{"slug":"abaloparatide","seoKey":"abaloparatide","inn":"abaloparatide","displayName":"Abaloparatide","codes":["BA058","BA-058","BIM-44058","H05AA04"],"synonyms":["Abaloparatid","abaloparatida","abaloparatidum","abaloparatide acetate","abaloparatide-SC","[Glu22,25, Leu23,28,31, Aib29, Lys26,30] hPTHrP(1-34)-NH2"],"legalClass":"rx","identifiers":{"cas":"247062-33-5","pubchemCid":76943386,"unii":"AVK0I6HY2U","inchikey":"BVISQZFBLRSESR-XSCWXTNMSA-N","drugbankId":"DB05084","chemblId":"CHEMBL3301581","wikidataQid":"Q4834481","formula":"C174H300N56O49","molecularWeight":3961,"sequence":"Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH2"},"approvals":[{"market":"US","status":"approved_rx","date":"2017-04-28","note":"Approved and prescription-only since 2017-04-28 as a new molecular entity. For postmenopausal women at high risk of fracture the labelling states a reduction of vertebral and non-vertebral fractures; for men, added on 2022-12-19, it covers only an increase in bone density, with no fracture claim. The boxed warning on osteosarcoma was removed in December 2021, but the osteosarcoma warning remains in the labelling, and use beyond two years in a lifetime is still not recommended. Labelling revision August 2026 (hypersensitivity warning and contraindication added).","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22abaloparatide%22"},{"market":"EU","status":"approved_rx","date":"2022-12-12","note":"Centrally authorised and prescription-only since 2022-12-12 (EMEA/H/C/005928), under additional monitoring, for postmenopausal women only. A first application (EMEA/H/C/004157) was refused on 2019-01-07: non-vertebral fracture efficacy was not satisfactorily shown, data from two centres were unreliable because of good-clinical-practice breaches, and there were cardiac concerns. The current product information caps the total treatment duration at 18 months, citing osteosarcoma in rats.","source":"https://www.ema.europa.eu/en/documents/product-information/eladynos-epar-product-information_en.pdf"},{"market":"DE","status":"approved_rx","date":"2022-12-12","note":"Approved and prescription-only through the centralised EU authorisation, which applies directly here. The substance is additionally named in annex 1 of the prescription-only ordinance (full-text check 2026-09-23 with working control terms), so the prescription requirement attaches to the substance itself. It is NOT named in the annex to the anti-doping act. Whether the product is actually on the German market was not checked.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","date":"2023-03-27","note":"Licensed for Great Britain since 2023-03-27 (PLGB 49876/0025, originally PLGB 56979/0001) via the reliance route on the EU decision, for postmenopausal women only, with the same 18-month cap. The regulator's product index returned 3 documents on 2026-09-23 (controls: teriparatide 38, romosozumab 11). An explicit legal category was not found verbatim; parenteral medicines are prescription-only under regulation 62 of the Human Medicines Regulations 2012.","source":"https://products.mhra.gov.uk/search/?search=abaloparatide"},{"market":"AU","status":"approved_rx","date":"2024-11-28","note":"Registered and prescription-only (Schedule 4), first approved 2024-11-28, for postmenopausal women only, with an 18-month cap. CAVEAT ON VERIFICATION: the regulator's website (register search and public assessment report) timed out on 2026-09-23, so no register extract was seen. The status rests on the published Australian product information, which states the schedule and the date of first approval; the register entry number 430937 comes only from search-engine metadata.","source":"https://medsinfo.com.au/api/documents/Eladynos_PI?format=pdf"},{"market":"CA","status":"not_approved","note":"Not approved. The drug product database returned no entry for the active ingredient or for either international brand name on 2026-09-23, while a control query for teriparatide returned 7 entries, so the interface was working.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=abaloparatide&lang=en&type=json"},{"market":"CH","status":"approved_rx","date":"2024-03-07","note":"Approved since 2024-03-07 (authorisation number 69246, valid until 2029-03-06) and dispensed on prescription only (category B), with the black-triangle marking, for postmenopausal women at high risk of fracture. An application to add men was received on 2025-10-29; its outcome is open. The Swiss professional information, including the treatment-duration limit, was not read.","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":"NCT01343004","name":"ACTIVE — pivotal fracture trial against placebo, with an open-label teriparatide arm, 18 months","phase":"Phase 3","n":2463,"status":"COMPLETED"},{"nct":"NCT01657162","name":"ACTIVExtend — open-label extension with alendronate for 24 months","phase":"Phase 3","n":1139,"status":"COMPLETED"},{"nct":"NCT03512262","name":"ATOM — men with osteoporosis, bone density endpoint (no fracture endpoint)","phase":"Phase 3","n":228,"status":"COMPLETED"},{"nct":"NCT04064411","name":"wearABLe — microneedle patch against injection (non-inferiority missed)","phase":"Phase 3","n":511,"status":"COMPLETED"},{"nct":"NCT00542425","name":"Dose-finding study in postmenopausal women against placebo and teriparatide","phase":"Phase 2","n":222,"status":"COMPLETED"},{"nct":"NCT04974723","name":"Real-world matched cohort against teriparatide in US claims data (manufacturer-sponsored)","n":22054,"status":"COMPLETED"},{"nct":"NCT01674621","name":"Transdermal delivery in postmenopausal women","phase":"Phase 2","n":250,"status":"COMPLETED"},{"nct":"NCT03710889","name":"Early effects on tissue-based indices of bone formation and resorption","phase":"Phase 3","n":23,"status":"COMPLETED"},{"nct":"NCT06898060","name":"Chinese abaloparatide injection against teriparatide","phase":"Phase 3","n":282,"status":"NOT_YET_RECRUITING"},{"nct":"NCT06154187","name":"Korean bridging study of a copy product","phase":"Phase 3","n":60,"status":"UNKNOWN"},{"nct":"NCT03841058","name":"Spinal fusion surgery in postmenopausal women and men","phase":"Phase 2","n":96,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT04467983","name":"Added to ongoing denosumab versus denosumab alone","phase":"Phase 4","n":70,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT04249232","name":"Pelvic fracture healing","phase":"Phase 2","n":48,"status":"COMPLETED"},{"nct":"NCT04167163","name":"Before total knee arthroplasty","phase":"Phase 4","n":58,"status":"COMPLETED"},{"nct":"NCT04760782","name":"Type II odontoid fracture (terminated for low recruitment)","phase":"Phase 2","n":22,"status":"TERMINATED"}],"sameAs":["https://www.wikidata.org/wiki/Q4834481","https://pubchem.ncbi.nlm.nih.gov/compound/76943386","https://go.drugbank.com/drugs/DB05084","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3301581/"],"lastVerified":"2026-09-24","version":"1.0","published":true,"locale":"en","title":"Abaloparatide: what the trials show, status and safety","summary":"Abaloparatide is a laboratory-made, slightly altered copy of a hormone fragment that switches on the body's bone-building cells. In the main trial, new spine fractures seen on X-ray affected 0.6 per cent of women on abaloparatide against 4.2 per cent on placebo over 18 months. The evidence for other fractures is weaker: the result away from the spine was borderline and did not hold up in the European reanalysis, and a benefit for the hip has never been shown. It is a prescription medicine in six major markets and carries a bone-cancer warning based on rat studies.","updated":"2026-09-24","url":"https://mypep.app/peptides/abaloparatide"}