» Articles » PMID: 30411311

Vibegron: First Global Approval

Overview
Journal Drugs
Specialty Pharmacology
Date 2018 Nov 10
PMID 30411311
Citations 17
Authors
Affiliations
Soon will be listed here.
Abstract

Vibegron is a selective beta 3 adrenergic receptor (βAR) agonist that is being developed in Japan jointly by Kyorin Pharmaceutical Co., Ltd and Kissei Pharmaceutical Co., Ltd and in other regions worldwide (except in several other Asian countries) by Urovant Sciences for the treatment of overactive bladder (OAB). Based on results from Japanese phase III trials, vibegron received approval in Japan in September 2018 for this indication. This article summarizes the milestones in the development of vibegron leading to this first global approval for the treatment of OAB.

Citing Articles

Health utility value of overactive bladder in Japanese older adults.

Yoshioka T, Omae K, Funada S, Minami T, Goto R BJUI Compass. 2025; 6(1):e471.

PMID: 39877574 PMC: 11771497. DOI: 10.1002/bco2.471.


Age-Dependent Effects of Oxytocin and Oxytocin Receptor Antagonists on Bladder Contractions: Implications for the Treatment of Overactive Bladder Syndrome.

Badshah M, Ibrahim J, Su N, Whiley P, Middendorff R, Whittaker M Biomedicines. 2024; 12(3).

PMID: 38540287 PMC: 10968663. DOI: 10.3390/biomedicines12030674.


Inside the Biology of the β3-Adrenoceptor.

Pasha A, Tondo A, Favre C, Calvani M Biomolecules. 2024; 14(2).

PMID: 38397396 PMC: 10887351. DOI: 10.3390/biom14020159.


Vibegron shows high selectivity and potent agonist activity for β3-adrenoceptors, irrespective of receptor density.

Yamamoto S, Kusabuka H, Matsuzawa A, Maruyama I, Yamazaki T PLoS One. 2023; 18(9):e0290685.

PMID: 37656760 PMC: 10473532. DOI: 10.1371/journal.pone.0290685.


A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder.

Shin J, Jeong S, Kim S, Oh C, Chung K, Shin D Int Neurourol J. 2023; 27(2):106-115.

PMID: 37401021 PMC: 10325944. DOI: 10.5213/inj.2346022.011.


References
1.
Edmondson S, Zhu C, Kar N, Di Salvo J, Nagabukuro H, Sacre-Salem B . Discovery of Vibegron: A Potent and Selective β3 Adrenergic Receptor Agonist for the Treatment of Overactive Bladder. J Med Chem. 2015; 59(2):609-23. DOI: 10.1021/acs.jmedchem.5b01372. View

2.
Di Salvo J, Nagabukuro H, Wickham L, Abbadie C, DeMartino J, Fitzmaurice A . Pharmacological Characterization of a Novel Beta 3 Adrenergic Agonist, Vibegron: Evaluation of Antimuscarinic Receptor Selectivity for Combination Therapy for Overactive Bladder. J Pharmacol Exp Ther. 2016; 360(2):346-355. DOI: 10.1124/jpet.116.237313. View

3.
Yoshida M, Takeda M, Gotoh M, Nagai S, Kurose T . Vibegron, a Novel Potent and Selective β-Adrenoreceptor Agonist, for the Treatment of Patients with Overactive Bladder: A Randomized, Double-blind, Placebo-controlled Phase 3 Study. Eur Urol. 2018; 73(5):783-790. DOI: 10.1016/j.eururo.2017.12.022. View

4.
Yoshida M, Kakizaki H, Takahashi S, Nagai S, Kurose T . Long-term safety and efficacy of the novel β -adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study. Int J Urol. 2018; 25(7):668-675. DOI: 10.1111/iju.13596. View

5.
Mitcheson H, Samanta S, Muldowney K, Pinto C, Rocha B, Green S . 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. Eur Urol. 2019; 75(2):274-282. DOI: 10.1016/j.eururo.2018.10.006. View