Project Timeline
OrganShield Development Roadmap Q2 2026 - Q2 2028
PreclinicalCompleted
Protocol Finalization
Q2 2026
Finalize LNP-siRNA formulation and analytical methods validation
Progress100%
6 days remaining
PreclinicalIn Progress
MVE Completion
Q3 2026
Complete mesenchymal vesicle isolation and characterization studies
Progress65%
98 days remaining
RegulatoryUpcoming
Pre-IND Meeting
Q4 2026
Schedule and conduct pre-Investigational New Drug meeting with FDA
Progress0%
174 days remaining
PreclinicalUpcoming
GLP Toxicology
Q1 2027
Complete GLP toxicology and safety pharmacology studies
Progress0%
280 days remaining
RegulatoryUpcoming
IND Submission
Q2 2027
Submit Investigational New Drug application to FDA
Progress0%
371 days remaining
ManufacturingUpcoming
Manufacturing Scale-up
Q2 2027
Complete GMP manufacturing process validation and scale-up
Progress0%
371 days remaining
ClinicalUpcoming
Phase 1 Trial Initiation
Q4 2027
First-in-human clinical trial enrollment begins
Progress0%
555 days remaining
ClinicalUpcoming
Phase 1 Completion
Q2 2028
Complete Phase 1 safety and dose-escalation study
Progress0%
737 days remaining