{"id":"abaloparatide","name":"Abaloparatide","aliases":["Tymlos","Eladynos","BA058","PTHrP(1-34) analogue"],"url":"https://lyoresearch.com/compounds/abaloparatide","class":{"id":"endocrine-medicines","name":"Bone and endocrine peptide medicines","url":"https://lyoresearch.com/classes/endocrine-medicines"},"summary":"Abaloparatide is a 34-amino-acid analogue of parathyroid-hormone-related protein, given as a daily injection for osteoporosis at high fracture risk. In the ACTIVE trial, 2,463 postmenopausal women were randomised to abaloparatide, placebo or open-label teriparatide for 18 months; abaloparatide reduced new vertebral and non-vertebral fractures against placebo and caused less hypercalcaemia than teriparatide. Approved in the US since 2017 and the EU since 2022.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"ACTIVE RCT (n=2,463) + extension","regulatory_status":"Approved (Rx)","molecule":{"formula":"C174H300N56O49","molecular_weight":"3961","cas":"247062-33-5","pubchem_cid":76943386,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, once daily","half_life":"About 1 hour","licensed_regimen":"80 mcg subcutaneously once daily; use beyond 2 years in a lifetime not recommended","product":"Tymlos","source":{"title":"Tymlos prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8"}},"outcomes":[{"outcome":"Vertebral fracture risk (postmenopausal osteoporosis)","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"1 large RCT (n=2,463, 18 mo)","evidence":"New morphometric vertebral fractures in 0.6% on abaloparatide against 4.2% on placebo in the published analysis — a relative reduction of about 86%. The abstract reports the direction and refers to the paper's table for the figures.","references":[{"citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","where":"JAMA, 2016;316:722–733","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}],"verbatim":{"text":"Among postmenopausal women with osteoporosis, the use of subcutaneous abaloparatide, compared with placebo, reduced the risk of new vertebral and nonvertebral fractures over 18 months.","citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}},{"outcome":"Non-vertebral fracture risk","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"Same RCT","evidence":"Non-vertebral fractures 2.7% against 4.7% on placebo — a relative reduction of about 43% in the published analysis. Hip fractures were too few to judge.","references":[{"citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","where":"JAMA, 2016;316:722–733","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}]},{"outcome":"Hypercalcaemia (vs teriparatide)","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":true,"human_studies":"Same RCT, prespecified safety endpoint","evidence":"High blood calcium in 3.4% on abaloparatide against 6.4% on teriparatide — about half the rate, and the main claimed advantage over the older drug.","references":[{"citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","where":"JAMA, 2016;316:722–733","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}],"verbatim":{"text":"Incidence of hypercalcemia was lower with abaloparatide (3.4%) vs teriparatide (6.4%) (risk difference [RD], −2.96 [95%CI, −5.12 to −0.87]; P = .006).","citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}},{"outcome":"Bone mineral density","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"Same RCT","evidence":"Density rose at hip, femoral neck and spine against placebo (all P<0.001), with faster hip gains than teriparatide in the published comparison.","references":[{"citation":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","where":"JAMA, 2016;316:722–733","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/"}]}],"regions":[{"region":"European Union","status":"Approved, prescription-only","note":"Eladynos, centrally authorised December 2022 after a 2018 refusal."},{"region":"United States","status":"Approved, prescription-only","note":"Tymlos, FDA-approved April 2017; men at high fracture risk added 2022."},{"region":"United Kingdom","status":"Licensed, prescription-only","note":"Eladynos licensed by the MHRA."},{"region":"Australia","status":"Check the ARTG","note":"LYO did not find an ARTG entry at review; prescription-only if and when registered."},{"region":"Canada","status":"Check Health Canada","note":"LYO did not find a Drug Identification Number at review."},{"region":"Sport (WADA)","status":"Not prohibited","note":"Parathyroid hormone analogues are not on the Prohibited List."}],"faq":[{"q":"Abaloparatide or teriparatide?","a":"Both build bone and both cut spinal fractures by roughly 80% in their trials. Abaloparatide produced less high calcium and does not need refrigeration after first use. No trial has compared fracture rates head-to-head with adequate power."},{"q":"Why did the EMA first refuse it?","a":"In 2018 the committee judged the cardiovascular safety data insufficient — palpitations and a heart-rate rise were more common on the drug. Additional analyses satisfied it in 2022."},{"q":"Is it a steroid?","a":"No. It is a peptide hormone analogue with no anabolic-steroid action; 'anabolic' here means bone-building."}],"references":[{"cite":"Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).","where":"JAMA, 2016;316:722–733","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/","note":"2,463 women, 18 months; abaloparatide 80 µg vs placebo vs open-label teriparatide. Fracture percentages are in the paper's table, not the abstract."},{"cite":"Abaloparatide: EMA summary of the Eladynos authorisation (2022) following the 2018 negative opinion.","where":"EMA","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos","note":"Regulatory history."}],"last_reviewed":"2026-09-23","literature_searched_to":"2026-09-23","changelog":[{"date":"2026-09-23","note":"Initial publication. Grade A on ACTIVE."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}