{"slug":"teriparatide","seoKey":"teriparatide","inn":"teriparatide","displayName":"Teriparatide","codes":["LY333334","rhPTH(1-34)","PTH(1-34)","hPTH(1-34)","H05AA02"],"synonyms":["Teriparatid","teriparatida","tériparatide","teriparatidum","parathyroid hormone (1-34), human","recombinant human parathyroid hormone fragment 1-34"],"legalClass":"rx","identifiers":{"cas":"52232-67-4","pubchemCid":16133850,"unii":"10T9CSU89I","inchikey":"OGBMKVWORPGQRR-UMXFMPSGSA-N","drugbankId":"DB06285","chemblId":"CHEMBL525610","wikidataQid":"Q411781","formula":"C181H291N55O51S2","molecularWeight":4117.8,"sequence":"SVSEIQLMHNLGKHLNSMERVEWLRKKLQDVHNF"},"approvals":[{"market":"US","status":"approved_rx","date":"2002-11-26","note":"Approved and prescription-only since 2002-11-26, under a new drug application that still stands; a second, independently approved application followed on 2019-10-04 and three abbreviated generic applications were approved between 2023 and 2025. It is NOT a biological medicine here: at 34 amino acids the molecule sits below the 40-amino-acid threshold of the federal definition, which is precisely why true generics exist. The labelling covers three indications, all restricted to people at high risk of fracture: postmenopausal osteoporosis, osteoporosis in men, and glucocorticoid-induced osteoporosis. The boxed warning on bone cancer was removed in 2020 and the two-year lifetime restriction revised; the osteosarcoma text remains as an ordinary warning. Current labelling revision 2026-08-03.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22teriparatide%22"},{"market":"EU","status":"approved_rx","date":"2003-06-10","note":"Centrally authorised and prescription-only since 2003-06-10, valid in every member state; the authorisation was last renewed on 2013-02-13 and the product information was last revised on 2026-01-28. Four biosimilars have been authorised since (2017-01-04, 2017-01-11, 2020-08-27 and 2022-03-24); a fifth was withdrawn at the holder's request on 2020-11-24 and never marketed. Unlike the American labelling, the European one keeps a lifetime cap: a maximum total treatment duration of 24 months that is not to be repeated over a patient's lifetime, expressly justified by the osteosarcoma findings in rats.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo"},{"market":"DE","status":"approved_rx","date":"2003-06-10","note":"Approved and prescription-only through the centralised EU authorisation, which applies directly here. The prescription requirement does not depend on the individual product: the substance is named by name in annex 1 of the prescription-only ordinance, so it attaches to the substance itself — a research-use label changes nothing. The substance is NOT named in the annex to the anti-doping act; that negative finding was verified in the full text on 2026-09-20 against working control queries in the same file.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","date":"2003-06-10","note":"Approved and prescription-only; the original EU authorisation was converted into a national one after the withdrawal from the EU, and the indication is unchanged. CAVEAT ON VERIFICATION: the regulator's product index loads its results through JavaScript only and returned no usable result list on 2026-09-20, by web fetch or by direct HTTP request. The status therefore rests on the recognised compendium of product information, which carries the national licence number and the prescription-only classification, not on the regulator's own index. Labelling revision 2026-01-27.","source":"https://www.medicines.org.uk/emc/product/2215/smpc"},{"market":"AU","status":"approved_rx","note":"Approved and prescription-only, but only PARTLY verified. The regulator's own repository of product information returned three teriparatide products on 2026-09-20; a control query for the originator brand returned none, so the original product appears to be no longer held there with valid product information. CAVEAT: the register of therapeutic goods itself was unreachable by every route on that date, so no register numbers could be collected, and the full text of the Poisons Standard (in force since 2026-05-27) could not be extracted — whether the substance is scheduled by name is NOT verified. Prescription medicines are routinely schedule 4 