Tenapanor

Active substance
Tenapanor
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Hormonal disorders
Extended indication
Hyperphosphatemia

1. Product

Manufacturer
Ardelyx
Mechanism of action
Other
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Scrip pipeline watch 13 nov 2017: decreased potassium, well tolerated. "First-in-class inhibitor of gastrointestinal NHE3 sodium transporter reduces dietary sodium absorption".

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
Fosfaatbinders zoals sevelameer, ferrioxidesaccharaat, lanthaancarbonaat, calciumacetaat/​magnesiumcarbonaat
Therapeutic value
No judgement
Duration of treatment
Not found
References
Farmacotherapeutisch kompas.

4. Expected patient volume per year

Patient volume

< 11,832

Market share is generally not included unless otherwise stated.

References
GIPdatabank
Additional comments
Aantal patiënten dat fosfaatbinders heeft gekregen in 2016 betreft 11.832.

5. Expected cost per patient per year

Cost
3,300
References
GIPdatabank
Additional comments
Vergoeding per gebruiker voor fosfaatbinders in 2016 betreft €3.292,39

6. Potential total cost per year

Total cost

39,045,600

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Ook in PhIII voor de indicatie: "Constipation Predominant Irritable Bowel Syndrome".
References
Scrip, clinicaltrials.gov.

9. Other information

There is currently no futher information available.