Humedics "FDA Approves Phase 1 Plan for Dementia Treatment with 1-Month Efficacy"

Dementia Treatment Drug 'GB-5001'

Humedix recently announced on the 17th that it has obtained clinical trial approval (IND) from the Ministry of Food and Drug Safety for the dementia treatment drug GB-5001.

Humedics Second Factory.
[Photo by Humedics]

Humedix is jointly developing the one-month efficacy dementia treatment drug 'GB-5001' with G2G Bio and Korea Pharma. Humedix acquired shares of G2G Bio through strategic investment, citing high evaluation of G2G Bio's platform technology.

GB-5001 is an Alzheimer's disease treatment drug containing donepezil, formulated as an injectable using G2G Bio's platform technology 'InnoLamp.' Following the IND approval for phase 1 clinical trials, the three companies (Humedix, G2G Bio, and Korea Pharma) plan to evaluate the safety, tolerability, and pharmacokinetics of two formulations of GB-5001 (subcutaneous and intramuscular injections) compared to a placebo in healthy adults. Subsequently, depending on the progress of clinical development, they aim to enter the next clinical phase, obtain product approval, and commercialize the treatment.

Humedix will serve as a strategic partner for finished product manufacturing, producing and supplying clinical and finished pharmaceuticals.

A Humedix representative stated, "Through this clinical trial, we plan to confirm the safety and pharmacokinetics of the donepezil one-month efficacy injectable," adding, "We expect to provide a convenient treatment option for patients with Alzheimer's disease."

This content was produced with the assistance of AI translation services.