MA-ICURE-PHARMACEUTICAL
16.11.2021 15:03:14 CET | Business Wire | Press release
Icure Pharmaceutical Inc. (KOSDAQ: 175250), a biopharmaceutical company in Korea, 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.
The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.
Donepezil is a current typical treatment that has been widely prescribed for the longest period for Alzheimer’s disease patients in severity ranging from mild to moderate and severe ones among FDA-approved Alzheimer's treatments. Due to difficulty in the development of its formulations, donepezil has been commercialized for only oral administration to date.
With successful completion of a Phase III clinical trial for the first time in the world, the donepezil patch of Icure is expected to significantly improve the quality of life of patients with Alzheimer’s-type dementia and their caregivers by enhancing the convenience in its use from orally taking once daily to putting a patch on skin twice a week.
With nearly 400 mild and moderate dementia patients in Korea, Taiwan, Australia and Malaysia, Icure successfully conducted a Phase III clinical study for its donepezil patch. Specifically, the study demonstrated noninferiority compared to oral donepezil in Alzheimer's disease assessment scale cognitive subscale (ADAS-cog), a typical standard tool for evaluating abilities of memory, language, reorganization, action and orientation in patients with mild and moderate Alzheimer’s-type dementia.
“Based on outstanding efficacy and marketability of donepezil along with our technological prowess, we expect our donepezil patch will sufficiently take over the market of donepezil oral products as we have seen a high conversion rate of rivastigmine patches in the past,” said CEO YoungKweon Choi, Ph.D. of Icure, who led donepezil patch development. “We reported results of the Phase III clinical trial of donepezil patch at the Conference on Clinical Trials of Alzheimer’s Disease (CTAD) that was held on November 9~12, 2021 in Boston, Massachusetts.” He attended the CTAD Conference to present the results of the clinical study while making consultations on potential global transactions.
Now that its donepezil patch received FDA approval for Phase I clinical trial as an investigational new drug in April 2021, 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. Today, the global dementia treatments market is estimated to reach around USD 3 billion, and it is anticipated to increase to roughly USD 5 billion by 2024 as the world transforms into an aging society. Icure plans to expand the global business of transdermal drug delivery system (TDDS) as its production facilities in Wanju, Korea obtained the cGMP certification.
Starting with the donepezil patch, Icure diversifies pipelines by developing a variety of DDS-based incrementally modified drugs and new drugs. Following the donepezil patch, the company is developing a pramipexole patch that will be used for treating Parkinson’s disease. And Icure BNP, a subsidiary of Icure, is currently developing oral liraglutide peptide formulation from injectable liraglutide peptide product that is being used for treating diabetes and obesity while accelerating the development of microneedles and lipid-based nanoparticle (LNP) drugs through CuRsuS Bio and EBA BIO. In addition, Icure is also in the development of the world’s first oral peptide-based anticancer drug and a new drug based on PROTAC through oneCureGen and Dandi Cure, attracting attention on the potentiality of growing into a global pharmaceutical company by developing varied DDS-based new drugs.
