Vibegron

Vibegron, sold under the brand name Gemtesa, is a medication for the treatment of overactive bladder.[1][2][3]

Vibegron
Clinical data
Trade namesGemtesa
Other namesKRP-114V, MK-4618
AHFS/Drugs.com
License data
Routes of
administration		By mouth
Drug classBeta3 adrenergic receptor agonist
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.210.547
Chemical and physical data
FormulaC26H28N4O3
Molar mass444.535 g·mol−1
3D model (JSmol)

The most common side effects include headache, urinary tract infection, common cold, diarrhea, nausea, and upper respiratory tract infection.[2]

It was approved for medical use in the United States in December 2020.[1][2][3]

Medical uses

Vibegron is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.[1][2][3]

History

The U.S. Food and Drug Administration (FDA) approved vibegron based on evidence from one clinical trial (Trial 1/ NCT03492281) of 1085 adult participants 18 to 93 years old with overactive bladder.[2] The trial was conducted at 199 sites in the United States, Canada, Poland Hungary, Latvia, and Lithuania.[2] Some participants were previously treated for the symptoms of overactive bladder, and some were never treated before.[2] Participants received once daily treatment with either vibegron, placebo, or active control.[2] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed.[2]

Society and culture

Vibegron was approved for medical use in the United States in December 2020.[1][2][3]

Names

Vibegron is the international nonproprietary name (INN).[4]

References
  1. "Gemtesa- vibegron tablet, film coated". DailyMed. Retrieved 12 January 2021.
  2. "Drug Trials Snapshot: Gemtesa". U.S. Food and Drug Administration (FDA). 23 December 2020. Retrieved 12 January 2021. This article incorporates text from this source, which is in the public domain.
  3. "Sumitovant Biopharma Announces Urovant Sciences Receives U.S. FDA Approval of Gemtesa (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)" (Press release). Sumitovant Biopharma. 23 December 2020. Retrieved 23 December 2020 – via GlobeNewswire.
  4. World Health Organization (2013). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 70". WHO Drug Information. 27 (3): 318. hdl:10665/331167.
  • "Vibegron". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03492281 for "A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)" at ClinicalTrials.gov


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