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

Secondary outcomes by prior definitive treatment (tx) in patients (pts) with high-risk biochemically recurrent prostate cancer (hrBCR) treated with enzalutamide (enza) plus leuprolide (combo): EMBARK post hoc analysis. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT02319837 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Nursing Implications on the Impact of Treatment Suspension on Health-related Quality of Life from EMBARK (ONS 2025) - P3 | "The results showed that treatment was suspended in 90.4% (321/355) of patients treated with enzalutamide combination, 85.6% (304/355) treated with enzalutamide monotherapy, and 67.0% (240/358) treated with leuprolide alone. After treatment suspension, hormonal treatment-related symptoms gradually improved in all treatment arms. No clinically meaningful mean changes were observed in the other PRO domains analyzed, reflecting minimal impact of treatment on global HRQoL."

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

Incidence of Embark and EAU-High-Risk Biochemical Recurrence and Prostate cancer Mortality, a real-life population-based study (AUA 2025) - "INTRODUCTION AND OBJECTIVE: The EMBARK trial proved the efficacy of enzalutamide plus leuprolide in patients with prostate cancer (PCa) who have had high-risk biochemical recurrence (BCR). Incidence of High-Risk BCR vary according to the definition used and primary treatment. High risk BCR usually happen early after treatment and most patients with any PSA elevation will never experience High-risk BCR during the follow-up. Embark criteria currently represent the more stringent criteria with a very high risk of PCSM."

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

Testosterone recovery following treatment suspension of enzalutamide plus leuprolide or leuprolide alone in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis (AUA 2025) - "This post hoc analysis of EMBARK revealed that the vast majority of pts treated with enza combo or leuprolide alone fully recovered their T levels during tx suspension, irrespective of age subgroup. This finding may explain why hormonal tx-related QoL significantly improved during tx suspension in EMBARK."

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

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

Assessing Pubertal Suppression with 3.75 mg Monthly vs. 11.25 mg Three-Monthly Leuprolide Acetate in Girls with Central Precocious Puberty (ESPE-ESE 2025) - No abstract available

Endocrine Disorders

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

Therapeutic potential of GNRHR analogs and SRC/FAK inhibitors to counteract tumor growth and metastasis in breast cancer. (PubMed, Biochim Biophys Acta Mol Basis Dis) - "Treatments targeting the gonadotropin-releasing hormone receptor (GnRHR), such as the agonist leuprorelin (LEU) and antagonist degarelix (DEGA), are used for hormone-dependent tumors. Combining DEGA with PP2 or FAKi enhanced tumor inhibition, improving mice survival. These findings provide valuable insights into the essential regulatory role of gonadotropins in genes involved in tumorigenic processes, highlighting the potential of GnRHR antagonists combined with Src or FAK inhibitors as a promising strategy to develop new drugs that interfere with the ability of breast tumor progression."

Journal • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

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

High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) - P=N/A | N=146 | Active, not recruiting | Sponsor: Stanford University | Trial completion date: Dec 2026 ➔ May 2026

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

Real-world analysis of leuprorelin acetate microspheres-based neoadjuvant therapy for patients with high-risk prostate cancer. (PubMed, Front Oncol) - "Erectile dysfunction and loss of libido was the most common adverse event, with incidences of 84.9% during neoadjuvant therapy, 79.2% at M1, 71.7% at M3, 67.9% at M6, and 56.6% at M12. Boennuokang® leuprorelin acetate microspheres-based treatment as neoadjuvant therapy decreases PSA, testosterone, and prostate volume, with acceptable positive surgical margin rate in patients with high-risk prostate cancer and its safety profiles should be validated."

Journal • Real-world evidence • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

The Role and Potential of Modern Radiotherapy in the Treatment of Metastatic Prostate Cancer. (PubMed, Cancers (Basel)) - "The treatment regimen included bicalutamide, androgen deprivation therapy with leuprorelin, and six cycles of docetaxel chemotherapy, followed by a targeted radiotherapy regimen aimed at both the primary tumor and metastatic lymph nodes. This suggests a need for re-evaluating traditional approaches and exploring more personalized, multimodal treatment strategies. Enhanced imaging techniques, such as PET/PSMA scans, play a crucial role in accurately targeting metastatic sites, enabling more effective and individualized treatment."

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

Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK. (PubMed, Prostate Cancer Prostatic Dis) - P3 | "MFS and safety for enzalutamide ± leuprolide versus leuprolide alone were similar in EMBARK patients with EAU-consistent or protocol-defined high-risk BCR. Clinical trial registration number: NCT02319837."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Primary Biliary Cholangitis Combined with Multiple Synchronous Primary Malignant Tumors: A Case Report and Review of the Literature (APASL 2025) - "He received ursodeoxycholic acid for PBC and leuprorelin acetate for prostate cancer, but he refused the treatment for multiple myeloma. In the follow-up period after 1 year, the prostate cancer can be effectively managed with early detection and appropriate treatment."

