dermatology • Gynecology • Immunology • Urticaria • Women's Health

GnRH Agonist Therapy Induced Pituitary Apoplexy (ENDO 2025) - "Here, we report a case of a patient with no prior diagnosis of pituitary adenoma, who developed pituitary apoplexy in the context of GnRH agonist therapy for in vitro fertilization (IVF).Case Presentation: A 31-year-old female with a history of infertility and recurrent miscarriages presented with acute onset intractable headache, nausea and dizziness a few days after her initial round of IVF utilizing a micro-Lupron flare protocol for egg retrieval... Pituitary apoplexy, although rare, has been reported in association with GnRH agonist therapy, typically in patients with pre-existing gonadotropin-secreting or nonfunctioning pituitary adenomas. The latency between treatment and symptoms onset is variable. The proposed pathophysiologic mechanism involves pituitary stimulation by GnRH agonists, potentially leading to the underlying adenoma's growth and subsequent tissue infraction or hemorrhage."

CNS Disorders • Gynecology • Hematological Disorders • Infertility • Pain • Pituitary Gland Carcinoma • Sexual Disorders

Contrasting Clinical Presentations of Pediatric Leydig Cell Tumors: Two Cases with Unique Features (ENDO 2025) - "A Lupron stimulation test was performed with a non-pubertal peak LH of 4.9 IU/L (< 5 IU/L)...The first case demonstrates the classic presentation with peripheral precocious puberty, whereas the second case highlights progression to central precocious puberty, which complicated the diagnostic process. More studies are needed to determine baseline characteristics of Leydig tumors and risk factors for progression to central precocious puberty."

Clinical • Endocrine Disorders • Oncology • Pediatrics • Solid Tumor • Testicular Cancer

Effectiveness of 6-Month Gnrha Formulations for Pubertal Suppression in Youth Assigned Male-At-Birth (ENDO 2025) - "In addition to monthly and three-monthly formulations, new long-acting GnRHa products, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) have been approved for use in central precocious puberty (CPP). The majority of TG/NB patients AMAB in our study achieved pubertal suppression (biochemical, clinical, or both) with Triptodur® or Fensolvi® based on strict criteria used for CPP. Of those with subjective data, all reported adequate suppression. This study provides novel clinical and biochemical data of TG/NB patients AMAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can guide clinicians in their care."

Endocrine Disorders

Pubertal Suppression for Youth Assigned Female At Birth: Experience With 6-Month Formulations (ENDO 2025) - "Within the last decade, new long-acting GnRHa formulations, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) were approved for use in central precocious puberty (CPP). Extrapolating suppression criteria from the CPP literature, the majority of TG/NB patients AFAB achieved or maintained pubertal suppression (biochemical and/or clinical) with Triptodur® or Fensolvi®. To our knowledge, our study is the first one to provide clinical and biochemical data of TG/NB patients AFAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can serve as a guide to clinicians."

Endocrine Disorders