Voluntary Withdrawal of Alzheimer's Donepezil Patch US Phase 1 Trial, Avoiding 30 Billion KRW Clinical Cost
Icure voluntarily withdrew its US FDA Phase 1 clinical trial for the donepezil transdermal patch (IPI-401) for Alzheimer's disease
Reason for withdrawal: lack of business viability due to low-cost generic donepezil in the US market and failure to secure a partner to bear the approximately 30 billion KRW US clinical cost
The trial was a single-center, open-label, randomized, crossover Phase 1 study comparing the pharmacokinetics of IPI-401 patch twice weekly vs Aricept® oral once daily in healthy adults, targeting up to 40 subjects over about 12 months
Clinical trial plan approval date: 2021-04-28; withdrawal application date: 2026-05-21
KOSDAQ Filing Information
Major Management Matters Related to Investment Decisions (Voluntary Withdrawal of Clinical Trial Plan, etc.) (Voluntary Withdrawal of Donepezil Patch's US FDA Phase 1 Clinical Trial Plan)