{"slug":"oxytocin","seoKey":"oxytocin","inn":"oxytocin","displayName":"Oxytocin","codes":["H01BB02"],"synonyms":["OT","oxytocinum","ocytocine","oxitocina","alpha-hypophamine","oxytocin acetate"],"legalClass":"rx","identifiers":{"cas":"50-56-6","pubchemCid":439302,"unii":"1JQS135EYN","inchikey":"XNOPRXBHLZRZKH-DSZYJQQASA-N","drugbankId":"DB00107","chemblId":"CHEMBL395429","wikidataQid":"Q169960","formula":"C43H66N12O12S2","molecularWeight":1007.2,"sequence":"CYIQNCPLG-NH2"},"approvals":[{"market":"US","status":"approved_rx","date":"1980-11-19","note":"Approved and prescription-only as an injectable solution, held under new drug application 018261 alongside several further applications of other sponsors. The labelling covers induction of labour where a medical indication exists, stimulation or reinforcement of labour, adjunctive therapy in incomplete or inevitable abortion, uterine contraction in the third stage and control of postpartum bleeding. A boxed warning states that the substance is not indicated for elective induction of labour, because the available data are inadequate to weigh benefits against risks. No approved product carries a psychiatric, behavioural or sexual-medicine indication; a nasal spray was authorised historically and is no longer marketed. The substance is not listed among the products withdrawn for reasons of safety or effectiveness.","source":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22OXYTOCIN%22"},{"market":"EU","status":"approved_rx","note":"Authorised and prescription-only, but through national procedures only: as a long-established substance it has no centralised authorisation and no European public assessment report. All authorisations found in the member states cover injection and infusion preparations for obstetric use; no nasal preparation is authorised as a finished medicinal product in any of the European markets checked.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=oxytocin"},{"market":"DE","status":"approved_rx","date":"2004-03-29","note":"Authorised and prescription-only. The prescription-only annex lists the substance with a single narrow exemption, covering solely the supply to midwives for practice stock in postpartum bleeding, below a stated concentration and single volume. That exemption does not make the substance freely available and permits no supply to private individuals; for every other use, and in particular every non-obstetric use, it remains prescription-only. The authorised indications are obstetric before and after birth, and the product information restricts use to a clinical setting under medical supervision. No nasal spray is authorised as a finished medicinal product.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","date":"2016-01-18","note":"Authorised as a prescription-only medicine. Several concentrates for solution for infusion from different holders are listed in the medicines compendium; the date given is the first authorisation of the entry examined, not the first authorisation of the substance. The product information restricts administration to intravenous infusion and rules out bolus injection. Indications are obstetric before and after birth. No nasal preparation was listed on 2026-09-10.","source":"https://www.medicines.org.uk/emc/product/1971/smpc"},{"market":"AU","status":"approved_rx","date":"2026-05-28","note":"Prescription only: the Poisons Standard lists the substance in Schedule 4. A further entry in Appendix G sets a concentration limit of one microgram per litre or kilogram, below which the schedule requirements fall away for extremely dilute preparations such as homoeopathic ones; that entry changes nothing about the prescription requirement for therapeutically effective preparations. The register of therapeutic goods was unreachable on 2026-09-10 (timeouts and server errors), so no product-level register numbers could be established; the finding rests on the full text of the Poisons Standard. The date given is the registration of the instrument examined.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"approved_rx","date":"1981-12-31","note":"Authorised with drug identification numbers and classified as prescription. Three injectable products of different sponsors were marketed on 2026-09-10, for intramuscular and intravenous use; the date given is the earliest market date among them. The database additionally holds several veterinary authorisations, which are not intended for human use.","source":"https://health-products.canada.ca/api/drug/drugproduct/?lang=en&type=json&brandname=oxytocin"},{"market":"CH","status":"approved_rx","date":"1956-01-12","note":"Authorised and prescription-only in dispensing category B, under authorisation 22114 for the injection and infusion concentrate, first authorised on 1956-01-12, and under authorisation 25644 for a nasal spray, first authorised on 1959-09-09. This is the only one of the seven markets with a currently authorised nasal preparation. Its authorised indication is confined to promoting milk ejection and preventing mastitis; it carries no psychiatric, social or sexual-medicine indication and is expressly contraindicated during pregnancy and birth. Dispensing category B means supply on medical prescription, so the nasal form is not freely available either.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT01944046","name":"Intranasal oxytocin in children and adolescents with autism spectrum disorder over 24 weeks","phase":"Phase 2","n":290,"status":"COMPLETED"},{"nct":"NCT03610919","name":"Effects of dose frequency on behavioural and neural responses","phase":"Phase 1","n":150,"status":"UNKNOWN"},{"nct":"NCT01394471","name":"Treatment of social cognitive and functional deficits in schizophrenia","phase":"Phase 1","n":68,"status":"COMPLETED"},{"nct":"NCT03043053","name":"Intranasal oxytocin for obesity","n":61,"status":"COMPLETED"},{"nct":"NCT01908205","name":"Intranasal oxytocin for the treatment of children and adolescents","phase":"Phase 2","n":60,"status":"COMPLETED"},{"nct":"NCT02918864","name":"Oxytocin and social cognitive skills groups","phase":"Phase 2","n":40,"status":"COMPLETED"},{"nct":"NCT02849743","name":"Pilot crossover trial in hypothalamic obesity","n":13,"status":"COMPLETED"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/439302","https://www.wikidata.org/wiki/Q169960","https://go.drugbank.com/drugs/DB00107","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL395429/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Oxytocin: what the studies show, status and safety","summary":"Oxytocin is a hormone the body makes itself, and a prescription medicine used in childbirth. In all seven markets on this page it is prescription-only, and licensed for obstetric use alone. The cuddle hormone picture rests on one laboratory finding from 2005 that larger studies failed to reproduce. Trials in autism, schizophrenia, obesity and alcohol dependence came back negative.","updated":"2026-09-10","url":"https://mypep.app/peptides/oxytocin"}