
Daewoong's weekly weight-loss patch hits record absorption in human trial
The study, the first human trial of its kind, applied Daewoong Therapeutics' proprietary drug delivery platform, Clopam, to a semaglutide microneedle patch. With 70 healthy adults, the trial compared the blood concentration of semaglutide delivered via the patch to that of a subcutaneous injection, adjusting for dosage differences.
While existing microneedle patches with the same ingredient have shown about 30 percent bioavailability, Daewoong's patch demonstrated more than 80 percent -- the highest achievability among similar products -- and around 160 times higher absorption than oral semaglutide tablets.
The results also indicated that the patch can maintain stable blood concentration for a week, enabling a weekly, high-dose formulation.
According to Grand View Research, the global weight loss medication market is valued at $15.9 billion and is projected to reach $60.5 billion by 2030. Industry experts say that drug delivery technologies offering higher bioavailability and improved patient convenience will be a key factor in shaping the market.
Microneedle patch technology, which addresses the limitations of both painful injections and low-efficiency oral drugs, is seen as a potential game changer. Additionally, it also has the advantage of higher cost efficiency, and stability, compared to other methods which require cold temperatures for storage.
'This study proves our ability to deliver a high dose of semaglutide via a single weekly patch — a breakthrough beyond current obesity treatment patches,' said Kang Bok-ki, CEO of Daewoong Therapeutics. 'It's a major step toward global licensing and commercialization.'
Daewoong Pharmaceutical CEO Park Seong-soo added, 'Overcoming the high-dose delivery barrier marks a significant milestone. We will expand microneedle applications to other biologics and lead the global platform market.'
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Korea Herald
a day ago
- Korea Herald
Daewoong Therapeutics Microneedle Patch Achieves Best-in-Class Bioavailability, Proving the Strength of Its Drug-Delivery Platform
SEOUL, South Korea, Aug. 13, 2025 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) and Daewoong Therapeutics (CEO Bok-Ki Kang) announced that their proprietary semaglutide microneedle patch achieved more than 80%relative bioavailability compared to the injectable formulation in a pilot human pharmacokinetic study. This was based on the healthy volunteer study using semaglutide microneedle patch using Daewoong Therapeutics' CLOPAM® (CLO sed P acked A ero-pressured M icroneedle) drug-delivery platform. The study directly compared delivery efficiency with semaglutide subcutaneous injection. In the trial, 70 healthy adults received single dose of either a semaglutide microneedle patch or a subcutaneous injection. Plasma concentrations were measured and then compared with results from semaglutide subcutaneous injection under the same conditions. After adjusting to equivalent dose, the patch showed more than 80%relative bioavailability compared with injection. This result is the highest reported for a microneedle patch with the same active ingredient, far exceeding the approximately 30 percent achieved by existing patches. It also showed around 160 times higher bioavailability than semaglutide oral tablet. Therapeutic plasma levels were maintained for one week, supporting the potential for once-weekly dosing with a single high-load patch. The exposure profile was comparable to that of the injectable counterpart, which strengthens the commercial prospects for a patch-based obesity treatment. Technology as the Decisive Factor in the Obesity Market According to Grand View Research, the global obesity therapeutics market is valued at 15.9 billion US dollars in 2024 and is projected to grow to 60.5 billion US dollars by 2030. Currently, therapeutic and safety advantages in the GLP-1 drug class are limited, and experts expect Experts expect delivery technologies improving both bioavailability and patient convenience will be the factor that determines future market leaders. Microneedle patches are attracting attention because they address two key limitations of current therapies: pain of injections and low drug delivery efficiency of oral formulations. While semaglutide oral tablet is available on the market, it has very low bioavailability and requires complex medication regimen, such as fasting before dosing, limiting water intake, and avoiding co-administration with other drugs for chronic patients potentially lowering adherence. A once-weekly microneedle patch offers a simpler, needle-free option that could be used by a wider range of patients, including those who avoid injections. Daewoong's Microneedle Technology Innovation Leading the Global Market The results were made possible by Daewoong Therapeutics' patented CLOPAM® microneedle platform technology, a dissolving-type microneedle technology designed for precise, skin-based drug delivery. The platform uses pressurized drying and hermetic packaging to improve drug uniformity and stability, allowing accurate dosing with minimal contamination risk. CLOPAM® currently has 52 patent filings worldwide and is positioning to be one of Daewoong's leading technologies. Unlike other injectable products containing semaglutide that require cold-chain storage, Daewoong's patches remain stable at room temperature, which can reduce distribution costs. They also help cut down on medical waste from syringes and needles, aligning with sustainability goals in healthcare. Based on these results, Daewoong Therapeutics is planning to broaden the collaborative initiatives to the global market via technology licensing, co-development, and out-licensing to prepare for commercialization. "The microneedle patch must achieve not only high bioavailability but also a drug load sufficient for therapeutic effect," said Bok-Ki Kang, CEO of Daewoong Therapeutics. "In this study, we incorporated a high dose of semaglutide into a single patch and showed the potential for once-weekly application. This overcomes a key limitation of previous microneedle approaches and provides a strong foundation for global technology transfer and commercialization." "Microneedle formats have long promised better adherence, but high-dose delivery has been a challenge," said Seong-Soo Park, CEO of Daewoong Pharmaceutical. "This work is the first to overcome that barrier. We plan to expand microneedle technology to a wide range of biologics to lead the global platform market." About Daewoong Pharmaceutical Daewoong Pharmaceutical (KRX: established in 1945, is a global pharmaceutical company headquartered in South Korea. The company develops, manufactures, and markets innovative medicines and healthcare solutions with the mission to improve quality of life worldwide. Daewoong specializes in treatments for intractable and rare diseases, supported by in-house research and development, open innovation, and advanced manufacturing capabilities. Recent achievements include the development and approval of novel drugs for gastroesophageal reflux disease (Fexuprazan) and Type 2 diabetes (Enavogliflozin) in consecutive years. The company is also developing a first-in-class oral anti-fibrotic agent for idiopathic pulmonary fibrosis (Bersiporocin), which has received both orphan drug designation and Fast Track status from the US FDA. Daewoong Therapeutics Inc., is a subsidiary of Daewoong Group located in South Korea. The company is focused on developing novel drug delivery systems including the dissolving microneedle platform, CLOPAM®. CLOPAM® is currently being applied to various fields including obesity/metabolic diseases and others with aims to improve patient convenience and medication adherence.


