G2G Bio’s Dementia Injection GB-5001 Passes Phase 1 Trial, Aiming to Reduce Medication Burden With Monthly Dosing

G2G Bio’s long-acting injectable treatment for Alzheimer disease dementia, GB-5001, demonstrated safety and tolerability in a domestic phase 1 trial. The company announced the final results of the phase 1 trial, conducted in healthy male volunteers at Chungnam National University Hospital, through a regulatory disclosure. The trial was conducted with approval from the Ministry of Food and Drug Safety and the Institutional Review Board (IRB) of Chungnam National University Hospital.

GB-5001 was designed to address the structural limitations of existing oral dementia treatments. Donepezil tablets must be taken daily, but patients with dementia frequently forget when to take their medication or refuse it because of swallowing difficulties. GB-5001 is intended to address this issue through an intramuscular injection administered once every 4 weeks.

■ Blood concentrations comparable to oral therapy, with lower risk of adverse effects

The phase 1 trial consisted of a single-dose study (Parts A and B) and a multiple-dose study (Part C). The single-dose study was conducted from Jan. 3, 2024, through Oct. 16 of the same year, while the multiple-dose study ran from Sept. 17, 2025, through April 24, 2026.

The incidence of adverse drug reactions in the 140-mg multiple-dose group, which received four intramuscular injections, was 12.50% (1/8 participants, 3 events). No deaths, serious adverse events or drug hypersensitivity reactions occurred during the trial, and no participants discontinued the trial because of adverse events.

Pharmacokinetic analysis showed that after four doses administered at 28-day intervals, systemic exposure increased with the number of doses and approached steady state within three to four doses. The mean steady-state blood concentration (Cav,ss) was 20.32ng/mL, similar to the 22.65ng/mL observed with the existing oral drug Aricept 5mg.

The maximum steady-state blood concentration (Cmax,ss) was 24.93ng/mL, lower than the 32.08ng/mL observed with the 5mg oral Aricept tablet. This indicates a smaller difference between peak and trough blood concentrations, a clinically meaningful finding because it may reduce the risk of gastrointestinal adverse effects, such as nausea and vomiting, associated with sharp increases in drug concentration.

In the single-dose study, dose proportionality for systemic exposure was confirmed across the 70-280mg range, and increasing the dose did not produce a clear difference in its effect on safety.

■ InnoLAMP platform technology expands beyond dementia to obesity and diabetes

GB-5001 incorporates G2G Bio’s proprietary drug-delivery platform technology, InnoLAMP. The microsphere-based system is designed to release the drug gradually in the body, suppressing an initial burst release and maintaining consistent blood concentrations for more than 1 month.

The platform technology is not limited to dementia treatments. G2G Bio is also applying InnoLAMP to GLP-1-based obesity and diabetes treatments and is pursuing the co-development of long-acting injectables with global pharmaceutical companies, including Boehringer Ingelheim.

In addition, the project is not being developed solely by G2G Bio. It is being pursued through a collaborative model involving strategic investment and co-development partnerships with major domestic pharmaceutical companies, including Huons Lab and Korea Pharma.

■ Global debut and market size

G2G Bio participated in the Alzheimer’s Association International Conference (AAIC 2026), the world’s largest academic conference on dementia, held in London in July 2026, where it presented the multiple-dose phase 1 results for GB-5001 globally for the first time.

According to global market research firm DelveInsight, the Alzheimer disease treatment market in the seven major countries was worth approximately $4 billion (about 5.3 trillion won) in 2025. Donepezil alone generated approximately $1.5 billion in sales, making it a key active ingredient, and the overall market is expected to grow rapidly to approximately $40 billion by around 2036.

Jang-hee Hong, a professor at Chungnam National University Hospital who led the trial, said, “GB-5001 demonstrated favorable tolerability and stable pharmacokinetic characteristics, including suppression of initial release and maintenance of consistent blood concentrations for more than 1 month.” He added, “We expect it to become a new treatment option that reduces the medication burden and inconvenience for patients and caregivers.”

Based on the clinical data, the company plans to pursue various business collaborations with global pharmaceutical companies, including licensing (license-out) and co-development. Subsequent trials are expected to proceed to phase 2 and phase 3 studies in actual patients with Alzheimer disease, with full-scale product commercialization targeted for around 2028.

However, the company itself stated that the statistical probability that an investigational drug will ultimately receive approval as a pharmaceutical product is approximately 10%. Investors and stakeholders should note that the commercialization plan could be changed or abandoned if the clinical or marketing authorization process produces results that do not meet expectations.