Knight Therapeutics Submits GEMTESA Regulatory Application in Canada
核心洞察
Health Canada has accepted for review Knight Therapeutics' New Drug Submission for GEMTESA (vibegron) in overactive bladder (搜索), including adult males on pharmacological therapy for benign prostatic hyperplasia (搜索).
The submission covers OAB with urge urinary incontinence, urgency and frequency in adults, and the same symptoms plus nocturia in men treated for BPH.
Knight licensed Canadian commercialization rights to GEMTESA, ORGOVYX and MYFEMBREE from Sumitomo Pharma America under exclusive supply and distribution agreements signed in June 2025.
Knight Therapeutics Inc. (搜索) said Health Canada has accepted for review its New Drug Submission for GEMTESA (vibegron), proposed for the treatment of overactive bladder (搜索) (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and for OAB with those symptoms plus nocturia in adult males receiving pharmacological therapy for benign prostatic hyperplasia (搜索) (BPH).
Vibegron selectively targets beta-3 adrenergic receptors, relaxing the bladder detrusor muscle to increase capacity. The filing draws on the Phase 3 COURAGE trial (NCT03902080), which randomized 1,105 men aged 45 years or older on alpha-blockers, with or without 5-alpha-reductase inhibitors, for BPH to vibegron 75 mg once daily or placebo for 24 weeks. The study met both co-primary endpoints at Week 12, with least squares mean differences versus placebo of -0.74 in mean daily micturitions (95% CI -1.02, -0.46; P < .0001) and -0.95 in urgency episodes (95% CI -1.37, -0.54; P < .0001), and also met all prespecified secondary endpoints including nocturia and urge urinary incontinence episodes. Adverse events in 2% or more of participants were hypertension, COVID-19, urinary tract infection and hematuria.
The EMPOWUR Phase 3 program, a 12-week double-blind, placebo-controlled study of vibegron 75 mg in adults with OAB within a development program of more than 4,000 patients, showed significant reductions in daily urge urinary incontinence, micturition and urgency episodes and an increase in volume voided versus placebo. Knight entered exclusive supply and distribution agreements with Sumitomo Pharma America in June 2025 to commercialize GEMTESA, ORGOVYX (relugolix) and MYFEMBREE (relugolix/estradiol/norethindrone acetate) in Canada.
Source: Knight Therapeutics Announces Regulatory Submission of GEMTESA in Canada