Experimental neurogenic small molecule · Fact sheet

NSI-189

Also known as NSI-189 phosphate

NSI-189 is an experimental small molecule studied in depression. The larger phase 2 trial missed its primary depression endpoint; secondary and post hoc signals do not establish antidepressant or memory-enhancement efficacy.

Not FDA approvedEarly human evidence

Brain, mood & sleep

What is NSI-189?

The neurogenic description reflects a development hypothesis and preclinical findings. It does not mean proven human neuron regeneration.

Human trials used NSI-189 phosphate, which should be distinguished from unspecified preparations.

Benefits & claims

Readers encounter NSI-189 in discussions of cognition, mood or mental fatigue. The relevant study population and outcome determine whether those claims are supported.

What the evidence supports

Some self-rated or cognitive secondary outcomes favored the 40 mg group.
A later subgroup analysis was post hoc and cannot replace the original primary result.
The larger negative primary result must remain central to any claimed clinical benefit.

Research areas

Cognition and memory
Neurologic or psychiatric research

Dosage & frequency

Human study context

The original human study supplies an exposure reference, not an established cognitive-enhancement regimen.

NSI-189 phosphate phase 2 depression trial

220 adults with major depressive disorder

Amount: 40 or 80 mg daily in separate groups
Frequency: Daily for 12 weeks
Route studied or labeled: Oral

Neither dose met the primary MADRS efficacy comparison. The trial used a sequential-parallel comparison design; the regimen does not establish routine treatment or use in healthy adults.

A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.

How to read these amounts

An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.

Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences

Formulations, interactions & practical context

Identity and pharmacology: The neurogenic description reflects a development hypothesis and preclinical findings. It does not mean proven human neuron regeneration.
A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.

Formulation differences

Human trials used NSI-189 phosphate, which should be distinguished from unspecified preparations.

Interactions & precautions

The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.

What is still unresolved

Reproducible benefit on everyday function in the intended population
Long-term safety and clinically important interactions
Equivalence of nonstandard products to research formulations

A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder. NSI-189 phosphate, a novel neurogenic compound, selectively benefits moderately depressed patients: A post-hoc analysis of a phase 2 study of major depressive disorder.

Side effects & risks

The trials reported tolerability, but cannot establish safety for all psychiatric conditions or chronic unsupervised exposure.
Interactions and effects in people outside the selected depression trial population remain uncertain.

This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.

Clinical research

Early human evidence

A small phase 1b study generated encouraging exploratory findings. In 220 phase 2 participants, neither dose significantly improved the primary MADRS depression score versus placebo.

Studies

A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients.

24-person phase 1b dose-escalation study.

A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.

220-person phase 2 study; primary endpoint not met.

NSI-189 phosphate, a novel neurogenic compound, selectively benefits moderately depressed patients: A post-hoc analysis of a phase 2 study of major depressive disorder.

Post hoc subgroup analysis of the same phase 2 dataset.

Personal experiences

Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.

No attributable personal accounts were found in the sources reviewed.

Approval status

NSI-189 is not an FDA-approved treatment for the cognitive or mood uses discussed here. Regional use, historical trials and online availability are separate from U.S. drug approval.

Phase 2 research; no FDA-approved product

Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.

Open questions

Reproducible benefit on everyday function in the intended population
Long-term safety and clinically important interactions
Equivalence of nonstandard products to research formulations

Summary

The larger negative primary result must remain central to any claimed clinical benefit.

Sources

Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.

pubmedA Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients.
24-person phase 1b dose-escalation study.
pubmedA phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.
220-person phase 2 study; primary endpoint not met.
pubmedNSI-189 phosphate, a novel neurogenic compound, selectively benefits moderately depressed patients: A post-hoc analysis of a phase 2 study of major depressive disorder.
Post hoc subgroup analysis of the same phase 2 dataset.

How we assess sources · Suggest a correction