Leuco-methylthioninium

Active substance
Leuco-methylthioninium
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Dementia
Extended indication
Alzheimer’s disease, mild-to-moderate.

1. Product

Proprietary name
LMTX
Manufacturer
TauRx
Mechanism of action
Other
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)

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
donepezil, galantamine, rivastigmine.
Therapeutic value
No judgement
Substantiation
Leuco-methylthioninium zou een eerste disease modifying behandeling kunnen worden voor Alzheimer's. Echter, er zijn twijfels over de mogelijke effectiviteit.
Duration of treatment
Not found
References
"The results of study TRx-237-015 suggested the hypothesis that LMTM might be effective only as monotherapy" (Wilcock et al. J Alzheimer's Disease 2018)

4. Expected patient volume per year

Patient volume

< 21,000

Market share is generally not included unless otherwise stated.

References
http://www.levenmetalzheimer.nl/content/alzheimer/feiten-cijfers.asp, https://www.sfk.nl/publicaties/PW/2016/inzet-medicijnen-bij-dementie-loopt-terug
Additional comments
In Nederland zijn 270.000 mensen dement. Hiervan hebben 160.000 tot 190.000 mensen de ziekte van Alzheimer (max 70%). In totaal waren er in totaal 30.000 geneesmiddelengebruikers, die medicijnen kregen tegen dementie (SFK), uitgaande van 70% zal het maximaal gaan om 21.000 patiënten. Afhankelijk van de therapeutische waarde kan dit aandeel patiënten oplopen.

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

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.