donepezil transdermal patch (IPI-301) / Icure Pharm - LARVOL DELTA

Icure Acquires Drug Product Approval for World’s First Donepezil Patch for Treating Dementia of the Alzheimer Type in Korea (Businesswire) - “The world’s first donepezil patch is approved for the incrementally modified drug; Launching in 2022, its availability will be expanded to the global market. Icure Pharmaceutical Inc...announced today that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea…Icure will start to administer it to patients in the latter part of 2022. The company expects to begin in 2025 to provide the donepezil patch in the global market by reducing the period of clinical trials through the 505(b)2 clinical study track.”

Launch • Non-US regulatory • Alzheimer's Disease • CNS Disorders

Icure cleared to export donepezil patch for Alzheimer’s (Korea Biomedical Review) - "Icure Pharmaceutical recently obtained the Ministry of Food and Drug Safety’s nod to export patch-type donepezil, a treatment for Alzheimer’s disease....The export approval is expected to speed up the shipment of the patch to China in particular, as the company signed a deal to supply the product to China’s Hainan Province in October last year."

Commercial • Non-US regulatory • Alzheimer's Disease • CNS Disorders

Drugmakers try new forms of donepezil to treat Alzheimer’s (Korea Biomedical Review) - "Domestic pharmaceutical companies are working on new forms of donepezil, a treatment for Alzheimer’s disease....ICURE Pharmaceutical is soon to apply for the Ministry of Food and Drug Safety’s approval for a donepezil patch....Dong-A ST...aims to develop it as a once-weekly patch....Boryung Pharmaceutical is also working on a dementia patch."

Clinical • Alzheimer's Disease • CNS Disorders

Icure applies for phase 1 clinical trial to the US FDA for dementia treatment [Google translation] (Hankyung) - "Icure announced on the 31st that it has applied for a phase 1 clinical trial of donepezil patch, a treatment for Alzheimer's dementia, to the US Food and Drug Administration (FDA)….As ICure holds the results of phase 3 clinical trials in Korea and a US patent for the donepezil patch, it is expected that an application for product approval will be possible after phase 1 clinical trials are completed according to the FDA's approval procedure for an improved new drug."

IND • Alzheimer's Disease • CNS Disorders

A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease (clinicaltrials.gov) - P3; N=399; Completed; Sponsor: Icure Pharmaceutical Inc.; Recruiting ➔ Completed; Trial completion date: Nov 2019 ➔ Jul 2020; Trial primary completion date: Mar 2019 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease (clinicaltrials.gov) - P3; N=346; Recruiting; Sponsor: Icure Pharmaceutical Inc.; N=588 ➔ 346; Trial completion date: Apr 2019 ➔ Nov 2019; Trial primary completion date: Dec 2018 ➔ Mar 2019

Clinical • Enrollment change • Trial completion date • Trial primary completion date