GV1001 0.56mg – Neurodegenerative disease including Progressive Supranuclear Palsy (PSP),
For Alzheimer’s Disease(AD), the global phase 2 study has been ongoing since 2022, and the enrollment was completed in April 2024.
So, the drug, GV1001 for AD indication is not available currently on an expanded access basis.
GemVax may permit the provision of investigational products to individuals with high unmet medical needs who are unable to participate in clinical trials and have no remaining treatment options.
The local regulatory authority may allow patients access to GV1001, GemVax’s Investigational Product, through the EAP/Compassionate Use program before its marketing approval. However, since GV1001 has not yet received regulatory approval, its full risks and benefits to disease are unknown. Therefore, physicians and patients should carefully weigh all potential benefits and risks when seeking access to GemVax’s Investigational Product GV1001.