Health Canada accepts vibegron submission for overactive bladder

Health Canada has accepted for review a New Drug Submission for vibegron (Gemtesa), a β3-adrenergic receptor agonist, for the treatment of overactive bladder (OAB) in adults with urge urinary incontinence (UUI), urgency, and urinary frequency.¹ The proposed indication also includes adult men receiving pharmacological therapy for benign prostatic hyperplasia (BPH) who have OAB symptoms including nocturia.

Vibegron is currently approved for these indications in the US. Knight said it entered exclusive supply and distribution agreements with Sumitomo Pharma America in June 2025 to commercialize vibegron as well as relugolix (Orgovyx) and relugolix/ estradiol/norethindrone acetate (Myfembree) in Canada.

"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 CEO of Knight Therapeutics Inc, in a news release from the company.¹ "The acceptance of our submission for Gemtesa in Canada is an important step toward bringing this therapy to the patients who need it.”

The vibegron submission is supported by data from the phase 3 COURAGE trial, which evaluated vibegron in men with OAB symptoms despite pharmacological treatment for BPH, and the EMPOWUR trial, which assessed vibegron in adult patients with OAB.

COURAGE evaluated OAB symptoms in men receiving BPH pharmacotherapy

COURAGE (NCT03902080; URO-901-3005) was a 24-week, multicenter, randomized, double-blind, placebo-controlled phase 3 trial.² Participants were men aged 45 years or older with OAB symptoms who were receiving an α-blocker, with or without a 5α-reductase inhibitor, for BPH. Participants were randomly assigned 1:1 to vibegron 75 mg once daily or placebo.

The co-primary end points were changes from baseline at week 12 in mean daily micturitions and urgency episodes. Among 1105 randomized participants, 965 (87.3%) completed the trial. At week 12, the least-squares mean difference between vibegron and placebo was −0.74 episodes per day for micturitions (95% CI, −1.02 to −0.46; P < .0001) and −0.95 episodes per day for urgency episodes (95% CI, −1.37 to −0.54; P < .0001).

Vibegron also was associated with reductions in nocturia episodes (least-squares mean difference, −0.22; 95% CI, −0.36 to −0.09; P = .002) and UUI episodes (−0.80; 95% CI, −1.33 to −0.27; P = .003), along with an improvement in International Prostate Symptom Score storage score (−0.9; 95% CI, −1.2 to −0.6; P < .0001) and an increase in volume voided per micturition (15.07 mL; 95% CI, 9.13 to 21.02; P < .0001).

Adverse events occurred in 45% of participants receiving vibegron and 39% receiving placebo. Events occurring in at least 2% of participants in the vibegron group included hypertension (9.0% vs 8.3% with placebo), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%).

Broader OAB evidence includes the EMPOWUR phase 3 trial

The regulatory submission also builds on the broader clinical development program for vibegron in OAB. In the phase 3 EMPOWUR trial (NCT03583372), 1518 adults with OAB were randomly assigned 5:5:4 to vibegron 75 mg, placebo, or extended-release tolterodine for 12 weeks.³

At week 12, vibegron reduced daily micturitions by an adjusted mean of 1.8 episodes compared with 1.3 episodes with placebo (P < .001). Among participants with UUI, the corresponding reductions were 2.0 and 1.4 episodes per day, respectively (P < .0001), and 1.8 for tolterodine. Vibegron also significantly improved the number of urgency episodes and volume voided per micturition compared with placebo.

A 40-week double-blind extension of EMPOWUR provided additional longer-term safety data.⁴ Among 505 participants who received at least 1 dose of study drug, 2.4% discontinued because of adverse events. Across patients who received vibegron/tolterodine, the most common adverse events werehypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), headache (5.5%/3.9%), nasopharyngitis (4.8%/5.2%) and dry mouth (1.8%/5.2%).

REFERENCES

1. Knight Therapeutics announces regulatory submission of GEMTESA in Canada. News release. Knight Therapeutics Inc. September 15, 2026. Accessed September 18, 2026. https://www.globenewswire.com/news-release/2026/09/15/3361951/0/en/knight-therapeutics-announces-regulatory-submission-of-gemtesa-in-canada.html

2. Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999

3. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd Jr PN. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807

4. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd Jr PN. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574