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
Garvan Institute of Medical Research Joins Parse Biosciences’ Certified Service Provider Network15.7.2026 22:00:00 CEST | Press release
Researchers across Asia-Pacific gain a new option for high-quality single cell sequencing through Garvan's Evercode WT services Parse Biosciences, a QIAGEN company, and the leader in scalable and accessible single cell sequencing, today announced that the Genomics Platform Core Facility within the Garvan Institute of Medical Research has joined its Certified Service Provider (CSP) Program. The partnership broadens access to high-quality, scalable single cell sequencing across Australia, the wider Asia-Pacific region, and beyond. Garvan is one of Australia's preeminent medical research institutions, with the Genomics Platform having deep experience in cell sorting, capture, and sequencing. As a Certified Service Provider, Garvan will offer Parse's Evercode WT kits to researchers across the region. "We see a growing number of requests for Parse projects and find the technology easy to implement and run, generating great data," said Chris O'Keeffe, Cellular Genomics Lead at the Garvan Ins
Grafana Labs Named a Leader in 2026 Gartner® Magic Quadrant™ for Observability Platforms and Positioned Furthest in Completeness of Vision15.7.2026 20:21:00 CEST | Press release
Named a Leader for the third consecutive year and placed furthest in vision for the second year in a row, the company has had a landmark year of innovation as observability becomes essential infrastructure for teams building and running AI at scale. Grafana Labs, the company behind the open observability cloud, today announced it has been named a Leader in the Gartner® Magic Quadrant™ for Observability Platforms for the third consecutive year, and positioned furthest on the Completeness of Vision axis for the second year running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715814984/en/ 2026 Gartner® Magic Quadrant™ for Observability Platforms We believe this placement reflects where the market is headed: toward open, composable observability that helps teams in the AI era understand systems that are increasingly complex and agentic, and rapidly scaling thanks to AI-assisted engineering. A Platform Built for the AI Era
Spectro Cloud Raises $100 Million Series D to Help Customers Move AI Infrastructure Into Production Across Enterprise, Public Sector, Neocloud and Sovereign Cloud Environments15.7.2026 18:20:00 CEST | Press release
Growth Equity at Goldman Sachs Alternatives leads oversubscribed round with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus as organizations look to turn AI silicon into business outcomes Spectro Cloud, a leading provider of AI infrastructure management software, today announced it has raised more than $100 million in an oversubscribed Series D funding round led by Growth Equity at Goldman Sachs Alternatives, with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus. The new funding brings Spectro Cloud’s total capital raised to $260 million and will accelerate the company’s mission to help enterprises, public sector organizations, neoclouds and sovereign clouds build and operate production AI infrastructure with greater control over cost, security and governance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715551858/en/ Spectro Cloud raises $
K-Beauty Goes Global: Sales Surge 53% as Korean Innovation Reshapes Beauty Growth15.7.2026 16:00:00 CEST | Press release
New NIQ data shows K-Beauty value sales rose 53% year-over-year and 131% over two years, underscoring how regional beauty trends, social commerce and ingredient-led innovation are reshaping global beauty growth. NIQ (NYSE: NIQ), a global leader in consumer intelligence, today released new findings showing K-Beauty has become a rapidly growing global beauty segment, with value sales up 53% year-over-year and 131% over the past two years. The data points to a broader shift in beauty growth, as regional innovation, social commerce and digitally driven consumer demand increasingly shape what scales globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715867578/en/ K-Beauty accelerates across global markets In its latest report, K-Beauty Goes Global, NIQ shows how Korean beauty is reshaping consumer expectations, accelerating innovation cycles and redefining competitive dynamics across the global beauty market. What began
Viz.ai to Support the MINUTE Trial, a Landmark Multicenter Study Evaluating the SCUBA Technique for the Treatment of Intracerebral Hemorrhage15.7.2026 15:00:00 CEST | Press release
Viz Neuro™ Suite, including Viz ICH™ and Viz ICH Plus™, to facilitate rapid detection and care coordination for patients with basal ganglia hemorrhage across trial sites nationwide. Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced its support for the Minimally Invasive Neurosurgery Trial for Ultra-early Treatment (MINUTE) Trial, a prospective, multicenter, randomized study evaluating whether the SCUBA technique, an endoscopic, catheter-based approach for ultra-early evacuation of basal ganglia intracerebral hemorrhage (BGH), is a promising alternative to standard medical management to potentially improve functional patient outcomes. The study aims to initiate both randomization and surgical intervention within 120 minutes of key clinical time points, reflecting the urgent nature of intracerebral hemorrhage care. Participating sites will have the ability to leverage the Viz Neuro Suite platform, including Viz ICH and Viz ICH Plus, to
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