NTS-104 / NeuroTrauma Sci, Emory University - LARVOL DELTA

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults (clinicaltrials.gov) - P1 | N=48 | Terminated | Sponsor: NeuroTrauma Sciences, LLC | Completed ➔ Terminated; a second generation product was found to be more relevant for development

Trial termination • Cardiovascular • Ischemic stroke

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: NeuroTrauma Sciences, LLC | Recruiting ➔ Completed | N=32 ➔ 48 | Trial completion date: Aug 2023 ➔ Jan 2026

Enrollment change • Trial completion • Trial completion date • Cardiovascular • Ischemic stroke

Improvement in edema and cognitive recovery after moderate traumatic brain injury with the neurosteroid prodrug NTS-104. (PubMed, Neurotherapeutics) - "Cortical and hippocampal atrophy at 22 DPI did not improve, indicating that NTS-104/NTS-105 may promote post-TBI cognitive recovery by controlling edema and other processes. These results demonstrate that NTS-104/NTS-105 is a promising therapeutic approach to improve motor and cognitive recovery after moderate TBI."

Journal • CNS Disorders • Vascular Neurology

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: NeuroTrauma Sciences, LLC | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Apr 2023 | Trial primary completion date: Apr 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Trial primary completion date • Cardiovascular • Ischemic stroke

Pharmacological Characterization of a Novel Neuroactive Steroid Prodrug, NTS-104, and Its Neuroprotective Activity in Experimental Stroke Models. (PubMed, Stroke) - "NTS-104 is a novel prodrug that converts to a novel neuroactive steroid, NTS-105, which improves functional outcomes in experimental ischemic stroke models."

Journal • Cardiovascular • Ischemic stroke • CSF2 • ICAM1 • IL1B • IL6 • LGALS1

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: NeuroTrauma Sciences, LLC

New P1 trial • Cardiovascular • Ischemic stroke