Aribio: "UK GlobalData Publishes AR1001 White Paper... High Potential for Early Global Approval"

Aribio announced on December 12 that GlobalData, a leading market analysis firm based in London, UK, has evaluated the oral dementia treatment AR1001 as an innovative oral therapy capable of addressing unmet medical needs in Alzheimer's disease, according to a recently published white paper.

GlobalData also projected that, based on accumulated data and clinical progress, AR1001 has a very high likelihood of obtaining early new drug approval in major markets such as the United States and Europe.

GlobalData is a globally recognized market analysis institution that significantly influences corporate strategies and decision-making across the pharmaceutical and biotechnology industries. In its “2025 Global Alzheimer’s Disease Trends Analysis” released on January 1, GlobalData selected AR1001 as the dementia treatment with the highest probability of future commercial success. According to Aribio, GlobalData has tracked and analyzed AR1001 for several years, and the tone of its evaluation has steadily improved, culminating in the publication of this exclusive white paper.

GlobalData stated, “Among the numerous development candidates, AR1001 is currently the therapy closest to commercialization,” adding, “We analyzed the unique value of AR1001 based on its scientific mechanism, Phase 2 and 3 clinical data, and in-depth interviews with 10 globally renowned neurology key opinion leaders (KOLs).”

In the special report, GlobalData identified AR1001 as the world’s leading candidate for the first oral disease-modifying therapy (DMT). The report evaluated AR1001 as an innovative solution capable of simultaneously addressing the two major challenges cited by clinicians worldwide: treatment accessibility and safety. In particular, unlike existing therapies that require hospital visits and injections, AR1001’s once-daily oral administration was highlighted as a key advantage that significantly reduces the burden on patients and caregivers.

GlobalData cited AR1001’s core competitive strengths as patient convenience through once-daily oral dosing and a PDE5 inhibition mechanism with excellent blood-brain barrier penetration. Additionally, its multi-targeted mechanism, which simultaneously aims to suppress neuroinflammation and restore synaptic plasticity, was evaluated as a differentiating factor. The absence of side effects such as brain edema and brain hemorrhage (ARIA), and the lack of need for costly MRI monitoring, were also analyzed as clear advantages over existing antibody therapies.

The 10 neurologists from the United States, Europe, and Korea who participated in the interviews expressed high expectations for AR1001’s potential for success. They noted, “Monotherapy antibody treatments have limitations, so an oral, multi-mechanism therapy like AR1001 is essential,” and assessed it as “a universally applicable treatment optimized for patients in the early stages of Alzheimer’s disease.”

Experts also gave high marks to the ongoing global Phase 3 clinical trial design. The AR1001 global Phase 3 trial is being conducted across 13 countries with a total of 1,535 patients; patient enrollment has been completed, and the trial is now in its final stages. The trial is scheduled to conclude in the first half of next year, with topline results to be announced. GlobalData also predicted that AR1001 is highly likely to be designated for expedited review under the Country National Priority Voucher (CNPV) program introduced by the U.S. Food and Drug Administration (FDA).

GlobalData stated, “If consistent efficacy is demonstrated in Phase 3, AR1001 is highly likely to receive early approval as the world’s first oral disease-modifying therapy,” adding, “AR1001 is a next-generation innovative new drug with strong competitiveness in terms of clinical value, marketability, and policy acceptance.”

Jeong Jaejoon, CEO of Aribio, said, “It is significant that GlobalData has tracked AR1001 for years, gradually raising its evaluation, and has now summarized it in this exclusive white paper. We will prepare for the completion of Phase 3 and the new drug application with a strong sense of responsibility, meeting the expectations of patients worldwide who are waiting for this therapy.”

This AR1001 white paper is 20 pages in length. Meanwhile, Aribio is pursuing a merger with Kosdaq-listed Solux, with the planned merger date set for February 24, 2026.