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.
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
| Outcome | Grade | Effect size | Human studies | Where the evidence comes from |
|---|---|---|---|---|
| Vertebral fracture risk (postmenopausal osteoporosis) | AEstablished | Large | 1 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 risk | AEstablished | Moderate | Same RCT | 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.1 |
| Hypercalcaemia (vs teriparatide)adverse | AEstablished | Small | Same RCT, prespecified safety endpoint | 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.1 |
| Bone mineral density | AEstablished | Large | Same RCT | Density rose at hip, femoral neck and spine against placebo (all P<0.001), with faster hip gains than teriparatide in the published comparison.1 |
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.
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
- Formula
- C174H300N56O49
- Molecular weight
- 3961 g/mol
- CAS number
- 247062-33-5
- PubChem
- CID 76943386
PubChem record, read 23 September 2026.
- 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
Eladynos, centrally authorised December 2022 after a 2018 refusal.
Tymlos, FDA-approved April 2017; men at high fracture risk added 2022.
Eladynos licensed by the MHRA.
LYO did not find an ARTG entry at review; prescription-only if and when registered.
LYO did not find a Drug Identification Number at review.
Parathyroid hormone analogues are not on the Prohibited List.
Questions people actually ask
Abaloparatide or teriparatide?
Why did the EMA first refuse it?
Is it a steroid?
One page per claimed effect
- ADoes Abaloparatide help with vertebral fracture risk?1 large RCT (n=2,463, 18 mo)
- ADoes Abaloparatide help with non-vertebral fracture risk?Same RCT
- AHow common is hypercalcaemia with Abaloparatide?Same RCT, prespecified safety endpoint
- ADoes Abaloparatide help with bone mineral density?Same RCT
References
- 1Miller 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
Change log
- 2026-09-23Initial publication. Grade A on ACTIVE.
