Approximately a third of Alzheimer patients were found to be non-compliant with oral donepezil, resulting in large fluctuations in blood drug level and the occurrence of adverse effects like nausea and vomiting.
The injectable depot of donepezil that has the advantages of less dosing frequency, less fluctuation in blood drug concentration, less adverse effects, high bioavailability, and improved patients’ compliance could be an alternative formulation to overcome the limitations of oral regimen.
The commercialization of donepezil injection which lasts for one month is becoming visible. G2GBIO has been developing sustained-release injectable donepezil with one-month duration, called ‘GB-5001’, for Alzheimer’s dementia.
G2GBIO announced on October 22nd that it received approval from the Health Canada for phase 1 clinical trial of ‘GB-5001’. The clinical trial will conduct a pharmacokinetic test for each dose group of GB-5001 on 48 healthy people.
G2GBIO, a biotechnology company headquartered in Daejeon, South Korea, is devoted to developing advanced controlled-release drug delivery system using its proprietary cutting-edge technology, called ‘InnoLAMP: Innovative Long-Acting Microparticles’.
Canada is the first country where G2GBIO conducts clinical trials, but it plans to accelerate its overseas expansion following with this approval. The Clinical Trial Application (CTA) for phase 1 clinical trial has been submitted in India and is currently awaiting regulatory approval. Along with this, it is also planning clinical trials in the U.S. which has the world's largest drug market, with the aim of releasing products in 2025.
On October 12, G2GBIO signed an agreement with Humedix to cooperate on the development of long-acting injectable form of donepezil.
In addition to G2GBIO, Dongkook Pharmaceutical, Inventage Lab, and HLB Pharmaceutical are also developing donepezil injections in South Korea.
