Development Roadmap
Our strategic timeline is designed to advance our lead candidate from preclinical validation to regulatory approval with speed and scientific rigor.
2026: IND-Enabling Studies Completion of final formulation, GLP toxicology, and manufacturing (CMC) to secure FDA clearance for human trials.
2027: Phase I Clinical Trials First-in-human studies to evaluate safety, tolerability, and pharmacokinetics (PK) of our cyclic peptide platform.
2028–2029: Phase II & III Trials Expanded clinical studies to demonstrate therapeutic efficacy, cognitive improvement, and disease modification in patients.
2030: FDA Approval Process Submission of comprehensive data to regulatory authorities for final marketing approval.
