Meldonium (Mildronate)
3-(2,2,2-Trimethylhydrazinyl)propanoic acid
Also known as: Meldonium, mildronate, THP, mildronats
This ingredient is classified as unclassified risk (GIRI score: 8.0/10).
Safety Profile
Known Safety Concerns
- WADA-prohibited since 2016 — 170+ athlete positive tests in 2016 alone
- Not approved as drug or supplement in USA, EU or UK
- Prescription drug only in Latvia and post-Soviet states
- Cardiovascular and hypoglycaemic effects
- Sold illegally as supplement online
Contraindications
- WADA-prohibited since 2016 — 170+ athlete positive tests in 2016 alone
- Not approved as drug or supplement in USA, EU or UK
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Meldonium is a prescription cardiovascular drug approved in Latvia and several post-Soviet states. It was added to the WADA prohibited list in 2016 after widespread use among athletes was detected. It is not approved as a supplement or drug in the USA, EU, or UK. It is sold as a supplement in some Eastern European markets and online. Over 170 athletes tested positive for it after the WADA ban in 2016 alone.
Biological and Chemical Classification
- Scientific Name
- 3-(2,2,2-Trimethylhydrazinyl)propanoic acid
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 1 study reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Banned Substance
- Evidence consistency: High consistency across studies (100%)
- WADA-prohibited since 2016 — 170+ athlete positive tests in 2016 alone
- Not approved as drug or supplement in USA, EU or UK
- Prescription drug only in Latvia and post-Soviet states
- Cardiovascular and hypoglycaemic effects
- Sold illegally as supplement online
The available scientific evidence for Meldonium (Mildronate) indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 1/40 |
| Evidence consistency | 20/20 |
| Safety signals | 18/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 1 study reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 1 study reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 23 მარ 2026, 15:15
Evidence Distribution
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Observational / other LOW evidence YELLOWRegion-specific neuroprotective effects of meldonium pretreatment in two models of sepsis-associated encephalopathy. ↗Ruu017eiu010diu0107 A et al.. Region-specific neuroprotective effects of meldonium pretreatment in two models of sepsis-associated encephalopathy.. Front Pharmacol. 2025. PMID:40371344.PMID 40371344 ↗Journal Front PharmacolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40371344/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Meldonium (Mildronate). Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a high safety concern. Its use in dietary supplements is associated with documented adverse events.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the High classification for Meldonium (Mildronate)
A score of 8.0 places this ingredient in the High band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.