here.","source":"https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=teriparatide"},{"market":"CA","status":"approved_rx","note":"Approved and prescription-only under four drug identification numbers. The originator product has been cancelled post market since 2026-02-24, with its last batch expiring on 2026-06-30; three other products remain marketed, first placed on the market in 2020, 2020 and 2024. The classification is inconsistent in an instructive way: the recombinant products are additionally listed under schedule D (biological drugs), the chemically synthesised acetate product is not. The exact date of the notice of compliance was not retrieved; first marketing of the originator was 2004-07-15.","source":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=teriparatide"},{"market":"CH","status":"approved_rx","date":"2003-08-08","note":"Approved since 2003-08-08 and dispensed on medical prescription only (category B). Five authorisations plus one parallel-import authorisation appear in the published lists of authorised human medicines, dated 2003, 2017, 2018, 2018, 2022 and 2026; one of them carries the black-triangle marking for additional monitoring. As in the EU the substance counts as biological, so its copies are biosimilars — with one exception listed among the synthetics, a chemically synthesised acetate.","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":"NCT00670501","name":"Fracture Prevention Trial (pivotal registration trial, new vertebral fractures)","phase":"Phase 3","n":1637,"status":"COMPLETED"},{"nct":"NCT01709110","name":"VERO — head-to-head against risedronate over 24 months","phase":"Phase 4","n":1360,"status":"COMPLETED"},{"nct":"NCT00191425","name":"Two years of treatment versus one year followed by raloxifene or calcium/vitamin D","phase":"Phase 4","n":810,"status":"COMPLETED"},{"nct":"NCT00439244","name":"Combination with zoledronic acid in women with osteoporosis","phase":"Phase 3","n":412,"status":"COMPLETED"},{"nct":"NCT00414973","name":"Registration-programme trial in patients with osteoporosis","phase":"Phase 3","n":364,"status":"COMPLETED"},{"nct":"NCT00035256","name":"Sequential use with raloxifene in postmenopausal osteoporosis","phase":"Phase 4","n":330,"status":"COMPLETED"},{"nct":"NCT00130403","name":"OPTAMISE — effectiveness after prior alendronate or risedronate therapy","phase":"Phase 4","n":290,"status":"COMPLETED"},{"nct":"NCT00433160","name":"Japanese registration trial","phase":"Phase 3","n":207,"status":"COMPLETED"},{"nct":"NCT04589819","name":"Recovery from stress fracture of tibia or fibula (ongoing)","phase":"Phase 4","n":183,"status":"ENROLLING_BY_INVITATION"},{"nct":"NCT04003467","name":"Oral hPTH(1-34) formulation in women with low bone mass","phase":"Phase 2","n":161,"status":"COMPLETED"},{"nct":"NCT01473602","name":"Femoral neck fracture healing — two identical trials, pooled; PRIMARY ENDPOINT MISSED and both closed early for slow recruitment","phase":"Phase 3","n":159,"status":"COMPLETED"},{"nct":"NCT00190944","name":"Distal radius fracture healing — PRIMARY HYPOTHESIS NOT CONFIRMED","phase":"Phase 2","n":102,"status":"COMPLETED"},{"nct":"NCT00131469","name":"Adults with osteogenesis imperfecta (academic, outside the approved indications)","phase":"Phase 4","n":79,"status":"COMPLETED"},{"nct":"NCT02656810","name":"Follow-on product versus the originator in healthy adults (basis of the second American approval)","phase":"Phase 1","n":70,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q411781","https://pubchem.ncbi.nlm.nih.gov/compound/16133850","https://go.drugbank.com/drugs/DB06285","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL525610/"],"lastVerified":"2026-09-20","version":"1.0","published":true,"locale":"en","title":"Teriparatide: what the trials show, status and safety","summary":"Teriparatide is the active front section of human parathyroid hormone, made by recombinant bacteria and given by injection under the skin. Reaching the body in brief pulses, it stimulates bone-building cells, and the pivotal trial recorded new spine fractures in 5.0 per cent of treated women against 14.3 per cent on placebo. A reduction in hip fractures has never been shown. It is a prescription medicine in every market checked, and it carries a bone-cancer warning that began with rat studies.","updated":"2026-09-20","url":"https://mypep.app/peptides/teriparatide"}