Knight Therapeutics Submits GEMTESA® for OAB Treatment to Health Canada

MONTREAL, Sept. 15, 2026 /CourierPR/ -- Knight Therapeutics Inc has submitted a New Drug Submission (NDS) for GEMTESA® (vibegron) to Health Canada for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and OAB with symptoms of urge urinary incontinence, urgency, urinary frequency, and nocturia in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

GEMTESA® is a medication that works by selectively targeting β3 adrenergic receptors to relax the bladder detrusor muscle, thereby increasing the bladder's capacity and reducing OAB symptoms. The submission was accepted for review by Health Canada, marking an important step in bringing this therapy to patients who need it.

Samira Sakhia, President and CEO of Knight Therapeutics Inc, expressed enthusiasm about the submission.

In June 2025, Knight entered into exclusive supply and distribution agreements with Sumitomo Pharma America Inc (SMPA) to commercialize GEMTESA® in Canada. The company is dedicated to advancing innovative therapies that improve patient access to effective treatments.

Overactive bladder (OAB) is a common condition characterized by urinary urgency, often accompanied by increased urinary frequency and nocturia. The pooled global prevalence of OAB is estimated at approximately 20%, with higher prevalence in women (nearly 22%) compared to men (roughly 16%). In Canada, the prevalence is estimated to be between 14% and 18%, with prevalence increasing with age.

Benign prostatic hyperplasia (BPH) is a condition that affects many men, especially as they age. It is characterized by the proliferation of smooth muscle and epithelial cells within the prostatic transition zone, leading to an enlarged prostate gland. Symptoms of OAB, which are often associated with BPH, are frequently misattributed to normal aging. In the United States, approximately 14 million men are living with BPH, and up to 75% of these individuals experience OAB symptoms.

The COURAGE trial, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, evaluated GEMTESA® 75 mg once daily versus placebo over 24 weeks in men aged 45 and older with symptoms of OAB who were receiving pharmacological therapy with α-blockers, with or without 5α-reductase inhibitors, for BPH. The study met both co-primary endpoints at Week 12, demonstrating statistically significant reductions in mean daily micturitions and urgency episodes compared to placebo.

The EMPOWUR trial, a 12-week, double-blind, placebo-controlled Phase 3 study, evaluated vibegron 75 mg versus placebo in adults with OAB. The study demonstrated significant reductions in daily urge urinary incontinence episodes, micturition episodes, and urgency episodes, as well as an increase in volume voided, compared to placebo.

Knight Therapeutics Inc, headquartered in Montreal, Canada, is focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America. The company's shares trade on the Toronto Stock Exchange under the symbol GUD.