Vibegron

Active substance
Vibegron
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Extended indication
Overactive bladder

1. Product

Manufacturer
Urovant
Mechanism of action
Receptor agonist
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Beta-3 adrenergic receptor agonist.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Fase 3 Empowur studie resultaten: https://www.businesswire.com/news/home/20200302005268/en/Urovant-Sciences-Announces-Publication-Phase-3-EMPOWUR.

3. Therapeutic value

Current treatment options
Urologische spasmolytica
Therapeutic value
No judgement
Frequency of administration
1 times a day
Dosage per administration
75 mg
References
Farmakotherapeutisch kompas; NCT03492281

4. Expected patient volume per year

References
Kenniscentrum Urologie Slingeland Ziekenhuis
Additional comments
De overactieve blaas komt bij 10% van de volwassenen voor. Potentieel voor veel patiënten.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

Off label use
Yes
Indications off label use
Fase 2: OAB in Men with Benign Prostatic Hyperplasia (BPH), fase 1: irritable bowel syndrome (IBS) associated pain.
References
Urovant.com

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.