[Edaily Reporter KIM SAE-MI ] All eyes are on whether VIVOZON PHARMACEUTICAL(082800)’s non-narcotic analgesic “Anaprazu” will be able to expand beyond the domestic market into overseas markets. This is why attention is focused on the timing of the resumption of Phase 3 clinical trials in the U.S.

Expanding

the Domestic Prescription Base for Anaprazu… Targeting the Market with a Dual-Track Strategy

According to the pharmaceutical industry on the 18th, VIVOZON PHARMACEUTICAL recently placed an additional order for 120,000 vials of

Anaprazu

, fueling expectations of increased domestic prescriptions.

Anaprazu, the 38th domestically developed new drug to receive marketing approval from the Ministry of Food and Drug Safety in December 2024, is a non-narcotic analgesic injection. It began commercialization last October with its domestic launch as a non-reimbursed drug.

To establish Anapraju in the domestic market, VIVOZON PHARMACEUTICAL is implementing a dual-track strategy based on hospital size. For large hospitals, the company has secured a prescription base by gaining approval from the Drug Committees (DC) of major tertiary general hospitals, such as Samsung Seoul Hospital and Sinchon Severance Hospital. For small and medium-sized hospitals, it is expanding its sales network through joint promotions with HanmiPharm.

The key indicator for future performance is the extent to which the growth rate of Anapra’s sales can offset the initial launch costs. Since significant sales and marketing expenses are invested upfront during the early stages of a new drug’s launch, investors are particularly interested in when sales leverage will become evident. The company maintains that it is difficult to disclose the specific timing of when it will enter the leverage phase.

A representative from VIVOZON PHARMACEUTICAL stated, “We are efficiently managing our selling, general, and administrative expenses through joint sales partnerships with Daiichi Sankyo Korea and HanmiPharm,” but added, “It is difficult to disclose the specific timing of entering the revenue leverage phase or our internal financial targets and benchmarks, as these are related to our partners.”

Beyond Korea to Overseas… Preparing for a New Challenge After Past U.S. Clinical Trial Failure

While the pace of domestic prescription growth is important, Anapra’s success in entering overseas markets is ultimately expected to be the turning point for a revaluation of the company’s corporate value. This is because the domestic non-opioid analgesic market is a niche market estimated to be worth approximately 160 billion won.

In contrast, according to Grand View Research, the global non-opioid pain treatment market is projected to grow from $45.3219 billion (approximately 69 trillion won) in 2024 to $70.3095 billion (approximately 107 trillion won) by 2030. This is why Anapra must prove its competitiveness not only as a domestic new drug but also in the global non-opioid analgesic market.

For Anapra to prove its competitiveness in the global non-opioid analgesic market, it must deliver positive results in the U.S. Phase 3 clinical trial, which the company is pushing to begin within this year. Given that VIVOZON PHARMACEUTICAL suffered a setback in a previous U.S. clinical trial, it is reportedly preparing a more meticulous clinical trial design this time around.

Previously, in 2019, Vivzon conducted a U.S. Phase 3 clinical trial of Opiranerin (VVZ-149) in patients experiencing pain following abdominoplasty; however, it failed to achieve statistical significance for the primary endpoint, the 12-hour Sum of Pain Intensity Differences (SPID 12). SPID 12 is a metric that evaluates the total reduction in pain over time compared to pre-treatment levels.

Subsequently, Vivazon shifted its focus to post-hallux valgus surgery pain and proceeded with follow-up clinical trials in the U.S. After completing a U.S. Phase 2b clinical trial for post-hallux valgus surgery pain, the company began a U.S. Phase 3 clinical trial for the same indication in the second quarter of 2020; however, patient recruitment was suspended due to the COVID-19 pandemic and other factors.

In contrast, in South Korea, the company achieved statistical significance for SPID 12—the same primary endpoint—in a Phase 3 clinical trial targeting patients with pain following laparoscopic colectomy. Based on these results, Vivazon submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) in November 2023 and received approval for the opiranzerin injection, Anapraz, in December 2024.

Aiming

to Resume U.S. Clinical Trials for Anapra-Z Within the Year… Discussing Detailed Strategy with the FDA

According to Vivazon’s Q1 2026 report, the U.S. Phase 3 clinical trial—which was suspended in 2020—is listed as “To be resumed.” A VIVOZON PHARMACEUTICAL official stated, “The new U.S. Phase 3 clinical trial, which we are pushing to initiate within this year, is planned for patients experiencing pain following hallux valgus surgery,” adding, “We are currently coordinating with the U.S. Food and Drug Administration (FDA) to discuss and finalize the detailed clinical design and implementation strategy.”

VIVOZON PHARMACEUTICAL maintains that it has incorporated lessons learned from its previous failed U.S. clinical trial into the design of its domestic trial. The company identified the failure to meet the primary endpoint at that time as stemming more from limitations in the surgical model and clinical trial design than from a lack of drug efficacy. However, given that the primary endpoint was not met in that U.S. trial, the key challenge for the U.S. Phase 3 trial—which the company is pushing to resume within the year—is to finalize specific strategies to address these issues, including adjustments to the patient population, endpoints, and dosing regimen.

A VIVOZON PHARMACEUTICAL official emphasized, “We analyzed and refined the conduct and results of the previous trial and applied those insights to the design and strategy of the domestic Phase 3 clinical trial, which led to the successful achievement of the primary endpoint and new drug approval,” adding, “We are also preparing our strategy for the U.S. Phase 3 clinical trial in close communication with the FDA.”