Meldonium is a small molecule designed at the Latvian Institute of Organic Synthesis as a structural analogue of gamma-butyrobetaine, the precursor of carnitine.
Human trialsNon-peptide compound reference
Also known as: Mildronate dihydrate, Meldonium dihydrate, 3-(2,2,2-trimethylhydrazinium)propionate dihydrate, MET-88, Quaterin, Vasonat, UNII 22DC15W645, Meldonium anhydrous: PubChem CID 123868, C6H14N2O2, 146.19 g/mol
Amounts reported for Meldonium Dihydrate are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.
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No independently verified schedule
Clinical context
Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.
Storage, handling and interpretation
Product identity
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Storage & handling
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Prepared solutions
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Reported protocols for Meldonium Dihydrate
What published studies and recent community write-ups report about amounts, timing and course length. 9 clinical, 1 preclinical and 2 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
Context
Dose
Frequency
Route
Course
Source
Clinical9 rows
Latvian regulator's summary of product characteristicsAdults, as combination therapy; each hard capsule contains 250 mg or 500 mg of meldonium dihydrate
500-1000 mg a day, maximum 1000 mg; 500 mg a day for reduced work capacity and physical overload
The daily dose taken all at once or split into 2 doses
Oral capsules
Described as course-based treatment in stable exertional anginaNot specified in the label
The authoritative national label, held by the Latvian State Agency of Medicines and marked as agreed on 1 February 2024. Registered indications are stable exertional angina, chronic heart failure of NYHA class I to III, chronic ischaemic cerebral circulation disorders, reduced work capacity and physical overload, and the recovery period after cerebrovascular events or head trauma. The physical-overload indication is the nearest thing to a performance indication in any national label, and it carries the lower 500 mg daily ceiling. Pharmacokinetics in the label: peak concentration and exposure rise in proportion to dose across single oral doses of 25 to 1500 mg, peak plasma concentration at 1 to 2 hours, steady state 72 to 96 hours after the first dose, and food delays absorption without changing peak concentration or total exposure. Reduced doses are specified for renal or hepatic impairment.
Manufacturer's stated course lengthAdults treated for mild chronic cardiac insufficiency
500-1000 mg of meldonium per day; the maximum daily dose is 1000 mg
Once daily, or the daily dose divided into 2 doses
Oral
A treatment course of 4 to 6 weeksNot specified; the manufacturer defines a finite course rather than continuous use
Grindeks, the Latvian manufacturer, advises taking the drug in the morning because of a possible stimulating effect and with food to avoid gastrointestinal upset, and states a course length of 4 to 6 weeks. It is the manufacturer rather than the regulator putting a number on course duration, which is worth noting given that the trials below ran for 12 weeks and longer.
MILSS I, randomised placebo-controlled dose-ranging trial in stable angina512 patients with chronic coronary heart disease, functional class II to III, with ischaemia limiting their exercise test, across 72 centres in 4 countries
100, 300, 1000 or 3000 mg per day, given as 2x50, 2x150, 2x500 or 2x1500 mg, against placebo
This is the best human evidence meldonium has. The primary endpoint was change in bicycle ergometry exercise time at 12 weeks. The 100 mg and 300 mg groups did not differ from placebo. The 1000 mg per day group gained 35.18 seconds of total exercise time, significant at p equals 0.002, while 3000 mg produced a smaller gain than 1000 mg. The authors conclude the most effective dose in combination with standard therapy was 500 mg twice a day, and note in the paper that the usual clinical dose in those countries was already 500 mg twice daily with no dose-response data behind it. The effect size is 35 seconds of cycling in patients with angina.
Indexed record of the MILSS I trial512 patients with stable angina pectoris
500 mg twice a day identified as the most effective of the 4 doses tested
The PubMed record for the same trial, listed as a phase 2 randomised controlled trial run through the Research Institute of Cardiology at the University of Latvia with a large collaborator list across Russia, Ukraine, Georgia and Latvia. Secondary endpoints, maximum achieved load and time to onset of angina, moved in the same pattern as the primary endpoint.
Phase 2 trial in acute ischaemic stroke227 patients with acute cerebral infarction; 113 on mildronate and 114 on cinepazide as an active control, both groups also on aspirin
Not stated in the abstract or the registry; 113 on mildronate against 114 on cinepazide
A randomised, double-blind, active-controlled multicentre trial run at Xijing Hospital in China, which matters because almost all other meldonium trials come from the countries where it is registered. Patients were 18 to 80 with an NIHSS score of 5 to 22 and were enrolled within 7 days of a first stroke. There was no significant difference from the active control on the primary modified Rankin Scale endpoint at 3 months, nor on NIHSS or Barthel Index at 15 days, and serious adverse events were similar between groups. The conclusion is that mildronate is as effective and safe as cinepazide, which is a non-inferiority finding against another drug rather than evidence of benefit over placebo.
