[E-Daily Reporter KIM JI-WAN ] Mezzion Pharma Co., Ltd.(140410)has further enhanced the scientific credibility of its Fontan patient treatment, “Udenafil,” by presenting research results demonstrating its efficacy in improving liver disease to the international academic community. Subsequently, at BIO USA 2026—the largest biotech event in the U.S.—the company held discussions with global pharmaceutical firms focused on commercialization strategies, confirming that market interest is shifting beyond the success of clinical trials to the actual launch and commercialization stages.

On the 20th of last month, Mezion Pharma Co., Ltd. published a paper titled “The FUEL FALD Study: Effects of Udenafil on Liver Stiffness and Fibrosis after Fontan” in the international journal *Pediatric Cardiology*. This multicenter study analyzed the effects of udenafil on liver stiffness and fibrosis in patients who underwent Fontan surgery.

Fontan surgery is a standard procedure used to prolong the lives of patients with congenital single-ventricle syndrome. However, as blood flows back to the heart through the lungs, venous pressure remains consistently high, causing blood to reflux into the liver. Over time, this often leads to liver fibrosis and cirrhosis, in which the liver becomes increasingly hardened. This condition is known as Fontan-associated liver disease (FALD).

The problem is that there are virtually no drugs available to treat Fontan-associated liver disease. Patients must undergo lifelong monitoring of liver function, and in some cases, may need to consider a liver transplant if the disease worsens. Consequently, the development of treatments to slow or inhibit the progression of liver fibrosis is considered one of the greatest unmet medical needs in the field of Fontan treatment.

“Slowed the Rate of Liver Stiffening”… Research Recognized by the International Academic Community

Mezzion Pharma Co., Ltd. announced that it has confirmed the potential of sildenafil to inhibit the progression of liver fibrosis in Fontan patients.

A total of 88 participants were enrolled in this study and took 87.5 mg of udenafil twice daily for 12 months.

The research team measured the ELF (Enhanced Liver Fibrosis) Score using shear-wave elastography (SWE) and magnetic resonance elastography (MRE)—which assess how stiff the liver has become—as well as blood tests.

The liver fibrosis grade (LF Score) is a representative indicator of liver fibrosis calculated by combining levels of three fibrosis-related proteins in the blood: hyaluronic acid, PIIINP, and TIMP-1. A higher score indicates a greater accumulation of collagen in the liver and more advanced fibrosis. It is widely used internationally because it allows for an objective assessment of fibrosis severity without the need for a liver biopsy.

The study results showed that the LF Score decreased significantly from an average of 10.5 to 9.8 (p<0.0001), with 84% of all patients showing an improvement in their scores. In particular, the proportion of patients falling into the severe fibrosis category also decreased from 50% to 18%.

Among the key biomarkers comprising the LF Score, both hyaluronic acid and PIIINP also decreased significantly. The research team interpreted these results as indicating that the progression of liver fibrosis itself may be being suppressed as new collagen production decreases.

PIIINP (Procollagen III N-terminal Propeptide) is the “N-terminal propeptide of type III procollagen.” When the liver is damaged, the body produces type III collagen to repair the injury. However, rather than producing fully formed collagen from the start, it is synthesized in the form of a precursor called “procollagen.” During the process by which procollagen is converted into mature collagen, portions are cleaved off from both ends; the fragment that breaks off from the C-terminus is PIIINP. PIIINP is released into the bloodstream every time new collagen is produced. Simply put, PIIINP is a blood marker that indicates how actively new fibrosis (collagen) is being produced in the body.

Mezzion Pharma Co., Ltd. explained, “As the survival period for Fontan patients increases, liver disease is emerging as a greater problem than heart disease,” adding, “Once the liver becomes fibrotic, it is difficult to restore it to its original state, so the most important thing is to slow the progression of fibrosis.”

The representative continued, “This paper marks the first significant achievement in which the international academic community has objectively recognized the potential of Udenafil to not only improve blood flow but also inhibit the progression of liver fibrosis itself,” emphasizing, “It is significant that data which had previously been merely the company’s claim has now secured academic validation.”

He also noted, “We have set the LF Score as a secondary endpoint in the ongoing FUEL-2 clinical trial,” adding, “While previous studies lacked a placebo control group, FUEL-2 allows for direct comparison with a control group, so we expect to be able to more clearly demonstrate the efficacy in improving liver fibrosis.”

The atmosphere at BIO USA has changed… “The conversation was all about commercialization”

The most significant change Mezion Pharma Co., Ltd. noticed at this year’s BIO USA was that the focus of global pharmaceutical companies had completely shifted.

Whereas in the past, most questions centered on the mechanism of action of Udenafil or the likelihood of clinical success, this time discussions focused on commercialization—including post-launch market strategies, partnerships, supply systems, and expanding prescriptions.

A Mezion Pharma Co., Ltd. official said, “There were virtually no parties in the global market questioning Udenafil’s mechanism of action or development rationale,” adding, “Most of the discussions during meetings were based on commercialization, such as ‘When can it be launched?’, ‘How will it be established in the market?’, and ‘What strategy will be used to approach the rare disease market?’”

In particular, the official noted, “Interest has shifted completely from ‘Is it effective?’ to ‘How successfully can it enter the market?’” and added, “We truly felt on the ground that the development of a Fontan treatment is heading toward its final hurdle.”

At this event, Mezion Pharma Co., Ltd. held a series of meetings with major global pharmaceutical companies—including Companies J, U, T, and R—to discuss licensing, business partnerships, and market entry strategies.

The company particularly emphasized that, unlike existing PDE5 inhibitors, Udenafil is the only treatment that has accumulated long-term safety data in Fontan patients and secured clinical evidence specific to rare diseases.

Mezzion Pharma Co., Ltd. assessed that the presentation of the FALD paper and the market response observed at BIO USA signal that Udenafil has advanced to the next stage of development.

A Mezion Pharma Co., Ltd. official stated, “The most significant takeaway from this year’s BIO USA is that the market’s focus has shifted from ‘Is this drug effective?’ to ‘How can it be successfully commercialized?’” adding, “This means the drug is now recognized as a therapy moving beyond the scientific validation phase and preparing for actual market launch.”

He emphasized, “If the Phase 3 clinical trial results and the approval process proceed successfully, Udenafil could establish itself as the first rare disease treatment for Fontan patients,” adding, “Mezzion Pharma Co., Ltd. also plans to accelerate preparations for successful commercialization in collaboration with our global partners.”