{"slug":"hgh-191aa","seoKey":"hgh191aa","inn":"somatropin","displayName":"Somatropin (HGH 191AA)","codes":["LY-137998","CB-311","HSB-HGH","H01AC01"],"synonyms":["somatropin","somatropin (rDNA origin)","somatotropin","somatotropin human","growth hormone (human)","human growth hormone","hGH","rhGH","r-hGH","HGH 191AA","hGH 191aa","191AA","Wachstumshormon human","Growth Hormone (GH)","rh-Polypeptide-7"],"legalClass":"rx","identifiers":{"cas":"12629-01-5","unii":"NQX9KB6PCL","drugbankId":"DB00052","chemblId":"CHEMBL1201621","formula":"C990H1530O299N262S7","molecularWeight":22124.8,"sequence":"FPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFEEAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQFLRSVFANSLVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHNDDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGF"},"approvals":[{"market":"US","status":"approved_rx","date":"1986-10-16","note":"Approved and prescription-only, held as biologics licences. The register lists twelve applications with this active ingredient, the oldest cleared on 1986-10-16 under priority review and two of them wholly discontinued. Ten conditions are covered across three medical fields: in children, growth failure from insufficient growth hormone, Prader-Willi syndrome, being born small for gestational age without catch-up growth, Turner syndrome, idiopathic short stature, Noonan syndrome and chronic kidney disease; in adults, growth hormone deficiency, wasting in HIV and short bowel syndrome. A special criminal provision applies on top of prescription status: knowingly distributing growth hormone, or possessing it with intent to distribute, for any use other than a condition authorised by the health secretary and on a doctor's order carries up to five years in prison, ten where a person under 18 is involved. Unapproved material is also held at the border under an import alert last published on 2026-04-07.","source":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SOMATROPIN%22&limit=100 ; https://www.law.cornell.edu/uscode/text/21/333 ; https://www.accessdata.fda.gov/cms_ia/importalert_204.html"},{"market":"EU","status":"approved_rx","date":"2006-04-12","note":"Approved and prescription-only, both centrally and nationally. The date given is the first centralised authorisation, granted on 2006-04-12 to the first biosimilar of this substance; the national authorisations in the member states are older and carry no single starting date. Two further centralised authorisations no longer exist: one was withdrawn on 2012-05-12 for commercial reasons and was never marketed in any member state, the other lapsed on 2017-11-09 under the sunset clause because it had not been marketed within three years.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope ; https://www.ema.europa.eu/en/medicines/human/EPAR/valtropin ; https://www.ema.europa.eu/en/medicines/human/EPAR/somatropin-biopartners"},{"market":"DE","status":"approved_rx","date":"2006-04-12","note":"Approved and prescription-only. The substance is named in the schedule to the prescription-medicines ordinance, which makes it prescription-only by name rather than by inference; the national authorisations were not individually retrieved from a German primary source, and the date given is that of the EU-wide authorisation effective here. It is also named word for word in the schedule to the anti-doping act, in the section on growth hormone, its analogues, fragments, releasing factors and releasing peptides. A separate ordinance in force since 2023-03-16 sets 16 mg of the free compound as the quantity from which possession alone is a criminal offence.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html ; https://www.gesetze-im-internet.de/antidopg/anlage.html ; DmMV, BGBl. 2023 I Nr. 67, S. 5 ; https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope"},{"market":"UK","status":"approved_rx","note":"Approved and prescription-only. The regulator's full-text product index returned 607 documents for the substance on 2026-09-15, among them 144 product information sheets and named product licences for five brands; control queries in the same index returned 106 hits for a comparator and none for an unapproved substance, so the index answers and differentiates. NO DATE IS GIVEN because the index carries document metadata and no authorisation history, so first approval dates could not be derived. Prescription status follows from the regulation that classifies parenteral medicines as prescription-only, not from an express category statement in the product information examined.","source":"https://products.mhra.gov.uk/search/?search=somatropin ; https://www.legislation.gov.uk/uksi/2012/1916/regulation/62"},{"market":"AU","status":"scheduled","note":"Prescription-only