NSI-189 Dosage: Recommendations Based on Neuralstem's Clinical Trial

What NSI-189 dosage is recommended? Neuralstem used dosages of 40mg, 80mg, and 120mg in clinical trials, administered daily. The 80 and 120mg doses were given in multiple divided doses of 40mg each. Neuralstem is the pharmaceutical company that developed NSI-189 phosphate.

NSI-189 dosage

NSI-189 Dosage and Efficacy

Interestingly, Neuralstem reported that both the 40mg/80mg NSI-189 dosage were more effective than the 120mg dose. Lack of significant separation between the 40mg and 80mg dose may suggest a saturation effect at 40mg.

From Neuralstem’s recent press release about the Phase 1b data for NSI-189:

The Phase 1b study was a randomized, double-blind, placebo-controlled safety study (n=24) designed to evaluate the tolerability of NSI-189 in adult patients with MDD. Three doses were tested in equal cohort sizes (n=8/dose): 40 mg administered once (QD), twice (BID) or three times (TID) daily for 28 days. Patients in each cohort were randomly assigned to either active or placebo at 3:1 ratio and dosed and monitored in-clinic during the 28-day treatment period, after which they were discharged and monitored in periodic follow-up visits for eight additional weeks. The double-blind was maintained throughout the monitoring period, although no further treatment was administered. Various safety, pharmacokinetic, pharmacodynamic, and clinical assessments were conducted throughout the 84-day study.

What is NSI-189?

NSI-189 phosphate is a novel neurogenic compound that stimulates neurogenesis in the hippocampus. This sounds pretty cool, but it’s not new. The majority of antidepressants, independent of class (e.g., SSRI vs tricyclic) enhance neurogenesis.

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