Korea Herald
2 days ago
- Korea Herald
Daewoong's weekly weight-loss patch hits record absorption in human trial
Daewoong Pharmaceutical and Daewoong Therapeutics said Wednesday their proprietary semaglutide microneedle patch achieved over 80 percent bioavailability compared to injectables, in a pilot pharmacokinetic study on humans. The study, the first human trial of its kind, applied Daewoong Therapeutics' proprietary drug delivery platform, Clopam, to a semaglutide microneedle patch. With 70 healthy adults, the trial compared the blood concentration of semaglutide delivered via the patch to that of a subcutaneous injection, adjusting for dosage differences. While existing microneedle patches with the same ingredient have shown about 30 percent bioavailability, Daewoong's patch demonstrated more than 80 percent -- the highest achievability among similar products -- and around 160 times higher absorption than oral semaglutide tablets. The results also indicated that the patch can maintain stable blood concentration for a week, enabling a weekly, high-dose formulation. According to Grand View Research, the global weight loss medication market is valued at $15.9 billion and is projected to reach $60.5 billion by 2030. Industry experts say that drug delivery technologies offering higher bioavailability and improved patient convenience will be a key factor in shaping the market. Microneedle patch technology, which addresses the limitations of both painful injections and low-efficiency oral drugs, is seen as a potential game changer. Additionally, it also has the advantage of higher cost efficiency, and stability, compared to other methods which require cold temperatures for storage. 'This study proves our ability to deliver a high dose of semaglutide via a single weekly patch — a breakthrough beyond current obesity treatment patches,' said Kang Bok-ki, CEO of Daewoong Therapeutics. 'It's a major step toward global licensing and commercialization.' Daewoong Pharmaceutical CEO Park Seong-soo added, 'Overcoming the high-dose delivery barrier marks a significant milestone. We will expand microneedle applications to other biologics and lead the global platform market.'

Korea Herald
2 days ago
- Korea Herald
AMI Pharm Advances AYP-101 to Phase 3, Paving the Way for a New Era in Fat-Reduction Injectable drugs
— Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling — Phase 3 clinical trial underway in South Korea, following strong safety and efficacy results in earlier studies — AMI Pharm positions itself for global expansion in the multi-billion-dollar non-surgical aesthetics market SEOUL, South Korea, Aug. 11, 2025 /PRNewswire/ -- AMI Pharm, a biotechnology company specializing in next-generation aesthetic solutions, today announced that its lead drug candidate, AYP-101, has entered a pivotal Phase 3 clinical trial for the treatment of submental fat (commonly known as a "double chin"). This innovative injectable drug is designed to dramatically improve patient comfort by utilizing a novel biological mechanism that minimizes the pain and swelling commonly associated with existing treatments. A Paradigm Shift in Fat Reduction Therapy Currently, the only FDA-approved drug for localized fat reduction is based on deoxycholic acid, which destroys fat cells through necrosis —a process that induces inflammation and leads to significant side effects such as pain, bruising, and prolonged swelling. In contrast, AYP-101 is uniquely engineered to eliminate fat through apoptosis, a natural and controlled form of programmed cell death that does not trigger inflammation. This non-cytolytic mechanism offers a gentler, more tolerable alternative, potentially eliminating the need for social downtime and offering a safer, more comfortable experience for patients seeking non-surgical fat reduction. Phase 3 Trial Underway Following Strong Early Results The ongoing Phase 3 clinical trial involves 252 participants across multiple sites in South Korea and is expected to be completed by the end of 2025. The study builds on successful Phase 1 and 2 trials, which met all primary safety and efficacy endpoints. In the Phase 2 trial, over 70% of patients in the AYP-101 group achieved at least a 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) in the per-protocol (PP) population. The treatment also showed excellent tolerability and safety, with minimal adverse events reported. "AYP-101 represents the culmination of two decades of dedicated research aimed at creating a safe, effective, and globally competitive solution for localized fat reduction," said Ki-Taek Lee, CEO of AMI Pharm. "By leveraging a novel mechanism of action, we are pioneering the next generation of injectable drugs in aesthetic medicine." Targeting Global Expansion and Broader Indications AMI Pharm is actively preparing for global commercialization. The company is engaging international partners and showcasing its clinical data at world-renowned conferences, including the BIO International Convention and the IMCAS World Congress. While the current clinical focus is on submental fat, AMI Pharm is laying the groundwork to expand AYP-101's indications to address other high-demand aesthetic areas, including cellulite, deep buccal (cheek) fat, and upper arm fat. This broader R&D strategy highlights the company's commitment to addressing a wide spectrum of unmet needs in the aesthetic space and reinforces its ambition to become a global leader in non-surgical body contouring.