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Abaloparatide (Tymlos)
Abaloparatide is teriparatide's approved, more receptor-selective cousin — a PTH-related-protein analog cleared by FDA in 2017 on the strength of a real, large, randomized fracture trial that also used open-label teriparatide as an active reference arm. It's a useful direct contrast for this site's teriparatide page: same anabolic bone-building idea, different receptor-selectivity profile, and a large fracture-reduction effect size in its own pivotal trial.
On this page
In brief
Should you care? Yes if you've read this site's teriparatide page — abaloparatide is the newer entrant in the same anabolic-bone-therapy category, tested alongside it (as an open-label reference arm) in its own pivotal trial.The short version
- FDA-approved April 28, 2017 (Tymlos) for postmenopausal women with osteoporosis at high fracture risk; later expanded to men.
- A real 2,463-patient randomized trial (ACTIVE), published in JAMA, found an 86% reduction in vertebral fracture risk and a 43% reduction in nonvertebral fracture risk versus placebo.
- Designed as a more receptor-selective PTHrP analog than teriparatide — a real mechanistic distinction, though the trial wasn't designed to prove a head-to-head superiority claim.
What it is, and its real 2017 approval
Abaloparatide is a synthetic 34-amino-acid analog of human parathyroid hormone-related protein (PTHrP), developed by Radius Health. It activates the same PTH type 1 receptor (PTH1R) as teriparatide but is engineered to favor a receptor conformation associated more with bone formation than resorption — a real, distinct pharmacological rationale. FDA approved it (as Tymlos) on April 28, 2017, for postmenopausal women with osteoporosis at high risk of fracture; approval for men followed later.
The ACTIVE trial
The pivotal ACTIVE trial (Miller et al., JAMA 2016;316(7):722-733, PMID 27533157) randomized 2,463 postmenopausal women with osteoporosis to abaloparatide 80mcg daily, placebo, or open-label teriparatide, for 18 months. Versus placebo, abaloparatide reduced new vertebral fracture risk by 86% and nonvertebral fracture risk by 43% — a real, large, statistically significant effect from a properly randomized, placebo-controlled trial.
How it compares to teriparatide
Teriparatide was included in ACTIVE as an open-label reference arm, not blinded and not statistically powered for a formal superiority or noninferiority claim against abaloparatide — worth being precise about, since descriptive comparisons between the two arms are sometimes cited as though the trial proved one drug beat the other. The ACTIVExtend extension study followed ACTIVE participants onto alendronate after abaloparatide, showing continued fracture-risk reduction — real, longer-term follow-up data.
An active comparator, not a formal head-to-head claim
ACTIVE is a real, placebo-controlled trial of abaloparatide. It is not a blinded, powered head-to-head trial against teriparatide, even though teriparatide appeared in the same study as an open-label arm.
What's still being asked
Direct, independent, blinded head-to-head trials between abaloparatide and teriparatide are limited; most comparisons draw on ACTIVE's open-label design or on separate trials run under different conditions. The honest read is that both are real, approved, effective anabolic agents with overlapping but not identical trial bases — not that one has been rigorously shown superior to the other.
References
- 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," JAMA 2016;316(7):722-733, PMID 27533157, DOI 10.1001/jama.2016.11136.
- FDA approval of Tymlos (abaloparatide), April 28, 2017.
- ACTIVExtend Phase 3 extension study (abaloparatide followed by alendronate), PMC6916366.