Hepion says GV104 prevents fentanyl-induced cardiac arrest in simulations
HEPA•Hepion Pharmaceuticals said GV104 prevented all modeled fentanyl-induced cardiac arrests when taken before exposure. FDA feedback supported the modeling approach but called for revisions to strengthen evidence of long-term protection; commercial-scale registration batch production is planned for 2027.
1. Simulation results
Hepion Pharmaceuticals reported that its GV104 buccal film prevented all modeled fentanyl-induced cardiac arrests when taken before exposure. FDA feedback supported the modeling approach but called for revisions to strengthen evidence of long-term preventive protection, and the predicted protection could change after revisions.
2. Planned production
GV104 targets military personnel and first responders at risk of opioid exposure. Hepion said remaining work before a regulatory filing centers on manufacturing, with commercial-scale registration batch production planned for 2027.
