PEDEvidence

NSI-189

What it is & what research shows

Study example available

NSI-189 is an experimental neurogenic compound investigated for major depression and cognitive symptoms. The research below distinguishes observed findings from interpretation. [1.1]

Selected human research: 220 adults with major depressive disorder randomized to oral NSI-189 40 mg daily, 80 mg daily or placebo for 12 weeks. Neither dose significantly improved the primary clinician-rated depression outcome versus placebo. Some secondary self-report and cognitive measures favored 40 mg, but the Cogstate cognitive test did not. Both doses were described as well tolerated. Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults. Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults. [2.1]

Studied methods, not dosing advice. Selected evidence, not a complete literature review or formal quality appraisal.
Sources & reading scope

Study-summary coverage

No completed study summaries are linked to this compound page yet. This is a coverage gap on PED Evidence, not evidence that human studies or other research do not exist.

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Selected study reading notes

Source-linked summaries with studied methods. These are separate from the automated summary counts above and are not formal quality appraisals.

Human

NSI-189: what does this study show?

220 adults with major depressive disorder randomized to oral NSI-189 40 mg daily, 80 mg daily or placebo for 12 weeks.

Demonstrated findings

Neither dose significantly improved the primary clinician-rated depression outcome versus placebo. Some secondary self-report and cognitive measures favored 40 mg, but the Cogstate cognitive test did not. Both doses were described as well tolerated.

Limitations & adverse findings

Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.

What might this mean? · interpretation

These findings apply to the population and methods described above.

What might this mean, and what would change the interpretation?

Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.

What would clarify this: Independent replication with clinically meaningful outcomes and longer safety follow-up.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

More about NSI-189: identity, safety & reference details
Small moleculeBrain & cognition
Primary research area
Neurological & cognitive research
Regulatory status
See compound-specific sources
Evidence level
Human research · indication-specific
Primary mechanism
See the source-linked compound overview
Reference profile available · Coverage varies by section

What has been observed?

Selected source-linked reading notes, not the complete literature or a pooled conclusion.

Human · Abstract reviewed

NSI-189: what does this study show?

220 adults with major depressive disorder randomized to oral NSI-189 40 mg daily, 80 mg daily or placebo for 12 weeks.

Neither dose significantly improved the primary clinician-rated depression outcome versus placebo. Some secondary self-report and cognitive measures favored 40 mg, but the Cogstate cognitive test did not. Both doses were described as well tolerated.

Limits & adverse findings: Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults. Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.

Open primary source · Read interpretation separately
Explore outcomes for this compound
Uses & research

The research below distinguishes observed findings from interpretation. [1]

Known half-life

No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.

Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.
Evidence & important limits

Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults. [1]

Safety & evidence boundaries

Source-specific information, not a personal safety clearance or monitoring plan.

Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.

Human study: Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults. Source

Explore safety questions by system

These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.

Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.

Identity, names & formulations

Canonical compound: NSI-189 · nsi189

No additional aliases recorded.

Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.

Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.

Understand the evidence types

Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.

Randomized human trials
Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
Controlled human studies
Use a comparison group; allocation and confounding still matter.
Prospective human research
Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
Observational human research
Describes associations. Confounding can explain differences.
Case reports and series
Useful for unusual events and safety signals, not reliable rates or effect sizes.
Animal research
Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
Cell and tissue research
Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
Mechanistic and computational evidence
Helps explain or predict a pathway; predictions need experimental and clinical testing.
Anecdotal reports
Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.

Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.

Sources for this profile

  1. 1. Phase 2 placebo-controlled NSI-189 depression trial Human · primary publication abstract

Reference facts checked 2026-09-23. Source scope is listed above; this is not a formal quality appraisal. See each label for full prescribing information.

Browse all studies

Study model describes the source. Confidence depends on methods, replication, population and outcome.

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