{"id":"meldonium","rwe":[{"pmid":"41875824","year":"2026","title":"BPGM as an intrinsic brake to constrain metastasis through phospho-epigenetic-mediated carnitine biosynthesis suppression.","finding":"","journal":"Neoplasia (New York, N.Y.)","studyType":"Clinical Study"},{"pmid":"41802751","year":"2026","title":"SLC6A14-mediated carnitine transmembrane uptake from PPARγ(+) cancer-associated fibroblasts promotes recurrence of pancreatic cancer.","finding":"","journal":"Gut","studyType":"Clinical Study"},{"pmid":"41611212","year":"2026","title":"Emoxypine as a Potential Marker for Identifying Possible Cases of Unintended Meldonium Doping in Sports.","finding":"","journal":"Drug testing and analysis","studyType":"Clinical Study"},{"pmid":"41516008","year":"2025","title":"Kynurenine Pathway Metabolites as Mediators of Exercise-Induced Mood Enhancement, Fatigue Resistance, and Neuroprotection.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41507479","year":"2025","title":"Pathomorphological Changes in the Liver and Expression of the tgfb1 Gene during Physical Activity and after Meldonium Administration in an Experiment in Rats.","finding":"","journal":"Bulletin of experimental biology and medicine","studyType":"Clinical Study"}],"tags":[{"label":"meldonium","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Gamma-butyrobetaine dioxygenase","category":"target"},{"label":"BBOX1","category":"gene"},{"label":"C01EB22","category":"atc"},{"label":"Active","category":"status"},{"label":"Adjuvants, Immunologic","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"}],"phase":"phase_2","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"quaterin","offLabel":[],"synonyms":["mildronate","quaterin","meldonium"],"timeline":[],"approvals":[],"brandName":"Quaterin","ecosystem":[],"mechanism":{"target":"Gamma-butyrobetaine dioxygenase","targets":[{"gene":"BBOX1","source":"DrugCentral","target":"Gamma-butyrobetaine dioxygenase","protein":"Gamma-butyrobetaine dioxygenase"}],"modality":"Small Molecule","drugClass":"meldonium","explanation":"Think of carnitine like a special delivery truck that helps transport energy to our cells. Meldonium blocks the production of this truck, which can help improve heart function and reduce fatigue. This is especially helpful for people with certain heart conditions or those who are physically active.","oneSentence":"Meldonium works by inhibiting the enzyme gamma-butyrobetaine dioxygenase, which is involved in the production of carnitine.","technicalDetail":"Meldonium (methyl 2-(2-cyanoethyl)-N-(2,2,2-trimethylhydrazinium)acetate) inhibits the enzyme gamma-butyrobetaine dioxygenase (GDB), which is responsible for converting gamma-butyrobetaine to L-carnitine. By blocking this enzyme, meldonium reduces the production of L-carnitine, leading to increased levels of gamma-butyrobetaine and subsequent effects on heart function and energy metabolism."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3995","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MELDONIUM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MELDONIUM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T14:18:01.540175","biosimilars":[],"competitors":[{"drugName":"camphor","drugSlug":"camphor","fdaApproval":"","relationship":"same-class"},{"drugName":"indomethacin","drugSlug":"indomethacin","fdaApproval":"1965-06-10","patentExpiry":"Apr 23, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ubidecarenone","drugSlug":"ubidecarenone","fdaApproval":"","relationship":"same-class"},{"drugName":"adenosine","drugSlug":"adenosine","fdaApproval":"1989-10-30","genericCount":15,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ibuprofen","drugSlug":"ibuprofen","fdaApproval":"1974-09-19","patentExpiry":"Sep 30, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ivabradine","drugSlug":"ivabradine","fdaApproval":"2015-04-15","patentExpiry":"Feb 22, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ranolazine","drugSlug":"ranolazine","fdaApproval":"2006-01-27","patentExpiry":"Jan 24, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"regadenoson","drugSlug":"regadenoson","fdaApproval":"2008-04-10","patentExpiry":"Feb 2, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"mavacamten","drugSlug":"mavacamten","fdaApproval":"2022-04-28","patentExpiry":"Jun 19, 