Sponsor Overview
Explore verified public information about GemVax & KAEL Co. Ltd.'s expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 1 content categories.
ClinicalTrials.gov data sources power this status.
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Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“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.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria 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. Available Therapies via Single-Patient EA 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.
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