MA-ICURE-PHARMACEUTICAL
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
AI Won't Transform Mobility Without Unprecedented Collaboration, Study Reveals8.12.2025 09:25:00 CET | Press release
First comprehensive analysis of real-world AI applications exposes critical gap between technology's promise and scaled deployment, according to the MIT Mobility Initiative and Kearney Advanced Mobility Institute Artificial intelligence is quietly reshaping global transportation systems, but most deployments remain isolated pilots that haven't achieved scale – and the gap between AI's promise and its execution is widening, according to a landmark study launched today at CoMotion GLOBAL in Riyadh. The Envisioning the Future of Mobility Powered by AI report, developed by the MIT Mobility Initiative and Kearney Advanced Mobility Institute, analyzed input from 55 leading global organizations, including Google, Lyft, Uber Freight, Deutsche Bahn, and NEOM. The study mapped real-world AI applications across mobility systems in Europe, the Americas, APAC, and the Middle East – revealing both breakthrough potential and fundamental challenges in bringing AI-powered mobility to scale. The report
ATEC2025·Real-World Extreme Challenge Concludes with Zhejiang University Team Claiming $150,000 Prize for Breakthrough in Fully Autonomous Robotics8.12.2025 09:25:00 CET | Press release
Thirteen global teams push the boundaries of “no remote control” robotics, driving the evolution from teleoperated tools to autonomous agents The ATEC2025·Real-World Extreme Challenge successfully concluded on December 7 on the campus of The Chinese University of Hong Kong. A team from Zhejiang University emerged victorious from a field of 13 talented international squads by demonstrating exceptional fully autonomous embodied intelligence, securing the top prize of $150,000 USD. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207877880/en/ A Zhejiang University team wins ATEC2025·Real-World Extreme Challenge Organized by the Chinese University of Hong Kong and co-hosted by Advanced Technology Exploration Community (ATEC), Peking University, Beijing Normal University, and Ant Group, ATEC2025·Real-World Extreme Challenge was the world’s first intelligent robotics challenge held entirely outdoors on natural terrain—featuring
SIAL Paris 2026 : The Entire Food Industry in One Place – An Unmissable Event for Professionals8.12.2025 09:00:00 CET | Press release
SIAL Paris 2026 is more than ever the world’s must-attend food industry event With less than a year to go, SIAL Parisonce again stands as a key international gathering for food industry professionals. With 85% of exhibition space already booked, the show demonstrates very strong momentum and appeal. SIAL Paris will welcome 295,000 professionals from 200 countries across a stunning 280,000 m² of exhibition space, covering all sectors of the food industry. Innovation at the core of global food transformation In a context marked by major demographic, environmental and geopolitical challenges, SIAL Paris stands as THE hub where innovation drives action, business, and transformation. It brings across all sectors’ ideas, projects, and solutions that address today’s challenges, all while inspiring food business around the world. As in every edition, the show will offer a unique immersive experience, facilitating meaningful meetings and business opportunities. SIAL Paris serves as the global i
Merz Therapeutics to Present Broad Range of Clinical, Real-World and Mechanistic Data at TOXINS 20268.12.2025 08:00:00 CET | Press release
Merz Therapeutics to present more than 20 abstracts and posters at the TOXINS 2026 8th International Conference, taking place January 14-17 2026 in Madrid, Spain. Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that the company will present more than 20 clinical and non-clinical abstracts and posters spanning spasticity, movement disorders, and neurotoxin science at the TOXINS 2026 8th International Conference, taking place January 14–17, 2026, in Madrid, Spain. These presentations underscore the company’s commitment to addressing unmet needs in neurological disorders. “Our research reflects a relentless focus on improving patient outcomes through innovation in neurotoxin science,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “By presenting these new data at TOXINS 2026, we aim to foster scientific exchange and advance treatment strategies that address real-world challenges for patients and clinicians.”
Galderma Welcomes Increased Equity Investment From L’Oréal8.12.2025 07:05:00 CET | Press release
L’Oréal to acquire an additional 10% stake in Galderma recognizing its scientific leadership in dermatology and long-term growth potential Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that L’Oréal Groupe intends to increase its equity investment in the company, acquiring an additional 10% stake from Sunshine SwissCo GmbH (a consortium led by EQT, Abu Dhabi Investment Authority (ADIA), and Auba Investment Pte. Ltd., acting as sellers). Following the transaction, which is subject to customary approvals, L’Oréal’s total shareholding in Galderma will rise to 20%, building on its initial investment made in August 2024. The transaction is expected to close in Q1 2026. In connection with this increased investment, Galderma will consider nominating two non-independent board candidates from L’Oréal, replacing the board members representing the consortium led by EQT, at the 2026 Annual General Meeting. Additio
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