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MONTREAL, Sept. 15, 2026 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (“Knight”) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) for GEMTESA® (vibegron), proposed 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), has been accepted for review by Health Canada.
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“For patients living with overactive bladder, and for adult males managing OAB alongside BPH, having access to an effective treatment option can make a real difference in daily life,” said Samira Sakhia, President and Chief Executive Officer, Knight Therapeutics Inc. “The acceptance of our submission for GEMTESA® in Canada is an important step toward bringing this therapy to the patients who need it. At Knight, our commitment goes beyond building our portfolio. We are dedicated to improving access to innovative therapies that improve patient outcomes. We are also pleased to advance this milestone together with our partner, Sumitomo Pharma America Inc.”
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In June 2025, Knight entered into exclusive supply and distribution agreements with Sumitomo’s Pharma America (SMPA) to commercialize GEMTESA®, as well as ORGOVYX® (relugolix) and MYFEMBREE® (relugolix/estradiol/norethindrone acetate) in Canada.
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About GEMTESA®
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GEMTESA® (vibegron) is marketed in the US for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults and in adult males taking medication for benign prostatic hyperplasia (BPH). GEMTESA® works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity.1
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GEMTESA® is a registered trademark of Sumitomo Pharma Co., Ltd. All other trademarks are the property of their respective owners.
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About Overactive Bladder
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Overactive Bladder (OAB) is a symptom syndrome characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.2,3 These symptoms are commonly associated with involuntary contractions of the detrusor muscle, although they can also result from other forms of lower urinary tract dysfunction.2 The pooled global prevalence of OAB was estimated at approximately 20%, with prevalence higher in women (nearly 22%) than in men (roughly 16%).4 Canadian population based estimates reported in the Canadian Urological Association (CUA) guideline from May 2017 indicate an overall prevalence of approximately 14 to 18%, with prevalence increasing with age.5
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About Benign Prostatic Hyperplasia
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Benign Prostatic Hyperplasia (BPH) is a histologic diagnosis describing the proliferation of smooth muscle and epithelial cells within the prostatic transition zone, which commonly leads to enlargement of the prostate gland.6 In men presenting with lower urinary tract symptoms (LUTS), the symptoms are frequently presumed to arise from bladder outlet obstruction caused by the enlarged prostate.6 Even when the bladder outflow obstruction is relieved surgically, storage symptoms consistent with overactive bladder (OAB) may persist; detrusor overactivity has been reported in approximately 20% to 40% of men.7 LUTS are conventionally divided into storage, voiding, and postmicturition symptoms.2 In the population-based EPIC study, storage symptoms were the most prevalent category among men (51.3%), exceeding both voiding (25.7%) and postmicturition (16.9%) symptoms.8