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Cyp-001

Medicine

Extended indication Cyp-001 in combination with corticosteroids for treatment of high risk Acute graft versus host disease in adults and elderly who undergone allogeneic
Registration phase Clinical trials

Product

Active substance Cyp-001
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Graft versus Host
Extended indication Cyp-001 in combination with corticosteroids for treatment of high risk Acute graft versus host disease in adults and elderly who undergone allogeneic hematopoietic stem cell transplant (HSCT).
Manufacturer Cynata
Portfolio holder Cynata
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks iPSC‑derived mesenchymal stem cell (MSC) therapy

Registration

Registration route Centralised (EMA)
Submission date September 2026
Expected Registration October 2027
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Current treatment options steroïden, ruxolitinib
References NCT05643638

Expected patient volume per year

Patient volume 193 - 275

Market share is generally not included unless otherwise stated.
References (1) www.matchis.nl. (2). Behandeling van ernstige Graft versus Host ziekte na allogene stam cel transplantatie met prednisolon in vergelijking met behandeling met Mesenchymale Stromale Cellen en prednisolon. Een prospectieve, dubbel blinde, placebogecontrolleerde, gerandomiseerde fase III studie, HOVON.
Additional remarks Het aantal Nederlandse patiënten dat stamcellen ontving via een onverwante donor was in 2025 gelijk aan 550 (1). Graft-versus-Host-ziekte treedt op in 35% tot 50% van de getransplanteerde patiënten (2), wat uitkomt op 193 tot 275 patiënten.

Expected cost per patient per year

Additional remarks Er is nog niets bekend over de mogelijke prijs.

Potential total cost per year

Off label use

Indication extension

Other information