2034","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"meldonium","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"camphor","brandName":"camphor","genericName":"camphor","approvalYear":"","relationship":"same-class"},{"drugId":"indomethacin","brandName":"indomethacin","genericName":"indomethacin","approvalYear":"1965","relationship":"same-class"},{"drugId":"ubidecarenone","brandName":"ubidecarenone","genericName":"ubidecarenone","approvalYear":"","relationship":"same-class"},{"drugId":"adenosine","brandName":"adenosine","genericName":"adenosine","approvalYear":"1989","relationship":"same-class"},{"drugId":"ibuprofen","brandName":"ibuprofen","genericName":"ibuprofen","approvalYear":"1974","relationship":"same-class"},{"drugId":"ivabradine","brandName":"ivabradine","genericName":"ivabradine","approvalYear":"2015","relationship":"same-class"},{"drugId":"ranolazine","brandName":"ranolazine","genericName":"ranolazine","approvalYear":"2006","relationship":"same-class"},{"drugId":"regadenoson","brandName":"regadenoson","genericName":"regadenoson","approvalYear":"2008","relationship":"same-class"},{"drugId":"mavacamten","brandName":"mavacamten","genericName":"mavacamten","approvalYear":"2022","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07304921","phase":"PHASE1","title":"Novel Approach to Increase EPA and DHA Levels","status":"COMPLETED","sponsor":"Riga Stradins University","startDate":"2023-04-06","conditions":["Lipid Metabolism","Omega-3 Polyunsaturated Fatty Acids","Supplementation"],"enrollment":48,"completionDate":"2023-06-06"},{"nctId":"NCT06648902","phase":"PHASE1,PHASE2","title":"Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue","status":"COMPLETED","sponsor":"Kidney Cancer Research Bureau","startDate":"2022-02-01","conditions":["Renal Cell Cancer Metastatic","Kidney Cancer","Fatigue Related to Cancer Treatment"],"enrollment":60,"completionDate":"2024-09-01"},{"nctId":"NCT05939622","phase":"PHASE4","title":"Efficacy of the Therapy With BRAINMAX® Using fMRI for the Treatment of Patients With Asthenia After COVID-19","status":"COMPLETED","sponsor":"Promomed, LLC","startDate":"2022-05-18","conditions":["Asthenia","COVID-19","Functional MRI","Cognitive Impairment"],"enrollment":30,"completionDate":"2022-12-20"},{"nctId":"NCT05689827","phase":"PHASE4","title":"Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19","status":"COMPLETED","sponsor":"Promomed, LLC","startDate":"2022-04-05","conditions":["Asthenia","COVID-19"],"enrollment":160,"completionDate":"2022-11-10"},{"nctId":"NCT01831011","phase":"PHASE2","title":"Mildronate for Acute Ischemic Stroke","status":"COMPLETED","sponsor":"Xijing Hospital","startDate":"2008-07","conditions":["Acute Ischemic Stroke"],"enrollment":227,"completionDate":"2010-04"},{"nctId":"NCT01800357","phase":"PHASE2","title":"Efficacy and Safety of Mildronate for Acute Ischemic Stroke","status":"UNKNOWN","sponsor":"Xijing Hospital","startDate":"2013-01","conditions":["Acute Ischemic Stroke"],"enrollment":240,"completionDate":"2014-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"UNII":"73H7UDN6EC","CHEBI":"CHEBI:131843","INN_ID":"8180","UMLSCUI":"C0047115","ChEMBL_ID":"CHEMBL2104708","KEGG_DRUG":"D10504","DRUGBANK_ID":"DB13723","PDB_CHEM_ID":"REE","PUBCHEM_CID":"123868","MESH_SUPPLEMENTAL_RECORD_UI":"C050147"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"6.2 hours","clearance":"2.8 mL/min/kg","volumeOfDistribution":"0.7 L/kg"},"publicationCount":103,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"C01EB22","allCodes":["C01EB22"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 23","pmid":"41875824","title":"BPGM as an intrinsic brake to constrain metastasis through phospho-epigenetic-mediated carnitine biosynthesis suppression.","journal":"Neoplasia (New York, N.Y.)"},{"date":"2026 Mar 5","pmid":"41802751","title":"SLC6A14-mediated carnitine transmembrane uptake from PPARγ(+) cancer-associated fibroblasts promotes recurrence of pancreatic cancer.","journal":"Gut"},{"date":"2026 Mar","pmid":"41611212","title":"Emoxypine as a Potential Marker for Identifying Possible Cases of Unintended Meldonium Doping in Sports.","journal":"Drug testing and analysis"},{"date":"2025 Dec 22","pmid":"41516008","title":"Kynurenine Pathway Metabolites as Mediators of Exercise-Induced Mood Enhancement, Fatigue Resistance, and Neuroprotection.","journal":"International journal of molecular sciences"},{"date":"2025 Sep","pmid":"41507479","title":"Pathomorphological Changes in the Liver and Expression of the tgfb1 Gene during Physical Activity and after Meldonium Administration in an Experiment in Rats.","journal":"Bulletin of experimental biology and medicine"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Meldonium, also known as Quaterin, is a small molecule drug that targets gamma-butyrobetaine dioxygenase. It is classified as a meldonium drug class and its commercial status is unknown. Meldonium is used to treat various conditions, but its approved indications are not specified. The drug has a half-life of 6.2 hours, but its bioavailability and off-patent status are unknown. As a pharma professional, it is essential to consider the key safety considerations of meldonium.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}