Case report • Clinical • Review • Cholestasis • Fibrosis • Genito-urinary Cancer • Hematological Malignancies • Hepatology • Immunology • Liver Cirrhosis • Multiple Myeloma • Oncology • Primary Biliary Cholangitis • Prostate Cancer • Solid Tumor

The treatment of adenomyosis-induced ovarian hyperstimulation syndrome with leuprolide. (PubMed, Minerva Med) - No abstract available

Journal • Endometriosis • Women's Health

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

Modulation of Gonadotropin-Releasing Hormone Receptor Improves Voiding Hyperreflexia and Detrusor Sphincter Dyssynergia in Male Rats With Severe Spinal Cord Injury. (PubMed, Neurourol Urodyn) - "The potential of LA for the treatment of urinary disorders associated with SCI opens the way to a new therapeutic option for individuals with SCI who would like to have an impact on their daily lives."

Journal • Preclinical • Ataxia • CNS Disorders • Orthopedics • Overactive Bladder • GNRHR

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (clinicaltrials.gov) - P3 | N=287 | Completed | Sponsor: Kissei Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Aug 2024 | Trial primary completion date: May 2025 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Pathologic and Clinical Perspectives Regarding Subsequent Grading and Treatment Implications for Prostate Cancer Post Treatment (USCAP 2025) - "Most pathologists think ADT and HTx are similar, including all drugs that lower, block formation, or decrease efficacy of androgens, whereas many (57%) clinicians only include androgen lowering drugs (ie, leuprolide) as ADT... This survey highlights an unmet need for clinicopathologic discussion and standardization for PCa post treatment in an era of increased therapeutic options. Additionally, a clearer distinction of ADT and HTx, better histologic correlates, and unified pathologic reporting and clinical expectations for the omission or application of GS are needed."

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

Case report of stage IIIC low-grade serous ovarian cancer in a 13-year-old female treated with novel therapy. (PubMed, Gynecol Oncol Rep) - "Given the tumor's limited sensitivity to chemotherapy, she was treated with neoadjuvant endocrine therapy (ET) using fulvestrant, palbociclib, and leuprolide. This case supports the potential role of endocrine-based targeted therapy in managing pediatric LGSOC, offering a viable alternative for patients with limited treatment options. Further research is needed to optimize treatment strategies and improve survival outcomes in this rare population."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pediatrics • Peritoneal Cancer • Solid Tumor • ER • MUC16

Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology. (PubMed, Expert Opin Drug Saf) - "Except 4 antineoplastic agents, only 24 drugs indicated pancreatic cancer signals in 33,948 reports including 4 dipeptidyl peptidase-4 (DPP-4) inhibitors, 3 glucagon-like peptide-1 (GLP-1) analogues, 5 compound hypoglycemic agents, 3 hypotensive agents, ranitidine, pancrelipase, fondaparinux, naldemedine, daprodustat, megestrol acetate, leuprorelin, lecanemab, and lorcaserin. GLP1R (glucagon-like peptide 1 receptor) for GLP-1analogues, and PTEN (phosphatase and tensin homolog) for metformin might be a potential cause of pancreatic cancer. Clinicians providing these therapies should stay vigilant to detect pancreatic cancer early."

Adverse events • Journal • Real-world evidence • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • PTEN

ANYGEN Contract Signed Even Before FDA cGMP Approval (eDaily) - "On February 24, AnyGen announced that it had received an order for leuprorelin active pharmaceutical ingredient (API) from a U.S. pharmaceutical company, marking the start of its exports. This initial shipment is for sample testing, and if it passes the tests, the contract will transition into a clinical trial phase followed by full-scale commercial supply...The price of Ganirelix API is significantly higher at won 9 million ($6,700) per gram due to its complex structure containing numerous non-natural amino acids. This complexity makes ganirelix more technically challenging to manufacture and more expensive than leuprorelin."

Commercial • Pricing • Breast Cancer • Endometriosis • Prostate Cancer • Uterine Leiomyoma

Alopecia as a side effect of fertility treatments in women (AAD 2025) - "Specific ART drugs and procedures reportedly linked to hair loss include egg retrieval (15%), Lupron (8%), letrozole (7%), ovarian stimulation (5.7%), Clomid (2.5%), and embryo transfer (0.7%). Given the psychosocial consequences associated with both infertility and alopecia independently, patients experiencing both may simultaneously carry an unrecognized mental health burden. A better understanding of the prevalence, consequences, and factors influencing ART-associated alopecia is needed to better enhance patient experiences and optimize patient care."

Adverse events • Clinical • Alopecia • Immunology • Infertility • Sexual Disorders