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Dapansutrile

Extended indication Acute Gout Flare
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Dapansutrile
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Rheumatism
Extended indication Acute Gout Flare
Manufacturer Olatec
Mechanism of action Interleukin inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2025
Expected Registration February 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Anakinra en canakunumab.
Therapeutic value No estimate possible yet
Substantiation Er lopen fase 3 studies (lopen nog 2 jaar). Er worden voorlopig nog geen resultaten verwacht. Op dit moment is hierdoor nog niet te zeggen hoe effectief het is en hoe het ingezet gaat worden. Er zijn al goedkope alternatieven. Op dit moment worden bijvoorbeeld anakinra en canakunumab gegeven.
Duration of treatment Average 1 week / weeks
Frequency of administration 2 times a day
Dosage per administration 1000mg
References NCT05658575
Additional remarks An initial loading dose of 2.000mg dapansutrile on Day 1 followed by a maintenance regimen of 1.000mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.

Expected patient volume per year

References https://www.ntvg.nl/artikelen/jicht-4
Additional remarks De prevalentie varieert van 1 tot 7%. In Nederland waren er in 2017 bijna 500.000 mensen met jicht.

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.