- Knight Therapeutics announced that Health Canada has accepted its New Drug Submission (NDS) for Gemtesa (vibegron), advancing the therapy toward potential approval in Canada for adults with overactive bladder (OAB).
- The submission covers OAB with urge urinary incontinence, urgency and urinary frequency in adults, as well as OAB with nocturia in adult males receiving pharmacological therapy for benign prostatic hyperplasia (BPH).
- Gemtesa is a selective β3-adrenergic receptor agonist being evaluated as a treatment option for OAB. The Health Canada acceptance means the application will now undergo regulatory review; it does not indicate approval.
- Knight is developing Gemtesa in partnership with Sumitomo Pharma America, following exclusive Canadian supply and distribution agreements signed in June 2025 that also cover Orgovyx and Myfembree.
Takeaways:
Health Canada’s acceptance of Knight Therapeutics’ New Drug Submission for Gemtesa (vibegron) moves the therapy closer to potential approval in Canada for adults with overactive bladder (OAB), including men with OAB symptoms who are already on treatment for benign prostatic hyperplasia (BPH). If approved, Gemtesa would add a selective β3‑adrenergic agonist option to the Canadian OAB market, giving clinicians and patients an alternative to anticholinergics and existing β3‑agonists, and strengthening Knight’s urology portfolio alongside Orgovyx and Myfembree under its Sumitomo Pharma partnership.
Source: Globenewswire
