December 26, 2020
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Catalyst Info & Data Links
TITLE: Vibegron (beta-3 adrenergic agonist) - Overactive Bladder (OAB) - PDUFA
ClinicalTrial.gov (NCT03583372) An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB). (Empowur)
ClinicalTrial.gov (NCT03492281) A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
08-13-2020 Reports Fiscal First Quarter 2020 Results
2019: EMPOWUR Phase 3 Results
2020: 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. The Journal of Urology, 10-1097.
2019: Vibegron (RVT-901/MK-4618/KRP-114V) administered once daily as monotherapy or concomitantly with tolterodine in patients with an overactive bladder: a multicenter, phase IIb, randomized, double-blind, controlled trial. European Urology, 75(2), 274-282.
MECHANISM OF ACTION / RATIONALE
Urovant’s lead investigational product candidate, vibegron, is an oral, once-daily, small molecule beta-3 agonist. The beta-3 adrenergic receptor is the most prevalent beta-adrenergic receptor subtype on the smooth muscle around the bladder. Bladder filling involves the relaxation of this muscle and the contraction of the urethral smooth muscle, while voiding involves contracting the bladder muscle and relaxation of the urethral muscle. Studies of isolated human bladder smooth muscle have shown that selective activation of the beta-3 adrenergic receptor results in smooth muscle relaxation. Therefore, beta-3 stimulation can increase bladder capacity and reduce the symptoms of OAB. In March 2019, Urovant announced positive topline results from an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of vibegron 75mg in 1,518 adults with symptoms of overactive bladder. Urovant intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020. In addition to OAB, vibegron is being developed for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of pain associated with irritable bowel syndrome (IBS) (Learn more HERE).
Updated by HC
#UROV, #Vibegron, #OAB, #Over_Active_Bladder, #PDUFA
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