Registry record for the stroke trial227 patients with acute ischaemic stroke
No amount recorded in the registry; 1 mildronate arm against 1 cinepazide arm, both on aspirin
The registry lists this trial as completed with 227 participants. A second Xijing Hospital record, NCT01800357, planned 240 patients and is listed with unknown status. The registry also carries a completed phase 1 and 2 study of meldonium for treatment-associated fatigue in 60 patients with metastatic renal cell carcinoma, which is the most recent registered clinical use of the drug.
Controlled trial in chronic heart failure110 patients with chronic heart failure of NYHA functional class III to IV, already stable on conventional treatment
Not stated in the indexed record; added to standard therapy in 110 patients
A Georgian controlled clinical trial that assessed clinical status, functional class change, echocardiography and the 6-minute walk test, and concluded mildronate was effective as part of complex treatment. The indexed record does not report the dose or the course length, and this is the general shape of much of the meldonium heart-failure literature: small, from the countries where the drug is registered, and thin on reported detail.
Prevalence survey at the Baku 2015 European Games762 athlete urine samples and 662 athletes tested between 8 and 28 June 2015
Not a dosing study: 66 of 762 samples, 8.7%, tested positive
This is the surveillance study that changed meldonium's regulatory status. Meldonium was declared as imported by only 2 of 50 National Olympic Committee medical teams, yet athletes from 6 countries declared use and it was detected across 15 of the 21 sports at the Games, including among 13 competition winners. The authors describe this as widespread and inappropriate prescribing of a prescription drug in a generally healthy population, and note that WADA subsequently added meldonium to the 2016 Prohibited List.
Narrative review of the pharmacology and the performance claimReview of the clinical and sports literature
Not a dosing study: monitored from 2015, prohibited from 1 January 2016
This 2017 review in the British Journal of Sports Medicine records the regulatory timeline plainly: meldonium was monitored from 2015 and added to the WADA Prohibited List in January 2016 after reports of alarming prevalence among elite athletes. It attributes the drug's anti-ischaemic and cardioprotective effects mainly to inhibition of beta-oxidation and activation of glycolysis, notes it is registered in most Baltic countries and easily obtained over the internet, and states that the benefit for performance enhancement in athletes is speculative and discussed without sound scientific evidence.
Preclinical1 row
Mechanism and carnitine lowering in ratsRats, with an isolated heart infarction model
100 mg/kg per day
Once daily
Intraperitoneal
28 days, with the infarction model tested after 3, 7 and 14 days of treatmentNot applicable
The first experimental demonstration that mildronate not only lowers free carnitine but raises gamma-butyrobetaine, the substrate of the enzyme it inhibits: roughly fivefold in plasma and brain and sevenfold in the heart. Necrotic area in infarcted isolated hearts fell significantly after 14 days of treatment, and the cardioprotective effect tracked the rise in gamma-butyrobetaine rather than the fall in carnitine alone. A 2016 review from the same institute sets out the full mechanism, naming gamma-butyrobetaine hydroxylase and the carnitine transporter OCTN2 as the known drug targets and describing how falling carnitine stimulates glucose metabolism and lowers long-chain acylcarnitines and trimethylamine-N-oxide. These are rat doses.
Community-reported2 rows
Review of the athlete studies behind the performance reputation
500 mg twice daily for 21 days in the most frequently cited athlete study
Twice daily
Oral
21 days of dosing with follow-up to day 42Not described
Included here because it is the one source that examines the athlete studies rather than repeating them. This 2026 narrative review notes that athletic studies are rare, and that the most cited one, in 25 male youth ice-hockey players, was uncontrolled, lacked a placebo group and lacked proper statistical analysis. Of the parameters reported, three had higher mean values at day 42, two decreased and three were unchanged, and the share of players rating themselves in high comfort actually fell from 12% to zero. Another cited study allocated participants by exercise test performance rather than randomly, creating severe baseline imbalance. The review concludes the evidence for ergogenic potential in healthy athletes does not hold up.
Research-chemical vendor listing
400 mg per capsule, 60 capsules per bottle, 24,000 mg total
Not stated by the vendor
Supplied as oral capsules
Not stated by the vendorNot stated by the vendor
Community resource2026
A vendor claim. The guide gives a strength and a total content but no amount, frequency or schedule, frames the compound entirely in terms of carnitine-pathway and mitochondrial research, and states it is for laboratory and research use only and is not dosing guidance. The 400 mg figure is close to the 401.14 mg of meldonium that a registered 500 mg dihydrate capsule supplies, so one capsule sits just under the regulator's 500 mg daily ceiling for the physical-overload indication and at roughly 40% of the 1000 mg cardiovascular ceiling.
