Teverelix is a potential treatment option for the prevention of acute urinary retention recurrence in men suffering from benign prostatic hyperplasia.

Purpose: To evaluate the efficacy and safety of teverelix in treatment naïve patients aged over 50 years with symptomatic benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), and to explore teverelix' potential in preventing AUR secondary to BPH with the aim to inform a planned Phase 2 trial.

Methods: This Phase 2, multicenter, randomized, double-blind, placebo-controlled study involved BPH patients with an International Prostate Symptom Score (IPSS) ≥ 13 and uroflow < 13 mL/sec. After a 4-week single-blind placebo run-in, patients were randomized to receive teverelix 60 mg (n = 41) or placebo (n = 40) subcutaneously on day 1 and day 3.

A Model-Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk.

Teverelix drug product (DP) is a parenteral gonadotropin-releasing hormone (GnRH) antagonist that has been successfully tested in phase 2 trials for hormone-sensitive advanced prostate cancer (APC) and benign prostatic hyperplasia (BPH). In previous APC trials, teverelix DP was administered as intramuscular (IM) and subcutaneous (SC) injections, using a loading dose and (in a single trial) a maintenance dose. Our objective was to derive an optimal dosing regimen for phase 3 clinical development, using a pharmacometrics modeling approach.

Survival prediction in patients with gynecological cancer irradiated for brain metastases.

Background And Purpose: This large population-based, retrospective, single-center study aimed to identify prognostic factors in patients with brain metastases (BM) from gynecological cancers.

Material And Methods: One hundred and forty four patients with BM from gynecological cancer treated with radiotherapy (RT) were identified. Primary cancer diagnosis, age, performance status, number of BM, presence of extracranial disease, and type of BM treatment were assessed.

Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial.

Background: Teverelix drug product (DP) is a novel injectable gonadotropin-releasing hormone antagonist.

Methods: An adaptive phase 2, open-label, multicenter trial was conducted in patients with advanced prostate cancer to evaluate the efficacy and safety of a combined subcutaneous (SC) and intramuscular (IM) loading dose regimen of teverelix DP of 120 mg SC + 120 mg IM (Group 1; N = 9) or 180 mg SC + 180 mg IM (Group 2; N = 41) administered at a single visit, followed by 6-weekly SC maintenance doses of 120 mg (Group 1) or 180 mg (Group 2), up to Day 168. The primary endpoint was the proportion of patients achieving castration levels with serum testosterone <0.