For more information on Icure Pharmaceutical Inc., visit https://icure.co.kr .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211116005684/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
AMCS Appoints Richard Humphrey as Chief Product and Technology Officer9.9.2026 15:00:00 CEST | Press release
Industrial software executive to lead global product strategy and accelerate AI innovation AMCS, a leading technology provider for the waste and recycling industry, today announced the appointment of Richard Humphrey as Chief Product and Technology Officer. Based in Boston, Humphrey will lead the company’s global product organisation. Humphrey brings more than 25 years of experience developing software for construction and other complex industrial environments. He joins AMCS as the company deepens its focus on waste and recycling and expands the role of AI across its platform. Most recently, Humphrey served as Chief Product and Technology Officer at Contruent, where he led product strategy for a construction cost-management platform used on major capital programmes. He previously held vice president roles at Bentley Systems and B2W Software. Earlier in his career, he spent more than a decade at Autodesk, where he led its Civil Design and Construction software business as Senior Directo
BBH Launches a New Technology Business, Braid, Solving for Intelligent Data Transformation9.9.2026 14:45:00 CEST | Press release
Braid’s agentic AI platform is purpose-built for financial services firms who need to transform, connect, and manage their data with confidence Brown Brothers Harriman (BBH) today announced the launch of a new technology affiliate, Braid LLC, focused on solving enterprise data transformation for financial services. Braid offers an AI-native data transformation platform that gives firms a scale solution to transform, connect, and manage their data with confidence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909294398/en/ Braid empowers teams to build, automate, and oversee reliable production-grade data transformations in a fraction of the time typically required today. Instead of requiring engineers to build data automations, Braid allows business users to describe their needs in natural language that AI agents use to build intelligent data transformations that are transparent and fully auditable. Braid’s enterprise-gr
LTM Collaborates with IBM and Red Hat on Lightwell to Advance AI-Driven Open-Source Software Remediation9.9.2026 14:30:00 CEST | Press release
Strengthens software supply chains by helping enterprises transform vulnerability discovery into scalable remediation outcomes LTM, the Business Creativity partner to the world's largest enterprises, today announced that it has collaborated with IBM and Red Hat on Lightwell to help enterprises safeguard the open-source software supply chain through AI-driven vulnerability remediation. As AI accelerates the discovery of software vulnerabilities, organizations must move beyond detection-focused approaches and adopt enterprise-scale remediation strategies that enable rapid risk mitigation without disrupting business-critical applications. Lightwell’s approach of delivering validated fixes for production environments aligns with LTM's aim of helping customers build secure, resilient, and operationally efficient software supply chains. By combining AI-powered remediation capabilities with enterprise-grade validation and deployment support, Lightwell aims to help organizations address securi
New England Journal of Medicine Publishes Data from Phase 3 Studies Demonstrating Oveporexton (ORZEYFUL) Improved the Full Range of Narcolepsy Type 1 Symptoms and Quality of Life9.9.2026 14:24:00 CEST | Press release
Data Demonstrated Significant and Clinically Meaningful Improvements with the Potential to Redefine Narcolepsy Type 1 (NT1) Care Beyond Individual Symptoms Oveporexton was Generally Well-Tolerated with Safety Profile Consistent with Previous Clinical Studies Oveporexton is the First and Only Approved Orexin Agonist Designed to Treat the Underlying Cause of NT1 and is Now Approved in the U.S., China and Japan, with Additional Regulatory Submissions Underway Takeda (TSE:4502/NYSE:TAK) announced that the New England Journal of Medicine published results from two Phase 3 studies evaluating oveporexton (ORZEYFUL), an oral orexin receptor 2 (OX2R) agonist, in people with narcolepsy type 1 (NT1).1 Oveporexton is the first and only medicine to treat the underlying cause of NT1. "People living with narcolepsy type 1 face persistent symptoms across the day and night, which can impact many aspects of daily life,” said Emmanuel Mignot, M.D., Ph.D., principal investigator for the FirstLight (TAK-86
ZincFive Launches Next-Generation BMS, Setting a New Standard for Nickel-Zinc Battery Management9.9.2026 14:05:00 CEST | Press release
Purpose-built Battery Management System (BMS) streamlines installation and supports the evolving power demands of AI data centers ZincFive®, the leader in nickel-zinc (NiZn) battery-based solutions for immediate power applications, today launched the ZincFive BMS, a next-generation battery management system purpose-built for its NiZn chemistry, designed and assembled in the U.S. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909653032/en/ The ZincFive BMS ships standard with every ZincFive BC Series UPS Battery Cabinets, serving as the primary interface for data center operators, UPS OEM partners, and system integrators to monitor and manage ZincFive’s technology. Built on years of experience managing NiZn in real-world data center environments, ZincFive engineered the BMS around the unique characteristics of its NiZn chemistry, rather than adapting a platform designed for lithium-ion or lead-acid batteries. The result is
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom