Vibegron is a selective beta 3 adrenergic receptor (β3AR) 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.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan Keam is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 1.Kyorin Pharmaceutical. Beova Tablets 50 mg: Japanese prescribing information. 2018. http://www.info.pmda.go.jp/downfiles/ph/PDF/230109_25900A7F1025_1_02.pdf. Accessed 3 Oct 2018.
- 2.Kyorin Pharmaceutical. Kyorin and Kissei signed an agreement for co-development and co-marketing of KRP-114V [media release]. 30 Mar 2016.Google Scholar
- 3.Roivant Sciences. Roivant Sciences launches Urovant to develop innovative therapies in urology [media release]. 6 Jun 2017.Google Scholar
- 5.Urovant Sciences. Pipeline. 2018. https://urovant.com/pipeline/. Accessed 24 Oct 2018.
- 6.Kyorin Pharmaceutical. Kyorin signed a license agreement with Merck on vibegron for overactive bladder in Japan [media release]. 22 Jul 2014.Google Scholar
- 7.Kyorin Holdings Inc. Kyorin acquired licenses from Merck & Co., Inc., Kenilworth, N.J., U.S.A. for investigational therapy for overactive bladder (Code:KRP-114V) in Asia [media release]. 11 Apr 2017.Google Scholar
- 8.Urovant Sciences Ltd SEC filing. 2018. https://www.nasdaq.com/markets/ipos/filing.ashx?filingid=12859913. Accessed 9 Oct 2018.
- 12.Mitcheson HD, Samanta S, Muldowney K, et al. 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. 2018. https://doi.org/10.1016/j.eururo.2018.10.006.CrossRefPubMedGoogle Scholar
- 13.Dmochowski R, Mitcheson D, Frenkl T, et al. Durable efficacy and safety of long-term once-daily vibegron, a novel oral B-3 adrenergic receptor agonist: a 52-week phase 2 study in patients with overactive bladder syndrome [abstract no. PD50-03]. J Urol. 2018;199(4 Suppl):e970-e1.Google Scholar
- 14.Kyorin Pharmaceutical. Kyorin receives marketing approval in Japan for “Beova® tablets 50 mg” for the treatment of overactive bladder [media release]. 21 Sep 2018.Google Scholar