Issues & Trends

G2GBIO, Inc. to Release Monthly Phase 1 Clinical Trial Data on Dementia Treatment at AAIC

"Long-Acting Donepezil Draws Attention"

Shin Ha-yeon
2026-07-16 15:00:02
[E-Daily Reporter Shin Ha-yeon ] #G2GBIO, Inc. announced on the 16th that it presented Phase 1 Multiple-Dose (MAD) clinical trial data for “GB-5001,” a once-monthly Alzheimer’s disease treatment currently in development, at the Alzheimer’s Association International Conference (AAIC 2026).

AAIC 2026 is an international academic conference that took place in London, UK, from the 12th to the 15th. G2GBIO, Inc. explained that Professor Seon Woo-jeong, a member of Professor Hong Jang-hee’s research team from the Department of Clinical Pharmacology at Chungnam National University Hospital—which conducted the GB-5001 clinical trial—presented findings on safety, tolerability, steady-state attainment, and pharmacokinetic results following repeated dosing at the conference.
Professor Seon Woo-jeong is presenting the GB-5001 multiple-dose data at AAIC. (Photo courtesy of G2GBIO, Inc.)

According to the company, the presentation drew significant interest and positive feedback from medical professionals at the conference, as GB-5001 is viewed as a long-acting dementia treatment option that can improve medication adherence.

G2GBIO, Inc. explained that there is high demand in the medical field for long-acting injectables because Alzheimer’s patients often struggle to take medication at scheduled times due to memory impairment, and more than 60–70% of patients are known to have dysphagia.

Previously, in a Phase 1 single-administration study (SAD) conducted on healthy adults, data showed that drug release was sustained for up to 99 days. Furthermore, following single doses of 70 mg, 140 mg, 280 mg doses, plasma drug concentrations were dose-proportional; the company stated that population pharmacokinetic simulations confirmed that the 140 mg dose exhibited steady-state pharmacokinetics similar to those of the 5 mg control drug Aricept, while the 280 mg dose was comparable to 10 mg of Aricept.

Seol Eun-young, Director of G2GBIO, Inc.’s Research Institute, said, “Although next-generation dementia drug candidates have been developed one after another recently, treatments with new mechanisms of action face limitations such as high drug prices and restricted patient populations.” She added, “In contrast, since donepezil is the standard of care used by a broad patient population due to its excellent accessibility and affordability, the importance of long-acting formulations in the market is expected to grow even further.”

She continued, “Building on the enthusiastic interest and positive reception at this conference, we plan to officially release detailed full data confirming safety and tolerability as soon as we receive the Clinical Study Report (CSR) this coming August.” She added, “Based on this, we intend to begin full-scale discussions on strategic partnerships and accelerate follow-up development to advance toward regulatory clinical trials.”

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