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Paltusotine

Extended indication Treatment of Acromegalie
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Paltusotine
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Metabolic diseases
Extended indication Treatment of Acromegalie
Manufacturer Crinetics
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanimse: Somatostatin receptor 2 agonists

Registration

Registration route Centralised (EMA)
ATMP No
Submission date December 2024
Expected Registration January 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks NCT05192382

Therapeutic value

Current treatment options Octreolin
Therapeutic value No estimate possible yet
Substantiation Het is vergelijkbaar met niet leverbaar Octreolin. Het voordeel van dit middel is dat het niet 2 maar 1 maal daags oraal kan en waarschijnlijk minder voedsel afhankelijk is. Het voordeel van orale therapie versus maandelijkse injectie (intramuraal of subcutaan) waarvoor vaak ook thuiszorg geregeld moet worden.
Additional remarks NCT05192382

Expected patient volume per year

Patient volume

< 1,200

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks Het gaat om ongeveer 1.200 patiënten die een Somatostatine gebruiken (injecties)

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.