Reviewed by: Methylene Blue Ultra Science Team
Evidence Database

Clinical Trials Database

Structured database of methylene blue clinical trials registered on ClinicalTrials.gov. Browse by condition, phase, and status. Links to published results where available.

12Registered Trials
11Completed
9Conditions Studied
5Phase III

Filter by Condition

Cognitive Function (1)Alzheimer's Disease (3)Vasoplegic Syndrome (1)Septic Shock (1)Malaria (2)Depression (1)Anxiety / PTSD (1)Stroke (1)Encephalopathy (1)

All Registered Trials

NCT IDConditionPhaseStatusYearOutcome
NCT01626391[PMC]Cognitive FunctionPhase IICompleted2016Improved fMRI BOLD signal during attention tasks (p<0.05)
NCT01689246Alzheimer's DiseasePhase IIICompleted2016Primary endpoints not met; secondary signals in monotherapy
NCT01689233Alzheimer's DiseasePhase IIICompleted2016Primary endpoints not met
NCT00515333EncephalopathyPhase IICompleted2010Prevention of ifosfamide neurotoxicity
NCT01365390Vasoplegic SyndromePhase IIICompleted2015Reduced vasopressor requirements
NCT00473616MalariaPhase IICompleted2009Parasite clearance rates
NCT02380573Septic ShockPhase IICompleted2018Hemodynamic stability outcomes
NCT03446001DepressionPhase IICompleted2020Hamilton Depression Rating Scale changes
NCT02594930MalariaPhase IIICompleted2017Fever clearance and parasite reduction
NCT04370288Alzheimer's DiseasePhase IIICompleted2022Long-term safety and efficacy monitoring
NCT02819193[PMC]Anxiety / PTSDPhase ICompleted2018Fear extinction retention
NCT01253122StrokePhase IITerminated2014Study terminated early

Research Landscape by Condition

Cognitive Enhancement

The Rodriguez et al. (2016) study (NCT01626391) remains the highest-quality evidence for cognitive effects, using fMRI to demonstrate improved attention and memory retrieval.

View Brain Health Research →

Alzheimer's Disease

Multiple Phase III trials of LMTM (TauRx) did not meet primary endpoints. Secondary analyses showed mixed signals. This is an honest acknowledgment of current trial status.

View Alzheimer's Research →

Critical Care (Vasoplegic / Sepsis)

IV methylene blue has established clinical use for vasoplegic syndrome following cardiac surgery and septic shock. These represent the most successful clinical applications, with reduced vasopressor requirements documented.

Malaria

Multiple trials in endemic regions have studied MB as combination therapy. Results show antimalarial activity, though this represents a different use case than supplement-context research.

Understanding Clinical Trial Data

What do the phases mean?

Phase I: Safety testing in small groups (20-100 people).
Phase II: Efficacy testing with larger groups (100-300) while monitoring safety.
Phase III: Large-scale efficacy confirmation (300-3,000+) required for regulatory approval.
Phase IV: Post-approval monitoring.

What does "primary endpoints not met" mean?

Primary endpoints are the main outcomes a trial is designed to measure. When these aren't met, it means the treatment didn't show statistically significant improvement on the predefined measures. Secondary analyses may still show effects, but these are considered less reliable evidence.

Why are IV and oral doses so different?

IV (intravenous) administration delivers 100% of the compound directly to the bloodstream. Oral bioavailability varies. Critical care applications (vasoplegic syndrome, sepsis) use IV at higher doses (1-2 mg/kg) for immediate effect. Cognitive studies use oral doses (~4 mg/kg) with different pharmacokinetics.

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Database Methodology

This database includes trials registered on ClinicalTrials.gov with methylene blue as an intervention. Selection prioritizes trials with published results or completed status. IV administration trials (critical care) are included for completeness but represent different use cases than oral supplementation. Last updated: March 2026.