Abaloparatide

AApproved (Rx)Bone and endocrine peptide medicines →TymlosEladynosBA058
In one paragraphAbaloparatide 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.
Schematic 3D structure of Abaloparatide
34 residues · PTHrP(1-34) analogue, helical · schematic
Overall gradeA Established
Human trialsACTIVE RCT (n=2,463) + extension
Outcomes graded4
Last reviewed23 September 2026
EvidenceWhat it isHow it worksUnknownsMolecule & PKRegulationQuestionsReferences

What the human research shows

Teriparatide's younger sibling, with the same kind of evidence — one large randomised trial with fracture endpoints — and one practical advantage in the calcium data. Grade A.

MetabolicCardioMuscleHealingNeuroImmuneSexualSkinAgeing

Evidence profile0–5

  • Metabolic & weight—0.0
  • Cardiovascular—0.0
  • Muscle & growth—0.0
  • Healing & repair—0.0
  • Neuro & sleep—0.0
  • Immune & inflammation—0.0
  • Sexual & hormonal—0.0
  • Skin & appearance—0.0
  • Ageing & longevity—0.0
No benefit outcome for Abaloparatide has both human evidence and a measurable effect, so the profile is empty. That is the finding, not a gap in the chart.
OutcomeGradeEffect sizeHuman studiesWhere the evidence comes from
Vertebral fracture risk (postmenopausal osteoporosis)AEstablishedLarge1 large RCT (n=2,463, 18 mo)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.1
Non-vertebral fracture riskAEstablishedModerateSame RCTNon-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.1
Hypercalcaemia (vs teriparatide)adverseAEstablishedSmallSame RCT, prespecified safety endpointHigh 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.1
Bone mineral densityAEstablishedLargeSame RCTDensity rose at hip, femoral neck and spine against placebo (all P<0.001), with faster hip gains than teriparatide in the published comparison.1
AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 23 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 18 interventional studies naming Abaloparatide as an intervention — 12 completed, and 9 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

StudyPhaseStatusParticipantsSponsorResults
Abaloparatide Before Total Knee ArthroplastyNCT04167163 · started Jan 2020Phase 4Completed58University of Wisconsin, MadisonPosted
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal WomenNCT01343004 · started Apr 2011Phase 3Completed2,463Radius Health, Inc.Posted
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With OsteoporosisNCT04064411 · started Aug 2019Phase 3Completed511Radius Health, Inc.Posted
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)NCT03512262 · started May 2018Phase 3Completed228Radius Health, Inc.Posted
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and ResorptionNCT03710889 · started Sept 2018Phase 3Completed23Radius Health, Inc.Posted
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With OsteoporosisNCT01674621 · started Sept 2012Phase 2Completed250Radius Health, Inc.Posted
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With OsteoporosisNCT00542425 · started Apr 2007Phase 2Completed222Radius Health, Inc.Posted
PTH Analog Type II Odontoid FractureNCT04760782 · started May 2022Phase 2Terminated22David LunardiniPosted

10 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

Abaloparatide is a synthetic analogue of the first 34 amino acids of parathyroid-hormone-related protein, engineered for a briefer receptor signal than teriparatide. Radius Health won FDA approval as Tymlos in 2017; the EMA refused it in 2018 on cardiovascular concerns and then approved it as Eladynos in 2022 on additional data.

It is the second of two approved bone-building peptides and is used the same way: daily injection for up to two years in people at highest fracture risk, followed by an antiresorptive.

How it is thought to work

Like teriparatide, it activates the PTH type 1 receptor in a daily pulse, which favours bone formation over resorption. It binds preferentially to the receptor's transient conformation, producing a shorter signal — the proposed reason for the smaller rise in blood calcium.

What is still unknown

  • Fracture benefit against teriparatide directly: ACTIVE's teriparatide arm was open-label and the trial was not powered for that comparison.
  • Long-term cardiovascular safety, the concern behind the EMA's first refusal; the approval rests on reanalysis, not a dedicated trial.

The molecule and how long it lasts

Identity
Formula
C174H300N56O49
Molecular weight
3961 g/mol
CAS number
247062-33-5
PubChem
CID 76943386

PubChem record, read 23 September 2026.

Pharmacokinetics
Route
Subcutaneous injection, once daily
Half-life
About 1 hour
Licensed regimen (Tymlos)
80 mcg subcutaneously once daily; use beyond 2 years in a lifetime not recommended

From the approved product's prescribing information: Tymlos prescribing information (DailyMed) The regimen is the label's own wording, reproduced as a regulatory fact.

Regulatory status

European Union
Approved, prescription-only

Eladynos, centrally authorised December 2022 after a 2018 refusal.

United States
Approved, prescription-only

Tymlos, FDA-approved April 2017; men at high fracture risk added 2022.

United Kingdom
Licensed, prescription-only

Eladynos licensed by the MHRA.

Australia
Check the ARTG

LYO did not find an ARTG entry at review; prescription-only if and when registered.

Canada
Check Health Canada

LYO did not find a Drug Identification Number at review.

Sport (WADA)
Not prohibited

Parathyroid hormone analogues are not on the Prohibited List.

Questions people actually ask

Abaloparatide or teriparatide?
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.
Why did the EMA first refuse it?
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.
Is it a steroid?
No. It is a peptide hormone analogue with no anabolic-steroid action; 'anabolic' here means bone-building.

One page per claimed effect

References

  1. 1
    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).JAMA, 2016;316:722–7332,463 women, 18 months; abaloparatide 80 µg vs placebo vs open-label teriparatide. Fracture percentages are in the paper's table, not the abstract.
  2. 2

Change log

  • 2026-09-23Initial publication. Grade A on ACTIVE.