UROV

Vibegron (beta-3 adrenergic agonist)

Overactive Bladder (OAB)

PDUFA

Exp Date

December 26, 2020

Amp Volatility Score

N/A

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?

  • PDUFA


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA

PRESS RELEASES

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

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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Recent Posts

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UROV - Urovant Sciences Announ...

Summary: Key secondary endpoint of Global Improvement Scale (GIS) showed numerical differences in favor of vibegron versus placebo, however data was not statistically significant Vibegron was generall...

UROV - Urovant Sciences Announ...

Summary: Extension study demonstrates favorable results in long term treatment of overactive bladder with vibegron, including improvements in incontinence efficacy, quality of life endpoints and with ...

UROV - Urovant Sciences Enters...

Summary: Urovant Sciences Shareholders to Receive $16.25 per share in cash Urovant Special Independent Committee of the Board Unanimously Recommends that all Shareholders Vote in Favor of the Transac...

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