and, beyond that, possession is restricted: the Poisons Standard of June 2026, made on 2026-05-27, lists the substance in schedule 4 and separately in Appendix D, clause 5, among substances a person must not possess without authority, alongside anabolic steroids and the familiar grey-market peptides. This is the strictest position of the seven markets here. No date is given because the scheduling decision is far older than the instrument that currently carries it. IMPORTANT CAVEAT: the register of therapeutic goods could not be reached from the working environment on 2026-09-15, so no register extract exists and the existence of individual registrations is unverified; the scheduling itself is primary-verified from the full text, with working control hits for comparable substances in the same document.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"approved_rx","date":"1987-12-31","note":"Authorised and prescription-only, classed both as prescription and as a biologic under the food and drug regulations. Fifty-one active-ingredient rows were checked: several brands are actively marketed, while many older drug identification numbers are cancelled, including all numbers of one long-established brand, the last of them in December 2025, so that product is no longer on the Canadian market even though the same one remains authorised in Switzerland. The date given is the earliest recorded first marketing date, 1987-12-31, which belongs to a number cancelled post market since 2021-01-15.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=somatropin&lang=en&type=json"},{"market":"CH","status":"approved_rx","date":"1990-05-23","note":"Authorised in the strictest dispensing category, which requires a prescription and permits a single dispensing against it, and additionally listed as a biotechnology product. Six authorisations for this substance appear in the published list of authorised human medicines, the oldest first authorised on 1990-05-23. The same list holds the long-acting analogues as separate authorisations of their own, which is how they are told apart from this substance.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/zugelassene_arzneimittel_ham_ind.xlsx.download.xlsx/Zugelassene_Arzneimittel_HAM.xlsx"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S2.2.3","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00396097","name":"Individualised, target-driven treatment of children with idiopathic short stature","phase":"Phase 3","n":316,"status":"COMPLETED"},{"nct":"NCT01563926","name":"Acceptance of a new liquid formulation in children with growth hormone deficiency","phase":"Phase 3","n":168,"status":"COMPLETED"},{"nct":"NCT00001221","name":"Growth hormone and/or ethinyl estradiol on adult height in Turner syndrome","phase":"Phase 2","n":160,"status":"COMPLETED"},{"nct":"NCT00001343","name":"Effects of hormones in growth hormone-treated girls with Turner syndrome","phase":"Phase 2","n":80,"status":"COMPLETED"},{"nct":"NCT00663611","name":"Growth hormone administration and the human immune system (healthy volunteers)","phase":"Phase 1","n":66,"status":"COMPLETED"},{"nct":"NCT03075644","name":"Weekly long-acting analogue against daily treatment over 52 weeks (active comparator, no investigational use of this substance)","phase":"Phase 3","n":62,"status":"COMPLETED"},{"nct":"NCT01109017","name":"Observational safety and efficacy study in adults with growth hormone deficiency","phase":"Observational","n":387,"status":"COMPLETED"},{"nct":"NCT01110928","name":"Observational study in still-growing children born small for gestational age","phase":"Observational","n":227,"status":"COMPLETED"},{"nct":"NCT00787878","name":"Long-term metabolic safety in children born small for gestational age","n":153,"status":"COMPLETED"}],"sameAs":["https://go.drugbank.com/drugs/DB00052","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201621/"],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Somatropin (HGH 191AA): what the trials show, status and safety","summary":"Somatropin is human growth hormone made in the laboratory, a chain of 191 amino acids with the same sequence as the hormone from the pituitary gland. It has been an approved, prescription-only medicine since October 1986, and it is prescription-only in all seven markets checked here. The grey-market name HGH 191AA is not a grade or a purity claim: every licensed product is 191AA. In healthy people two independent systematic reviews found no gain in muscle strength and none in maximal oxygen uptake, while swelling and exhaustion became more common. In the United States, supplying growth hormone for any use other than an approved medical condition is a federal offence.","updated":"2026-09-15","url":"https://mypep.app/peptides/hgh-191aa"}