Vietnam Launches Clinical Trials for XAFTY, World's First Oral Antiviral Drug for Dengue Fever Treatment
核心洞察
Vietnam has initiated clinical trials for XAFTY, a novel oral antiviral drug that could become the world's first specific treatment for dengue fever (搜索), addressing a critical unmet medical need.
The drug utilizes niclosamide with enhanced bioavailability through proprietary drug delivery technology, activating cellular autophagy mechanisms to eliminate viral particles rather than directly attacking the virus.
Previous Phase II trials in South Korea demonstrated XAFTY reduced COVID-19 (搜索) viral load by 56.65% within 16 hours and shortened symptom recovery time by 3.5 to 5 days compared to placebo.
Vietnam has launched clinical trials for XAFTY, a groundbreaking oral antiviral drug that could become the world's first specific treatment for dengue fever (搜索). The National Hospital for Tropical Diseases (搜索), in collaboration with South Korea-based Hyundai Bioscience (搜索), announced the initiation of trials on March 5, marking a significant milestone in the fight against a disease that currently has no approved specific treatment worldwide.
Novel Mechanism of Action
XAFTY represents a reinvented approach to antiviral therapy, utilizing niclosamide as its active ingredient—a drug long approved by the FDA. The breakthrough lies in the drug's unique mechanism of action: rather than directly attacking the virus, XAFTY activates the autophagy mechanism (搜索) of human cells themselves, instructing infected cells to clean up and destroy viral particles inside. This mechanism makes the drug immune to viral mutations, providing a significant advantage over traditional antiviral drugs.
Deputy Minister of Health Tran Van Thuan emphasized the clinical significance of this development, stating, "This event not only marks the beginning of a new scientific study, but also demonstrates the scientific community's aspiration to find effective treatments for viral infectious diseases, especially Dengue fever (搜索)."
Overcoming Bioavailability Challenges
The key innovation behind XAFTY lies in Hyundai Bioscience (搜索)'s proprietary Drug Delivery System (DDS) technology. While niclosamide has been proven to have broad-spectrum antiviral capabilities against 33 viruses, including 16 strains of COVID-19 (搜索), conventional niclosamide is almost unusable for treating systemic diseases due to its extremely low bioavailability of below 10%.
Hyundai Bioscience (搜索)'s DDS technology addresses this critical limitation by increasing the bioavailability of niclosamide by more than five times, ensuring the drug reaches the necessary concentration in the blood to effectively eliminate the virus.
Promising Clinical Data
Before arriving in Vietnam, XAFTY completed Phase II clinical trials for COVID-19 (搜索) patients in South Korea. The study, involving 300 patients, demonstrated significant therapeutic benefits. The drug reduced viral load by 56.65% within 16 hours of the first dose and shortened recovery time for 12 major disease symptoms by 3.5 to 5 days compared with the placebo group.
Trial Design and Implementation
The Vietnamese clinical trials will be conducted over two years at two key locations: Tien Giang General Hospital in Tien Giang province and the Central Hospital for Tropical Diseases in Hanoi. The trials will build upon existing research and safety foundations established in previous studies.
Director of the National Hospital for Tropical Diseases (搜索) Pham Ngoc Thach highlighted the potential impact, noting, "We now have a vaccine to prevent dengue fever (搜索). However, the vaccine is expensive so the number of people using it remains modest. If the trial is successful, this will be a great breakthrough, helping us to be more proactive in treatment, reduce mortality rates and alleviate the burden on lower-level hospitals."
Addressing Critical Medical Need
The urgency of developing effective dengue treatments is underscored by Vietnam's disease burden. Infectious disease surveillance data shows that in 2025, Vietnam recorded 190,040 cases of dengue fever (搜索), representing a 28.4% increase compared with 2024. Many localities continue to report severe and critical cases, making treatment difficult, costly, and potentially leaving long-term sequelae.
Currently, there are no approved specific antiviral drugs globally to treat dengue fever (搜索), with treatment relying primarily on symptomatic and supportive care. The mutation of the virus and the complexity of serotypes make the development of effective treatments a major challenge for international public health.
The goal of the Vietnamese trials is ambitious: to develop the world's first comprehensive oral antiviral drug for dengue fever (搜索). If successful, XAFTY could transform the treatment landscape for dengue fever, providing healthcare systems with a specific therapeutic option for a disease that consistently records cyclical increases, especially during rainy seasons, and puts significant pressure on healthcare infrastructure worldwide.