How a course is commonly described
1
Weeks 1-4Clinical
The registered course is 500 to 1000 mg a day by mouth for cardiovascular and cerebrovascular indications, taken all at once or split in two, and only 500 mg a day for reduced work capacity and physical overload. Steady state is reached 72 to 96 hours after the first dose.
2
Weeks 4-6Clinical
The manufacturer's course length is 4 to 6 weeks, after which the course ends rather than continuing indefinitely. It advises morning dosing because of a possible stimulating effect and dosing with food to avoid stomach upset.
3
Week 12 assessmentClinical
MILSS I ran longer than the manufacturer's course, 12 weeks at 500 mg twice daily on top of standard angina therapy, and measured its effect at that point: 35 seconds more total cycling time than placebo. Tripling the dose to 3000 mg a day produced less benefit, not more.
Every human figure here comes from patients with cardiovascular disease, mostly in countries where meldonium is a registered prescription medicine, and the clearest finding is a dose ceiling rather than a dose ladder: in the one large placebo-controlled trial, 1000 mg a day beat placebo and 3000 mg a day did worse than 1000 mg. The Latvian label caps the daily amount at 1000 mg, and at 500 mg for the physical-overload indication.
Meldonium has never been approved by the FDA or the EMA. It is registered as Mildronate by Grindeks in Latvia and sold across the Baltic states and several post-Soviet countries, which is why the clinical literature is concentrated in Russian, Ukrainian, Georgian and Latvian journals and often thin on reported method. Registered capsules contain meldonium dihydrate, so a 500 mg capsule supplies 401.14 mg of meldonium.
The World Anti-Doping Agency monitored meldonium through 2015 and added it to the Prohibited List on 1 January 2016, after 8.7% of urine samples at the 2015 European Games tested positive across 15 of 21 sports. The performance case itself is weak: the 2017 BJSM review calls it speculative, and a 2026 review of the athlete studies found the most-cited one uncontrolled, unblinded and without proper statistics.
Plus 1 community resource (a dosing guide, forum thread or vendor write-up), reported above but not linked.
Overview
Meldonium is a small molecule designed at the Latvian Institute of Organic Synthesis as a structural analogue of gamma-butyrobetaine, the precursor of carnitine; by inhibiting gamma-butyrobetaine hydroxylase and the carnitine transporter OCTN2 it lowers carnitine levels, which shifts cardiac metabolism away from fatty acid oxidation and towards glucose. It has been registered since the 1980s as Mildronate by the Latvian manufacturer Grindeks and is sold in Latvia, the Baltic states and several post-Soviet countries as 250 mg and 500 mg capsules of the dihydrate, for stable angina, chronic heart failure and ischaemic cerebral circulation disorders; it has never been approved by the FDA or the EMA. Human trials exist, most substantially a 512-patient randomised placebo-controlled study in stable angina, and the World Anti-Doping Agency added meldonium to the Prohibited List on 1 January 2016 after a year of monitoring found it widespread among elite athletes.
What researchers are exploring
These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.
1
Metabolic research
Energy balance, body composition and incretin signaling.
2
Muscle & performance
Androgen receptor modulators, myostatin pathways and exercise-mimetic research.
3
Latvian regulator's summary of product characteristics
The authoritative national label, held by the Latvian State Agency of Medicines and marked as agreed on 1 February 2024. Registered indications are stable exertional angina, chronic heart failure of NYHA class I to.
4
Manufacturer's stated course length
Grindeks, the Latvian manufacturer, advises taking the drug in the morning because of a possible stimulating effect and with food to avoid gastrointestinal upset, and states a course length of 4 to 6 weeks. It is the.
5
MILSS I, randomised placebo-controlled dose-ranging trial in stable angina
This is the best human evidence meldonium has. The primary endpoint was change in bicycle ergometry exercise time at 12 weeks. The 100 mg and 300 mg groups did not differ from placebo. The 1000 mg per day group gained.
6
Indexed record of the MILSS I trial
The PubMed record for the same trial, listed as a phase 2 randomised controlled trial run through the Research Institute of Cardiology at the University of Latvia with a large collaborator list across Russia, Ukraine.
What the current evidence can support
Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.
Human
Human studies and registrations
9 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.
Animal
Preclinical models
1 protocol row describe animal, cell or toxicology work. Amounts from these rows do not translate to people.
Not graded
Community-reported use
2 rows record what blogs, vendor write-ups or forums describe for Meldonium Dihydrate. None has been verified against primary literature.
Chemistry identifiers
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.