Stage (next event)
Phase 3 (Top-line Data)
Catalyst Info & Data Links
TITLE: Vibegron (beta-3 adrenergic agonist) in Over Active Bladder (OAB) in Men with Benign Prostatic Hyperplasia (BPH) - Phase 3 Top-line Data
ClinicalTrial.gov (NCT04103450) Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
ClinicalTrial.gov (NCT03902080) Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
WHAT IS THE NEXT CATALYST EVENT?
Phase 3 Top-line Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
H2 2021 (see slide 6)
Mechanism of Action
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
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