SPT-300 / Major Depressive Disorder With Anxious Distress / Major Depressive Disorder (MDD) · Phase 2 Trial

An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 open-label extension study of SPT-300 (GlyphAllo) in adults with major depressive disorder, with or without anxious distress, designed to assess safety and tolerability over 49 days. No results have been posted in this registry record; the study is currently enrolling by invitation with an estimated target of 360 participants.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress; age from 18 Years; to 66 Years. Intervention: SPT-300. n = 360. 40 sites across 7 countries.

Key findings

Safety

Actual enrollment, baseline characteristics, adverse events, and clinical scale outcomes are not provided in this registry entry.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 open-label extension study with no results posted; it is designed to assess safety and tolerability in a planned 360-participant cohort, typical of early-phase investigation.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures (assessed at Up to Day 49)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationMajor Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress; age from 18 Years; to 66 Years

Sample size360

InterventionSPT-300

Setting40 sites across 7 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment360

Study phasePhase 2

Follow-up durationUp to Day 49

Primary outcome measureSafety and tolerability based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures

Caveats

This is a registry record only; no results are posted or reported.
Open-label design without control or blinded comparator limits causal inference.
Actual enrollment, baseline characteristics, adverse events, and clinical scale outcomes are not provided in this registry entry.
Study status is enrolling by invitation; completion date and data availability are unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label extension design without blinding or control arm.

Directness

moderate

Safety and tolerability endpoints are directly relevant to clinical practice.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

limited

Open-label design carries inherent risk of bias; no blinding.

Sample adequacy

moderate

Estimated 360 participants planned; actual enrollment unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07161700). This is a study registration, not published results. Lead sponsor: Seaport Therapeutics. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 360 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress. Interventions: DRUG: SPT-300. Primary outcome measures: Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures , Up to Day 49. Brief summary: This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07161700Seaport TherapeuticsSPT-300Major Depressive Disorder With Anxious DistressMajor Depressive Disorder (MDD)