Drug intelligence / Profile preview

NeuroSTAT

Development stage
Phase 2
Lead developer
NeuroVive
Modality
Small Molecules, Cyclic Peptides → Modified Peptides → Peptides
Administration
Intravenous
01

Overview

NeuroSTAT is a proprietary intravenous formulation of cyclosporine developed for the treatment of moderate to severe traumatic brain injury (TBI). Cyclosporine is a small molecule immunosuppressant that acts primarily by inhibiting calcineurin and suppressing T-cell activation. In the context of TBI, NeuroSTAT’s mechanism centers on protecting and stabilizing mitochondria in neurons by inhibiting the mitochondrial permeability transition pore (mPTP), thereby preventing secondary neurological damage following trauma. The drug has demonstrated safety and blood-brain barrier penetration in phase II clinical studies and has shown signals of clinical efficacy based on biomarker analyses. NeuroSTAT has received Orphan Drug designation in both the US and Europe as well as Fast Track status from the FDA[4][5][6][8].

Brand names
NeuroSTAT
Other names
OWL-1410OWL1410OWL 1410cyclosporine (as the active ingredient)cyclosporin Aciclosporin A
02

Targets

PPIF (Cyclophilin D)

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