{"slug":"l-carnitine","seoKey":"lcarnitine","inn":"levocarnitine","displayName":"L-Carnitine","codes":["A16AA01"],"synonyms":["L-carnitine","levocarnitine","Levocarnitin","Levocarnitinum","Carnitin","карнитин","(R)-carnitine","L-(-)-carnitine","vitamin BT","3-hydroxy-4-(trimethylammonio)butanoate","acetyl-L-carnitine and propionyl-L-carnitine are DIFFERENT substances with their own registry numbers; D- and DL-carnitine are pharmacologically undesirable"],"legalClass":"supplement","identifiers":{"cas":"541-15-1","pubchemCid":10917,"unii":"0G389FZZ9M","inchikey":"PHIQHXFUZVPYII-ZCFIWIBFSA-N","drugbankId":"DB00583","chemblId":"CHEMBL1149","wikidataQid":"Q20735709","formula":"C7H15NO3","molecularWeight":161.2},"approvals":[{"market":"US","status":"approved_rx","date":"1985-12-27","note":"Prescription medicine since 1985. Three original applications are on file: the oral forms from 1985-12-27, a further oral dosage form from 1986-04-10 and the intravenous solution from 1992-12-16, all three reviewed with priority. Eight generic applications are additionally listed, all prescription. The approved indications are primary systemic carnitine deficiency, the acute and chronic treatment of an inborn error of metabolism causing secondary deficiency, and the prevention and treatment of deficiency in dialysis patients. No label names weight reduction, fat burning, sports performance or cosmetic use, and the oral labels state expressly that they are not for parenteral use. Oral products outside these medicines are marketed as dietary supplements, for which there is no approval procedure.","source":"https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020182"},{"market":"EU","status":"approved_rx","note":"No centrally authorised medicinal product: the full agency medicines list was downloaded and searched on 2026-09-10 with no hit, against a working control search. Authorisations therefore exist at national level only. In parallel the substance is an authorised food ingredient under the 2009 regulation on substances for particular nutritional uses, and infant formula must contain at least a minimum amount of it under the 2016 delegated regulation, so it is a required nutrient for the most sensitive consumer group. It is not a novel food. No health claim is authorised: the food safety authority rejected the article 13(1) claims in 2011 and concluded in 2018 that a cause and effect relationship with normal lipid metabolism has not been established.","source":"https://www.ema.europa.eu/en/medicines/download-medicine-data"},{"market":"DE","status":"scheduled","note":"Split status, and that split is the point. Annex 1 of the prescription ordinance carries the entry for the substance limited to parenteral use, so the injectable and infusion form is prescription-only while the oral form circulates freely as a food supplement. No individual German finished medicinal product could be evidenced from a regulator document for this monograph, which is why the market is recorded as scheduled rather than as an approved product. The substance appears in none of the three annexes of the narcotics act. Anyone injecting grey-market material is acting outside both the prescription requirement and any authorisation.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","date":"2025-06-16","note":"Prescription only medicine. Two paediatric oral solutions from different companies are listed in the medicines compendium; the first was authorised on 2025-06-16 and its product information was last revised on 2026-04-28. The authorised indication is the treatment of primary and secondary carnitine deficiency in children under twelve years, in infants and in newborns.","source":"https://www.medicines.org.uk/emc/product/9538/smpc"},{"market":"AU","status":"unknown","note":"Not established. The therapeutic goods register could not be queried on 2026-09-10: several access routes returned timeouts or server errors, so whether medicinal products are registered in this market is not evidenced. What is evidenced is the absence from the Poisons Standard: its full text was searched on the same day with no hit, against a working control search, so the substance is not scheduled as a poison.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"approved_rx","date":"1995-12-31","note":"Prescription medicine. Six drug identification numbers are listed in the regulator's product database: three marketed since 1995-12-31 as tablets, oral solution and intravenous solution, a further oral solution marketed since 2019-11-18, and two intravenous solutions approved on 2025-11-24 and on 2026-03-25. All carry the prescription schedule.","source":"https://health-products.canada.ca/api/drug/"},{"market":"CH","status":"approved_rx","note":"Prescription medicine, dispensing category B. Four dosage forms of one preparation are authorised under the same metabolic ATC code: an injection solution, a syrup, an oral solution and chewable tablets. The stated field of use is carnitine deficiency. The substance also appears as an excipient in single-dose eye drops in dispensing category D, which is an unrelated context with no bearing on systemic use.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/authorized-medicines/list-of-authorized-medicinal-products.html"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT05602194","name":"Protection of the liver during chemotherapy for leukaemia or lymphoma","phase":"Phase 3","n":440,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT00775645","name":"Prevention of taxane neuropathy in early breast cancer (acetyl ester; primary endpoint missed, significant worsening at 24 weeks)","phase":"Phase 3","n":437,"status":"COMPLETED"},{"nct":"NCT01580553","name":"Injection in heart failure","phase":"Phase 2/Phase 3","n":268,"status":"COMPLETED"},{"nct":"NCT01665092","name":"Rapid administration in septic shock (primary endpoint missed)","phase":"Phase 2","n":250,"status":"COMPLETED"},{"nct":"NCT01538251","name":"Propionyl ester in mild ulcerative colitis (terminated)","phase":"Phase 3","n":147,"status":"TERMINATED"},{"nct":"NCT01731236","name":"Gut-flora-dependent metabolism of dietary carnitine and cardiovascular risk","phase":"Early Phase 1","n":100,"status":"ACTIVE_NOT_RECRUITING"}],"sameAs":["https://www.wikidata.org/wiki/Q20735709","https://pubchem.ncbi.nlm.nih.gov/compound/10917","https://go.drugbank.com/drugs/DB00583"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"L-Carnitine: what the studies show, status and safety","summary":"L-Carnitine is not a peptide. It is a small molecule the body builds for itself and also gets from food, above all red meat. Its job is to ferry long-chain fats into the part of the cell that burns them. Four countries license it as a prescription medicine for rare metabolic disorders and for dialysis patients. The same substance is sold freely as a supplement to swallow. The weight trials find about one kilogram, and the effect fades the longer people take it. Europe's food safety authority has turned down every health claim put to it.","updated":"2026-09-10","url":"https://mypep.app/peptides/l-carnitine"}